[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University College Dublin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":730},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,49,83,114,145,178,206,226,254,283,305,333,368,395,421,455,482,507,539,566,591,618,642,677,704],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100643668","eating-behaviour-before-during-and-after-obesity-medication-100643668",false,"NCT07636395","Eating Behaviour Before, During, and After Obesity Medication","Qualitative and Quantitative Measures of Eating Behaviours in Humans Taking Obesity Medications Before, During, and After.","Inclusion Criteria:\n\nSigned informed consent prior to any study-related procedure Age 16-80 years-old BMI range \\> 27 kg\u002Fm2 Receiving obesity medication as part of usual care.\n\nExclusion Criteria:\n\n* Substance abuse\n* Pregnancy\n* Regular use, for more than three times a week for the last 2 months and\u002For 7 days prior to inclusion, of medications which according to the principal investigator can interfere with the study.\n* After being included in the study, starting any medication or treatment that could potentially influence the study participation and\u002For study analysis.\n* Patients that have had bariatric surgery.","ALL","16 Years","80 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","This study will examine how eating behaviour changes during the first 18 months of treatment with obesity medications in patients attending the St Vincent's Healthcare Group obesity service. Obesity is increasingly understood as a chronic, relapsing, multifactorial disease that requires long-term management rather than short-term advice alone. Newer anti-obesity medications, particularly glucagon-like peptide-1 receptor agonists and related therapies, have improved weight-loss outcomes and altered the experience of hunger, fullness, food reward, and meal size for many patients. However, while weight reduction is well described in the literature, less is known about how patients themselves experience eating behaviour over time as treatment progresses from initiation to active weight loss and then towards weight maintenance. This study is designed to address that gap by exploring the lived experience of appetite and food-related behaviour across clinically meaningful stages of treatment. The study will use a longitudinal mixed-methods design. Thirty participants aged 16 to 80 years with a body mass index above 27 kg\u002Fm2 who are commencing weight-loss medication as part of routine care will be recruited. The sample size includes an allowance for a modest dropout rate over the study period. Participants will be followed at four time points: baseline, approximately 3 months after treatment initiation, around 12 months, and at 18 months, with a visit window of plus or minus 13 days. These time points were selected to reflect distinct phases of treatment. Baseline will capture pre-treatment or very early-treatment experience. Three months is expected to reflect a period of early therapeutic response, when medication effects on appetite may be most noticeable. Twelve months is likely to represent a later phase, when weight loss may be slowing and some patients may be approaching their lowest weight. Eighteen months is intended to capture maintenance or stabilisation, when behavioural changes may differ from those seen earlier in treatment. Data collection will include both questionnaires and semi-structured telephone interviews. The questionnaire component will measure key aspects of eating behaviour, including hunger, fullness, food thoughts, portion size, and palatability. Repeated administration at each study time point will allow changes in these behaviours to be tracked over time. The interview component will provide a richer understanding of how participants describe and interpret their experiences. All interviews will be conducted by one co-investigator using the same core interview guide to ensure consistency. Open-ended questions will allow participants to describe changes in appetite, eating patterns, cravings, meal satisfaction, food preferences, and daily routines in their own words, while additional probing may be used to clarify how these experiences evolve through treatment. Interviews are expected to last 15 to 45 minutes, will be audio-recorded with verbal confirmation, and transcribed for analysis. The central research question is how hunger, fullness, food thoughts, portion size, and food palatability change over time during treatment with obesity medications. The hypothesis is that appetitive and consummatory behaviours will decrease from baseline to an early low point, particularly around 3 months, and may then gradually rise again as treatment continues, before stabilising during a later maintenance phase. This pattern would reflect the possibility that the strongest appetite-suppressing effects occur early, followed by behavioural and physiological adaptation over time. At the same time, the study recognises that patients may not all follow the same course, and individual variation will be an important part of the analysis. Quantitative data will be used to describe behavioural trends across time points, while qualitative data will be analysed thematically to identify recurring experiences, challenges, and adaptations. Integrating these two forms of data will strengthen the study by linking measurable change with patient perspective. The study is expected to provide clinically useful insight into how anti-obesity medications influence the lived experience of eating, and how this may change between the active weight-loss phase and maintenance. By focusing on patient-reported hunger, satiety, food preoccupation, portion size, and palatability, the research may help clinicians better understand when patients need additional support, how expectations can be managed, and what aspects of treatment are most important for long-term success. The findings may also contribute to more personalised obesity care by highlighting the behavioural dimensions of treatment that are not captured by weight change alone.",[25,26],"Obesity Type 2 Diabetes Mellitus","Obesity & Overweight",[28,29,30,31,32,33,34,35],"Weight loss","medications","hunger","fullness","food thoughts","palatability","portion size","food noise","RECRUITING","2026-06-02",{"date":39,"type":40},"2026-06-09","ACTUAL",{"date":42,"type":21},"2026-05-25",{"date":44,"type":21},"2026-10-25",{"name":46,"class":47},"University College Dublin","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":48},"100635973","the-oat-trail-the-obesity-anti-coagulation-thromboprophylaxis-trial-100635973","NCT07559643","The OAT Trail: The Obesity Anti-Coagulation Thromboprophylaxis Trial.","A Prospective, Randomised Controlled Trial Comparing Weight-based Tinzaparin Versus Weight-based Enoxaparin for Peri-operative Thromboprophylaxis in Patients Undergoing Bariatric Surgery: Evaluation of Anti-Xa Levels and Clinical Outcomes.","The OAT-RCT","Inclusion Criteria:\n\n* Age ≥18 years\n* BMI ≥40 kg\u002Fm², or BMI ≥35 kg\u002Fm² with at least one obesity-related comorbidity (type 2 diabetes, hypertension, obstructive sleep apnoea, dyslipidaemia, or metabolic dysfunction-associated steatotic liver disease (MASLD))\n* Scheduled to undergo laparoscopic bariatric surgery (sleeve gastrectomy or gastric bypass) at St Vincent's University Hospital, Dublin, Ireland\n* Capacity to provide written informed consent\n\nExclusion Criteria:\n\n* Current therapeutic anticoagulation for any indication Known allergy or hypersensitivity to tinzaparin, enoxaparin, heparin, or any heparin-derived product, including documented heparin-induced thrombocytopaenia (HIT) Any other contraindication to LMWH therapy Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) Known haematological disorder or coagulopathy Pregnancy, breastfeeding, or planning pregnancy during the study period Active major bleeding or high bleeding risk at the discretion of the treating clinician Inability to provide written informed consent Participation in another interventional clinical study within 30 days prior to enrolment","18 Years",{"count":59,"type":21},180,"INTERVENTIONAL",[62],"NA","Blood clots in the legs or lungs (called venous thromboembolism or VTE) are one of the most serious complications after weight loss surgery. Most blood clots occur after patients go home from hospital, within the first 30 days after surgery. To prevent blood clots, all patients having weight loss surgery receive a daily blood-thinning injection for 21 days after their operation.\n\nTwo blood-thinning injections are currently used at St Vincent's University Hospital for this purpose: enoxaparin (Clexane®) and tinzaparin (Innohep®). Both belong to a group of medicines called low molecular weight heparins (LMWHs). Patients with obesity process these medicines differently to the general population, and previous studies from our hospital have shown that fewer than 53% of patients achieve adequate blood-thinning levels with either injection when measured by a blood test called an anti-Xa level.\n\nPatients will be randomly assigned (like a coin toss) to receive either tinzaparin or enoxaparin for 21 days after their surgery. Both injections are already in routine use at this hospital. A single extra blood sample will be taken on the second day after surgery to measure the anti-Xa level, which tells us whether the injection is providing adequate protection against blood clots. This blood sample will be taken at the same time as routine post-operative blood tests so that no additional blood draws are required.