[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":517},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,43,75,108,133,152,184,206,231,260,288,315,345,370,399,428,448,467,491],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100644045","dietary-approaches-for-the-management-of-overweight-and-obesity-in-type-1-diabetes-100644045",false,"NCT07667504","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes","Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study","D1ANA","Inclusion Criteria:\n\n* T1D treated with intensive insulin therapy (multiple daily insulin injections or continuous subcutaneous insulin infusion systems)\n* HbA1c 6.5-9%\n* BMI ≥ 25 and ≤ 45 kg\u002Fm2\n* Active prescription and use of CGM\n* Active prescription for glucagon\n\nExclusion Criteria:\n\n* Pregnancy, pregnancy planning, or breastfeeding\n* Forms of diabetes other than T1D, or T1D duration \\\u003C 1 year\n* Previous cardiovascular events (acute myocardial infarction or stroke), heart failure, unstable coronary artery disease, chronic kidney disease with estimated glomerular filtration rate ≤ 30 mL\u002Fmin\u002Fm², cirrhosis, or presence of active cancer\n* Unstable diabetes, episodes of glycemic decompensation (diabetic ketoacidosis) or severe hypoglycemia (level 3) within the past year.\n* Planned change in treatment during the study (switching from multiple daily insulin injections to continuous insulin infusion, or vice versa)\n* Use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1\u002FGIP agonists, or other medications that may influence weight loss\n* Having experienced a change in body weight greater than 5% within the 3 months before screening\n* Following any form of diet prior to inclusion, carbohydrate restriction, or intermittent fasting\n* History of eating disorders or alcohol abuse\n* Inability to follow the dietary recommendations\n* Presence of other conditions that, in the investigator's judgment, may compromise participation in the study.","ALL","18 Years","65 Years",{"count":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25],"NA","Although type 1 diabetes (T1D) has traditionally been considered a disease associated with a lean phenotype, it is estimated that up to 2 out of 3 people living with T1D are overweight or obese, factors linked to an increased risk of complications in these patients. The available evidence regarding nutritional strategies for weight loss in T1D is very limited, and clinical trials are needed to determine how to effectively and safely promote weight loss in this population. In recent years, low-carbohydrate diets and several intermittent fasting protocols have demonstrated efficacy in promoting weight loss both in patients with type 2 diabetes and in patients with obesity without diabetes. In this study, we will evaluate the efficacy of moderate carbohydrate restriction, time-restricted eating, and standard calorie restriction for weight loss in adults with T1D and overweight\u002Fobesity.",[28,29],"Type 1 Diabetes (T1D)","Obesity & Overweight","NOT_YET_RECRUITING","2026-06-18",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":22},"2026-07",{"date":38,"type":22},"2028-07",{"name":40,"class":41},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":42},"100641110","sucromet-nutritional-intervention-trial-100641110","NCT07656298","SucroMet Nutritional Intervention Trial","SucroMet' Nutritional Intervention: Study of the Metabolic Impact of Sucrose (Natural Sugar) and Sucralose (Artificial Sweetener) Intake at Different Doses and Modes of Consumption in Adults With Normal Weight, Overweight, and Obesity","Inclusion Criteria:\n\n* Adults aged 18 to 65 years at the time of enrollment.\n* Body Mass Index (BMI) between 18.5 and 39.9 kg\u002Fm².\n* Men and women who report a preference for sweet taste and habitual consumption of sugar and\u002For sweeteners.\n* Individuals in good general health, as determined by:\n\n  1. Medical history and clinical evaluation;\n  2. Absence of uncontrolled chronic diseases, such as diabetes, metabolic syndrome, severe hypertension, or advanced liver or renal disease; and\n  3. Baseline biochemical parameters within normal reference ranges, including fasting plasma glucose \\\u003C100 mg\u002FdL, HbA1c \\\u003C5.7%, normal liver and renal function (ALT\u002FAST and creatinine within reference ranges), and blood pressure \\\u003C140\u002F90 mmHg without pharmacological treatment.\n* Less than 4 hours per week of moderate-to-vigorous physical activity.\n* Not following special or restrictive diets (e.g., ketogenic, strict vegetarian, or vegan diets).\n* Not taking medications known to affect metabolism, including, for example, antidiabetic drugs, systemic corticosteroids, weight-loss medications, or high-dose antioxidant supplements, except for stable use of hormonal contraceptives.\n* Willingness to maintain habitual diet and physical activity throughout the study, with the only modification being the assigned sweetener intervention.\n* Ability and willingness to comply with all study procedures and scheduled visits.\n* Provision of written informed consent before participation.\n\nExclusion Criteria:\n\n* Gastrointestinal disorders influencing digestion or nutrient absorption (e.g., inflammatory bowel disease, celiac disease, malabsorption syndromes).\n* History of cancer not in remission.\n* Uncontrolled thyroid disorders.\n* History of bariatric surgery or extreme weight loss within the past 12 months.