[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundació Sant Joan de Déu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":437},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,55,96,128,153,181,206,240,267,295,322,349,370,404],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100576989","eplatform-for-promoting-health-in-schools-100576989",false,"NCT06792461","ePlatform for Promoting Health in Schools","A Randomized Controlled Trial to Evaluate the Implementation of an eHealth Platform for Promoting Healthy Habits Among Adolescents From Socially Disadvantaged Settings: the ePro-Schools Project","ePro-Schools","Inclusion Criteria\n\nAdolescents:\n\n* Students enrolled in 1st, 2nd, or 3rd year of ESO (ages approximately 11-16) at participating secondary schools located in the Central Catalonia region, particularly those in socially disadvantaged settings.\n* All genders will be eligible.\n* Written informed consent must be provided by both the adolescent and their parent(s)\u002Flegal guardian(s).\n\nPhysical Education Teachers:\n\n* Physical education teachers currently working at the participating secondary schools.\n* Must be 18 years of age or older.\n* Must provide written informed consent to participate.\n\nExclusion Criteria\n\n* Individuals (adolescents or teachers) who do not provide written informed consent will be excluded.\n* No other exclusion criteria will be applied.",true,"ALL","11 Years","16 Years",{"count":22,"type":23},1000,"ESTIMATED","INTERVENTIONAL",[26],"NA","There are few public health and educational policies specifically aimed at promoting physical activity, healthy dietary habits, and reducing sedentary behaviour among adolescents from socially disadvantaged backgrounds. ePro-Schools will co-design, pilot and evaluate an evidence-based program, delivered via a modular eHealth platform, to promote physical activity and healthy eating, and reduce time in sedentary behaviours. A profound co-creation process involving adolescents, school staff, and policymakers-alongside the adaptation of previous interventions by consortium members-will support the program's development. The ePro-Schools platform will contain modules for adolescents and their parents, teachers and school administration. Although the platform will be implemented through schools, it will include content to be implemented outside the school setting. The intervention program will be evaluated through a randomised controlled trial conducted in six secondary schools in Central Catalonia that aims to include 1000 adolescents. Schools have been randomised (1:1) into an intervention and a waiting-list control group.\n\nThe evaluation of the program includes effectiveness, cost-effectiveness and process evaluation. Physical activity, sedentary behaviour and eating habits are the primary effectiveness outcomes of the trial. Secondary outcomes include fitness, water consumption, quality of life, depressive symptoms, social isolation and sleep quality. Using implementation science methodology, ePro-Schools will co-design transferable evidence-based practices and methodologies and guidance for scaling up the platform with policymakers and stakeholders, as well as informing specialists, policymakers and the general public.",[29,30,31,32,33],"Health Promotion","Health Education","Physical Activity","Nutrition","Behaviour Change",[35,36,37,38,39,40,41],"eHealth","Adolescents","Socially disadvantaged settings","Randomized control trial","Co-design","School-based interventions","Health promotion","RECRUITING","2026-04-23",{"date":45,"type":46},"2026-04-29","ACTUAL",{"date":48,"type":46},"2025-09-08",{"date":50,"type":23},"2027-03",{"name":52,"class":53},"Fundació Sant Joan de Déu","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":24,"phases":67,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100632071","phase-1-effects-of-5-methyltetrahydrofolic-acid-supplementation-on-maternal-health-and-one-carbon-metabolism-during-lactation-100632071","NCT07508917","Effects of 5-Methyltetrahydrofolic Acid Supplementation on Maternal Health and One-Carbon Metabolism During Lactation","OCMS","Inclusion Criteria:\n\n* Maternal age between 18 and 42 years\n* Gestational age at birth ≥ 37 weeks.\n* Exclusive breastfeeding at enrollment.\n* Infant age 0-1 months\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Presence of disease or malformations in the infant.\n* Weight-Standard Deviation Score \\\u003C -1 at enrollment.\n* Use of folate-containing multivitamin supplements during breastfeeding","FEMALE","18 Years","42 Years",{"count":66,"type":23},36,[68,69],"PHASE1","PHASE2","This double-blind, randomized, placebo-controlled parallel trial evaluates the effects of maternal 5-methyltetrahydrofolate (5-MTHF) supplementation during breastfeeding. Thirty-six lactating mother-infant dyads will be randomized (1:1) to receive 5-MTHF or placebo for 6 weeks, stratified by infant sex and mode of delivery. Tolerability and adverse events will be monitored.