\n\nThe study will also look at rates of blood clots and bleeding events within 30 days of surgery, and will ask patients to complete a short questionnaire at their six-week follow-up appointment about their experience with the injection.",[65,66,67,26],"Bariatric Surgery","Anti-Xa Activity","VTE (Venous Thromboembolism)",[69,70,71,72,73],"Anti-Xa","Metabolic Bariatric Surgery","Obesity","VTE","DVT","NOT_YET_RECRUITING","2026-05-14",{"date":77,"type":40},"2026-05-18",{"date":79,"type":21},"2026-08-01",{"date":81,"type":21},"2026-12-01",{"name":46,"class":47},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":60,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":48},"100633271","neoshark-anatomical-versus-round-facemasks-for-breathing-support-in-preterm-and-term-newborn-infants-100633271","NCT07524517","NeoSHARK: Anatomical Versus Round Facemasks for Breathing Support in Preterm and Term Newborn Infants","NeoSHARK: Neonatal Study of Two-Handed Anatomical Versus Round facemasK Ventilation in Preterm and Term Infants; a Randomised Controlled Trial","NeoSHARK","Inclusion Criteria:\n\n* All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication, and who require mask ventilation prior to intubation attempt.\n\nExclusion Criteria:\n\n* Neonates with a congenital malformation that would impact mask seal will not be included.",{"count":92,"type":21},50,[62],"When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. There are various types of facemasks that can be used, including round and anatomical (triangular) masks, depending on the preference of the hospital, but it is unclear if one is better for the baby. Both types of facemasks are recommended in international guidelines, without any advice whether one is better than the other. Previous studies published by our research group demonstrated that a variety of different masks are used around the hospitals in Ireland. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that we are trying to give. We currently do not have enough evidence to say which type of mask is better to reduce the risk of this potential leaking of air.\n\nRecent studies have suggested that holding a mask with two hands (instead of one) is better in round facemasks. The combination of an anatomical mask and a two-handed hold has not yet been studied in babies.\n\nIn this study, we will compare two different facemasks (round and anatomical) when holding the mask on a baby's face with two hands to help them breathe. We will randomly allocate each baby to either a round mask or an anatomical (triangular) mask and we will measure how much air leaks out around the mask during each breath. We will do this in babies who are in the neonatal unit.",[96],"Neonatal Intensive Care",[98,99,100,101,102,103,104,105],"Neonatology","Facemask ventilation","Face mask ventilation","Anatomical face mask","Round face mask","Two-handed mask hold","Two-handed facemask ventilation","Neonatal mask shape comparison","2026-05-07",{"date":108,"type":40},"2026-05-12",{"date":110,"type":21},"2026-05",{"date":112,"type":21},"2027-02",{"name":46,"class":47},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":122,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":60,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":4},"100626772","phase-1-encapsulated-probiotics--gut-microbiota-100626772","NCT07439978","Encapsulated Probiotics & Gut Microbiota","A Physiological Study of a Fermented Yogurt Drink Containing Probiotics","Probiotics","Inclusion Criteria:\n\n* Capacity to obtain and sign informed consent before any study-related procedure\n* BMI range 18.5-31.9 kg\u002Fm2\n* Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages).\n* Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded:\n\n* Smoking\n* Substance abuse\n* Pregnancy\n* Diagnosis of type 1 and\u002For type 2 diabetes\n* Current (or within the last 4 weeks prior to study start) use of probiotic supplementation.\n* Immobile (defined as the inability to participate in all study-related procedures)\n* History of complicated gastrointestinal surgery\n* Diagnosed with inflammatory bowel disease (IBD)\n* Current diagnosis of psychiatric disease\u002Fs or syndromes\n* Current diagnosis of neurodegenerative disease\n* Systemic use of antibiotics and\u002For steroid medication in the last 4 months prior to inclusion\n* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months\n* Consumption of any NSAID within 7 days of study start\n* Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) or in any other way with the outcome of the study, as decided by the principal investigator's discretion\n* Regular smoking, use of snuff, nicotine, cannabidiol narcotics\u002Fsupplements, or e-cigarette use\n* Drinking more than 9 standard cups of alcohol per week and\u002For more than 3 standard cups of alcohol per occasion\n* Regular use, for more than three times a week for the last 2 months and\u002For 7 days prior to inclusion, of medications which, according to the principal investigator, can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)\n* After being included in the study, starting any medication or treatment that could potentially influence the study participation and\u002For study analysis.",true,"25 Years","65 Years",{"count":92,"type":21},[127],"PHASE1","The aim of this study is to determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function.\n\nTwenty-five participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the blood and faecal effects of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+\u002F13 days.\n\nThe current study will provide important information on the physiological function of probiotics in the small bowel. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.",[130,131],"Colonization, Asymptomatic","Colonisation",[133,134,135,136],"Probiotic","Microbiota","Colonization","Dairy","2026-05-05",{"date":139,"type":40},"2026-05-08",{"date":141,"type":21},"2026-04",{"date":143,"type":21},"2026-08",{"name":46,"class":47},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":60,"phases":156,"briefSummary":157,"conditions":158,"keywords":164,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},"100574304","a-stepped-wedge-cluster-randomised-trial-of-video-versus-direct-laryngoscopy-for-intubation-of-newborn-infants-100574304","NCT06757543","A Stepped Wedge Cluster Randomised Trial Of Video Versus Direct Laryngoscopy For Intubation Of Newborn Infants","NEU-VODE","Inclusion Criteria:\n\n* Infants of any gestational age in whom endotracheal intubation is attempted can be included in this study once there is parental consent to the use their infant's data.\n\nExclusion Criteria:\n\n* Infants will be excluded if parents do not consent for their infants' data to be used.","0 Minutes","1 Month",{"count":155,"type":21},840,[62],"Many newborn babies have difficulty breathing. When babies need a lot of help, a doctor will intubate them - i.e. put a tube into their windpipe (trachea) - so that they can be given support with a breathing machine. Intubation is a difficult procedure, during which many babies have falls in their blood oxygen levels and heart rate. When doctors intubate babies, they use a device called a laryngoscope to identify the entrance to the windpipe. A standard laryngoscope has a light at its tip. When doctors use this device, they insert it into the baby's mouth and then look directly into the mouth to find the entrance (direct laryngoscopy). Less than half of first attempts to insert a tube are successful using this device. More recently, video laryngoscopes have been developed. These devices also have a camera at the tip and display a magnified view of the entrance to the windpipe on a screen. A study at one hospital showed that the doctors there inserted the tube at the first attempt more often when they used a video laryngoscope instead of a standard laryngoscope. This study was not large enough to see whether fewer babies had low oxygen levels or heart rate during the procedure.\n\nThe goal of this clinical trial is to see whether more newborn babies are intubated at the first attempt without falls in their blood oxygen levels or heart rate when the doctors use video laryngoscopy compared to direct laryngoscopy.\n\nHospitals where doctors routinely intubate babies by looking directly into the mouth will take part in the NEU-VODE study. From the start of the study, the doctors at each hospital will continue with their usual approach to intubation and collect information about intubation attempts. As the study progresses, the doctors at each participating hospital will switch one--by-one to routinely attempting intubation with a video laryngoscope. The date on which they switch will be determined by chance. By the end of the study, each hospital will have had a study period where babies were routinely intubated using direct laryngoscopy and video laryngoscopy.\n\nAt the end of the study, the information collected from all the babies intubated during the study will be compared to see if more babies were successfully intubated at the first attempt without falls in their blood oxygen levels or heart rate in the video laryngoscopy group.",[159,160,161,162,163],"Intubation","Intubation Complications","Infant, Newborn","Infant Respiratory Distress Syndrome","Video Laryngoscopy",[165,166,167,168],"infant, newborn","video laryngoscopy","intubation","stepped wedge cluster randomised trial","2026-04-28",{"date":171,"type":40},"2026-05-04",{"date":173,"type":40},"2025-01-13",{"date":175,"type":21},"2026-08-31",{"name":46,"class":47},17,{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":60,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":48},"100375918","semaglutides-efficacy-in-achieving-weight-loss-for-those-with-hiv-100375918","NCT04174755","Semaglutide's Efficacy in Achieving Weight Loss for Those With HIV","SWIFT","Inclusion Criteria:\n\n* Be over 18 years old\n* Be HIV-1 antibody positive as determined by a positive 4th generation Ag\u002FAb ELISA assay\n* Be stable on ART with a viral load suppressed \\\u003C40 copies\u002FmL for a minimum of 2 years\n* Have a CD4 count ≥200 cells\u002Fmm3 for a minimum of 1 year\n* Have a BMI ≥30kg\u002Fm2 or have a BMI ≥27kg\u002Fm2 and hypertension, dyslipidaemia or type 2 diabetes mellitus\n* Understand the study procedures, be able to comply with the study procedures, and voluntarily agree to participate by giving written informed consent for the trial\n\nExclusion Criteria:\n\n* Subjects unable to comply with the study protocol or unable to self-administer subcutaneous semaglutide\n* History of obesity induced by other endocrine disorders: hypothyroidism, Cushing's syndrome, primary and secondary hypogonadism, hypothalamic disorders, polycystic ovary syndrome, insulinoma\n* History of obesity induced by use of anti-psychotic medications known to be associated with weight gain (i.e. olanzapine, clozapine).