[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Ghent\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":651},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,60,0,25,[9,49,74,96,131,153,186,215,251,279,304,326,351,375,399,423,450,477,499,522,541,557,591,611,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100645093","the-muscle-monitor-early-skeletal-muscle-indicators-of-insulin-resistance-and-cardiometabolic-risk-100645093",false,"NCT07678736","The Muscle Monitor: Early Skeletal Muscle Indicators of Insulin Resistance and Cardiometabolic Risk","The Muscle Phenotype and Cardiometabolic Health Monitoring Project","MUSCLE MONITOR","Inclusion Criteria:\n\n* Sex: Males and females\n* Age: 20-30 years\n* BMI \\\u003C35\n* Healthy (no diagnosed chronic disease)\n\nExclusion Criteria:\n\n* Chronic disease deemed to affect study outcomes\n* Disease that increase haemorrhage risk\n* Daily intake of medication that could confound study outcomes\n* Regular smokers\n* Active pregnancy\n* Immobilization (inactivity due to injury or illness, e.g. cast or brace) for more than a week in the month prior to the study or for more than 4 weeks in the past 6 months prior to the study\n* Very high structured physical exercise level (\\>10 h\u002Fweek).\n* Participants not willing to adhere to standardized meal prescriptions included in the study protocols will also be excluded (due to e.g. allergies or specific dietary preferences)","ALL","20 Years","30 Years",{"count":22,"type":23},250,"ESTIMATED","OBSERVATIONAL","Insulin resistance is an early etiological factor in the development of type-2 diabetes (T2D), which constitutes a large societal health burden with an expected additional rise in the years to come.\n\nSkeletal muscle is the body's largest lean tissue mass and the major site of glucose disposal in response to insulin stimulation. Prior studies have suggested that a fast skeletal muscle phenotype, including a predominant fast muscle fiber composition, reduced capillary density, low fat oxidation and muscle oxidative capacity may be implicated in insulin resistance and TD2 development. However, key questions pertain in relation to the cause and effect of these relationships as well as the interaction with potential confounders and effect-modifiers including life-style factors (e.g. diet and physical activity levels) and general participant characteristics (e.g. body composition and training status).\n\nIn the present project, we therefore aim to derive muscle fiber type and extensively map the proteomic signature of the early stages of insulin resistance in a large cross-sectional study using a young and apparently healthy cohort prior to T2D development, including a thorough participant characterization. We will recruit \\~250 participants (men and women) in the age of 20-30 years and conduct extensive phenotyping and tissue sampling across one laboratory-based test day and a scan visit, as well as measurements of physical activity level and glucose handling in free-living conditions with wearable sensors.\n\nThe study has a longitudinal aspect as participants will be re-invited at 5-year intervals for up to 20 years to delineate the trajectory of metabolic health in relation to muscle phenotype measures.\n\nThe results of the project are expected to lead to significant advancements in our understanding of the importance of muscle phenotype for early-stage insulin resistance and metabolic health trajectories. Such understanding has potentially important clinical implications, as it can open new avenues for targeted interventions and individualized early preventive strategies to counter or delay the progression of insulin resistance and associated metabolic and cardiovascular disorders.",[27,28,29,30,31],"Insulin Resistance","Insulin Resistance and Type 2 Diabetes","Cardiometabolic Risk Factors","Physical Activity","Muscle Fiber Type",[33,34,35],"Insulin sensitivity","Skeletal muscle","Physical activity","RECRUITING","2026-06-24",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":40},"2025-05-19",{"date":44,"type":23},"2046-12-31",{"name":46,"class":47},"University Ghent","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":48},"100642300","user-evaluation-think-life-100642300","NCT07654127","User Evaluation Think Life","Evaluation of User Experiences With the Online Self-help Course Think Life","Inclusion Criteria:\n\n* age: 18 years or older\n* user of the online self-help course Think Life\n\nExclusion Criteria:\n\n* not meeting the inclusion criteria",true,"18 Years",{"count":59,"type":23},1000,"This study aims to evaluate user experiences with the online self-help course Think Life, a suicide prevention intervention for individuals experiencing suicidal thoughts. Think Life was developed by the Flemish Centre of Expertise in Suicide Prevention (VLESP) and is freely available via Zelfmoord1813.be. The course was originally developed in 2014 and updated in 2025 to improve its look and feel, usability, and inclusiveness, without fundamental changes to its core content.\n\nThe researchers seek to better understand how users experience the updated version of Think Life, including perceived strengths, usability, and overall satisfaction with the course.\n\nUsers of the Think Life self-help course will be invited through a call displayed on the course homepage to voluntarily participate in an online user evaluation study. Interested individuals can access an online informed consent form via a public internet link hosted on REDCap. Participants who provide online informed consent and meet the inclusion criteria will automatically be redirected to the online questionnaire, which is also hosted on REDCap.\n\nApproximately 1000 participants aged 18 years or older can be included in this study. Participants are invited to complete a one-time online questionnaire with an estimated completion time of approximately 10 minutes.",[62,63,64],"Suicidal Ideation","Suicide Prevention","mHealth Intervention","NOT_YET_RECRUITING","2026-06-11",{"date":68,"type":40},"2026-06-17",{"date":70,"type":23},"2026-06-01",{"date":72,"type":23},"2031-06-01",{"name":46,"class":47},{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":48},"100640369","needs-assessment-regarding-mental-well-being-enhancing-programs-for-soon-to-be-and-recently-retired-individuals-100640369","NCT07630285","Needs Assessment Regarding \"Mental Well-being-enhancing\" Programs for Soon-to-be and (Recently) Retired Individuals","Inclusion Criteria:\n\n* Aged 18 years or older\n* Being within a period ranging from two years prior to retirement up to five years after retirement\n* Having access to the internet\n* Having sufficient proficiency in the Dutch language\n\nExclusion Criteria:\n\n* Not meeting the inclusion criteria",{"count":81,"type":23},500,"This study aims to improve understanding of the needs and well-being of individuals during the transition to retirement. The researchers seek to explore which activities and forms of support are perceived as helpful, which are already known or used, and which needs may currently remain unmet.\n\nFor the purpose of this study, \"nearly or recently retired individuals\" refers to people who are expected to retire within the next two years or who have retired within the past five years.\n\nBy examining participants' experiences and perceived needs during this transition period, the researchers aim to identify both existing strengths and potential gaps in the support currently available. Participants are invited to complete an online one-time questionnaire (10-15 minutes). The questionnaire includes questions about experiences related to the transition to retirement, awareness and use of activities or support initiatives, perceived strengths and limitations of these initiatives, and factors that may facilitate or hinder participation. The findings of this study may contribute to the development of recommendations to strengthen the support and resources available for (nearly) retired individuals in Flanders (Belgium).",[84],"Retirement",[86,87,88],"needs assessment","retirement","well-being",{"date":90,"type":40},"2026-06-05",{"date":92,"type":23},"2026-05-26",{"date":94,"type":23},"2026-12-15",{"name":46,"class":47},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":130,"locationsCount":48},"100636175","using-woundpilot-to-support-wound-care-decisions-in-patients-with-chronic-wounds-100636175","NCT07562269","Using WoundPilot to Support Wound Care Decisions in Patients With Chronic Wounds","Evaluation of the Effect of WoundPilot on the Accuracy and Consistency of Clinical Decision-Making in Chronic Wound Care: A Randomized Parallel Vignette Study Among Primary Care Nurses","Inclusion Criteria:\n\n* Primary care nurses involved in wound care decision-making\n* Nurses working in home care or nursing home settings\n* Nurses who assess and\u002For adapt wound management in clinical practice\n* Nurses with a qualification corresponding to European Qualification Framework (EQF) level 5 or 6\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Nurses not involved in wound care decision-making\n* Nurses not working in a primary care setting\n* Inability to understand the study procedures or complete the assessment tasks\n* Refusal or inability to provide informed consent",{"count":104,"type":23},40,"INTERVENTIONAL",[107],"NA","This study evaluates whether a digital decision support tool, called WoundPilot, can help primary care nurses make more accurate and consistent decisions when caring for patients with chronic wounds.\n\nIn daily practice, treatment decisions for chronic wounds can vary between clinicians, even when they assess the same patient. This variation may lead to delays in appropriate care, inconsistent treatment choices, or unnecessary referrals. WoundPilot was developed to guide clinicians through a structured wound assessment and link this assessment to clear treatment recommendations.