\n\nPre- and post-intervention assessments include breast milk one-carbon metabolites and oligosaccharides; maternal plasma one-carbon metabolites and metabolic health markers. Maternal mental health will be evaluated using the SCL-90-R questionnaire. A follow-up visit at 4 months will reassess infant anthropometry and microbiome outcomes.",[72],"Breastfeeding",[74,75,76,77,78,79,80,81,82,83,84,85],"5-Methyltetrahydrofolate (5-MTHF)","One-carbon metabolism","Human milk oligosaccharides","Breast milk composition","Betaine","Early-life nutrition","Maternal supplementation","Maternal mental health","5-MTHF","Gut Microbiome","Metabolomics","Infant Microbiota","NOT_YET_RECRUITING","2026-03-27",{"date":89,"type":46},"2026-04-02",{"date":91,"type":23},"2026-04-15",{"date":93,"type":23},"2027-02-28",{"name":52,"class":53},2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":18,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":24,"phases":107,"briefSummary":108,"conditions":109,"keywords":116,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":127,"locationsCount":54},"100629020","behavioral-parent-training-with-and-without-ai-support-for-children-with-disruptive-behaviors-100629020","NCT07469215","Behavioral Parent Training With and Without AI Support for Children With Disruptive Behaviors","A Pilot Randomized Controlled Trial of Behavioral Parent Training (BPT) With or Without AI Support in Children With Disruptive Behaviors","Inclusion Criteria:\n\n* Being a primary caregiver with a child aged 5 to 12 years exhibiting disruptive behaviors (e.g., symptoms of ODD, CD, IED, ADHD, and\u002For unspecified behavioral problems).\n* Having access to an electronic device and regular internet access.\n* Stable concomitant intervention including medications throughout the study.\n* Speak Spanish or Catalan language.\n* Signed informed consent by parents or legal guardians of the child.\n\nExclusion Criteria:\n\n* Having ASD as primary diagnosis.\n* Psychosis, self-harming behaviors, severe mood disorder.\n* Known Intelligent quotient \\\u003C 70\n* Caregivers and\u002For children receiving any concurrent psychological treatment.\n* No signing the informant consent.","5 Years","12 Years",{"count":106,"type":23},40,[26],"The goal of this clinical trial is to learn if adding an artificial intelligence (AI) application called to standard Behavioral Parent Training (BPT) helps families with children who have disruptive behavior problems. It will also help researchers understand if the app is easy to use and helpful for parents.\n\nThe main question it aims to answer is:\n\n\\- Is it feasible and acceptable for parents to use the AI app alongside their therapy sessions?\n\nThe secondary questions it aims to answer are:\n\n* Does the app help reduce children's disruptive behaviors and irritability more than therapy alone?\n* Does using the app help lower stress, anxiety, and depression levels for the parents?\n\nResearchers will compare:\n\n1. Standard BPT: Parents receive 8 weekly group training sessions (online).\n2. BPT plus ParenteAI: Parents receive the same 8 weekly sessions plus 24\u002F7 access to an AI virtual assistant for personalized support.\n\nParticipants will:\n\n* Attend 8 weekly group training sessions.\n* Complete surveys about their child's behavior and their own well-being at baseline, after group training sessions 4 and 8, and 3 and 6 months after finalizing the group training.\n* If in the experimental group, use the ParenteAI app to get real-time coaching and support for managing their child's behavior at home.\n* Provide feedback on their experience and satisfaction with the program.",[110,111,112,113,114,115],"Behavior Problem of Childhood and Adolescence","Parent Management Training","Artificial Intelligence (AI)","Disruptive Behaviours","Irritability","Attention Deficit Disorder With Hyperactivity (ADHD)",[117,111,118,114,119,120],"Disruptive behaviors","Artifical intelligence","Behavior problems","Attention Deficit Disorder with Hyperactivity (ADHD)","2026-03-09",{"date":123,"type":46},"2026-03-13",{"date":125,"type":23},"2026-04",{"date":50,"type":23},{"name":52,"class":53},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":24,"phases":137,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":54},"100627211","transcutaneous-spinal-cord-stimulation-tscs-during-assisted-cycling-training-for-incomplete-spinal-cord-injury-100627211","NCT07445685","Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury.","Transcutaneous Spinal Cord Stimulation (tSCS) During Assisted Cycling Training for Incomplete Spinal Cord Injury: a Randomized, Double-blind Study.","tSCS_SJD_PMI_1","Inclusion Criteria:\n\n* Age at least 18.