\n* Treatment with GLP-1 receptor agonists (including liraglutide, semaglutide or exenatide), dipeptidyl peptidase-4 (DPP-4) inhibitors or insulin within the last 3 months (including saxagliptin, linagliptin, sitagliptin)\n* History of severe renal impairment, as defined by a baseline creatinine clearance \\\u003C30ml\u002Fmin\n* Individuals with a diagnosis of HIV-associated lipoatrophy\u002Flipodystrophy, based on physician's assessment\n* Individuals with severe hepatic impairment (Child Pugh score \\>9)\n* Subjects with active hepatitis B infection (defined as hepatitis B sAg positive) or hepatitis C (defined as hepatitis C Ab and RNA positive) co-infection\n* Any active illness (including AIDS-defining illness) which in the opinion of the investigator precludes participation in the study\n* History of cancer (apart from treated Kaposi's Sarcoma) and\u002For receiving chemotherapy or radiotherapy\n* Active illicit intravenous drug use\n* Subjects concurrently enrolled in another clinical trial of an investigational medicinal product.\n* The investigator may decide that a subject cannot proceed in the study if there is any relevant other abnormal results in the screening assessments\n* Subjects with any known or suspected hypersensitivity to semaglutide or any of the excipients of semaglutide\n* Subjects on another medicinal product prescribed primarily for weight loss e.g. orlistat (see prohibited\u002Fcautioned concomitant medications\u002Ftherapies section)\n* For female subjects: pregnancy or breastfeeding at screening, planning future pregnancies or unwilling to take measures to avoid pregnancy for the duration of the study",{"count":186,"type":21},80,[62],"The prevalence of obesity is rising worldwide, both in low- and high-income countries, including people with HIV (PWH). Semaglutide's efficacy in achieving weight loss in obese PWH is still unexplored. The aim of this study is to assess the efficacy and safety of semaglutide in achieving greater weight loss compared to diet and excercise alone in obese PWH and to explore the effect of semaglutide on the immune function, markers of immune activation, viral reservoir, markers of glucose and lipid metabolism and gut microbiome.",[71,190],"HIV-1-infection",[192,193,194,195,196,197,198],"obesity","HIV","weight loss","GLP-1 analogue","immune activation","viral reservoir","gut microbiome",{"date":200,"type":40},"2026-04-29",{"date":202,"type":40},"2022-06-22",{"date":204,"type":21},"2027-07",{"name":46,"class":47},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":133,"eligibilityCriteria":212,"healthyVolunteers":122,"sex":16,"minAge":123,"maxAge":124,"enrollmentInfo":213,"targetDuration":4,"studyType":60,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100632176","phase-1-probiotic-delivered-to-the-small-intestine-changes-microbiota-100632176","NCT07510282","Probiotic Delivered to the Small Intestine Changes Microbiota","A Physiological Study on How Probiotic Delivered to the Small Intestine Changes Microbiota","Inclusion Criteria:\n\n* Capacity to obtain and sign informed consent before any study-related procedure\n* BMI range 18.5-31.9 kg\u002Fm2\n* Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages).\n* Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study.\n\nExclusion Criteria:\n\n* Smoking\n* Substance abuse\n* Pregnancy\n* Diagnosis of type 1 and\u002For type 2 diabetes\n* Current (or within the last 4 weeks prior to the study start) use of probiotic supplementation.\n* Immobile (defined as the inability to participate in all study-related procedures)\n* History of complicated gastrointestinal surgery\n* Diagnosed with inflammatory bowel disease (IBD)\n* Current diagnosis of psychiatric disease\u002Fs or syndromes\n* Current diagnosis of neurodegenerative disease\n* Systemic use of antibiotics and\u002For steroid medication in the last 4 months prior to inclusion\n* Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months\n* Consumption of any NSAID within 7 days of study start\n* Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, IBS, IBD) or in any other way with the outcome of the study, as decided by the principal investigator's discretion\n* Regular smoking, use of snuff, nicotine, cannabidiol narcotics\u002Fsupplements, or e-cigarette use\n* Drinking more than 9 standard cups of alcohol per week and\u002For more than 3 standard cups of alcohol per occasion\n* Regular use, for more than three times a week for the last 2 months and\u002For 7 days prior to inclusion, of medications which, according to the principal investigator, can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)\n* After being included in the study, starting any medication or treatment that could potentially influence the study participation and\u002For study analysis.",{"count":5,"type":21},[127],"This study will determine whether encapsulation of probiotic bacteria using natural plant protein can enhance bacterial colonisation. Lactobacillus rhamnosus is an ideal strain for the intervention, as it has been shown to affect overall gut health, gut-brain axis, and brain function. Participants aged 25 to 65 years will be recruited and assessed on four occasions to compare the effects of the blood chemicals and bacterial composition in faeces of a 28-day ingestion of a yoghurt beverage with and without the probiotic strain of interest. The study window will be 70+\u002F13 days. This study will provide important information regarding the physiological function of probiotics in the small intestine. Understanding the underlying physiological effects of targeted probiotic delivery to the intestine and the impact on the microbiome is important for health outcomes.",[130,135],[133,134,135,136],"2026-03-29",{"date":220,"type":40},"2026-04-03",{"date":222,"type":21},"2026-04-15",{"date":224,"type":21},"2026-12",{"name":46,"class":47},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":60,"phases":233,"briefSummary":234,"conditions":235,"keywords":242,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":48},"100626374","exploring-the-feasibility-of-using-virtual-reality-as-an-educational-tool-in-chronic-pain-rehabilitation-100626374","NCT07434804","Exploring the Feasibility of Using Virtual Reality as an Educational Tool in Chronic Pain Rehabilitation","Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosed with chronic pain by a consultant in pain medicine or a general practitioner with any type of chronic pain for at least 3 months\n* Report a pain intensity of \\>3 on a Numerical Rating Scale\n* Be proficient in written and spoken English\n\nExclusion Criteria:\n\n* Not able to provide informed consent\n* Scheduled for surgical treatment related to their pain condition within the next 6 months\n* Have a medical\u002Fpsychiatric condition that would prevent engagement in the pain education programme",{"count":92,"type":21},[62],"Introduction: Chronic pain significantly impacts quality of life and requires comprehensive management strategies. Traditional pain education programs are beneficial but often require significant and prolonged patient engagement. Virtual reality (VR) offers a novel approach by creating immersive environments that may enhance the effectiveness of pain education. This protocol outlines a feasibility study to investigate the use of a Virtual Reality (VR) pain education program for people living with chronic pain (PwCP).\n\nAim of the investigation: To evaluate the feasibility and acceptability of delivering a VR pain education program for PwCP. The secondary aim will explore the pre-to-post-test changes in clinical outcomes as proof of concept for a future larger scale investigation.\n\nMethods: We will use Reality Health™ as the VR tool to deliver pain science education. The study will be conducted as a single-arm feasibility study using a pretest:posttest design. Fifty PwCP will engage in the six-week Reality Health™ programme. This education programme focuses on the neurophysiology of pain, pain modulation techniques, cognitive-behavioural strategies and guided virtual exercises.\n\nResults: Primary outcome measures will include the feasibility, acceptability and safety of Reality Health™ including recruitment, retention, intervention adherence and attrition rates. Secondary outcomes will explore the pre-to-post-test changes in outcome measures relating to pain intensity, pain interference, pain self-efficacy, pain self catastrophizing, quality of life and depression as proof of concept for a future larger scale investigation.\n\nConclusions: Results will establish the feasibility, acceptability and safety of using Reality Health™ in the treatment of chronic pain, informing a future randomised control trial.\n\nEthical approval: Ethics has been granted from University College Dublin's Human Research Ethics Board (HREC-LS-25-868587).\n\nAcknowledgements: This work is funded through the Interreg north-west Europe project 'Scale-Up Rehab,'approved and funded by the European Commission \\[NWE0100082\\].\n\nDisclosures: None.