\n* Pregnancy, breastfeeding, or planning pregnancy during the study period.\n* Acute illness, major infection, hospitalization, or major surgery within the previous 6 months.\n* Any condition that, in the investigators' judgment, could compromise participant safety, protocol adherence, or interpretation of the study results.",true,{"count":52,"type":22},120,[25],"SucroMet is designed to evaluate how adding two commonly used sweeteners-sucrose (table sugar) and sucralose (a low-calorie sweetener)-at low and high doses may influence glucose regulation, including insulin resistance and fasting plasma glucose, in adults aged 18 to 65 years with normal weight, overweight, or obesity.\n\nThe low-dose intervention consists of 5% of the Estimated Energy Requirement (EER) from sucrose or 5 sucralose tablets per day (approximately 33.35 mg\u002Fday of sucralose). The high-dose intervention consists of 10% of EER from sucrose or 10 sucralose tablets per day (approximately 66.7 mg\u002Fday of sucralose). These doses maintain the planned 1:2 exposure ratio between the low- and high-dose intervention groups.\n\nBefore the intervention begins, participants' habitual dietary intake is assessed and, when necessary, minor dietary adjustments are made to support a stable overall eating pattern while maintaining energy intake. Participants then complete a four-week run-in period during which these recommendations are followed, and dietary records are used to verify dietary stability before the intervention starts.\n\nParticipants will consume the assigned sweetener incorporated into foods or beverages that they already consume as part of their habitual diet, without substantial changes to their usual eating patterns. The intervention includes two consecutive 12-week phases, one involving solid food intake and the other involving liquid intake, separated by a two-week washout period. This design allows evaluation of the effects of sweetener type, dose, and mode of consumption.\n\nThe primary outcomes are changes in glucose regulation, including fasting plasma glucose and insulin resistance assessed by HOMA-IR. Secondary outcomes include changes in body composition, anthropometric measurements, blood pressure, routine biochemical parameters, gut microbiota composition, DNA methylation patterns in peripheral blood cells, and biomarkers related to inflammation, oxidative stress, and metabolomic profiles measured in blood and urine.\n\nParticipants will attend scheduled study visits for anthropometric assessments, dietary evaluations, and biological sample collection. Blood, urine, and stool samples will be obtained at baseline and after each intervention phase.\n\nThe study aims to address the following questions:\n\n1. Do metabolic responses to sucrose and sucralose, including changes in insulin resistance (HOMA-IR) and fasting plasma glucose, differ according to participants' body mass index (BMI)?\n2. Do low and high doses of sucrose and sucralose differentially affect glucose regulation, body composition, and metabolic health?\n3. Does the mode of intake (solid versus liquid) influence changes in gut microbiota composition?\n4. Are changes in DNA methylation patterns in peripheral blood cells associated with the consumption of sucrose and sucralose at different doses and in different forms?\n5. Do different doses of sucrose and sucralose influence biomarkers related to inflammation, oxidative stress, and metabolomic profiles?",[56,57],"Overweight , Obesity","Glucose Metabolism",[59,60,61,62,57,63,64,65,66,67],"Sucrose","Sucralose","Sweeteners","Body Composition","Gut Microbiota","DNA Methylation","Inflammation","Oxidative Stress Biomarkers","Nutritional Intervention","RECRUITING","2026-06-15",{"date":31,"type":34},{"date":36,"type":22},{"date":73,"type":22},"2027-09",{"name":40,"class":41},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":42},"100620825","single-cell-immune-response-to-controlled-gluten-ingestion-in-pediatric-celiac-disease-100620825","NCT07362654","Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease","Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease","CELLiomicS","Inclusion Criteria:\n\n* Age 8 to 14 years at study entry.\n* Diagnosis of celiac disease according to ESPGHAN 2020 criteria.\n* At least 18 months on a strict gluten-free diet (GFD).\n* Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.\n* Asymptomatic from a gastrointestinal perspective in the preceding weeks.\n* Ability to swallow the gluten\u002Fplacebo preparation.\n* Written informed consent from parents\u002Flegal guardians and assent from the child.\n\nExclusion Criteria:\n\n* Obesity defined as BMI ≥ 95th percentile according to WHO criteria.\n* Diagnosed inflammatory bowel disease or diabetes mellitus.\n* Acute infectious illness at the time of inclusion.\n* Chronic hepatic, pulmonary, renal, or rheumatologic disease.\n* History of severe acute reactions to accidental gluten ingestion.\n* Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.\n* Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.","8 Years","14 Years",{"count":86,"type":22},51,[25],"This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.