\n* Diagnosis of spinal cord injury at levels C2-T11, classified as ASIA Impairment Scale grades B, C, or D.\n* Less than 1 year since the injury.\n* Ability to follow instructions and tolerate the intervention.\n\n  .-Spasticity grade less than 3 on the Modified Ashworth Scale.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Comorbidities that limit active participation (severe heart disease, serious active infections, pressure ulcers in the area).\n* Use of devices incompatible with electrical stimulation.\n* Metallic implant in the T11-T12 area.\n* History of epilepsy.\n* Fixed joint contractures limiting range of motion.\n* Significantly reduced bone density (osteoporosis).\n* Unhealed fractures.\n* Pregnancy.\n* Active tumor process.",{"count":106,"type":23},[26],"The goal of this clinical trial is to learn if transcutaneous spinal cord stimulation works to improve lower limb motor function in adults with incomplete spinal cord injury. It will also learn about the safety of transcutaneous spinal cord stimulation when combined with assisted cycling training.\n\nThe main questions it aims to answer are:\n\nDoes transcutaneous spinal cord stimulation while training with assisted cycling improve lower limb motor function? Does transcutaneous spinal cord stimulation while training with assisted cycling reduce muscle spasms or improve bladder or bowel function?\n\nResearchers will compare transcutaneous spinal cord stimulation to a sham (a look-alike stimulation that does not deliver therapeutic electrical current) to see if transcutaneous spinal cord stimulation during assisted cycling improves motor function in people with incomplete spinal cord injury.\n\nParticipants will:\n\nParticipate in the training program with assisted cycling. Receive active stimulation or placebo stimulation during this training. Undergo motor function assessments, and be monitored about muscle spasms, bladder and bowel function and side effects.\n\nThe study will include 40 participants with incomplete spinal cord injury with less than 12 months since injury.",[140],"Incomplete Spinal Cord Injury (SCI)",[142,143,144],"Incomplete Spinal Cord Injury","Transcutaneous Electrical Spinal Cord Stimulation","Cycling","2026-03-02",{"date":147,"type":46},"2026-03-04",{"date":149,"type":23},"2026-03-01",{"date":151,"type":23},"2027-12",{"name":52,"class":53},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},"100580077","mindfulness-based-cognitive-therapy-mbct-for-the-prevention-of-depression-relapse-or-recurrence-using-videoconference-100580077","NCT06832605","Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference","Effectiveness and Cost-Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for the Prevention of Depression Relapse or Recurrence Using Videoconference in the Spanish National Health System","BECOME","Inclusion Criteria:\n\n* Age over 18.\n* Diagnosis of recurrent major depressive disorder, with ≥ 2 previous major depressive episodes (MDD).\n* Current partial remission (no current depressive episode; a score ≥8 on the HDRS).\n* Internet access (via smartphone or personal computer).\n* Spanish literacy (spoken and written).\n\nExclusion Criteria:\n\n* Current or past psychosis, bipolar disorder, a history of schizophrenia, schizoaffective disorder, organic mental disorder, current severe substance abuse, organic brain damage, pervasive developmental delay, persistent antisocial behaviour, recent (in past 3 months) self-injury requiring clinical management or therapy according to medical records and clinical judgment.\n* Formal concurrent structured psychotherapy during the intervention period.\n* No experience in the use of new technologies (smartphones or computers).\n* Having completed a mindfulness-based structured training and\u002For extensive meditation experience (i.e., previous participation in meditation retreats (≥1) or regular (≥ weekly) meditation practice) in the previous year, or intending to commence meditation retreats or meditation practice during the study.",{"count":162,"type":23},315,[26],"Objectives: To evaluate the clinical- and cost-effectiveness of two delivery formats of mindfulness-based cognitive therapy (MBCT) - (i) MBCT delivered through eight videoconference group sessions (group MBCT), and (ii) MBCT delivered through a self-help manual plus three low-intensity videoconference group support sessions (supported MBCT self-help) - when added to treatment as usual (TAU; mental health outpatient care), compared with TAU alone, in patients with recurrent depression in partial remission. We will identify potential predictors and moderators of response and examine psychological mechanisms of change. Study design: Multicentre randomised controlled trial, with pre-post, 6- and 12-months follow-ups. Centres: Parc Sanitari Sant Joan de Déu (St. Boi