\n\nKeywords: Virtual Reality, Chronic Pain, Pain Education, Feasibility Study, Protocol",[236,237,238,239,240,241],"Pain","Chronic Pain","Chronic Pain (Back \u002F Neck)","Adults","Virtual Reality","Neuroscience Pain Education",[243,244,245],"Physiotherapy","rehabilitation","Ireland","2026-02-19",{"date":248,"type":40},"2026-02-27",{"date":250,"type":21},"2026-02-20",{"date":252,"type":21},"2026-12-31",{"name":46,"class":47},{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":261,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":60,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":48},"100625022","the-impact-of-concurrent-training-on-women-experiencing-symptoms-of-menopause-100625022","NCT07417228","The Impact of Concurrent Training on Women Experiencing Symptoms of Menopause","Impact of Concurrent Training on Physical and Psychological Health in Women Experiencing Menopause","Inclusion Criteria:\n\n1. Women experiencing perimenopause (irregular menstrual cycles of ≥7-day difference in cycle length of consecutive menstrual cycles) and early postmenopause (\\\u003C 5 years post menopause).\n2. Able to safely engage in a concurrent training interventions that combine both aerobic and resistance training.\n3. Must have reliable internet access and a device capable of participating in online training on zoom.\n4. Willingness and ability to provide informed consent and comply with study procedures.\n5. Aged between 40 and 60 years\n\nExclusion Criteria:\n\n1. BMI \\>35 and \\\u003C18.5.\n2. Currently taking psychotropic medication\n3. Has undergone a hysterectomy\n4. Current substance abuse\n5. Current diagnosis of a mental health disorder\n6. Current diagnosis of a chronic illness\n7. Currently participating in other structured exercise programmes.\n8. Recent surgery or hospitalisation in the past 6 months.\n9. Currently taking hormonal contraceptive","FEMALE","40 Years","60 Years",{"count":265,"type":21},90,[62],"The aim of this study is to examine the impact of a concurrent training exercise intervention on menopausal symptoms and key physical and mental health outcomes. The proposed study is powered based on a primary outcome of examining the change in menopausal symptoms using the MenQoL questionnaire. Participants (n=70) will be randomised to an intervention or control group. The intervention group will participate in a 12 week online (via zoom) concurrent training programme, consisting of three forty-five minute sessions (on non-consecutive days) per week that align with WHO exercise recommendations for adults and the control group will maintain their regular activity. The exercise classes will be delivered by qualified Sport \\& Exercise Scientists and will consist of a combination of bodyweight and resistance band exercises. Each class will consist of a 5 minute warm up, 15 minutes of aerobic exercise, 20 minutes of resistance training, and a 5 minute cool-down. Both groups will engage in pre and post testing through questionnaires (GAD-7, Patient Health Questionnaire-9 (PHQ-9), Menopause-Specific Quality of Life Questionnaire (MENQOL), Body Appreciation (BAS-2)), Pittsburgh Sleep Quality Index Sleep, International physical activity questionnaire (IPAQ), Body image questionnaire (BAS-2) and physical tests (Bod pod, grip-strength, 3-RM leg press, 3-RM cable pull, counter-movement jump and Astrand Rhyming submaximal aerobic test).",[269],"Menopause Symptoms",[271,272,273,274],"Menopause","Perimenopause","Concurrent training","Exercise","2026-02-10",{"date":277,"type":40},"2026-02-18",{"date":279,"type":40},"2025-12-12",{"date":281,"type":21},"2027-12-15",{"name":46,"class":47},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":124,"enrollmentInfo":291,"targetDuration":4,"studyType":60,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":48},"100622658","strategic-timing-of-resistance-training-to-guard-against-antipsychotic-induced-metabolic-syndrome-100622658","NCT07386483","Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome","Strategic Timing of Resistance Training to Guard Against Antipsychotic-Induced Metabolic Syndrome (START GAAIMS): A Feasibility Study for a Prospective, Two-Arm, Randomised Controlled Trial to Evaluate the Effects of a Resistance Training Intervention on Body Composition and Metabolic Health in People With First-Episode Psychosis","START GAAIMS","Inclusion Criteria:\n\nTo be eligible for inclusion, a participant must meet the following criteria:\n\n1. Aged between 18 and 65 years.\n2. Has the capacity to provide written informed consent.\n3. Has a clinical diagnosis of a First-Episode Psychosis (affective or non-affective) made within the past three months.\n4. Has had a cumulative lifetime exposure to antipsychotic medication for less than four weeks at the time of enrolment.\n5. Be prescribed an antipsychotic medication at the time of enrolment.\n6. Every effort will be made to include the migrant population, who have double the risk of developing psychosis compared to the general population. An interpreter service will be used during the consent stage to ensure fully informed consent is established.\n\nExclusion Criteria\n\nA participant will be excluded from the study if they meet any of the following criteria:\n\n1a. A medical condition that, in the investigator's opinion, would prevent them from giving informed consent.\n\n1b. A medical condition that, in the investigator's opinion, would prevent them from safely participating in an exercise programme (e.g., severe, unstable cardiovascular disease, significant musculoskeletal injury).\n\n2\\. Pregnant women will not be included, as hormonal changes would increase the risk of musculoskeletal injury (due to relaxin increasing laxity in ligaments and joints), maternal and foetal cardiovascular strain during the Valsalva manouevre, and additional confounders (due to pregnancy's effects on metabolism, energy levels, and physical capacity). Pregnancy is also associated with changes in body composition which affect the measurement of the primary outcome.\n\n3\\. Currently participating in another clinical trial of an investigational medicinal product or device.",{"count":292,"type":21},40,[62],"This study is evaluating whether a supervised resistance training (strength training) programme is feasible to perform in a first-episode psychosis service. It is also evaluating if resistance training can prevent harmful weight gain and improve physical health in people who have recently been diagnosed with First-Episode Psychosis and are starting antipsychotic medication.\n\nAntipsychotic medications are essential for treating psychosis, but they frequently cause rapid weight gain and metabolic side effects (such as changes in blood sugar and cholesterol) within the first few months of treatment. Resistance training is a form of exercise that builds muscle and improves how the body uses energy. An excess of calories, which would otherwise lead to accumulation of fat (adipose tissue), can help build strength and increase muscle size when paired with resistance training.\n\nParticipants in this study will be randomly assigned to one of two groups:\n\nIntervention Group: Participants will receive their standard medical care plus a 12-week resistance training programme. This involves attending two 60-minute exercise sessions per week, supervised by a qualified instructor. The sessions will include exercises using resistance bands, machine weights, and free weights tailored to the individual's ability.\n\nControl Group: Participants will receive standard medical care only for the first 12 weeks.\n\nThe study uses a \"crossover\" design, which means that after the initial 12 weeks, the Control Group will be offered the same 12-week resistance training programme.\n\nThe main goals of this study are to determine if it is feasible to run this type of exercise programme for this group of patients and to measure the effects of the training on body fat levels, muscle strength, and overall physical and mental health",[296],"Psychosis","2026-02-04",{"date":299,"type":40},"2026-02-09",{"date":301,"type":21},"2026-02-01",{"date":303,"type":21},"2028-04-30",{"name":46,"class":47},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":122,"sex":16,"minAge":57,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":60,"phases":315,"briefSummary":316,"conditions":317,"keywords":321,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":332,"locationsCount":48},"100588271","supporting-university-students-transition-towards-sustainable-and-healthy-dietary-behaviours-a-living-lab-approach-100588271","NCT06939231","Supporting University Students Transition Towards Sustainable and Healthy Dietary Behaviours: A Living Lab Approach.","Supporting University Students' Transition Towards Sustainable and Healthy Dietary Behaviours: A Living Lab Approach.","Student participants:\n\nInclusion Criteria:\n\n* Be a UCD student (aged 18-30 years) attending Belfield Campus.\n* Be a healthy adult between the age of 18-30 years old, and in good general health.\n\nExclusion Criteria:\n\n* Do not attend UCD Belfield Campus.\n* Are under 18 years of age or over 30 years of age.\n* Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnoses include (but are not limited to) cardiovascular disease, diabetes mellitus, cancers (within the last 5 years), etc.