\n\nIn this study, primary care nurses will assess a series of clinical cases either with or without the support of WoundPilot. Their decisions will be compared with an expert reference standard to determine whether the use of WoundPilot improves the accuracy of decisions and reduces differences between nurses.\n\nThe results of this study will help determine whether WoundPilot can support more consistent and evidence-based wound care in clinical practice.",[110,111,112],"Wound Complication","Wound Care","Wound and Injuries",[114,115,116,117,118,119,120,121,122,123],"chronic wound","wound care","clinical decision-making","decision support system","WoundPilot","Primary Care Nursing","Wound Assessment","decision-making","clinical reasoning","hard-to-heal wound","2026-04-24",{"date":126,"type":40},"2026-05-01",{"date":70,"type":23},{"date":129,"type":23},"2026-09",{"name":46,"class":47},{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":48},"100635633","intraoral-scan-and-cbct-aided-diagnosis-of-dental-plaque-and-caries-100635633","NCT07555223","Intraoral Scan and CBCT-Aided Diagnosis of Dental Plaque and Caries","Intra Oral Scan and CBCT Aided Diagnosis of Dental Plaque and Caries","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Not pregnant and not planning pregnant\n* At least 20 teeth present\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Conditions that prevent proper intraoral examination (e.g., severe gag reflex, limited mouth opening)\n* patient unable to provide informed consent","70 Years",{"count":140,"type":23},50,"This prospective clinical study aims to evaluate the diagnostic accuracy of intraoral scans (IOS) for the detection of dental plaque and caries. The diagnostic performance of IOS will be compared with current clinical reference standards. For plaque assessment, IOS-based evaluation will be compared with plaque detection using disclosing agents. For caries detection, IOS (including white-light imaging and caries detection features) will be compared with conventional visual inspection and bitewing radiography. Adult patients aged 18 to 70 years will be included.",[143,144],"Dental Plaque","Dental Caries","2026-04-21",{"date":147,"type":40},"2026-04-29",{"date":149,"type":40},"2025-04-03",{"date":151,"type":23},"2027-07",{"name":46,"class":47},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":105,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100546828","dual-tasking-effect-on-gait-in-children-with-developmental-coordination-disorder-100546828","NCT06400043","Dual-tasking Effect on Gait in Children With Developmental Coordination Disorder","The Influence of an Interceptive Task on Gait in Children With Developmental Coordination Disorder Compared to Typically Developing Children","Inclusion Criteria:\n\n* They have an official DCD diagnosis;\n* Are aged between 7 and 17 years old;\n* Can walk at least 15 minutes consecutively;\n* Have good or corrected vision.\n\nExclusion Criteria:\n\n* They suffer from a neurological disorder;\n* Take medications that affect gait and balance;\n* Have undergone surgical procedures on the lower limbs in the past;\n* Experience pain in their lower limbs or back at the time of testing.","7 Years","17 Years",{"count":163,"type":23},23,[107],"The aim of the study is to collect data in children with developmental coordination disorder (DCD) aged between 7 and 17 years for analyses of the gait pattern while walking at the Gait Real-time Analysis Interactive Lab (GRAIL) at the university hospital of Ghent.\n\nChildren with DCD will be asked to take a motor test (M-ABC-2) as well as walk on the treadmill during a single session of approximately 3 hours.\n\nThe following data will be collected on the GRAIL while subjects walk at different gait speeds: 3D kinematics, kinetics, and EMG.\n\nAdditionally, 3D kinematics, kinetics, and EMG data will be collected when performing either a cognitive (Stroop Color and Word Test) or motor (requiring arm swing) dual-task while walking at comfortable walking speed..",[167],"Gait",[169,170,171,172,173,174,175,176],"Gait analysis","Dual-tasking","EMG","Kinematics","Kinetics","Selective motor control","Developmental Coordination Disorder","DCD","2026-03-19",{"date":179,"type":40},"2026-03-20",{"date":181,"type":40},"2024-07-12",{"date":183,"type":23},"2026-08-31",{"name":46,"class":47},2,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":105,"phases":196,"briefSummary":197,"conditions":198,"keywords":202,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":48},"100619333","pilot-study-on-follow-up-of-acutely-suicidal-individuals-from-the-flemish-suicide-helpline-100619333","NCT07343258","Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline","Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline, Zelfmoordlijn 1813, to Promote Continuity of Care","CONT-1813","1. Callers\n\n   Inclusion criteria:\n   * The caller is 18 years or older.\n   * The caller speaks Dutch.\n   * The caller calls the Zelfmoordlijn 1813 for themselves due to suicidal ideation.\n   * The caller must benefit from callback conversations fitting one of the three callback profiles.\n   * The caller is not a frequent caller to the Zelfmoordlijn 1813.\n   * The caller can be called back directly on a personal device.\n   * The caller is legally competent, meaning they can oversee the potential consequences of participation, such as time investment and availability.\n   * At the time of recruitment, the caller is not receiving support within a care trajectory where attention is paid to their suicidality. Or the care provider is not available quickly enough (e.g., due to maternity leave) if the caller falls within the callback profile focusing on a safety conversation.\n\n   Exclusion criteria:\n   * The caller is younger than 18 years.\n   * The caller does not speak Dutch.\n   * The caller does not call the Zelfmoordlijn 1813 for themselves.\n   * The caller is a frequent caller to the Zelfmoordlijn 1813.\n   * The call responder assesses that urgent medical help is necessary.\n   * The caller expresses a homocide threat during the original conversation to the Zelfmoordlijn 1813.\n   * The caller cannot be called back on a personal device (e.g., persons in detention).\n   * The caller is not legally competent to oversee the consequences of participation (e.g., under the influence of alcohol and\u002For drugs).\n   * At the time of recruitment, the caller is receiving support within a care trajectory where attention is paid to their suicidality.\n2. Call responders The CPZ chooses to recruit call responders who have extensive experience in answering calls at the Zelfmoordlijn 1813. Therefore, not all call responders of the Zelfmoordlijn 1813 are trained to recruit callers.\n3. Callback callers The staff members of the CPZ who are involved in developing and implementing the callback methodology will also participate in the research by means of an interview.",{"count":195,"type":23},98,[107],"This pilot study aims to assess the acceptance, feasibility, and added value of follow-up calls at the suicide helpline, Zelfmoordlijn 1813, in Flanders (Belgium). It serves as a crucial preparatory step in the development and implementation process of the callback methodology at Zelfmoordlijn 1813.",[199,200,201],"Suicide","Suicidal Ideation and Behavior","Crisis Intervention",[203,204,205,206],"suicidal ideation","suicide-related coping","suicidal behavior","crisis line","2026-02-16",{"date":209,"type":40},"2026-02-19",{"date":211,"type":40},"2026-01-05",{"date":213,"type":23},"2026-09-30",{"name":46,"class":47},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":105,"phases":225,"briefSummary":226,"conditions":227,"keywords":233,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":4},"100623547","general-practitioner--pharmacist-support-for-discontinuing-long-term-antidepressants-in-clinically-stable-patients-100623547","NCT07398053","General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients","General Practitioner & Pharmacist Support for Discontinuing Long-term Antidepressants in Clinically Stable Patients: a Cluster Randomised Pragmatic Trial in Primary Care","GPS-AD","Inclusion Criteria:\n\nPatients will be eligible for inclusion in the study if they meet all of the following criteria:\n\n* Are 18 years or older and capable of providing informed consent.\n* Have their Global Medical File (GMD) managed by one of the participating GPs.\n* Have been prescribed AD (any type) by their GP for the treatment of depression, with:\n\n  * at least 6 months of continuous daily use following a first depressive episode, or\n  * at least 2 years of continuous daily use in the context of a relapsed depression\u002Frecurrent episode\n* Are judged by their GP as no longer meeting the criteria for a current depressive disorder.\n\nExclusion Criteria:\n\nPatients will be excluded from participation in the study if they meet any of the following criteria:\n\n* AD discontinuation is considered contra-indicated by the treating GP.\n* The patient is judged by the GP to be at high risk of relapse. This includes any of the following:\n\n  * Current significant depressive symptoms, defined as a score of ≥12 on the PHQ-9\n  * Current significant anxiety symptoms, defined as a score of ≥10 on the Generalised Anxiety Disorder-7 (GAD-7) scale.\n  * Current suicidal ideation, defined as a score \\>0 on item 9 (suicidality) of the PHQ-9.\n  * The patient is currently receiving only psychiatric treatment (out- or inpatient) for depression\n\nIn addition to the criteria increasing the risk of relapse, the following will also be an exclusion criteria:\n\n* The patient has a current psychiatric comorbidity (e.g. bipolar disorder, psychosis, substance use)\n* The patient has a diagnosis of dementia or significant cognitive impairment (assessed by GP judgement) or is living in a nursing home.