de Llobregat), Hospital Universitario Miguel Servet (Zaragoza), and Hospital del Mar (Barcelona). Participants: Adult patients (n=315) with recurrent depression in partial remission will be randomly assigned to group MBCT, supported MBCT self-help, or TAU. Primary outcome: time from randomisation to depressive relapse\u002Frecurrence at 12-month follow-up (DSM-5). Secondary outcomes: residual symptoms, well-being, quality of life, costs, and quality-adjusted life years. Process measures: rumination, mindfulness, decentering, affectivity, and self-compassion. Main statistical analyses: Hazard ratios will be calculated using survival analysis. Secondary outcomes, predictors, and moderators will be tested using regression-based approaches. Incremental cost-effectiveness ratios from healthcare system and societal perspectives will be estimated, alongside mediation analyses. Expectations and acceptability will be evaluated using qualitative methods. Conclusions: This study will inform the implementation of two accessible MBCT formats in Spain for preventing depressive relapse\u002Frecurrence. The use of different delivery formats will provide information on effectiveness, scalability, and value for money.",[166],"Major Depressive Disorder, Recurrent, in Remission",[168,169,170,171,172],"Depression","MBCT","Relapse\u002Frecurrence prevention","RCT","cost-effectiveness","2026-02-25",{"date":175,"type":46},"2026-02-27",{"date":125,"type":23},{"date":178,"type":23},"2028-06",{"name":52,"class":53},3,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":54},"100610743","cuidame-longitudinal-data-collection-from-patients-with-spinal-muscular-atrophy-in-spain-100610743","NCT07231549","CuidAME: Longitudinal Data Collection From Patients With Spinal Muscular Atrophy in Spain","CUIDAME","Inclusion Criteria:\n\n* Genetically confirmed 5q SMA\n* Patient or caregivers written informed consent has been obtained (except for paediatric patients deceased).\n\nExclusion Criteria:\n\n* Further types of SMA (non-5q SMA).\n* Patient without legal capacity who cannot understand the nature, significance, and consequences of the project.",{"count":22,"type":23},"OBSERVATIONAL","The goal of this observational study is to set up a longitudinal data collection study to perform a long-term follow-up of SMA patients in a real-world setting, and to standardise and homogenize the data collection process for SMA patient's data.\n\nTreated and untreated patients will be followed based on the routine clinical practice schedule.",[192],"Spinal Muscular Atrophy",[194,195,196,197],"registry","natural history","adult","pediatric","2025-11-14",{"date":200,"type":46},"2025-11-17",{"date":202,"type":46},"2020-05-05",{"date":204,"type":23},"2026-12",{"name":52,"class":53},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":24,"phases":216,"briefSummary":217,"conditions":218,"keywords":221,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":54},"100599965","cognitive-and-metacognitive-evaluation-in-vr-based-avatar-therapy-for-psychosis-100599965","NCT07091344","Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis","Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy","Meta-VR-AVATAR","\\*\\*Inclusion Criteria:\\*\\*\n\n* Adults aged 18 years or older.\n* Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria.\n* Experience of persistent auditory hallucinations for at least 3 months (PANSS hallucination score ≥ 3).\n* Stable medication dosage for at least 4 weeks prior to recruitment.\n* Fluent in the spoken language of the study site (Spanish).\n* Able to provide informed consent.\n* Regular psychiatric follow-up care.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Inability to identify a dominant voice for Avatar Therapy intervention.\n* Intellectual disability based on medical history.\n* Active substance abuse.\n* Central nervous system injury or neurological disorders affecting cognitive performance.\n* Severe visual impairment that precludes the use of VR technology.\n* Aversion to virtual reality or prior experience of simulator sickness.\n* Current suicidal ideation or risk.\n* Lack of cooperation or inability to comply with study procedures.",{"count":215,"type":23},30,[26],"This study aims to evaluate the relationship between cognitive, metacognitive and social cognition variables in patients with psychosis undergoing VR-based Avatar Therapy for the treatment of auditory hallucinations. In addition to the primary intervention, participants will be assessed using validated tools for emotion recognition, attributional style, theory of mind, neurocognition, and metacognition. The study also explores the potential role of trauma as a predisposing factor. Assessments will be conducted at four time points: screening (week 0), baseline (week 12), intervention period (weeks 12-24), and post-therapy