\n\nStakeholder participants:\n\nInclusion Criteria:\n\n\\- Stakeholder on or connected to UCD Campus.","30 Years",{"count":314,"type":21},520,[62],"The aim of this study is to test the efficacy, feasibility, and acceptability of the UCD PLAN'EAT Living Lab in promoting sustainable and healthy dietary behaviours among university students. This study will compare within participant changes in diet-related pre-specified outcomes (detailed below) at Living Lab baseline and endpoint and examine differences across participant engagement levels (e.g., low engagement versus high engagement) in Living Lab studies and events\u002F activities.",[318,319,320],"Dietary Behaviours","Sustainable Healthy Diet","Personalised Nutrition",[322,323,324,325,326,327],"Sustainable diet","Personalised nutrition","Dietary behaviours","University","Students","Living Lab",{"date":299,"type":40},{"date":330,"type":40},"2024-02-26",{"date":252,"type":21},{"name":46,"class":47},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":122,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":343,"conditions":344,"keywords":349,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":48},"100623816","assessment-and-prediction-of-cardiovascular-health-and-disease-risk-using-wearable-biometrics-100623816","NCT07401550","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Wearable Biometrics.","Assessment and Prediction of Cardiovascular Health and Disease Risk Using Longitudinal Wearable Biometrics: a Prospective Cohort Study.","BEACON-HEART","Inclusion Criteria:\n\n* Adults aged 18 years, or older\n* Internet access\n* Possession of a smartphone compatible with the Fitbit mobile app\n\nExclusion Criteria:\n\n* Pregnancy\n* Unstable medical condition\n* Inability to provide informed consent\n* Mental or cognitive impairment precluding adherence to study protocol\n* Smartwatch cannot be worn, (e.g., allergic reactions), or cannot be worn in accordance with manufacturer guidelines (e.g., amputation, dark tattoos at wrist)",{"count":342,"type":21},100,"This prospective, observational cohort study will evaluate the associations between wearable-derived biometrics and cardiovascular health, quantified by the American Heart Association's Life's Essential 8 framework, as well as related cardiovascular risk factors. The study aims to determine whether wearable biometrics can support the assessment of cardiovascular health and cardiovascular disease risk, both when used in isolation and in combination with point-of-care assessments.",[345,346,347,348],"Cardiovascular Diseases (CVD)","Cardiovascular Disease Prevention","Cardiovascular Disease Risk Factor","Coronary Artery Disease (CAD)",[350,351,352,353,354,355,356,357,358,359,360,361],"wearables","wearable devices","cardiovascular health","cardiovascular disease","wearable technology","fitbit","fitabase","remote monitoring","cardiovascular disease prevention","cardiovascular risk reduction","digital biomarker","coronary artery disease","2026-02-03",{"date":275,"type":40},{"date":365,"type":40},"2025-12-09",{"date":224,"type":21},{"name":46,"class":47},{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":122,"sex":16,"minAge":57,"maxAge":263,"enrollmentInfo":374,"targetDuration":4,"studyType":60,"phases":376,"briefSummary":377,"conditions":378,"keywords":382,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":48},"100609082","inter--and-intraindividual-variability-of-the-acute-glucose-response-to-exercise-in-healthy-adults-and-people-living-with-type-1-diabetes-a-cross-over-replicate-trial-100609082","NCT07209930","Inter- and Intraindividual Variability of the Acute Glucose Response to Exercise in Healthy Adults and People Living With Type 1 Diabetes: A Cross-over Replicate Trial","Inclusion Criteria:\n\n(Healthy and T1D phases):\n\n* age between 18 and 60 years old;\n* being healthy individuals;\n* engagement in physical activity at least once a week; (T1D phase):\n* diagnosis of T1D for \\>18 months;\n* hypoglycaemia self awareness.\n\nExclusion Criteria:\n\n(Healthy and T1D phases)\n\n* presence of cardiovascular disease or contraindications to exercise;\n* infectious or inflammatory conditions;\n* chronic renal or liver disease;\n* pregnancy;\n* gestational diabetes;\n* diagnosed eating disorders;\n* any physical or mental condition preventing participation; (Healthy phase)\n* diabetes mellitus (type 1 or type 2); (T1D phase)\n* inability to self-manage diabetes.",{"count":375,"type":21},24,[62],"The goal of this clinical trial is to investigate if blood glucose responses are similar between and within individuals in response to standardized exercise in adults with and without Type 1 diabetes. The main questions it aims to answer are:\n\nWhat is the reproducibility of acute glycaemic responses to exercise within and between subjects in adults living with Type 1 Diabetes and in healthy adults? What is the agreement between glucose levels obtained by continuous glucose monitor (CGM) and blood glucose monitor?\n\nParticipants will cycle on a cycle ergometer or rest after consuming a standardized breakfast, while glucose levels are monitored by CGM and capillary blood sampling.",[274,379,380,381],"Healthy Participants","Glucose Variability","Type 1 Diabetes (T1D)",[383,384,385,386],"reproducibility","exercise","Type 1 diabetes","glucose","2025-09-29",{"date":389,"type":40},"2025-10-07",{"date":391,"type":40},"2025-01-28",{"date":393,"type":21},"2026-07-31",{"name":46,"class":47},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":261,"minAge":57,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":60,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":4},"100607489","implementation-and-evaluation-of-bump2baby-and-me-programme-for-gestational-diabetes-mellitus-in-routine-maternity-care-setting-100607489","NCT07189221","Implementation and Evaluation of Bump2Baby and Me+ Programme for Gestational Diabetes Mellitus in Routine Maternity Care Setting.","BUMP2BABY & ME+ (B2B&ME+): A Multi-Country, European Implementation Project to Reduce Adverse Birth Outcomes, Improve Maternal and Child Health and Reduce Non-Communicable Disease Risk","B2B&ME+","Inclusion Criteria:\n\n* Pregnant women attending their first\u002Fearly antenatal appointments at participating sites\n* Gestation less than 24 weeks at enrolment\n* Age 18 years or older\n* Ability to provide informed consent\n\nAdditional for the intervention group (Block B):\n\n* Identified as higher risk for GDM using the MMLGDST\n* Ownership of a smartphone compatible with the B2B\\&Me+ app\n\nExclusion Criteria:\n\n* 24 weeks gestation or higher\n* Multiple pregnancy (twins, triplets, etc.)\n\nAdditional for the intervention group (Block B):\n\n* Participation in another health behaviour change intervention study during pregnancy\n* Inability to understand the language of the intervention (English in Ireland, Spanish in Spain, Norwegian in Norway, Polish in Poland)\n* Severe mental illness, drug or alcohol abuse that would impair ability to participate\n* Cancer (not in remission)\n* Myocardial infarction in the last three months\n* Pre-existing diabetes (Type 1 or Type 2), or early GDM.\n* Not owning a smartphone capable of hosting the intervention app",{"count":404,"type":21},3600,[62],"Gestational diabetes mellitus (GDM) affects approximately 1 in 7 pregnancies globally and is associated with significant short and long-term health consequences for both mothers and infants. While lifestyle interventions during pregnancy can effectively reduce GDM risk and its complications, there is limited guidance on how to translate this evidence into routine antenatal and postpartum care. This project looks to address this gap by exploring the effectiveness of the B2B\\&Me+ programme within regular maternity services across four European countries and how best to implement it.\n\nWomen identified as being at higher risk of developing GDM using a GDM screening tool will receive access to the smartphone application that connects them with their health coach, who will provide personalised support about healthy eating, physical activity, mental wellbeing, and infant care from early pregnancy until 9 months after birth. The participants will be randomised initially to a specific referral pathway for the intervention.",[408],"Gestational Diabetes Mellitus (GDM)",[410,411,412],"Pregnancy","GDM","Lifestyle Intervention","2025-09-16",{"date":415,"type":40},"2025-09-23",{"date":417,"type":21},"2025-12-01",{"date":419,"type":21},"2028-05-31",{"name":46,"class":47},{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":122,"sex":16,"minAge":57,"maxAge":312,"enrollmentInfo":429,"targetDuration":4,"studyType":60,"phases":431,"briefSummary":432,"conditions":433,"keywords":438,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":48},"100593709","an-exploratory-feasibility-study-100593709","NCT07009964","An Exploratory Feasibility Study","AI-Enhanced Educational Intervention to Support Contextual Well-being in Young Adults (ContextWell)","Contextwell","Inclusion Criteria:\n\nPrimarily healthcare students, young adults enrolled in higher education (18-30 years old)\n\nAccess to a computer or mobile device with an internet connection;\n\nWillingness to participate in the educational webinar;\n\nWillingness to complete AI-driven assignments;\n\nAble to read and understand English.\n\nExclusion Criteria:\n\nAre under the age of 18, or above 30;\n\nInability to access a computer or mobile device with internet connection;\n\nInability to read or understand English;\n\nUnwillingness to participate in the webinar or complete assignments.",{"count":430,"type":21},12,[62],"This study explores the feasibility of ContextWell, a well-being education programme that combines an online webinar with an AI-powered behavioural nudging system. The programme aims to support university students, particularly those in healthcare disciplines, in enhancing well-being and adopting healthier lifestyle habits.\n\nThe primary objective is to determine whether the programme can be feasibly delivered within university settings. A secondary objective is to assess its potential to improve student well-being and encourage behavioural changes aligned with lifestyle medicine principles.\n\nThe intervention builds on the understanding that healthcare professionals' lifestyle habits and well-being have a direct impact on patient care. Focusing on healthcare students helps advance the integration of lifestyle medicine within health education and clinical practice.\n\nThis single-group feasibility study delivers the full intervention to all participants. Students participate in an online well-being webinar and receive AI-generated behavioural prompts designed to promote self-awareness and healthier daily choices.