\n* The AD is prescribed for a primary indication other than depression, such as anxiety alone without comorbid depressive disorder, or chronic pain.\n* The patient has insufficient language proficiency in Dutch or French to participate in the study procedures (e.g. providing consent, completion of questionnaires, interviews).\n* use of trazodon as AD as this is mainly used for sleep problems",{"count":224,"type":23},324,[107],"In Belgium, many adults who have suffered from depression keep using antidepressants on a daily basis for years afterwards, sometimes longer than guidelines recommend. Yet for some people who have been feeling well for a long time, this is no longer necessary, while the continued use of antidepressants can lead to side effects and causes additional costs for the healthcare system.\n\nHowever, reducing the doses of antidepressants or stopping altogether is not always easy. Some patients are afraid that their depression will return, and GPs and pharmacists often find the subject difficult to broach.\n\nThis is why the GPS-AD study is investigating a new approach in which GPs and pharmacists work more closely together to provide better support to patients. First, the GP invites patients who have been taking antidepressants for a long time for a consultation. Together, they discuss whether tapering of the medication is reasonable and feasible. If they agree to stop the treatment, the GP draws up a tapering plan tailored to the patient. The pharmacist helps monitor this process, offering advice and support to the patient while the doses are gradually reduced.\n\nThe study will extend over a period of two years and will take place in GP practices throughout Belgium. The new approach based on closer collaboration between GPs and pharmacists will be compared to the current standard of care, to determine whether it helps more long-term users to stop taking antidepressants without experiencing a recurrence of depressive symptoms.\n\nThe name of the study, GPS-AD (General Practitioner and Pharmacist Support for Antidepressant Discontinuation), refers to the collaboration between GPs and pharmacists in tapering of antidepressants, and also symbolises the support and guidance (the 'GPS') provided to patients and healthcare providers in assessing whether long-term use of antidepressants is still necessary.",[228,229,230,231,232],"Deprescribing","Antidepressant","Depression Disorder","Discontinuation","Primary Care",[234,235,236,237,238,239,240,241,242],"deprescribing","discontinuation","tapering","depression","antidepressants","long-term use","chronic use","medication review","primary care","2026-02-02",{"date":245,"type":40},"2026-02-09",{"date":247,"type":23},"2026-03-01",{"date":249,"type":23},"2028-05-31",{"name":46,"class":47},{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":259,"enrollmentInfo":260,"targetDuration":4,"studyType":105,"phases":261,"briefSummary":263,"conditions":264,"keywords":269,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":48},"100580070","phase-4-investigating-gender-and-sex-differences-in-immune-responses-through-vaccination-of-transgender-and-cisgender-persons-100580070","NCT06832514","Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons","An Investigator-initiated, Single-center Academic Study in Healthy Transgender and Cisgender Persons Aged Between 18 and 50 Years to Investigate Gender and Sex Differences in Immune Responses to Meningococcal Serogroup B Vaccination","Vaxxygender","Inclusion Criteria:\n\n1. Written signed informed consent form (ICF) obtained before any study-related activities.\n2. Participants aged between, and including, 18 and 50 years of age at the time of signing the ICF which equals with the time of the first study intervention.\n3. Participants who are considered to be in good general health as determined by the investigator by medical evaluation including medical history andphysical examination at enrollment.\n4. Participants with a BMI within the range 18.5 to 35 kg\u002Fm2 inclusive at screening.\n5. POCBP (18-50 years of age) who are not pregnant or breastfeeding or planning to become pregnant during the clinical study.\n6. Transgender persons need to be under stable gender-affirming hormone therapy (GAHT) for at least 6 months. Compliance needs to be documented by hormonal lab tests.\n7. POCBP must have a negative urine pregnancy test at each vaccination visit (Visit 1 and Visit 5) Refer to Section 8.6.5 for Pregnancy Testing.\n8. Participants who are willing and able to comply with the study procedures and are capable to comply with the requirements of the protocol (e.g. return for follow-up visits) as determined by the investigator.\n\nExclusion Criteria:\n\n1. Current or previous, confirmed or suspected disease caused by N. meningitidis and N. gonnorrhoea.\n2. Household contact with and\u002For intimate exposure (e.g. sexual or saliva contact) to an individual with laboratory confirmed N. meningitidis infection during life.\n3. Transgender persons in a diagnostic phase (no hormonal intervention) or undergoing treatment based on the suppression of endogenic hormones (e.g. gonadotropin releasing hormone analogues).\n4. Current or previous infection with hepatitis B, hepatitis C or human immunodeficiency virus (HIV) as determined by anamnesis and medical history.\n5. Past or current confirmed or suspected immune-suppressive or immune-deficient condition, at the discretion of the investigator, including but not limited to blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders, lupus erythematosus and associated conditions or disorders (e.g. rheumatoid arthritis, scleroderma) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).\n6. History of confirmed hypersensitivity, anaphylaxis and\u002For other severe allergic reactions (e.g., generalized urticaria, angioedema, bronchospasm) to any component of the study vaccine or excipients (sodium chloride, histidine, sucrose, kanamycin and water for injection), medical products, or medical equipment whose use is foreseen in this study, as determined by the investigator.\n7. Clinical conditions representing a contraindication for IM administration and blood draws, as judged by the investigator, e.g. thrombocytopenia or history of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties.\n8. History of asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.\n9. Active malignancy or malignancy within the past 5 years that, in the opinion of the investigator, may affect immune response or participant safety - except for localized and fully treated cancers not requiring long-term therapy such as chemotherapy or radiotherapy (e.g. completely resected basal cell carcinoma, cervical intraepithelial neoplasia, melanoma in situ, early-stage thyroid cancer), based on the investigator's clinical judgement.\n10. History of idiopathic urticaria within the past year.\n11. Currently pregnant, breast-feeding or planning to become pregnant. Cisgender women with permanent infertility due to an alternate medical cause (e.g. documented bilateral oophorectomy, androgen insensitivity, gonadal dysgenesis) are excluded to participate. For individuals with permanent infertility due to an alternate medical cause other than the above, investigator discretion should be applied to determining study entry. Additionally, cisgender women in a postmenopausal state, defined as no menses for 12 months without an alternative medical cause are also excluded to participate. Refer to\n12. Any other clinical condition that, in the opinion of the investigator, could compromise the participant's safety and\u002For compliance with the study protocol (e.g. current or recent (\\\u003C 1 years ago) heavy smoking (\\> 20 cigarettes per day) or daily heavy vaping (equivalent to 20 cigarettes), drug- or alcohol (\\> 15 units for cisgender men and transgender women or \\> 10 units or cisgender women and transgender men per week) abuse\u002Faddiction.\n13. Behavioral or cognitive impairment, unstable psychiatric conditions (e.g. forced admission, suicidal thoughts in the last two year) or other psychiatric disease that, in the opinion of the investigator, may interfere with study compliance, as well as with the subject's ability and\u002For safety to participate in the study. Stable psychiatric conditions (e.g. under-controlled depression) will be evaluated based on the investigators judgement.\n14. Donation of blood or blood products within 90 days prior to the first vaccination visit (Visit 1) until Day 56 (Visit 9).\n15. Previous vaccination against any group B meningococcal vaccine (Bexsero®, Trumenba®) at any time prior to informed consent.\n16. Prior receipt of a live-attenuated vaccine in the 28 days prior to administration of the 4CMenB vaccine, within 14 days for subunit or inactivated vaccines or planning to receive a vaccine in between the first and second vaccine administration, as well as 28 days following administration of the second 4CMenB vaccine dose.\n17. Currently participating in another clinical study, or planning to participate in another study during the study period, or administration of any investigational drug or medical device in the 28 days prior to study vaccination.\n18. Prior receipt of blood, blood-derived products or immunoglobulins in the 6 months prior to administration of the study vaccine, or planning to receive such product during the study period.\n19. Chronic administration (defined as 14 consecutive days in total) of immunosuppressants (e.g. corticosteroids (PO\u002FIV\u002FIM) or other immune-modifying drugs (e.g. antineoplastic agents, radiotherapy) during the period starting 90 days prior to vaccination or planned administration during the study (excluding topical, inhaled and intranasal preparations and intra-articular injections). For corticosteroids, this will mean prednisone ≥ 20 mg\u002Fday, or equivalent.