follow-up (week 24). By investigating these variables, this study seeks to better understand their impact on treatment outcomes and contribute to the development of personalized therapeutic approaches.",[219,220],"Schizophrenia Disorders","Treatment Resistant Hallucinations",[222,223,224,225,226,227,228,229,230,231],"VR-based Avatar Therapy","cognition","metacognition","social cognition","psychosis","schizophrenia spectrum disorders","auditory hallucinations","trauma and psychosis","emotion recognition","Personalized therapy","2025-08-22",{"date":234,"type":46},"2025-08-29",{"date":236,"type":46},"2024-03-01",{"date":238,"type":23},"2026-12-30",{"name":52,"class":53},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":248,"targetDuration":250,"studyType":189,"phases":4,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":180},"100595531","impact-of-in-utero-exposure-to-immunomodulatory-drugs-on-neonatal-immune-system-development-100595531","NCT07033663","Impact of In Utero Exposure to Immunomodulatory Drugs on Neonatal Immune System Development","Study of the Impact of Intrauterine Exposure to Immunomodulatory Drugs on the Development of the Immune System of Children Born to Mothers With Chronic Inflammatory or Oncologic Diseases: The NEWborn-IMM-PACT Study","NEWbornIMMPACT","Inclusion Criteria:\n\nPregnant women with immune-mediated inflammatory or oncologic diseases, categorized into:\n\n1. High-exposed group: monoclonal treatment throughout pregnancy.\n2. Low-exposed group: monoclonal treatment limited to the first\u002Fsecond trimester.\n3. Non-exposed group: No monoclonal exposure or treatment with non-placental-crossing biologics, serving as a control to distinguish immunological changes attributable to maternal disease.\n\n   \\-",{"count":249,"type":23},90,"12 Months","What is this project about? This project aims to better understand how the immune system develops in babies whose mothers received immunomodulatory treatments during pregnancy. These treatments are necessary for women with autoimmune, inflammatory, allergic, or cancer-related diseases who cannot stop their medication while pregnant.\n\nWhy is it important? Although these treatments help keep the mother and baby healthy, some medications can cross the placenta and affect the baby's immune system. Since pregnant women are usually not included in clinical trials, the investigators still don't know exactly how these drugs might influence the baby's immune development.\n\nHow will the investigators do it? The investigators will follow a group of pregnant women receiving these treatments and monitor their babies at birth, and at 3, 6, and 12 months. The study will take place in three leading hospitals in Spain: Hospital Sant Joan de Déu, Hospital Clínic, and Vall d'Hebron. The investigators will also use organoid models in the lab to better understand how these drugs affect fetal development.\n\nWho will benefit? This study will help parents concerned about the impact of treatments during pregnancy on their child's health. It will also give doctors the evidence they need to make safer treatment decisions, and support the creation of new clinical guidelines to protect both mothers and babies.",[253,254],"Pregnancy Related","Immune-mediated Diseases",[256,257,258],"monoclonal antibodies","pregnancy","immunomodulators","2025-08-11",{"date":261,"type":46},"2025-08-15",{"date":263,"type":46},"2018-06-01",{"date":265,"type":23},"2028-05-01",{"name":52,"class":53},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":24,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":54},"100558832","effectiveness-of-a-digital-platform-in-engagement-and-prognosis-of-patients-in-an-early-intervention-pychosis-programme-100558832","NCT06556251","Effectiveness of a Digital Platform in Engagement and Prognosis of Patients in an Early Intervention Pychosis Programme","Evaluating the Effectiveness of a Digital Platform in the Engagement and Prognosis of Patients in the Early Intervention Programme in Psychosis","Inclusion criteria:\n\n* Age between 18 and 40 years\n* Fulfil the criteria for one of the three groups (First Psychotic Episodes, Critical Period or Ultra High Risk of Psychosis; UHR)\n* To undergo community-based treatment as part of one of our facility's early intervention programmes for psychosis\n* Have signed the informed consent form for the study.\n\nExclusion criteria:\n\n* No mobile phone\u002Flaptop\u002Ftablet to use the platform.\n* Lack of skills and\u002For knowledge to use the platform.\n* Not have knowledge of the Catalan or Spanish language.\n* Have a diagnosed mental disability (premorbid Intelligence Quotient \\\u003C70).