\n\nKey evaluation measures will indicated the feasibility of the programme among young adults in academic environments. Participant feedback and initial outcomes will support future development and inform larger-scale research.",[434,435,436,437],"Well-Being","Lifestyle, Healthy","Young Adult","Behavior and Behavior Mechanisms",[439,440,441,442,443,444,445,446,447],"Student well-being","Artificial Intelligence","Contextual Well-being","Contextual AI","Preventive health","Digital Health","Lifestyle medicine","Pilot study","Proof of concept","2025-06-18",{"date":450,"type":40},"2025-06-19",{"date":452,"type":21},"2025-11-01",{"date":301,"type":21},{"name":46,"class":47},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":462,"targetDuration":464,"studyType":22,"phases":4,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":48},"100588365","conduit-anterior-lumbar-interbody-fusion-alif-cage-system-in-lumbar-degenerative-disease-100588365","NCT06940453","CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System in Lumbar Degenerative Disease","Clinical\u002FRadiological Outcomes Associated With CONDUIT™ Anterior Lumbar Interbody Fusion (ALIF) Cage System With Supplemental Fixation for Treatment of Lumbar Degenerative Disc Disease at One or Two Contiguous Spinal Levels From L2-S1","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Consenting patients undergoing anterior lumbar interbody fusion (ALIF) procedure whom the Conduit cage system is appropriate will be included in this study.\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Non-surgical candidates, patients with contraindications to surgery (e.g. medical comorbidities, known infection, pregnancy etc.),\n* Patients with established osteoporosis\n* Long-term, systemic steroid use\n* Systemic diseases (e.g. rheumatoid arthritis, AIDS, HIV, etc.),\n* Patients unwilling or unable to give informed consent, or patients unwilling or unable to complete Health-related quality of (HRQOL) outcome life measures at the specified study time points pre- and post-operatively.\n* Subjects who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.",{"count":463,"type":21},35,"24 Months","This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. This study will follow patients undergoing anterior lumbar interbody fusion (ALIF) procedure. This trial seeks to evaluate the performance of this CE-marked device, and to assess outcomes in frail and non-frail patient cohorts. The CONDUIT™ ALIF Cage System are intervertebral body fusion devices intended for use for anterior lumbar interbody fusion in skeletally mature patients. The devices are 3D printed cellular titanium implants that feature 80% porous macro-, micro- and nanostructures, are designed to mimic cortical and cancellous bone, and facilitate fusion. This pilot study hypothesizes that the use of CONDUIT ALIF Cage system to treat lumbar degenerative disc disease will achieve results comparable to historical cases using SYNFIX Systems.",[467],"Lumbar Degenerative Disease",[469,470,471,472,473],"INTERBODY FUSION","SPINE SURGERY","LUMBAR DEGENERATION","SPINAL FUSION","SPINAL FIXATION","2025-04-15",{"date":476,"type":40},"2025-04-23",{"date":478,"type":40},"2024-06-28",{"date":480,"type":21},"2027-12-31",{"name":46,"class":47},{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":506,"locationsCount":4},"100573239","meta-trial---a-mixed-methods-process-evaluation-100573239","NCT06743698","META Trial - a Mixed Methods Process Evaluation","A Mixed Methods Process Evaluation of a Randomised Controlled Trial (META Trial) to Evaluate the Use of Metformin in HIV-Positive Persons With Pre-Diabetes","META","Inclusion Criteria:\n\n* Participants who participated in the META Trial\n* Participants who have the capacity to provide written informed consent",{"count":491,"type":21},60,"The aim of this study is to conduct a mixed methods process evaluation of the META trial. Semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.",[193,494],"Pre-diabetes",[496,497,498,499,193,494],"Qualitative Research","Process evaluation","Metformin","Africa","2025-04-08",{"date":502,"type":40},"2025-04-11",{"date":504,"type":21},"2025-06-01",{"date":112,"type":21},{"name":46,"class":47},{"id":508,"slug":509,"hasResults":11,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":60,"phases":518,"briefSummary":519,"conditions":520,"keywords":527,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":531,"lastUpdatePostDateStruct":532,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":48},"100585164","an-educational-intervention-to-improve-the-success-of-intubation-in-newborns-using-a-video-laryngoscope-by-reducing-the-time-the-procedure-takes-100585164","NCT06898801","An Educational Intervention to Improve the Success of Intubation in Newborns Using a Video Laryngoscope by Reducing the Time the Procedure Takes.","Neonatal INtubation After \"Just-in-time\" Audiovisual Training: a Randomised Controlled Trial","NINJA","Inclusion Criteria:\n\nNeonates of any age or gestation who require endotracheal intubation in the Neonatal Intensive Care Unit in the National Maternity Hospital during the study period.\n\nExclusion Criteria:\n\n* Neonates with an upper airway malformation.\n* If it is deemed by the treating clinical team that the clinical scenario does not allow time for the intervention e.g. cardiac arrest","1 Year",{"count":517,"type":21},140,[62],"This research focuses on one of the most common problems in newborn medicine: breathing difficulties. Breathing problems are the most common reason for admission to our neonatal unit at the National Maternity Hospital. When a baby has serious breathing difficulty, inserting a breathing tube to place them on a ventilator can be lifesaving. A breathing tube must be placed through the vocal cords into the windpipe (trachea). A device called a laryngoscope is placed in a patients mouth to allow the doctor to see the vocal cords and insert the tube correctly.\n\nThe skill of placing this breathing tube (intubation) is important for doctors and specialists to learn so that they can confidently perform it in an emergency.\n\nIn the past, doctors had more opportunities during their training to learn and practice this with supervision from seniors. In recent years, babies, thankfully, need to be intubated less frequently and doctors working hours are better regulated. As a result, junior doctors have less chances to perform this skill. There is a need to improve how we teach the procedure of intubating babies to doctors in training to meet the needs of trainees today.\n\nThe investigators want to perform a study to help teach doctors in training how to perform intubation of a newborn using a video laryngoscope. The team are looking to assess if showing a short educational video to the doctor and team just before performing an intubation using a video laryngoscope will reduce the time the procedure takes. This is called a \"Just-in-Time\" video. The investigators aim to demonstrate a benefit by performing a randomised control trial. This means that when a baby requires intubation as decided by their treating doctors, the team will be randomly allocated to view a \"Just-in-Time\" video before performing the intubation or not. The investigators will then compare the two groups to see if there is a difference in the total time the procedure takes.",[521,522,523,524,525,526],"Respiratory Distress Syndrome, Newborn","Endotracheal Intubation","Neonatal Intubation Performance","Prematurity","Neonate","Education, Medical",[528,529,530],"Just-in-Time","Neonatal intubation","Teaching","2025-03-20",{"date":533,"type":40},"2025-03-27",{"date":535,"type":21},"2025-03",{"date":537,"type":21},"2027-05",{"name":46,"class":47},{"id":540,"slug":541,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":11,"sex":16,"minAge":152,"maxAge":546,"enrollmentInfo":547,"targetDuration":549,"studyType":22,"phases":4,"briefSummary":550,"conditions":551,"keywords":555,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100574377","a-prospective-observational-study-of-video-laryngoscopy-versus-direct-laryngoscopy-for-insertion-of-a-thin-endotracheal-catheter-for-surfactant-administration-in-newborn-infants-100574377","NCT06758492","A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants","NEU-VODEtec","Inclusion Criteria:\n\n* newborn infants of any sex who are are having a thin catheter inserted into their trachea for the purpose of surfactant administration\n\nExclusion Criteria:\n\n* no parental consent provided to share their data","28 Days",{"count":548,"type":21},600,"600 Days","Many premature babies have breathing difficulty after birth and receive help with a breathing machine (nasal continuous positive airway pressure, NCPAP). Some of the babies whose breathing gets worse despite NCPAP are treated with surfactant, a medication that is given directly into their windpipe (trachea). Some of the babies who are given surfactant get it through a ventilation tube (endotracheal tube, ETT), while others get it through a thin catheter that is too small for ventilation. When doctors insert a tube or a thin catheter into the windpipe of a baby, they use an instrument called a laryngoscope, which has a light at its tip, to identify the entrance. Most often doctors look directly into the baby's mouth with a standard laryngoscope to identify the entrance to the windpipe. However, newer video laryngoscopes have a camera along with the light at their tip, which displays a picture of the entrance to the windpipe on a screen. In a study performed at one hospital, doctors inserted an ETT first time more often when they used a video laryngoscope.