\n20. POCBP (cisgender women and transgender men) who use the following contraceptive methods will not be included in the study\n\n    * Oral, injectable, intravaginal (i.e. intravaginal ring) or transdermal combined (oestrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation.\n    * Oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.\n21. Current anti-tuberculosis prophylaxis or therapy.\n\n25\\. Participants with a history of any medical conditions that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the participants when participating in the study.","50 Years",{"count":22,"type":23},[262],"PHASE4","Sexual differences are a well-established source of biological variation in immune system functioning, with men often displaying lower adaptive immune responses (e.g. antibody production) to infections and vaccinations compared to women. The impact of sex and gender on immune responses and immune functioning warrants more in-depth investigation. This study is an investigator-initiated project aimed at prospectively assessing the immune response towards a vaccine in transgender and cisgender individuals. Transgender individuals retain their chromosomal sex while undergoing a significant hormonal shift that aligns with their experienced gender. Immune responses induced by the four-component meningococcal serogroup B (4CMenB; Bexsero®) vaccine will be evaluated in transgender individuals and compared with responses observed in cisgender individuals. Both humoral and cellular immune responses induced by two doses of the 4CMenB vaccine will be quantified and analysed. This approach is expected to provide new insights into the effects of gender and sex differences on innate and adaptive immune responses.",[265,266,267,268],"Meningococcal Meningitis, Serogroup B","Transgender Persons","Sex Differences in Immune Response","Vaccination",[270],"Gender","2026-01-15",{"date":273,"type":40},"2026-01-20",{"date":275,"type":40},"2025-01-31",{"date":277,"type":23},"2026-12-31",{"name":46,"class":47},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":105,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":48},"100579145","comparison-of-three-transmucosal-augmentation-techniques-in-immediate-implant-placement-100579145","NCT06820489","Comparison of Three Transmucosal Augmentation Techniques in Immediate Implant Placement","A Three-arm Randomized Controlled Trial Comparing Transmucosal Augmentation Techniques in Immediate Implant Placement","Inclusion Criteria:\n\n* At least 20 years old\n* Good oral hygiene defined as full-mouth plaque score ≤ 25%\n* Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present\n* At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability\n* Intact buccal bone wall (type I) or limited buccal bone dehiscence (type IIa or IIb) at the time of extraction\n* Written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy\n* Systemic diseases\n* Smoking; suppuration\n* \\> 1 mm gingival asymmetry between the failing and contralateral tooth\n* Untreated periodontal disease\n* Untreated caries lesions.",{"count":287,"type":23},54,[107],"Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage. 54 patients will be randomly assigned to either conventional connective tissue graft (C-CTG), scarf tissue graft (S-CTG) or dual zonde conept (DZ). Sealed envelopes are prepared for that purpose, of which 18 are internally labeled as C-CTG, 18 as S-CTG and 18 as DZ. Following IIP, a sealed envelope will be opened to reveal the treatment concept.\n\nSuccessful regeneration (primary outcome) is achieved when the combination of socket grafting and transmucosal augmentation (C-CTG or S-CTG or DZ) would be able to counteract any buccal soft tissue loss at level -1 mm. It is assessed on the basis of superimposed CBCTs taken pre-operatively and at one-year follow-up. Secondary outcomes include: horizontal buccal bone loss, vertical buccal bone loss, increase in buccal soft tissue thickness, patient-reported outcomes, plaque, bleeding on probing, probing depth, marginal bone loss, change in buccal soft tissue profile, midfacial soft tissue level, mesial and distal papilla level, Pink Esthetic Score.",[291],"Bone Resorption",[293,294,295],"Dental Implant, Single-Tooth","Immediate","Connective tissue graft","2026-01-07",{"date":298,"type":40},"2026-01-09",{"date":300,"type":40},"2025-04-01",{"date":302,"type":23},"2031-11-01",{"name":46,"class":47},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":48},"100428072","introduction-of-an-operating-room-black-box-to-identify-analyse-and-prevent-errors-in-the-vascular-hybrid-room-100428072","NCT04854278","Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room","Development of Strategies to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room - an Inter-professional Approach to Enhance Technical and Non-technical Performance and to Improve Patient Safety","Inclusion Criteria:\n\n* Patients undergoing elective (planned more than 48 hours) endovascular procedures.\n* Symptomatic aortic-iliac-femoral-popliteal-below the knee atherosclerotic stenotic or occlusive disease (PVI)\n* Endovascular exclusion of thoracic aortic, infrarenal abdominal aortic and\u002For iliac aneurysm repair (EVAR)\n\nExclusion Criteria:\n\n* No consent of patient\n* No consent of all endovascular team members\n* Emergency procedure (planned \\\u003C 48h before)\n* Endovascular procedure not treating atherosclerotic aortic-iliac-femoral-popliteal-below the knee disease or aortic-iliac aneurysm",{"count":312,"type":23},400,"The \"OR Black box\", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures.\n\nSecondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery.\n\nThis novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level.\n\nHypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.",[315,316,317],"Patient Safety","Endovascular Procedures","Quality Improvement","2025-12-15",{"date":320,"type":40},"2025-12-22",{"date":322,"type":40},"2019-02-19",{"date":324,"type":23},"2027-12-31",{"name":46,"class":47},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":350,"locationsCount":48},"100612886","co-creation-of-tools-for-people-in-detention-with-suicidal-thoughts-andor-behavior-100612886","NCT07259408","Co-creation of Tools for People in Detention With Suicidal Thoughts and\u002For Behavior","For professionals working in detention:\n\nInclusion criteria:\n\n* Aged 18 years or older\n* Currently working in a professional care role within a prison setting (e.g., psychologist, psychiatirst, social worker, nurse, etc.)\n* Experience in supporting or treating incarcerated individuals with suicidal thoughts or behaviours\n\nExclusion Criteria:\n\n* Under the age of 18\n* Not employed in a professional caregiving role within detention (e.g., correctional officers or security staff)\n\nFor people in detention:\n\nInclusion criteria:\n\n* Aged 18 years or older\n* Experienced suicidal thoughts within the past three years\n\nExclusion criteria:\n\n* Under the age of 18\n* Significant cognitive limitations that would make the participation in an interview infeasible\n* Insufficient command of the Dutch language to understand and respond to interview questions",{"count":104,"type":23},"People in detention are at significantly higher risk of suicide compared to the general population. In Belgian prisons, the suicide rate is five times higher than average. Despite the availability of suicide prevention tools, many are not scientifically validated or adapted to the detention context, leading to inconsistent use and missed warning signs.\n\nThis study aims to evaluate and adapt three evidence-based suicide prevention tools-the Safety Plan, the guideline for the care and evaluation of suicidality , and the Risk Formulation template-for use in detention settings. Through interviews with both professionals working in prisons and individuals in detention, the study explores how these tools can be made more relevant, practical, and effective in this unique environment.\n\nThe research involves 40 participants: 20 professionals and 20 individuals in detention. Interviews will gather feedback on the tools' usability, clarity, and fit with the realities of prison life. The ultimate goal is to improve suicide prevention practices in detention by offering tailored, scientifically grounded tools that support both staff and detainees.",[63,199,62],[336,337,338,339,340,341,342,343],"Safety Plan","Safety Planning","Suicide prevention","Risicoformulering","risk formulation","detention","prison","incarceration","2025-11-26",{"date":346,"type":40},"2025-12-02",{"date":348,"type":40},"2025-10-27",{"date":126,"type":23},{"name":46,"class":47},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":359,"minAge":57,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":105,"phases":362,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":48},"100603305","phase-2-maternal-probiotic-intervention-to-improve-gut-health---trial-ii---burkina-faso-mpigh-ii-100603305","NCT07134790","Maternal Probiotic Intervention to Improve Gut Health - Trial II - Burkina Faso (MPIGH-II)","Ability of the Probiotic VE818 to Reduce Enteropathogen Colonization and Improve Environmental Enteropathy in Pregnant Women: A Proof-of-Concept and Phase II Randomized Placebo-Controlled Trial in Bangladesh, Pakistan, Zambia, and Burkina Faso.","MPIGH-II","All pregnant women in their first or early second trimester of pregnancy, residing in the icddr,b service area of Matlab, who meet the eligibility criteria decribed below.