\n\nUsing single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.",[90,91,92],"Celiac Disease","Gluten Sensitivity","Autoimmune Diseases",[90,94,95,96,97,98,99],"Gluten Exposure","Single-Cell RNA Sequencing","Gluten-Free Diet","Immune Response","Pediatrics","Omics","2026-04-22",{"date":102,"type":34},"2026-04-27",{"date":104,"type":34},"2025-07-07",{"date":106,"type":22},"2026-11",{"name":40,"class":41},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":42},"100635594","chronobiology-and-enteral-nutrition-100635594","NCT07554716","Chronobiology and Enteral Nutrition","Chronobiology and Chronodisruption in People Receiving Medical Nutritional Therapy and Its Impact on the Quality of Life of Patients and Caregivers. A Descriptive and Interventional Study. Chronumet.","Inclusion Criteria:\n\n* Use of enteral nutrition (EN) for 15 days or more. Participants must be from the Regional University Hospital of Málaga (HRUM), Virgen del Rocío Hospital of Seville (HVR), Reina Sofía University Hospital of Córdoba, or the NUPA Association.\n* Participants must not have experienced acute metabolic decompensation in the last 7 days.\n* Participants must be able to answer the questionnaires with or without family support.\n* Participants must provide informed consent (patient or legal representative).\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of melatonin for sleep.\n* Uncontrolled psychiatric condition.",{"count":116,"type":22},60,[25],"Medical Nutritional Therapy (MNT) is critical for patients with impaired oral intake and is typically administered via enteral nutrition (EN). Current infusion practices-continuous 24-hour enteral nutrition for hospitalised patients-may induce circadian misalignment (chronodisruption). This misalignment can negatively impact metabolic function, sleep quality, and overall quality of life for both patients and caregivers. Synchronising MNT administration with circadian rhythms may improve metabolic balance, sleep, and patient well-being.\n\nHypothesis: The timing of the administration of Medical Nutritional Therapy via continuous enteral nutrition (EN) in hospitalised patients may induce chronodisruption in biological rhythms (clock genes). This disruption can affect the metabolism of carbohydrates, lipids, and proteins, contributing to morbidity and altering chronotype, quality of life, and sleep patterns.",[120],"Hospitalised Patients With Enteral Nutrition",[122,123,124],"Chronobiology","Enteral Nutrition","Biological rhythms","2026-04-21",{"date":127,"type":34},"2026-04-28",{"date":129,"type":34},"2025-10-10",{"date":131,"type":22},"2027-12-31",{"name":40,"class":41},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":113,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":151,"locationsCount":42},"100635593","chronobiology-and-home-parenteral-nutrition-study-chrono-hpn-study-100635593","NCT07554703","Chronobiology and Home Parenteral Nutrition Study. CHRONO-HPN Study","Inclusion Criteria:\n\n* Participants must have been receiving nighttime home parenteral nutrition (NPN) for at least two consecutive months.\n\nReferred from the Regional University Hospital of Málaga (HRUM), Virgen del Rocío Hospital of Seville (HVR), Reina Sofía University Hospital of Córdoba, or the NUPA Association.\n\n* Participants must not have suffered any recent acute illnesses.\n* Participants must not have been hospitalized, received transfusions, or visited the emergency room in the last month.\n* Participants must not have made significant changes to their diet or physical activity during the last two months.\n* Participants must provide informed consent (patient or legal representative).\n* Participants must be able to answer the questionnaires.\n* Participants must be metabolically and clinically stable.\n\nExclusion Criteria:\n\n* Known sleep or circadian rhythm disorders.\n* Use of melatonin for sleep.",{"count":140,"type":22},20,[25],"Medical Nutritional Therapy (MNT) is critical for patients with impaired oral intake and is typically administered via parenteral nutrition (PN). Current infusion practices-nocturnal home parenteral nutrition (NHPN)-may induce circadian misalignment (chronodisruption). This misalignment can negatively impact metabolic function, sleep quality, and overall quality of life for both patients and caregivers. Synchronising MNT administration with circadian rhythms may improve metabolic balance, sleep, and patient well-being.\n\nHypothesis: The timing of the administration of Medical Nutritional Therapy via nocturnal home parenteral nutrition (NHPN) in outpatients may induce chronodisruption in biological rhythms (clock genes). This disruption can affect the metabolism of carbohydrates, lipids, and proteins, contributing to morbidity and altering chronotype, quality of life, and sleep patterns.",[144],"Patients With Home Parenteral Nutrition",[122,146,124],"Parenteral Nutrition",{"date":127,"type":34},{"date":149,"type":34},"2025-08-18",{"date":131,"type":22},{"name":40,"class":41},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":166,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":42},"100634066","nima-colon-cancer-study-100634066","NCT07534852","NIMA-Colon Cancer Study","Nutritional, Inflammatory, and Muscular Assessment (NIMA) in Patients With Colon Cancer","NIMA","Inclusion Criteria:\n\n* Adults aged 18 to 75 years.\n* Male and female participants.\n* Diagnosis of colon cancer at localized or locally advanced stages (TNM stages I-III).\n* Patients scheduled for primary surgical treatment.\n\nExclusion Criteria:\n\n* Metastatic disease (stage IV)\n* Diagnosis of rectal cancer or tumors involving the rectum\n* Prior neoadjuvant chemotherapy or radiotherapy before surgery.