\n* Have had a medical condition that better explains the psychotic symptoms.","40 Years",{"count":276,"type":23},128,[26],"This is a randomised, prospective, controlled trial in which one group (experimental group; GE) receives access to the PIPPEP (Intervention Programme for Early Psychosis) platform in addition to the treatment as usual (TAU) in PIPPEP, while the other group (control group; GC) receives only TAU in PIPPEP.\n\nMain objective:\n\n\\- To assess whether the use of the PIPPEP platform improves psychosocial and pharmacological treatment adherence in mental health programmes.\n\nSecondary objectives:\n\n* To assess the cost-effectiveness of the PIPPEP app.\n* Evaluation of the dissemination of the platform.\n* To assess the clinical and functional outcomes of patients using the PIPPEP platform in terms of 1) positive symptoms, 2) side effects of antipsychotic medication, 3) perceived social self-stigma, 4) risk assessment, 5) comorbid symptoms and 6) social functioning\n\nThe participants are 1) between 18 and 40 years of age, who are being treated in one of the PIPPEP programmes for early intervention in psychosis at Sanitary Parc Sant Joan de Déu and who meet the inclusion criteria \"extremely high risk of psychosis\", \"critical phase or \"first psychotic episode\" and 2) agree to participate in the study and sign the informed consent form.",[280],"Device Adherence",[282,283,284,285,286],"platform","technologies","young people","early psychosis","adherence","2025-05-20",{"date":289,"type":46},"2025-05-25",{"date":291,"type":46},"2024-09-18",{"date":293,"type":23},"2027-12-31",{"name":52,"class":53},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":18,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":54},"100524427","evaluation-of-the-effect-of-a-psychological-program-for-children-with-autism-spectrum-disorder-and-feeding-difficulties-100524427","NCT06108583","Evaluation of the Effect of a Psychological Program for Children With Autism Spectrum Disorder and Feeding Difficulties","Evaluation of the Effectiveness of a Mixed (Multifamily Group) Psychological Intervention Program for Children With Autism Spectrum Disorder and Feeding Difficulties (ASD+FD)","Inclusion Criteria:\n\n* age range between 3 and 8 years old\n* confirmed diagnosis of cut-off at the Autism Diagnostic Observation Schedule-2 (ADOS-2, Lord et al., 2000)\n* presence of significant feeding difficulties, defined as one or more of the following issues: significant food rejection, significant disruptive behavior at meals, significant selectivity based on type, texture, and presentation, and significant stress to family caused by these feeding difficulties.\n* acquired oral-motor abilities to chew food\n* accepts eating at least three foods (and a maximum of 20).\n\nExclusion Criteria:\n\n* severe intellectual disability (intellectual or adaptive functioning below 35)\n* severe behavioral problems\n* medical risk situation that required more intensive intervention.","3 Years","8 Years",{"count":215,"type":23},[26],"Feeding difficulties are frequent in children with Autism Spectrum Disorder (ASD). The main goal of this project was to develop TEAlimento, a behavioral program for children ages 3-8 with ASD and feeding difficulties. The intervention combines parent training in group and individual sessions, as well as group sessions with children. The second goal was to conduct a pilot study to evaluate the effect of the program.\n\nIt was hypothesized that the intervention would decrease food rejection and disruptive behavior during meals, as well as increase the number of foods tried. A decrease in parent stress was also expected.",[308],"Autism Spectrum Disorder",[310,311,312,313],"Autism","Feeding difficulties","Clinical trial","Intervention","2025-04-23",{"date":316,"type":46},"2025-04-27",{"date":318,"type":46},"2018-01-10",{"date":320,"type":23},"2026-12-31",{"name":52,"class":53},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":17,"sex":18,"minAge":330,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":24,"phases":333,"briefSummary":334,"conditions":335,"keywords":339,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":4},"100558857","e-intervention-enhancing-mental-health-in-adolescents-100558857","NCT06556576","e-Intervention Enhancing Mental Health in Adolescents","e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)","IMPROVA","Inclusion Criteria:\n\n* Adolescents enrolled in the selected secondary schools will be eligible.\n* Parents of adolescents enrolled in the selected schools will be eligible\n* Teachers and school staff: All teachers and school staff working in the selected schools will be eligible.\n* Participants can be of any gender.\n* Teachers and school staff will have to be older than 18 years.