\n\nInclusion criteria\n\n1. Women aged 18 years or older in their first or early second trimester of pregnancy (13-17 weeks of gestational age \\[GA\\]), living in defined geographical areas of Bangladesh (Matlab), Pakistan, Zambia, and Burkina Faso, where it can be assumed that environmental enteropathy is prevalent\n\n   AND\n2. Presence of any 2 out of 11 selected bacterial pathogen targets (Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli, Enteropathogenic Escherichia coli, Enterotoxigenic Escherichia coli, Plesiomonas, Shigella\\_EIEC, Salmonella and Klebsiella pneumoniae in fecal samples measured by TAC-qPCR.\n\n   AND\n3. Presence of any of the following WASH conditions -\n\n1\\. use surface water, unimproved water, or limited water for drinking; OR 2. use surface water, unimproved water, or limited water for cooking; OR 3. use surface water, unimproved water, or limited water for washing utensils; OR 4. practice open defecation, use unimproved sanitation (toilet facility), or limited sanitation (toilet facility); OR 5. lack facility or have limited facility for handwashing\n\nExclusion criteria\n\nPotential participants will not be enrolled if they:\n\n1. have MUAC ≥30 cm\n2. are carrying more than one fetus (i.e., multiple pregnancy)\n3. have diarrhea, defined as the passage of three or more loose stools per 24 hours, or have had diarrhea in the preceding 14 days\n4. have fever or an active infection\n5. have taken antibiotics or probiotics in the preceding 14 days\n6. have taken steroids or non-steroidal anti-inflammatory drugs in the preceding 14 days\n7. have severe anemia as determined using finger stick Hb \\\u003C 8 g\u002Fdl\n8. have a history of chronic digestive disease\n9. have any gastrointestinal contraindication to ingestion of a capsule (known or suspected gastrointestinal obstruction, stricture, fistula, gastroparesis, or any swallowing disorder)\n10. have known immunocompromised status (known history of HIV infection, autoimmune disease, diabetes mellitus, etc.)\n11. have known drug hypersensitivity\u002Fallergy\u002Fintolerance\n12. have chronic disease or any other illness or condition which in the opinion of the investigator will complicate the assessment of safety or efficacy\n13. are medically disqualified: Any potential participant who is deemed medically unfit for trial enrollment by a non-study healthcare provider, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation\n14. have a plan to observe fast any time during the intervention period\n15. have a plan to leave the study area within the follow-up period\n16. are participating in any other interventional trial\n17. belong to a household from which another woman is already enrolled in the study\n\nbut may be enrolled if\u002Fwhen these disqualifiers have expired.","FEMALE",{"count":361,"type":23},144,[363],"PHASE2","Burden: Environmental Enteric Dysfunction (EED) is an enteropathic condition characterized by altered gut permeability, infiltration of immune cells and changes in villous architecture and cell differentiation. EED is a major reason of malnourishment, poor neurological development, stunting, oral vaccine failure, and infection. It is believed that EED is responsible for 40% of all childhood stunting.\n\nKnowledge gap: To date the focus of research on childhood stunting has been on the young child. It is increasingly appreciated, however, that stunting often begins in utero and the focus has shifted to women's health and pregnancy. Results from rural Bangladesh reveal poor gestational weight gain that ultimately leads to intrauterine growth restriction, low birth weight and ultimately stunting and wasting. Another study recently completed in slum settlements of Dhaka, Bangladesh demonstrated a high prevalence of EED among undernourished women. Intestinal histopathology was abnormal in more than 80% of women. We postulate that growth retardation in utero is a consequence of EED in the mother during pregnancy and lactation. This leads to systemic inflammation, which lead to disadvantageous partitioning of nutrients, and reduced nutrient availability.\n\nRelevance: This trial will explore the conceptual framework that a probiotic or live biotherapeutic product that can improve the composition of gut microbiota, can also displace enteropathogens and reduce biomarkers of intestinal inflammation to promote gut health. This will restore healthy microbial signaling to the host epithelium, ameliorate barrier function through secretion of mucus and antimicrobial factors, and improve nutrient availability.\n\nObjectives: The primary objective is to assess if administration of oral vancomycin followed by VE818 to pregnant women colonized with at least 2 out of 11 selected bacterial enteropathogens results in a significant change in the mean count of these organisms between the baseline and 2 weeks after completion of the intervention (Study Day 35d +2), compared to oral vancomycin followed by placebo.\n\nMethods: Pregnant women will be recruited in antenatal clinics and in the community in Matlab in Bangladesh, Bobo-Dioulasso in Burkina Faso, Matiari in Pakistan, and Lusaka in Zambia. Study population will be women aged 18 years or older in the first trimester or early second trimester of pregnancy. Study procedures will be explained in detail and written consent will be taken before enrollment. Those women who give consent to participation will undergo a screening process which will check if any exclusion criteria are fulfilled. After consent and screening they will be randomized into either of the three arms: intervention arm (oral vancomycin followed by VE818), placebo-control arm (oral vancomycin followed by placebo), or observation-only arm. The allocation sequence will be generated by the trial statistician using a code with block permutation. The participant will remain free to withdraw at any time from the trial without giving reasons and without prejudicing her further treatment. Biological samples, including blood, saliva, urine, stool, vaginal swab, and intestinal luminal contents through CapScan. CapScan is a non-invasive device (capsule) that collects gastrointestinal samples along the gastrointestinal tract following ingestion and passes into stool.\n\nOutcome measures\u002Fvariables: The primary endpoint is the change in the mean count in the number of 11 selected fecal bacterial pathogen groups present between baseline and 2 weeks after completion of the 14-day course with Placebo or VE818 (Study arms 2 and 3), which corresponds to 35th day, +2 from the first dose of oral vancomycin.\n\nThe 11 enteropathogen targets will be detected by customized real-time quantitative PCR-based TaqMan Array Cards (TAC-qPCR) and include the following organisms: Aeromonas, Campylobacter coli, Campylobacter jejuni, Campylobacter Pan, Enteroaggregative Escherichia coli (E. coli), Enteropathogenic E. coli, Enterotoxigenic E. coli, Plesiomonas, Shigella\\_Enteroinvasive E. coli (EIEC), Salmonella and Klebsiella pneumoniae.",[366],"Environmental Enteric Dysfunction (EED)","2025-11-14",{"date":369,"type":40},"2025-11-17",{"date":371,"type":40},"2025-07-30",{"date":373,"type":23},"2027-06-07",{"name":46,"class":47},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":56,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":105,"phases":383,"briefSummary":384,"conditions":385,"keywords":386,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":185},"100599147","state-of-the-art-immediate-implant-placement-in-the-premaxilla-100599147","NCT07080710","State of the Art Immediate Implant Placement in the Premaxilla","A Clinical Study on Immediate Implant Placement in the Premaxilla With Flapless Guided Surgery, Hard and Soft Tissue Augmentation and Immediate Provisionalization","Inclusion Criteria:\n\n* At least 20 years old\n* Good oral hygiene defined as full-mouth plaque score ≤ 25%\n* Presence of one or more incisors, cuspids or premolars in the maxilla that need to be extracted for any reason with at least one neighboring tooth present\n* At least 3 mm bone available at the apical or palatal aspect of the alveoli as assessed on a three-dimensional radiograph to ensure primary implant stability\n* Written informed consent.\n\nExclusion Criteria:\n\n* Pregnancy (will be explicitly asked)\n* Systemic diseases\n* Smoking; suppuration\n* \\> 1 mm gingival asymmetry between the failing teeth and contralateral teeth\n* Failing teeth outside the bone envelop as assessed on a three-dimensional radiograph\n* Untreated periodontal disease; untreated caries lesions.",{"count":140,"type":23},[107],"The goal of this clinical study is to learn how well immediate implant placement works in the front upper jaw (premaxilla) when using flapless guided surgery, hard and soft tissue augmentation, and immediate provisional crowns. It will also learn about the safety and esthetic results of this treatment approach.\n\nThe main questions it aims to answer are:\n\nPrimary:\n\nHow much buccal bone thickness remains one year after implant placement 1mm below the implant shoulder?\n\nSecondary:\n\n* How do patients rate pain, healing, and esthetics after treatment?\n* Are there any complications over the course of five years?\n* How much buccal bone thickness remains one year after implant placement 3mm and 5mm below the implant shoulder?\n* Marginal bone loss at one-year and five-year follow-up?\n* Peri-implant health at one-year and five-year follow-up?\n* Soft tissue changes at one-year and five-year follow-up?\n\nResearchers will compare treatment results in patients with intact bone sockets to those with damaged (non-intact) sockets.