\n\nThe investigators are doing a study at many hospitals where doctors usually use a standard laryngoscope to insert tubes and thin catheters into a baby's trachea by looking directly into the mouth. Each hospital will switch one-by-one to using a video laryngoscope when inserting a tube. The investigators will compare the information we collect to see if more babies who have a tube inserted first time without falls in their oxygen levels or heart rate with a video laryngoscope. The investigators will also collect information on babies who have a thin catheter inserted to compare whether doctors use fewer attempts when they use a video laryngoscope.",[552,553,163,554],"Respiratory Distress Syndrome (Neonatal)","Respiratory Distress Syndrome (RDS)","Surfactant",[165,556,557,166],"respiratory distress syndrome","surfactant","2025-02-18",{"date":560,"type":40},"2025-02-20",{"date":173,"type":40},{"date":563,"type":21},"2025-12-31",{"name":46,"class":47},16,{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":573,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":574,"conditions":575,"keywords":578,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":48},"100578866","symphony-oct-system-for-instabilities-of-the-upper-thoracic-and-cervical-spine-100578866","NCT06816862","SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine","Clinical\u002FRadiologic Outcomes Associated With the SYMPHONY™ OCT System for Treatment of Acute and Chronic Instabilities of the Craniocervical Junction, the Cervical Spine and the Upper Thoracic Spine","Inclusion Criteria:\n\n* Consenting patients presenting for the treatment of acute and chronic instabilities of the craniocervical junction, the cervical and upper thoracic spine for whom the SYMPHONY OCT System is a suitable choice will be included in this study.\n* Patients undergoing surgical treatment for upper cervical spine traumatic spinal fractures and\u002For traumatic dislocations, failed previous fusions (pseudarthrosis) and tumours involving the cervical\u002Fthoracic spine will be included in this study.\n\nExclusion Criteria:\n\n* Non-surgical candidates, patients with contraindications to surgery (e.g. severe medical comorbidities, known infection, etc.),\n* Patients with established osteoporosis\n* Long-term, systemic steroid use\n* Systemic diseases (e.g. rheumatoid arthritis, AIDS, HIV, etc.),\n* Patients unwilling or unable to give informed consent, or patients unwilling or unable to complete Health-related quality of (HRQOL) outcome life measures at the specified study time points pre- and post-operatively.\n* Subjects who have a history of drug or alcohol use that, in the opinion of the investigator would interfere with adherence to study requirements.",{"count":463,"type":21},"This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. Consecutive patients undergoing posterior-only surgery or combined anterior and posterior surgery for degenerative cervical pathology, traumatic spinal fractures or dislocations, failed previous fusions or treatment for tumour involving the cervical\u002Fthoracic spine will be enrolled. This is a post-market trial, with a CE-marked medical device called the SYMPHONY OCT System which is currently in use in both centres. The SYMPHONY™ OCT System is a portfolio of internal fixation tools including screw, rods and hooks used as an adjunct to fusion for posterior stabilisation of the upper spine in skeletally mature patients. This pilot study hypothesizes that the use of SYMPHONY™ OCT System to treat upper spine instabilities will achieve results comparable to historical cases using the Mountaineer performed until 2021.",[576,577],"Cervical Instabilities Spine","Spine; Instability",[579,580,581,582],"Spine Fusion","Spine Fixation","Spine Surgery","Cervical Instabilities","2025-02-04",{"date":585,"type":40},"2025-02-10",{"date":587,"type":40},"2024-12-01",{"date":589,"type":21},"2026-06-30",{"name":46,"class":47},{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":60,"phases":601,"briefSummary":602,"conditions":603,"keywords":605,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":615,"leadSponsor":617,"locationsCount":4},"100574910","optimising-general-practice-long-covid-care---an-educational-intervention-100574910","NCT06765421","Optimising General Practice Long COVID Care - an Educational Intervention.","Optimising General Practice Long COVID Care - Feasibility Trial of a Pilot Educational Intervention.","GP-COV-ED","Inclusion Criteria:\n\n1. Age: Aged 18 years or older at the time of enrolment.\n2. Registration: Are registered as patients at the study's participating practices.\n3. COVID-19 Diagnosis:\n\n   * Previously received a positive COVID-19 PCR or antigen test, or\n   * Previously been clinically diagnosed with COVID-19 by a healthcare provider.\n4. Persistent Symptoms:\n\n   o Have spoken with their general practitioner (GP) about experiencing persistent symptoms lasting four weeks or more since their COVID-19 diagnosis.\n5. Consent: Willing and able to provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n1\\. Vulnerability: Deemed by participating GPs to be a vulnerable individual whose best interests are served by not participating in the study, such as (but not limited to):\n\n* People with language difficulties that prevent meaningful communication.\n* Individuals with a recognised or diagnosed intellectual, physical, or mental impairment.\n* Older adults considered particularly vulnerable.\n* Individuals residing in institutions (e.g., care homes or prisons).\n* Individuals with an unequal relationship with the researcher(s) (e.g., hierarchical dependence).\n* Members of marginalised or disadvantaged groups for whom participation may present undue burden or risk.",{"count":600,"type":21},72,[62],"This trial will evaluate the feasibility of a pilot educational intervention for GPs that aims to enhance care and care outcomes among patients with long COVID at six general practices in the Ireland East region.\n\nOur first objective is to conduct focus groups with key stakeholders (GPs, other health professionals, patients, families\u002Fcarers) that will inform the contents of an education intervention. The second objective will be to implement this educational intervention, and the third objective will be to determine whether the intervention is feasible.\n\nStudy outcomes will include:\n\n* Qualitative findings from co-design focus groups and post-intervention semi-structured interviews with GPs.\n* Practice and patient study recruitment and retention data.\n* GP \u002F Practice characteristics: age \\& gender, practice location, general and COVID-19 patient population figures.\n* Patient characteristics: Patient age, gender, COVID-19 vaccination status, and medical history details.\n* Patient scores on a self-report measure assessing the symptoms, symptom severity, functional impact, and overall health (COVID-19 Yorkshire Rehabilitation Scale (C-19-YRS)).",[604],"Long COVID",[606,607,608,609,610],"Feasibility Studies","General Practice","long COVID","Pilot Study","Medical Education","2025-01-02",{"date":613,"type":40},"2025-01-09",{"date":535,"type":21},{"date":616,"type":21},"2025-04",{"name":46,"class":47},{"id":619,"slug":620,"hasResults":11,"nctId":621,"briefTitle":622,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":60,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":48},"100558932","prophylactic-surfactant-by-thin-endotracheal-catheter-for-preterm-infants-at-birth-the-protect-trial-100558932","NCT06557551","Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial","proTeCt","Inclusion criteria\n\n* Infants of any sex born before 28 weeks of gestation\n* Clinicians plan to provide intensive care\n* Consent for their participation provided by parent(s)\u002Fguardian(s) before their birth\n\nExclusion criteria\n\n• Major congenital anomalies (e.g. upper airway anomaly, diaphragmatic hernia, gastroschisis, exomphalos major, intestinal atresias, open neural tube defect, aneuploidy, cardiac lesions other than ASD\u002FPFO\u002FVSD\u002FPDA )","30 Minutes",{"count":627,"type":21},164,[62],"The goal of this clinical trial is to learn whether giving surfactant through a thin endotracheal catheter to extremely premature babies shortly after birth reduces the number of them who are ventilated in the first 3 days of life.\n\nThe main question it aims to answer is:\n\nDo fewer babies who receive prophylactic thin catheter surfactant under video laryngoscopy shortly after birth go on to be ventilated within 72 hours of birth?\n\nExtremely premature babies who are receiving breathing support through a face mask will either:\n\n* Receive surfactant through a thin catheter that is inserted into their windpipe (trachea) under video laryngoscopy at or after 5 minutes of life, have the catheter removed immediately, and return to face mask breathing support; or\n* Continue on face mask breathing support.