\n\nExclusion Criteria:\n\n• Apart from not signing the informed consent, no exclusion criteria will be applied.","10 Years",{"count":332,"type":23},6000,[26],"The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study will co-design, test, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and wellbeing, early detect mental health problems and prevent common mental problems in adolescents. IMPROVA will be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff in complementary and synergistic modules based on materials designed and tested in \\>20 projects carried out by the consortium members. After alpha, beta and pilot testing of the platform, the IMPROVA program will be implemented via a randomised controlled trial in secondary education schools in France, Germany, Romania and Spain, including approximately 6,000 adolescents. A 360º evaluation of IMPROVA will include Effectiveness, Implementation, Economic, and Social Return on Investment analysis. The primary outcome to assess the effectiveness of the IMPROVA program is the overall mental health of adolescents. A series of secondary outcomes will also evaluate the potential impact of the platform on other health-related outcomes (e.g., wellbeing, social isolation, anxiety, life satisfaction). Using implementation science methodology, IMPROVA will co-design transferable evidence-based guidance for scaling up the platform with users and policymakers. IMPROVA aims to provide an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.",[336,337,338],"Well-Being, Psychological","Depressive Symptoms","Social Isolation",[36,40,41,340],"Mental health","2024-08-21",{"date":343,"type":46},"2024-08-23",{"date":345,"type":23},"2024-09",{"date":347,"type":23},"2025-12-31",{"name":52,"class":53},{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":18,"minAge":63,"maxAge":356,"enrollmentInfo":357,"targetDuration":4,"studyType":24,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":54},"100474260","effectiveness-of-the-combination-of-water-aerobics-and-metacognitive-training-100474260","NCT05455593","Effectiveness of the Combination of Water Aerobics and Metacognitive Training","Efficacy of the Combination of Water Aerobics and Metacognitive Training (MCT) on Psychological and Physical Health Variables and Their Relationship With SP1 and SP4 Biomarkers in People With Psychosis","Inclusion Criteria:\n\n* Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.\n* Psychopatological stability\n* 18 to 55 years old\n* Interested in participating in both water aerobics and MCT groups\n\nExclusion Criteria:\n\n* Head injury or intellectual disabillity (premorbid IQ \\\u003C=70)\n* Present scores on the PANSS \\>=5 in hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group\n* Patients with substance dependence disorder\n* Problems related to water activities (phobia, severe mobility problems...)","55 Years",{"count":358,"type":23},50,[26],"The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. One purpose is to analyze the improvement of clinical, cognitive, metacognitive and psychosocial variables, motor coordination and physical health condition. Another purpose is to study the changes in SP1 and SP4 biomarker transcription levels as a function of the intervention received. The hypothesis is that the combined intervention will enhance the benefits of each intervention separately, specifically in symptoms, cognition, metacognition and psychosocial variables.",[362],"Psychosis",{"date":364,"type":46},"2024-08-22",{"date":366,"type":46},"2021-08-02",{"date":368,"type":23},"2026-06",{"name":52,"class":53},{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":18,"minAge":104,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":24,"phases":380,"briefSummary":381,"conditions":382,"keywords":388,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":54},"100549272","evaluation-of-a-new-treatment-program-for-adolescents-with-eating-disorders-minerva-program-100549272","NCT06431854","Evaluation of a New Treatment Program for Adolescents With Eating Disorders: MINERVA Program","The Efficacy, Efficiency, and Patient Experience of a New Intensive Treatment Program for Adolescents With High-complexity Eating Disorders: MINERVA","Inclusion Criteria for the prospective experimental group:\n\n* Patient diagnosed with an Eating Disorder (according to the DSM-5) through a semi-structured interview (K-SADS PL-5)\n* Aged between 12 and 17 years old\n* Both patients and parents are willing to participate in the study and sign the informed consent to accept participation\n* Patient with a poor response to treatment, defined as having one of the following two conditions:\n\n  1. undergoing over a year of treatment, including partial and total hospitalization, without symptom stabilization, experiencing severe psychological distress, eating symptomatology, comorbidities, or family dysfunction during this period (clinical improvement of at least 50 on the CGAS functioning scale) OR\n  2. undergoing more than three admissions without symptom stabilization (clinical improvement of at least 50 on the CGAS functioning scale).