\n\nParticipants will:\n\n* Receive a dental implant and temporary crown on the same day as the tooth extraction\n* Undergo guided, flapless surgery with bone and soft tissue grafting\n* Take antibiotics and anti-inflammatories for 4 days after surgery\n* Visit the clinic at 1 week, 3 months, 1 year, and 5 years for follow-up exams\n* Have X-rays, digital scans, and photos taken to measure bone and soft tissue changes\n* Answer questions about pain and esthetic satisfaction",[291],[387,294,388,389,390,391],"dental implant, single-tooth","connective tissue graft","socket grafting","intact alveolus","non-intact alveolus",{"date":393,"type":40},"2025-11-18",{"date":395,"type":40},"2025-07-01",{"date":397,"type":23},"2032-02-01",{"name":46,"class":47},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":406,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":48},"100606484","evaluation-of-the-quality-of-chat-conversations-with-the-suicide-helpline-zelfmoordlijn-1813-100606484","NCT07176156","Evaluation of the Quality of Chat Conversations With the Suicide Helpline Zelfmoordlijn 1813","CHATQ-1813","Inclusion Criteria:\n\n* being at least 16 years of age\n* they are chatting on their own behalf (not for someone else)\n\nExclusion Criteria:\n\n* indication that they do not meet these criteria or are not interested in the study","16 Years",{"count":408,"type":23},373,"Suicide remains a serious public health issue in Flanders. Every day, nearly three people die by suicide, and many more attempt it or struggle with suicidal thoughts. The Zelfmoordlijn 1813 is a free and confidential helpline that offers support to people in crisis through phone, chat, and email. In 2024, volunteers had over 23,000 conversations, including nearly 3,000 via chat.\n\nThis study, led by the Flemish Centre of Expertise in Suicide Prevention (VLESP) in collaboration with the Centre for Suicide Prevention (CPZ), aims to better understand how people experience the chat service of the Zelfmoordlijn 1813. While previous research has looked at the impact of phone conversations, little is known about how chat conversations affect suicidal thoughts and feelings.\n\nTo explore this, people who contact the chat service will be invited to fill out a short questionnaire before and after their conversation. These questionnaires take about 3 minutes each and are completely voluntary. They ask about feelings like hopelessness, crisis, and perceived support, as well as satisfaction with the chat.\n\nThe goal is to improve the quality of chat-based crisis support and ensure that people in emotional distress receive the best possible help. This research will help strengthen suicide prevention efforts in Flanders.",[63,411,199,62],"User Experience",[413,414,203,415],"suicide prevention","suicide","helpline","2025-09-08",{"date":418,"type":40},"2025-09-16",{"date":420,"type":23},"2025-09-23",{"date":277,"type":23},{"name":46,"class":47},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":56,"sex":18,"minAge":430,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":48},"100604296","fnirs-grasping-task-in-infants-100604296","NCT07147673","fNIRS Grasping Task in Infants","Brain Function During Grasping Task in Three to Nine Months Infants Using fNIRS , the Difference Between Full and Preterm Born Infants","Inclusion Criteria:\n\n* 3-9 months old\n* can tolerate the fNIRS cap\n* performs at least 2 grapsing attempts with one hand within one minute when prompting the hand with a toy\n\nExclusion Criteria:\n\n* history of periferal neurological lesion such as plexus brachialis lesion\n* presence of epilepsia, congenital brain malformation,\n* no informed consent\n* severe visual impairments\n* syndromal or genetical diseases resulting into developmental delay","3 Months","9 Months",{"count":433,"type":23},100,"This study aims to investigate the neural mechanisms involved in the development of reach-to-grasp function in infants. Reaching and grasping are crucial motor skills that develop early in infancy and are essential for later motor and cognitive milestones. Understanding how these skills emerge and the underlying neural processes can provide valuable insights into both typical and atypical development.\n\nThe study will focus on infants aged 3 to 9 months, a critical period for the development of reach-to-grasp skills. A total of 100 infants will be recruited, including 50 full-term infants and 50 preterm infants (born \\\u003C36 weeks gestational age). Reach-to-grasp function will be evaluated through a cross-sectional assessment at a single time point. Functional near-infrared spectroscopy (fNIRS) will be used as the brain imaging technique to measure brain activity during the reach-to-grasp task. The use of fNIRS will allow for a non-invasive assessment of neural activity in real time, providing insights into the brain mechanisms supporting the development of motor skills. The findings may offer important information about the neural basis of motor development in infancy, particularly in the context of preterm birth.",[436],"Preterm and Term Infants",[438,439,440,441],"fNIRS","grasping","infants","preterm infants","2025-08-22",{"date":444,"type":40},"2025-08-29",{"date":446,"type":40},"2022-09-26",{"date":448,"type":23},"2027-09-30",{"name":46,"class":47},{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":457,"maxAge":458,"enrollmentInfo":459,"targetDuration":4,"studyType":105,"phases":461,"briefSummary":462,"conditions":463,"keywords":466,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":48},"100602934","oromyofunctional-training-an-innovative-rehabilitation-program-for-pediatric-obstructive-sleep-apnea-100602934","NCT07129967","Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea","OROFIT","Inclusion Criteria:\n\n* Children aged between 6-12\n* Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\\\u003C1)\n\nExclusion Criteria:\n\n* History of Orofacial Myofunctional Therapy\n* Undergoing an orthodontic procedure during the study period\n* Undegoing an OSA treatment during the study period\n* Orofacial congenital deformities\n* Mental retardation (\\>2 SD above P50)","6 Years","12 Years",{"count":460,"type":23},90,[107],"Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. However, adenotonsillectomy, the standard therapeutic approach for children with OSA, is often inadequate. Research shows that 20-40% of children still have residual OSA symptoms after surgery. Therefore, exploring other treatment options, specifically for those patients who currently have insufficient therapeutic options, is an interesting and relevant avenue for research.\n\nThis study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with obstructive sleep apnea (OSA). Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions and strengthen upper airway muscles that are involved in maintaining airway patency. Both objective and subjective\u002Fpatient-reported outcomes are collected to obtain a comprehensive understanding of the potential of orofacial myofunctional therapy as a treatment for OSA.",[464,465],"Obstructive Sleep Apnea (OSA)","Orofacial Myofunctional Disorders",[467,468],"Orofacial myofunctional therapy","obstructive sleep apnea","2025-08-11",{"date":471,"type":40},"2025-08-19",{"date":473,"type":40},"2024-08-08",{"date":475,"type":23},"2027-01-01",{"name":46,"class":47},{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":454,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":12,"sex":18,"minAge":484,"maxAge":57,"enrollmentInfo":485,"targetDuration":4,"studyType":105,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":48},"100602361","oromyofunctional-therapy-a-rehabilitation-program-for-osa-in-children-with-down-syndrome-and-prader-willi-syndrome-100602361","NCT07122505","Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome","OROFIT-P","Inclusion Criteria:\n\n* Children aged between 4-18\n* Diagnosed with Down syndrome or Prader-Willi syndrome\n* Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\\\u003C1)\n\nExclusion criteria:\n\n* History of Orofacial Myofunctional Therapy\n* Undergoing an orthodontic procedure during the study period\n* Undegoing an OSA treatment during the study period\n* Orofacial congenital deformities (not related to Down syndrome or Prader-Willi syndrome)","4 Years",{"count":5,"type":23},[107],"Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children is an interesting and relevant avenue for research.\n\nThis study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions and strengthen upper airway muscles that are involved in maintaining airway patency. Both objective and subjective\u002Fpatient-reported outcomes are collected to obtain a comprehensive understanding of the potential of orofacial myofunctional therapy as a treatment for OSA.",[464,465],[467,490,491,492],"Obstructive sleep apnea","Down syndrome","Prader-Willi syndrome",{"date":494,"type":40},"2025-08-14",{"date":496,"type":40},"2024-04-15",{"date":475,"type":23},{"name":46,"class":47},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":406,"maxAge":507,"enrollmentInfo":508,"targetDuration":4,"studyType":105,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":185},"100601802","validation-of-an-upper-extremity-physical-performance-test-battery-in-patients-after-shoulder-dislocation-100601802","NCT07115225","Validation of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation","Predictive Validity of an Upper Extremity Physical Performance Test Battery in Patients After Shoulder Dislocation: a Prospective Study","VAL_PPT_P","Inclusion Criteria:\n\n* Practising sports with moderate to high demand on the shoulder (based on Degree of Shoulder Involvement in Sport (DOSIS) scale), minimal weekly 3 hours\n* Shoulder instability event (anterior direction)\n* Healthy contralateral shoulder\n* Completion of the postoperative rehabilitation protocol\n\nExclusion Criteria:\n\n* Other upper limb pathologies\u002F associated injuries: e.g. posterior instability, or rotator cuff tear,...