\n* Presence of synchronous malignant tumors.\n* Pregnant or breastfeeding women.\n* Presence of severe medical conditions, including acute pancreatitis, severe liver or kidney disease, heart failure, severe pulmonary disease, or peripheral arterial disease affecting the lower limbs.\n* Diagnosis of anorexia nervosa or other severe eating disorders.\n* Known allergy or intolerance to any nutritional supplements used in the study.\n* Medical contraindications to moderate-to-vigorous physical activity.\n* Regular participation in high-intensity exercise programs.\n* High risk of poor adherence to the study procedures, as determined by the study team.","75 Years",{"count":52,"type":22},[25],"The goal of this study is to evaluate the effects of nutritional supplementation and physical activity interventions on recovery, muscle strength, nutritional status, inflammation, and metabolic health in adults with colon cancer undergoing surgery.\n\nPatients with colon cancer frequently experience loss of muscle mass, reduced physical function, and nutritional deterioration both before and after surgery, which may adversely affect recovery and quality of life.\n\nA key objective of this study is to assess whether a postoperative intervention combining nutritional supplementation with beta-hydroxy beta-methylbutyrate (HMB) and vitamin D, together with a structured physical activity program, can improve muscle strength and functional recovery following colon cancer surgery.\n\nThis study aims to answer the following questions:\n\n* Does nutritional supplementation with HMB and vitamin D, combined with postoperative physical activity, improve muscle strength and physical function following colon cancer surgery?\n* How do nutritional and lifestyle interventions influence nutritional status, gut microbiota composition, and biological markers of inflammation and metabolism during the recovery period?\n* Are there differences in recovery outcomes between patients receiving different types of nutritional support, with or without supervised physical activity?\n\nParticipants will be adults diagnosed with colon cancer who undergo surgical treatment at the Hospital Universitario Virgen de la Victoria in Málaga, Spain. Patients will be recruited prior to surgery and will enter a prehabilitation phase integrated into routine care provided by the Endocrinology and Nutrition Department.\n\nDuring this prehabilitation phase, nutritional status will be assessed and optimized using standard clinical care, including oral nutritional supplementation when indicated. The aim is to improve the patient's condition before surgery. Approximately one month after surgery, once initial postoperative recovery has been completed, participants will enter the intervention and assessment phase (baseline visit).\n\nParticipants will then be randomly assigned to one of four study groups in a 2×2 factorial design. These groups combine two nutritional strategies (standard care or supplementation with HMB and vitamin D) and two physical activity approaches (supervised exercise or general activity recommendations). The physical activity component, supervised by the Endocrinology and Nutrition team, will be objectively evaluated using an accelerometer-based device. Participants will be followed for approximately six months, with assessments at about 3 and 6 months after the baseline visit.\n\nAt each visit, participants will undergo:\n\n* Body composition measurements\n* Muscle strength and physical performance tests\n* Collection of blood, urine, and stool samples\n* Questionnaires on health status and quality of life\n\nThe results of this study will contribute to a more profound understanding of how tailored nutritional strategies and postoperative physical activity may support recovery and functional health in patients undergoing surgery for colon cancer.",[165],"Colon Cancer",[167,168,169,170,65,171,172,173,174,175],"Colon cancer","Nutritional supplementation","Physical activity","Muscle strength","Gut microbiota","Beta-hydroxy beta-methylbutyrate supplementation","Vitamin D supplementation","Quality of life","Body composition","2026-04-10",{"date":178,"type":34},"2026-04-16",{"date":180,"type":34},"2025-07-01",{"date":182,"type":22},"2027-12",{"name":40,"class":41},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":42},"100580151","mentalizing-and-epistemic-trust-in-patients-with-anxiety-and-depression-100580151","NCT06833567","Mentalizing and Epistemic Trust in Patients With Anxiety and Depression.","Brief Mentalization-based Group Psychotherapy for Anxiety and Depression Disorders and Spanish Cultural Adaptation and Validation of the Epistemic Trust Questionnaire (QET)","Inclusion Criteria:\n\n* Participants are 18 years or older.\n* Participants have a diagnosis of ICD-10 F32, F33, F34, F41.1, F41.2, F43 or F43.2.\n* Participants have minimal relational skills to participate in group therapy.\n* Participants agree to be part of the study by giving signed written consent.\n\nExclusion Criteria:\n\n* Participants have a diagnosis of ICD-10 F10-19, F20-29, F31, F42, F43.1, F60.\n* Participants with cognitive deficits assessed during the initial interview or diagnosis of ICD-10 F70-79.\n* Participants with planning or structured suicidal ideation.