\n\n     Exclusion criteria for the prospective group:\n* Acute ED pathology and biological decompensation that require urgent pediatric attention or admission to an acute psychiatric ward.\n\nInclusion criteria for the retrospective control group:\n\n* Aged between 12 and 17 years old\n* Diagnosed with an Eating Disorder (according to the DSM-5)\n* Received treatment in Sant Joan de Déu between 2012 and 2022\n* Patient with a poor response to treatment, defined as having one of the following two conditions:\n\n  1. undergoing over a year of treatment, including partial or total hospitalization, without achieving stabilization of ED symptomatology (needing high-intensive treatment units i.e. not being able to follow individual treatment in external consultations) OR\n  2. undergoing more than three admissions without symptom stabilization once referred to partial hospitalization in less than one year, including a similar psychological state and characteristics as the first condition\n\nExclusion criteria for the retrospective control group:\n\n* Missingness of 20% or more of the required data","17 Years",{"count":379,"type":23},120,[26],"The aim of this study is to investigate the efficacy, efficiency, and patient experience of a new intervention program on adolescents with high-complexity eating disorders (ED). A prospective group of adolescents with ED (N=60) will follow this treatment program including four different phases: 1) Inpatient treatment; 2) Family Treatment Apartment; 3) Home Treatment; 4) Recovery within the community. The investigators will use a retrospective, control group (N=60) that matched the prospective group in age, sex, ED diagnosis, and severe symptomatology. Primary variables regarding Body Mass Index (BMI), ED symptomatology, functionality, recovery (yes\u002Fno), type of outpatient services (low\u002Fmid\u002Fhigh intensity), number of readmissions, and patient experience will be assessed at discharge, and after 6 and 12 months. Secondary variables include anxiety, depression, readiness to recover, quality of life symptoms, caregiver skills, and functionality of the family",[383,384,385,386,387],"Eating Disorders in Adolescence","Anorexia Nervosa","Bulimia Nervosa","Binge-Eating Disorder","Other Specified Feeding or Eating Disorder",[389,390,391,392,393,394,395,396],"Eating Disorders","Adolescence","Inpatient treatment","Home treatment","Cognitive Behaviorial Therapy","Family-Based Treatment","Dialectical Behavioral Therapy","Systemic Family Treatment","2024-05-21",{"date":399,"type":46},"2024-05-29",{"date":401,"type":46},"2023-10-23",{"date":204,"type":23},{"name":52,"class":53},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":18,"minAge":412,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":24,"phases":416,"briefSummary":417,"conditions":418,"keywords":422,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":54},"100546466","effects-of-the-application-of-piomi-in-the-oral-feeding-of-premature-100546466","NCT06395298","Effects of the Application of PIOMI in the Oral Feeding of Premature","Effects of the Application of PIOMI (Premature Oral Motor Intervention) in the Oral Feeding of the Premature: Randomized Clinical Trial","PIOMI","Inclusion Criteria:\n\n* Neonates born at the Sant Joan de Déu Hospital with a gestational age between 29-30 weeks carrying an external feeding device due to the difficulty of oral feeding and that the medical team in charge considers clinically stable.\n\nExclusion Criteria:\n\n* Endotracheal intubation or high-flow ventilatory support.\n* Exclusive parenteral nutrition.\n* Hyporeactive due to the use of sedative drugs.\n* Condition of prematurity associated with other pathologies (syndromes, acquired brain damage, gastrointestinal malformations, airway and craniofacial malformations).","29 Weeks","30 Weeks",{"count":415,"type":23},35,[26],"The goal of this clinical trial is assess whether the application of the premature oral motor intervention (PIOMI) combined with the Newborn Individualized Developmental Care and Assessment Program (NIDCAP), allows withdrawal of the external feeding device with guarantees of the patient's nutritional status, determining breastfeeding rates at hospital discharge and swallowing safety earlier than if only the care activity corresponding to the NIDCAP model is carried out, as well as the applicability of this standardised protocol in the neonatal intensive care unit of a tertiary hospital.",[419,420,421],"Dysphagia","Disorder; Feeding, Newborn","Premature",[423,424,425,426,427,428,429],"Swallowing","Swallowing disorders","Nutritional support","Feeding disorders","Preterm","Neonates","Sucking Behavior","2024-04-29",{"date":432,"type":46},"2024-05-02",{"date":434,"type":46},"2023-02-13",{"date":238,"type":23},{"name":52,"class":53},""]