\n* Being pregnant\n* No intention to return to pre-injury sport","55 Years",{"count":509,"type":23},129,[107],"The goal of this exploratory prospective study is to determine if an upper extremity test battery, comprised of physical performance tests, analytical tests and patient-reported outcome measures, can predict successful return to sports and quality of life in athletes (age 16-55) after shoulder dislocation.\n\nThe main research questions are:\n\n* Can an Upper Extremity Physical Performance Test Battery predict successful return to sports (= return to pre-injury sports level) in athletes after shoulder stabilization procedure\n* Can an Upper Extremity Physical Performance Test Battery predict the quality of life in athletes after shoulder stabilization procedure\n\nParticipants will:\n\n* Fill out questionnaires pre-operatively\n* Fill out the SIRSI questionnaire throughout the rehabilitation\n* Undergo a testing battery in the return to sport phase, including physical performance tests, analytical tests and patient-reported outcome measures\n* Fill out questionnaires every 3 months after return to sports, up to 1 year.",[513,514],"Return to Sport","Shoulder Dislocation or Subluxation","2025-08-04",{"date":469,"type":40},{"date":518,"type":40},"2025-07-03",{"date":520,"type":23},"2029-01-01",{"name":46,"class":47},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":105,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":48},"100599149","evaluation-of-e-learning-on-suicide-prevention-for-professionals-in-a-detention-context-100599149","NCT07080736","Evaluation of E-learning on Suicide Prevention for Professionals in a Detention Context","Inclusion Criteria:\n\n≥ 18 years old Have access to internet Speak Dutch Working within a penitentiary institution, in particular in the establishments in Ypres, Merksplas, Bruges and Mechelen.\n\nExclusion Criteria:\n\nStaff of prisons not working in participating institutions",{"count":529,"type":23},1300,[107],"This study aims to investigate to what extent a gatekeeper training (e-learning) for people working in prison is applicable in their daily practice.\n\nMoreover the study wants to investigate the impact of the e-learning on the knowledge, the attitudes and perceptions of the people working in prison on suiicide (prevention) as well as their feeling of self-efficacy in dealing with people in prison suffering from suicidal ideation of behavior.",[63],"2025-07-14",{"date":535,"type":40},"2025-07-23",{"date":537,"type":40},"2025-06-26",{"date":539,"type":23},"2026-03-31",{"name":46,"class":47},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":56,"sex":18,"minAge":406,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":549,"conditions":550,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":555,"leadSponsor":556,"locationsCount":48},"100598471","user-evaluation-of-zelfmoord1813be-and-its-related-websites-100598471","NCT07071922","User Evaluation of Zelfmoord1813.be and Its Related Websites","Inclusion Criteria:\n\n* 16 y\u002Fo or older\n* visit(ed) websites zelfmoord1813.be, mee-leven.be, werkgroepverder.be or komuitjekop.be\n\nExclusion Criteria:\n\n* \u002F",{"count":548,"type":23},3000,"Monitoring the availability and accessibility of suicide prevention information in Flanders remains crucial. In 2022, 1,024 people died by suicide in Flanders, and approximately 10,000 individuals required emergency care following a suicide attempt.\n\nThe third Flemish Suicide Prevention Action Plan outlines several strategies aimed at achieving the health objective of reducing the suicide rate by 10% by 2030 compared to 2020.\n\nOne of the initiatives under the first Flemish Suicide Prevention action plan was the creation of a central online platform for suicide prevention. This led to the launch of Zelfmoord1813.be at the end of 2013. The platform serves as a central point of access to relevant and scientifically grounded information on suicide prevention in Flanders. It provides immediate crisis support through Zelfmoordlijn 1813, a free and anonymous helpline available via phone, chat, or email. In addition, the site offers resources for professionals, journalists, students, and others seeking information on suicide prevention.\n\nZelfmoord1813.be targets a broad audience across all age groups . The website is managed by the Flemish Centre of Expertise in Suicide Prevention, the government-appointed partner organization for suicide prevention in Flanders. One of the key responsibilities of the Flemish Centre of Expertise in Suicide Prevention is to regularly assess the use, reach, and relevance of Zelfmoord1813.be, partly through recurring user research.\n\nThis user research investigates visitors' reasons for accessing the platform, whether they find what they are looking for, and their satisfaction with the content. The findings help evaluate whether all target groups are being reached effectively and inform future strategies for promotion, content development, and improvements.\n\nA first user study was conducted in 2020. The researchers now aim to repeat this evaluation. In recent years, three affiliated websites have also been launched: WerkgroepVerder.be (for suicide bereavement support), Mee-Leven.be (focused on suicide prevention in the social environment) and KomUitJeKop.be (specifically tailored to men). These websites are also managed by the Flemish Centre of Expertise in Suicide Prevention and will be included in the current study.\n\nThe study aims to include 3,000 participants aged 16 and older. Visitors to Zelfmoord1813.be, WerkgroepVerder.be, Mee-Leven.be or KomUitJeKop.be will see a pop-up invitation to participate after 30 seconds, which disappears after 20 seconds. If they click \"yes,\" they are redirected to a Qualtrics page, where they complete a short informed consent and a 5-minute questionnaire before being returned to the original website.\n\nAdditionally, a message on each website will read: \"We are curious about your opinion of our website. Please take your time to explore the site. When you're ready, you can share your feedback by clicking this link.\" This allows users to participate after reviewing the content at their own pace.",[63,411],"2025-07-08",{"date":553,"type":40},"2025-07-17",{"date":518,"type":40},{"date":539,"type":23},{"name":46,"class":47},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":56,"sex":18,"minAge":565,"maxAge":566,"enrollmentInfo":567,"targetDuration":4,"studyType":105,"phases":569,"briefSummary":570,"conditions":571,"keywords":573,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":4},"100595732","reducing-and-breaking-up-school-related-sedentary-behaviour-among-adolescents-using-co-creation-100595732","NCT07036276","Reducing and Breaking up School-related Sedentary Behaviour Among Adolescents Using Co-creation","Reducing and Breaking Up School-related Sedentary Behaviour Among Adolescents Using Co-creation","G072223N","Inclusion Criteria:\n\n* Secondary schools need to have at least 150 pupils in the first two grades (Grade 7 and 8).\n\nExclusion Criteria:\n\n* None","11 Years","15 Years",{"count":568,"type":23},600,[107],"Adolescents spend the majority of the day sedentary, especially at school whilst sitting in class and at home when performing school-related tasks. As high levels of sedentary time are associated with adverse health effects, effective interventions are needed. To improve effectiveness, literature recommends a co-creative approach in which adolescents and other key stakeholders (such as teachers) are actively involved in the choice and development of intervention strategies. Therefore, this project aims to co-adapt a previously co-created intervention targeting adolescents' school-related sedentary behaviour. Further, the effect of this co-adapted intervention on adolescents' sedentary behaviour and related determinants, sleep, and mental wellbeing will be evaluated via a three-arm clustered controlled trial, including a co-adaptation intervention arm, a standard intervention arm (including schools that were not involved in co-adapting the intervention) and a control arm (continuing their curriculum as usual). By comparing these three arms, the investigators can evaluate the added value of co-creation compared to not involving adolescents or stakeholders in the development of an intervention. Lastly, the investigators will conduct a process evaluation of (1) the co-adaptation approach used to adapt the co-created intervention and (2) the implementation of both the co-adapted and standard interventions. Studies that evaluate co-created interventions are scarce. However, if such interventions prove to be more effective, this approach could be promising to change adolescents' health behaviour.",[572],"Sedentary Behaviour",[574,575,576,577,578,579,580,581,582],"Adolescents","Youth","Student","School","Classroom","Sedentary behaviour","Participatory research","Co-creation","Co-adaptation","2025-06-23",{"date":585,"type":40},"2025-06-25",{"date":587,"type":23},"2025-09-01",{"date":589,"type":23},"2026-06-30",{"name":46,"class":47},{"id":592,"slug":593,"hasResults":12,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":457,"maxAge":458,"enrollmentInfo":599,"targetDuration":4,"studyType":105,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":48},"100596463","oral-myofunctional-pattern-in-children-with-anterior-open-bite-100596463","NCT07045779","Oral Myofunctional Pattern in Children With Anterior Open Bite","The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite","OMBIT","Inclusion Criteria:\n\n* Presence of anterior open bite (AOB)\n* Early or intermediate mixed dentition phase\n\nExclusion Criteria:\n\n* History of or active engagement in orofacial myofunctional therapy (OMT)\n* History of or active engagement in orthodontic therapy\n* Congenital abnormalities, syndromes, or surgical needs affecting the oral and maxillofacial region\n* Disorders affecting motor or cognitive development\n* Current or recent (\\\u003C 3 months) non-nutritive sucking habits",{"count":600,"type":23},33,[107],"Oral myofunctional disorders (OMD) are a key, internationally acknowledged environmental factor causing dental and skeletal malocclusion. For the past 15 years, research regarding the efficacy of orofacial myofunctional therapy (OMT) to reduce OMD and to contribute to the treatment of malocclusions has been significantly increased. Despite the growing interest, high-quality evidence is still lacking because studies show a lack of standardized assessment techniques, outcome measures, and inclusion criteria, important methodological limitations such as small sample sizes, a variety of content and service delivery models and a lack of long-term follow-up.