\n* Participants with difficulties in relational skills evaluated during the initial interview.",{"count":192,"type":22},100,[25],"This randomized clinical trial aims to evaluate the effects of mentalization-based group psychotherapy in patients diagnosed with anxiety and\u002For depression disorders. In total 100 users of mental health communitary services will be recruited for this study. Participants will be randomized in two parallel groups: to receive usual acceptance and commitment therapy group intervention (control group) or to receive brief mentalization-based group psychotherapy (intervention group). Participants in the trial will be assessed at baseline and at 3 months.",[196,197],"Anxiety Disorders","Depression","2026-03-19",{"date":200,"type":34},"2026-03-23",{"date":202,"type":34},"2024-04-28",{"date":204,"type":22},"2026-06",{"name":40,"class":41},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":17,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100618488","phase-3-levothyroxine-as-adjuvant-to-a-hypocaloric-diet-for-the-treatment-of-obesity-100618488","NCT07332273","Levothyroxine as Adjuvant to a Hypocaloric Diet for the Treatment of Obesity.","Effect of Levothyroxine as Adjuvant Therapy to a Hypocaloric Diet in the Treatment of Obesity: a Randomized Placebo-controlled Trial.","Inclusion Criteria:\n\n* Adults 25-60 years of age.\n* Obesity grade I-II: BMI 30.0-39.9 kg\u002Fm².\n* Either subclinical hypothyroidism (TSH 5-10 mIU\u002FL with normal peripheral hormones) or euthyroid with TSH in the highest tertile of the population reference range (no known thyroid disease).\n* Able and willing to provide written informed consent.\n* Women of childbearing potential: not pregnant or breastfeeding and using a highly effective contraception method (failure rate \\\u003C1%) per CTCG guidance (e.g., hormonal methods, IUD\u002FIUS, sterilization, or dual barrier with spermicide).\n\nExclusion Criteria:\n\n* Diabetes mellitus (HbA1c ≥6.5%, fasting glucose ≥126 mg\u002FdL, or 2-h OGTT ≥200 mg\u002FdL).\n* Any prior thyroid disease (hyperthyroidism, overt hypothyroidism) or prior LT4 treatment.\n* Current or recent (≤3 months) use of levothyroxine, hypoglycaemic agents, antibiotics, or regular probiotics\u002Fprebiotics.\n* Active cancer or cancer within the last 5 years (except basal-cell carcinoma).\n* Chronic liver disease with total bilirubin ≥2.0 mg\u002FdL or AST \\>3× ULN.\n* Established cardiovascular disease (e.g., stroke, ischemic heart disease, peripheral artery disease).\n* Atrial fibrillation or any arrhythmia history.\n* Uncontrolled hypertension (\\>160\u002F100 mmHg) despite therapy (assessed by ABPM at screening).\n* Any heart failure; resting HR \\>85 bpm; eGFR \\\u003C60 mL\u002Fmin.\n* Known HIV, HBV, or HCV infection.\n* Acute inflammatory disease or inflammatory bowel disease.\n* Serious underlying disease that, in the investigator's judgment, could affect participation.\n* Drug\u002Falcohol abuse, life expectancy \\\u003C12 months, inability to follow the recommended diet or attend visits.\n* Positive pregnancy test, pregnant, expecting pregnancy, or breastfeeding.\n* Hypersensitivity to any component of the investigational product.\n* Inability or unwillingness to provide informed consent.","25 Years","60 Years",{"count":216,"type":22},286,[218],"PHASE3","Obesity is a chronic disease with high relapse rates after initial weight loss. Thyroid hormones modulate energy expenditure, body composition, and thermogenesis; higher TSH within the reference range and subclinical hypothyroidism have been associated with adverse metabolic profiles and weight gain. These signals suggest the thyroid axis could influence weight-loss response and subsequent regain. Levothyroxine (LT4) is widely used for hypothyroidism; evaluating its adjuvant role in obesity management is clinically relevant.\n\nThis is a phase III, randomized, double-blind, placebo-controlled, multicentre clinical trial conducted in five Spanish hospitals. A total of 286 adults (25-60 years) with grade I-II obesity will be enrolled if they have subclinical hypothyroidism (TSH 5-10 mIU\u002FL with normal peripheral hormones) or are euthyroid with TSH in the highest tertile of the reference range. Participants are randomized 1:1, stratified by age, sex, and BMI.\n\nIntervention: LT4 88 µg once daily or matching placebo for 9 months. During months 0-3, all participants receive a structured hypocaloric Mediterranean diet (≈600 kcal\u002Fday deficit; macronutrients 45% carbohydrates, 35% fats, 20% proteins) plus standardized physical-activity advice. From months 3-9, lifestyle support continues with a normocaloric Mediterranean diet. Physical-activity guidance targets ≥150 min\u002Fweek of moderate-to-vigorous activity (spread over ≥3 days) and 2-3 resistance sessions\u002Fweek.\n\nPrimary endpoint (3 months): change in body weight (kg and %) and body composition (BMI, waist\u002Fhip circumferences, fat mass, fat-free mass, total body water by bioimpedance) comparing LT4 versus placebo under the same lifestyle program. The study is powered for n=286.\n\nKey secondary endpoints (up to 9 months): prevention of weight regain; changes in obesity stage; cardiometabolic markers (lipids, glucose\u002FHbA1c, HOMA-IR, adipokines, inflammation, blood-pressure patterns); resting energy expenditure by indirect calorimetry; objectively measured physical activity by accelerometry; cardiac parameters (ECG) and safety; quality of life (EuroQol-5D). Mechanistic substudies assess adipose-tissue metabolic activity (gene\u002Fprotein expression, browning markers, mitochondrial DNA) and explore gut microbiota, epigenetic signatures, nitrogen balance, and sex-specific differences in response.