\n\nAll babies will be closely watched to see whether they are ventilated for breathing support in the first 72 hours of life.",[631,524,632,633],"Infant, Newborn, Diseases","Prematurity; Extreme","Respiratory Distress Syndrome in Premature Infant","2024-10-08",{"date":636,"type":40},"2024-10-15",{"date":638,"type":40},"2024-08-19",{"date":640,"type":21},"2027-02-28",{"name":46,"class":47},{"id":643,"slug":644,"hasResults":11,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":648,"eligibilityCriteria":649,"healthyVolunteers":11,"sex":16,"minAge":262,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":60,"phases":652,"briefSummary":654,"conditions":655,"keywords":658,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":48},"100412187","phase-2-european-blood-pressure-intensive-control-after-stroke-100412187","NCT04647292","European Blood Pressure Intensive Control After Stroke","European Blood Pressure Intensive Control After Stroke - Pilot Trial","EPICS-Pilot","Inclusion Criteria:\n\n1. Age ≥40\n2. Ischaemic stroke1, high-risk TIA, proven by imaging (brain CT\u002FMRI)\n3. Living at home and independent (walking without the aid of another person, but may have some help for daily activities)\n4. SBP≥140mmHg at entry (average of 2 measures, seated, in the same arm, after resting alone in office for 10 minutes)\n5. Qualifying event between 30 days and 1 year of randomisation\n6. Glomerular filtration rate (eGFR) greater than or equal to 50ml\u002Fmin\u002Fm2 (within 3 months of randomisation)\n7. Medically-stable and capable of participating in a randomised trial, including home BP measures, in the opinion of the study physician\n8. Willing to provide informed consent (no surrogate consent will apply)\n\nExclusion Criteria:\n\n1. SBP \\\u003C110mmHg after 3 minutes of standing or other contra-indication to intensive SBP lowering in opinion of treating clinician (eg. Orthostatic symptoms, syncope or pre syncope, recurrent falls)\n2. Qualifying stroke due to intracerebral haemorrhage (ICH), cardio-embolism or other defined causes (eg. dissection, endocarditis, other specified)\n3. Severe stenosis or occlusion of large cranio-cervical artery (\\>70% stenosis\u002Focclusion of cervical carotid, vertebral, or Circle of Willis artery)\n4. Unlikely to comply with study procedures due to severe or fatal comorbid illness (eg. dementia, active malignancy, severe frailty) or other factor (eg. inability to travel)\n5. Pregnancy or breastfeeding",{"count":651,"type":21},142,[653],"PHASE2","Stroke is the third most common cause of death worldwide and the leading cause of disability. High blood pressure is an important risk factor for stroke. Lowering a person's blood pressure reduces the risk of future stroke or heart attack, and current guidelines recommend treatment to a target of \\\u003C130mmHg for secondary prevention.\n\nHome blood pressure measurement and telemonitoring are acceptable to patients, but there is uncertainty over the use of out of office blood pressure measurements in stroke patients in guidelines.\n\nThis is a study designed to establish the feasibility of a larger clinical trial, comparing home blood pressure monitoring, telemonitoring and medication titration with standard care. The study hypothesis is that home BP measurement and telemonitoring with medication titration may lead to improved BP control compared to standard of care clinical practice.",[656,657],"Ischemic Stroke","Transient Ischemic Attack",[659,660,661,662,663,664,665,666,667,668],"ischemic stroke","transient ischemic attack","blood pressure","hypertension","recurrence","prognosis","prevention","randomized control trial","myocardial infarction","vascular events","2024-07-09",{"date":671,"type":40},"2024-07-11",{"date":673,"type":40},"2024-05-02",{"date":675,"type":21},"2026-03",{"name":46,"class":47},{"id":678,"slug":679,"hasResults":11,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":683,"eligibilityCriteria":684,"healthyVolunteers":122,"sex":261,"minAge":57,"maxAge":685,"enrollmentInfo":686,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":688,"conditions":689,"keywords":693,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":703},"100538912","the-impact-of-e-cigarettes-during-pregnancy-on-childhood-health-outcomes-study-100538912","NCT06297005","The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes Study","The Impact of E-cigarettes During Pregnancy on Childhood Health Outcomes (ECHO) Study.","ECHO","Inclusion Criteria:\n\n* Women aged 18 or greater and less than 46 years of age at booking\n* Pregnant with a singleton fetus\n* Smokers (exhaled CO reading of greater than or equal to 4) or\n* Self-reported vaper or\n* Dual user (smoker\u002Fvaper)\n* Non-smokers\n* Able to understand and read English.\n* Willing to agree to follow-up for the two-year duration of the study in the postnatal period (ie. unlikely to move out of the catchment area).\n\nExclusion Criteria:\n\n* Women pregnant with twins or higher order multiples\n* Late bookers - defined as booking after 24+0 weeks' gestational age\n* Fetus or infant diagnosed with a major congenital abnormality (major structural abnormality, ie congenital diaphragmatic hernia (CDH), omphalocele, major cardiac defects ie. which require immediate admission to NICU +\u002F- transfer to cardiology for surgery, chromosomal abnormalities, syndromes - Turner's\u002FNoonan's) or a lethal fetal anomaly\n* Any inherited disorder of metabolism or Cystic Fibrosis on Guthrie Card\u002F neonatal blood spot screening\n* History of significant medical disorder in pregnancy e.g. cardiac, haematological, or endocrine disease (including gestational diabetes requiring insulin)\n* Significant maternal psychiatric disorder, e.g. delusional or psychotic disorders, severe depression requiring hospitalisation, use of \\>1 psychotropic drugs for treatment\n* Serious co-morbid addiction issues e.g. opiate abuse, methadone maintenance program\n* Severe intellectual disability or lack of capacity","46 Years",{"count":687,"type":21},1200,"Tobacco smoking in pregnancy is now widely accepted as having adverse health outcomes for both the mother and fetus. Tobacco smoking in pregnancy is associated with increased incidence of miscarriage, stillbirth and preterm birth as well as low birthweight, respiratory infections, wheeze and asthma in childhood. E-cigarettes are a popular method for trying to quit smoking in Ireland and there has been an explosion in the use of e-cigarettes over the past ten years. However, there is currently insufficient evidence on their long-term safety and effectiveness as a smoking cessation tool. E-cigarettes contain varying combinations of compounds and flavours which are used differently in different e-cigarette types, with unknown long-term effects. Research has shown that pregnant women perceive e-cigarettes to be a healthier option when compared with tobacco smoking. But, there is very little known about the long-term health impact of exposure of unborn babies to e-cigarettes during pregnancy.\n\nThe ECHO study will determine what the long-term health outcomes are in children born to mothers who use e-cigarettes during pregnancy. Specifically, we will focus on birth, nutritional, brain development and respiratory outcomes in children. To answer this research question, the ECHO study will recruit infants born to women who use e-cigarettes during pregnancy across three maternity hospitals and follow them up over 2 years. We will invite women at their booking visit to take part in this research study. We plan to also recruit a similar number of both non-smoking and tobacco smoking pregnant women for comparison. We will record a detailed record of e-cigarette and tobacco use by women during pregnancy as well as checking smoking using special monitoring tools. After the baby is born, we will perform growth measurements, neurocognitive assessments and a respiratory questionnaire at 6 months, one year and two years of age.",[690,691,692],"Vaping","Pregnancy Related","Pediatric Respiratory Diseases",[690,410,694],"Paediatric health","2024-04-11",{"date":697,"type":40},"2024-04-12",{"date":699,"type":40},"2023-10-09",{"date":701,"type":21},"2027-08-31",{"name":46,"class":47},3,{"id":705,"slug":706,"hasResults":11,"nctId":707,"briefTitle":708,"officialTitle":709,"acronym":710,"eligibilityCriteria":711,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":712,"enrollmentInfo":713,"targetDuration":4,"studyType":60,"phases":715,"briefSummary":716,"conditions":717,"keywords":720,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":725,"completionDateStruct":727,"leadSponsor":729,"locationsCount":48},"100523435","study-comparing-platelet-transfusion-volumes-in-premature-babies-100523435","NCT06095648","Study Comparing Platelet Transfusion Volumes in Premature Babies","Platelets for Neonatal Transfusion - 3: (PlaNeT-3) a Randomised Controlled Trial of Platelet Transfusion Volumes in Babies Born at Less Than or Equal to 32+0 Weeks Gestation or Less Than 1500g","PlaNeT-3","Inclusion Criteria:\n\n* Infants born at or before 32+0 weeks' gestation or less than 1500g at birth\n* Written informed consent obtained from parent\n* Admission to a participating NICU (includes postnatal transfers)\n* Severe Thrombocytopenia (platelet count \\\u003C25 x109\u002FL)\n* Cranial ultrasound scan undertaken less than 24 hours prior to randomisation shows no recent major intraventricular haemorrhage (IVH) or significant extension of previous haemorrhage.\n\nExclusion Criteria:\n\n* Major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA\u002FASD\u002FVSD), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g., T21, T13, T18, Fanconi's anaemia, Thrombo-cytopenia Absent Radius syndrome).\n* Infants on a palliative care pathway\n* Neonates within 72 hours of major bleed\n* All fetal intracranial haemorrhages excluding subependymal haemorrhage from any antenatal ultrasound scan.\n* Known immune thrombocytopenia or family history of allo-immune thrombocytopenia or maternal anti platelet antibodies or maternal idiopathic thrombocytopenic purpura\n* Neonates who did not receive parenteral vitamin K","32 Weeks",{"count":714,"type":21},370,[62],"Platelet transfusions can help clotting but may also have risks. Currently when babies get platelet transfusions they get as much as three times (per kilogram of body weight) as much as adults do. The goal of this clinical trial is to to find out which volume of platelets should be transfused to premature babies with low platelets and no bleeding. The main question it aims to answer is if a smaller volume for platelet transfusion can help prevent death and severe bleeding and also have fewer side effects for the baby.\n\nParticipants will be placed at random into one of two groups: In Group 1, babies will get a platelet transfusion based on the volume of 5mls\u002Fkg weight, in Group 2, babies will get a platelet transfusion based on the volume of 15mls\u002Fkg weight. Babies will remain in their allocated group during their stay on the neonatal unit so that they always receive the allocated volume unless a clinician decides otherwise.",[718,719],"Thrombocytopenia","Transfusion",[721],"Neonatal Platelet Transfusion","2023-10-18",{"date":724,"type":40},"2023-10-23",{"date":726,"type":21},"2023-10-28",{"date":728,"type":21},"2028-08",{"name":46,"class":47},""]