\n\nThe goal of this clinical trial is to evaluate the effects of structured OMT on anterior open bite (AOB) in children in early or intermediate mixed dentition. The main questions it aims to answer are:\n\n* Does a structured OMT program affect orofacial myofunctional patterns, dental occlusion, and oral health-related quality of life (OHRQoL) in children with AOB?\n* Are there differences in treatment outcomes between children receiving a traditional OMT program, a reduced OMT program, and a sham treatment?\n\nParticipants will undergo baseline and follow-up assessments of dental occlusion, orofacial myofunctional patterns, and OHRQoL. They will follow a structured OMT protocol tailored to their assigned group and participate in weekly therapy sessions over a defined intervention period.",[465,604],"Anterior Open Bite Malocclusion",{"date":395,"type":40},{"date":607,"type":40},"2023-02-22",{"date":609,"type":23},"2026-05",{"name":46,"class":47},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":615,"acronym":4,"eligibilityCriteria":616,"healthyVolunteers":56,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":105,"phases":618,"briefSummary":619,"conditions":620,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":48},"100596267","evaluation-of-creative-materials-supporting-healthcare-professionals-in-discussing-suicidality-in-children-and-adolescents-100596267","NCT07043231","Evaluation of Creative Materials Supporting Healthcare Professionals in Discussing Suicidality in Children and Adolescents","Inclusion Criteria:\n\n* Participants must be healthcare professionals (e.g., general practitioners, psychiatrists, psychologists, psychotherapists, or nurses) working in mental health care.\n* Participants must work with children or adolescents who may be experiencing suicidality.\n* Participants must be 18 years of age or older.\n* Participants must have internet access and sufficient proficiency in Dutch.\n\nExclusion Criteria:\n\n* Individuals who do not meet the inclusion criteria.",{"count":104,"type":23},[107],"Preliminary research clearly indicates a significant shortage of evidence-based tools and interventions specifically targeting suicidality among children and adolescents. The need for such methodologies is substantial, as suicidal ideation and suicide attempts are relatively common within this age group. According to the 2022 Health Behaviour in School-aged Children (HBSC) study, 16% of boys and 28% of girls aged 13 to 18 reported having had suicidal thoughts on two or more occasions in their lifetime (Schrijvers et al., 2023). Compared to the previous HBSC study conducted in 2018, this represents a negative trend, as 13% of boys and 22% of girls reported suicidal thoughts at that time (Dierckens et al., 2019).\n\nFacilitating open discussions about suicidal thoughts is therefore of critical importance. Research has shown that discussing suicidality does not increase suicidal behavior; rather, it can contribute to a reduction in risk (Blades et al., 2018; Dazzi et al., 2014; DeCou \\& Schumann, 2018; Polihronis et al., 2022). Breaking the taboo around suicidality and attuning to the emotional experiences of children and adolescents may serve as an initial step toward providing effective support. Such openness can help reduce feelings of loneliness and isolation by fostering a safe environment in which young people feel heard and understood. Moreover, the act of speaking openly about suicidality is associated with increased social support-an important protective factor (Batty et al., 2018; Calati et al., 2019).\n\nIn 2023, a project was launched aimed at developing creative materials to support professionals in initiating conversations about suicidality with children and adolescents. This material is being developed through a co-creative process (EC code: ONZ-2024-0211), in collaboration with youth care professionals, method developers, and young individuals with lived experience of suicidal thoughts. These young people provide essential contributions to ensure that the materials are aligned with their needs and expectations for support. This co-creative approach aims not only to produce a theoretically grounded methodology, but also to yield a practically applicable tool that effectively addresses the real-world challenges faced by both professionals and youth. The creative materials are currently under development and are designed to facilitate exploration and discussion of suicidality, ultimately supporting professionals in formulating a risk assessment and developing a Safety Plan. This approach aligns with the recommendations outlined in the guideline \"Detection and Interventions for Suicidal Thoughts and Behaviors in Children and Adolescents\" (Dumon et al., 2023).\n\nThe next phase of the project focuses on evaluating the creative materials. The evaluation aims to gain insight into their usability and applicability in professional practice. This will be conducted through an evaluation study. Professionals working in Flanders will be recruited via calls on www.zelfmoord1813.be, relevant partner organizations, social media, and newsletters from VLESP and other partners. Additionally, professionals may be invited via email. Those who have used the materials over a three-month period will be asked to retrospectively share their experiences. The study consists of the following steps:\n\nRegistration: Eligible professionals complete a short registration form (duration: approximately 5 minutes).\n\nUse of the creative materials: Participants use the materials in their professional context over a period of three months.\n\nPost-assessment: At the end of the three-month period, participants complete a questionnaire regarding their experiences with the materials (duration: approximately 10-15 minutes).\n\nThe post-assessment focuses on evaluating user-friendliness, practical applicability, and the potential of the creative materials to facilitate conversations about suicidality. Collected feedback will be used to further refine and optimize the materials. If participants do not complete the post-assessment promptly, they will receive reminder emails after 2 and 4 days. The target sample size for the study is 40 participants.",[62],"2025-06-20",{"date":623,"type":40},"2025-06-29",{"date":625,"type":40},"2025-06-02",{"date":627,"type":23},"2025-12",{"name":46,"class":47},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":56,"sex":18,"minAge":458,"maxAge":637,"enrollmentInfo":638,"targetDuration":4,"studyType":105,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":48},"100527850","validity-of-an-upper-extremity-physical-performance-test-battery-in-healthy-athletes-100527850","NCT06153121","Validity of an Upper Extremity Physical Performance Test Battery in Healthy Athletes","Construct and Predictive Validity of an Upper Extremity Physical Performance Test Battery in Healthy Athletes: a Cross-sectional and Prospective Study","VAL_PPT_H","Inclusion Criteria:\n\n* In good general health\n* Play tennis or swim competitively, at least 3 hours per week (training + competition)\n\nExclusion Criteria:\n\n* History of shoulder dislocation in dominant and\u002For nondominant shoulder\n* History of upper extremity surgery\n* At the moment of participation, participants should not report a substantial injury (defined by the Oslo Sports Trauma Research Centre questionnaire on health problems) in the past two months. A substantial injury is defined as a moderate or severe reduction in training volume or reduction in sports performance or complete inability to participate in sport as substantial injuries and illnesses.\n* Neurological symptoms in any extremity\n* Suffering from a systemic disease (such as diabetes, lupus, arthrosis,.. )","40 Years",{"count":639,"type":23},200,[107],"This project comprises two studies; a cross-sectional study and a prospective study.\n\n1. The cross-sectional study aims to develop and validate a new sport-specific test battery (PROMs, analytical and physical performance tests) in healthy tennis players and swimmers.The construct validity of this upper extremity test battery will be examined through two different methods.\n\n   1. Firstly, the performance on the test battery will be correlated to sport performance (sprint time at 100m freestyle in swimming and serve speed\u002Faccuracy in tennis)\n   2. Secondly, the correlation between test battery performance and upper limb\u002Ftrunk kinematics in a tennis serve (measured via inertial measurement units (IMUs)) will be examined.\n2. In the prospective study, the predictive validity of the test battery will be evaluated. Healthy swimmers and tennis players will be tested at baseline using the same test battery as mentioned above. The athletes will be followed for one year and new injuries will be recorded via a weekly questionnaire. Performance on the test battery will be associated with the incidence of musculoskeletal injuries.",[643],"Athletic Injuries","2025-06-19",{"date":585,"type":40},{"date":647,"type":40},"2023-11-22",{"date":649,"type":23},"2029-11",{"name":46,"class":47},""]