\n\nAssessments are performed at baseline and follow-up visits through 9 months and include anthropometry, bioimpedance, laboratory panels, indirect calorimetry, ambulatory blood-pressure monitoring, ECG, diet\u002Fphysical-activity questionnaires, and biobanking of blood, urine, and stool; an adipose-tissue biopsy is obtained in a subsample.\n\nThe trial uses intention-to-treat analyses with mixed linear models and is designed with 90% power to detect a clinically meaningful between-group difference in 3-month weight loss; total sample size is 286 (143 per arm). Overall study duration is 21 months (12 months of recruitment plus 9 months of treatment\u002Ffollow-up); each participant remains in the study for 9 months.\n\nIn summary, this trial tests whether adding LT4 88 µg\u002Fday to a structured Mediterranean-diet and exercise program enhances early weight loss and helps prevent regain versus placebo in adults with obesity and high-normal TSH or subclinical hypothyroidism, while characterizing metabolic mechanisms and biomarkers of response.",[221],"Obesity","2026-01-09",{"date":224,"type":34},"2026-01-12",{"date":226,"type":34},"2025-11-05",{"date":228,"type":22},"2027-05",{"name":40,"class":41},5,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":242,"studyType":243,"phases":4,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":259,"locationsCount":4},"100601170","climair-ai-to-assess-the-impact-of-pollution-and-climate-on-respiratory-health-in-europe-100601170","NCT07107009","ClimAIr: AI to Assess the Impact of Pollution and Climate on Respiratory Health in Europe","Climate Change and Air Contamination: Artificial Intelligence Applied on the Correlation Between Air Pollutants and Non-communicable Respiratory Diseases in Europe (ClimAIr)","ClimAIr","Inclusion Criteria:\n\n1. Patients with health insurance based in Malaga, Milan, Luxembourg, Thessalonikki, Lodz, Berlin, Toulousse, Chervnivtsi and Brasov (the places where environmental\u002Fclimate information will be obtained from, only one recruitment place for partner).\n2. 3-year history of chronic rhinitis symptoms during the corresponding pollen season, while residing in the same household AND attending the same school\u002Fcollege or holding the same job position.\n3. Positive SPT and serum allergen-specific IgE \\>0.35 kUA\u002FL. The pollen species driving the nasal symptoms will be Olea europaea, Phleum pratense or Betula pendula.\n4. Patients can be sensitized to other aeroallergens if the nasal symptoms occur exclusively or aggravate unequivocally during the pollen season of the three allergens of interest.\n\nExclusion Criteria:\n\nLack of reliable information in e-health records, allergen immunotherapy (any allergen) during the previous 5 years, systemic immunosuppressants or biologicals in the previous six months, chronic rhinosinusitis, and severe systemic conditions.","12 Years",{"count":241,"type":22},1906,"3 Months","OBSERVATIONAL","The ClimAIr project will expand the evidence-based understanding of climate change, air pollution, and non-communicable respiratory diseases by using Artificial Intelligence (AI) tools. It will gather data on greenhouse gases levels and disaster risks, information on serious air pollutants and respiratory diseases' prevalence. The AI powered tools will be employed to generate better intervention methods and improve public health outcomes.\n\nFederated Learning (FL) will be used to develop AI models to protect patients' privacy. By raising public awareness and delivering the ClimAIr tool - specifically designed to health workers, urban planners and policy makers - the project aims to influence policy decisions, promote healthier environments, and reduce respiratory diseases in Europe, which will be tested and validated the ClimAIr tool in specific municipalities that are part of the project. ClimAIr draws on a consortium of 21 partners from 15 European countries, including carefully selected health centres across Europe - in Spain, Luxembourg, Ukraine, Italy, France, Germany, Greece, Romania and Poland - focused on respiratory diseases, which will provide disease data and explore metabolic routes of the studied contaminants\u002Fdiseases. ClimAIr is composed of an interdisciplinary team formed by research centres, ethical AI and modelling experts, SSH specialists, municipal governance, and a Communication \\& Dissemination (C\\&D) expert team dedicated to achieving and spread the results of the project.",[246,247],"Allergic Rhinitis","Asthma",[249,250,251,252,237],"Air contamination","Air pollutants","Non-communicable respiratory diseases","Climate change","2025-12-09",{"date":255,"type":34},"2025-12-17",{"date":257,"type":22},"2026-01",{"date":182,"type":22},{"name":40,"class":41},{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":273,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":42},"100581569","effects-of-peptamen-16-in-malnourished-patients-or-at-risk-with-pancreatic-neoplasia-undergoing-cephalic-pancreaticoduodenectomy-cpd-a-mechanistic-study-100581569","NCT06852014","Effects of Peptamen 1.6 in Malnourished Patients (or at Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Mechanistic Study","Effects of Peptamen 1.6 in Malnourished Patients (or in Risk) With Pancreatic Neoplasia Undergoing Cephalic Pancreaticoduodenectomy (CPD): A Study Mechanistic.","Inclusion Criteria:\n\n* Ambulatory patients who are malnourished or at risk of malnutrition, with a confirmed diagnosis of neoplasms of the periampullary region, pancreas, and duodenum, or pancreatic cancer, and who have undergone cephalic pancreaticoduodenectomy (CPD).\n* No prior neoadjuvant treatment (preoperative chemotherapy or radiotherapy): Patients must not have received neoadjuvant therapy as these treatments can affect metabolism, nutritional status, and gut microbiota, potentially interfering with the objectives of the study's nutritional intervention.\n\nExclusion Criteria:\n\n* Refusal to sign informed consent: Informed consent is a mandatory requirement for study participation. Any patient unwilling to participate voluntarily will be excluded.\n* Patients who underwent surgery more than three months ago will be excluded, as the nutritional intervention must begin in the immediate postoperative period to adequately evaluate its impact on nutritional and metabolic status.\n* Presence of severe cardiac disease, nephropathy, or other severe comorbidities: Conditions such as severe cardiac disease, renal failure, or comorbidities that could induce malnutrition or impair the patient's ability to tolerate nutritional treatment will be exclusion criteria. These conditions may interfere with assessing the effects of nutritional supplementation in the context of pancreatic cancer treatment.\n* Diarrhoea associated with antibiotics, laxatives, or osmotically active agents: Diarrhoea caused by medications may alter nutrient absorption and affect tolerance to the nutritional supplement, potentially skewing results attributable solely to the nutritional intervention.\n* Treatment with other nutritional support: Patients receiving other oral nutritional supplement, enteral or parenteral nutrition will be excluded, as interactions with the studied formula could confound the efficacy results of the study's nutritional intervention.\n* Pregnancy or possibility of becoming pregnant.\n* Type 1 or Type 2 diabetes with HbA1c \\>8%.\n* Galactosaemia, fructosaemia, or allergies to components of the nutritional supplement.",{"count":140,"type":22},[25],"Malnutrition is a common challenge in patients with pancreatic cancer undergoing cephalic pancreaticoduodenectomy (CPD), impacting postoperative recovery and overall prognosis. Nutritional support plays a crucial role in optimising metabolic, inflammatory, and digestive outcomes. This randomised, double-blind, crossover clinical trial aims to evaluate the effects of Peptamen 1.6, a hydrolysed whey protein-based enteral formula, compared to Resource HP\u002FHC, a high-protein and high-calorie polymeric formula, in malnourished or at-risk patients with pancreatic cancer undergoing PD.\n\nThe study comprises both in vivo and in vitro analyses. The in vivo component will assess the impact of Peptamen 1.6 on digestive tolerance, amino acid absorption, nutritional status, metabolic profile, inflammatory markers, and gut microbiota composition. The in vitro component will utilise human intestinal organoid models to explore how enteral nutrition formulations influence intestinal permeability and metabolism, with a focus on microbiota interactions.\n\nPrimary outcomes include improvements in metabolic status, assessed through serum biomarkers (albumin, immune markers, intestinal permeability, and myosin profile), inflammatory status via peripheral blood mononuclear cells (PBMCs), and microbiota shifts in faecal samples. Additionally, adherence to treatment, digestive tolerance, and changes in body composition will be monitored using bioelectrical impedance, dynamometry, and functional mobility tests.\n\nBy elucidating the mechanisms through which different enteral nutrition strategies influence clinical, physiological, and molecular parameters, this study aims to enhance personalised nutritional interventions for patients with pancreatic cancer. The findings could contribute to optimising nutritional support strategies, ultimately improving patient outcomes following CPD.",[271,272],"Pancreatic Cancer, Adult","Cephalic Duodenopancreatectomy",[274,275,276,277,278,279],"Pancreatic cancer","malnutrition","pancreaticoduodenectomy","oral nutritional supplement","gut microbiota","organoids","2025-08-26",{"date":282,"type":34},"2025-09-02",{"date":284,"type":34},"2025-05-29",{"date":286,"type":22},"2026-09-01",{"name":40,"class":41},{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":296,"enrollmentInfo":297,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":313,"leadSponsor":314,"locationsCount":4},"100598585","omalizumab-for-plant-food-allergy-due-to-sensitization-to-ltp-or-profilin-100598585","NCT07073404","Omalizumab for Plant-Food Allergy Due to Sensitization to LTP or Profilin","Omalizumab for the Monotherapy Treatment of Patients With Allergy to Foods of Plant Origin Due to Sensitization to Lipid Transfer Proteins (LTPs) and Profilin","Omlyclo","Inclusion Criteria:\n\n* Males or females aged 14-55 years who sign the informed consent (IC) for the study and Biobank sample storage.\n* Allergy to plant foods due to sensitisation to LTP, patients allergic to profilin confirmed by a suggestive clinical history, positive skin tests and specific IgE to Pru p 3 (peach LTP) and Pho d 2 (Phoenix dactylifera profilin).\n* Positive oral challenge test (OPT) to peach and at least one other food in patients allergic to LTP and positive oral challenge test to melon and at least one other food in patients allergic to profilin.\n* Selection of a group of LTP-allergic individuals with therapeutic failure after treatment with ITSL-Pru p 3.\n\nExclusion Criteria:\n\n* Pregnancy and lactation.\n* Immunological diseases; treatment with immunomodulatory and\u002For blocking drugs.\n* Mental illness, which makes it impossible to follow and adhere to treatment (e.g. major depression, psychosis, etc.).\n* Severe atopic dermatitis according to SCORAD 5: FEV1\\\u003C70% (this test will be carried out as a priority in patients with a previous diagnosis of asthma).\n* Inflammation in the oral cavity with severe symptoms, as well as with oral surgery in the previous 7 days.\n* Immunotherapy with pollens in the previous 2 years.\n* Subjects unable to comply with the schedule of visits during the study, as well as due to the consumption of the food under investigation, for example, due to work difficulties.","55 Years",{"count":298,"type":22},37,"Omalizumab has demonstrated efficacy, increasing the tolerance threshold in patients with multiple food allergies, as well as reducing the risk of severe reactions when used as monotherapy. This favors improving the reactivity profile of patients with food allergy. In our setting, plant allergy caused by sensitization to panallergens such as lipid transfer proteins (LTPs) and profilins entails important limitations for the consumption of a healthy diet due to the extensive dietary restrictions.\n\nThe main objective of this project is to analyze the efficacy of treatment with omalizumab administered every 2-4\u002Fweeks, used in monotherapy in patients with plant allergy due to sensitization to profilin and LTPs and those patients in whom sublingual immunotherapy with Pru p 3 (peach LTP), has not been effective, by performing a before-after study we will evaluate the changes in clinical reactivity to LTP (peach) and profilin (melon) and the changes immunological effect after omalizumab intervention. In addition, we will evaluate the changes in reactivity to at least one food other than peach and melon in the different sensitization profiles.",[301],"Food Allergies",[303,304,305,306,307,308],"Omalizumab","FOOD ALLERGIES","LTP","Profilins","Allergy desensitization","Lipid transfer proteins","2025-08-06",{"date":311,"type":34},"2025-08-12",{"date":257,"type":22},{"date":182,"type":22},{"name":40,"class":41},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":333,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":42},"100598088","implementing-online-mental-health-program-100598088","NCT07066943","Implementing Online Mental Health Program","A Hybrid Type 3 Effectiveness-implementation Trial of an Online Psychotherapy Program for Mental Health Prevention Among Healthcare Professionals in the Andalusian Health System","IM-MIND-SAS","Inclusion Criteria:\n\n1. Being a current healthcare professional.\n2. Age between 18 and 70 years.\n3. Ability to understand Spanish.\n4. Digital literacy and access to a smartphone, tablet or computer with internet connection.\n5. Continuity in the same workplace for at least 6 months (6) signing the informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Diagnosis of serious mental illness.\n2. Suicidal ideation.\n3. Substance abuse or related disorders.","70 Years",{"count":325,"type":22},130,[25],"This study evaluates the feasibility, acceptability, and sustainability of MINDxYOU, a self-guided online psychotherapy program designed to reduce stress and improve the mental well-being of healthcare professionals in the Andalusian public health system. The trial uses a hybrid type 3 effectiveness-implementation design, combining the evaluation of implementation outcomes with observation of clinical effects on stress, anxiety, and depression. The intervention includes mindfulness, compassion, and acceptance-based practices delivered in four online modules over eight weeks. The study will be conducted in two phases: an initial hospital-based pilot and a broader rollout across primary care and hospital centers. Results will help identify how digital mental health interventions can be integrated into routine healthcare settings to support professionals working under high stress.",[329,330,331,332],"Stress","Healthcare Workers","Mindfulness","Prevention Intervention",[334,335,336],"Third-wave psychotherapies","mindfulness","healthcare workers","2025-07-04",{"date":339,"type":34},"2025-07-15",{"date":341,"type":22},"2025-11",{"date":343,"type":22},"2027-07",{"name":40,"class":41},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":352,"enrollmentInfo":353,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":42},"100588062","the-cooling-sensation-safe-deglution-study-100588062","NCT06936501","The Cooling Sensation Safe Deglution Study","Evaluation of the Perception of Freshness and Swallowing Safety in Stroke Patients With Dysphagia Receiving a Specially Designed Thickened Oral Nutritional Supplement: the Cooling Sensation Safe Deglution Study","Inclusion Criteria:\n\n* Men and women over 18 years old.\n* Currently hospitalized due to an acute stroke.\n* Confirmed diagnosis of dysphagia through V-VST (Volume-Viscosity Swallow Test).\n* Ability to collaborate and respond to questionnaire questions and other research tools used in the study.\n* Malnutrition or risk of malnutrition, requiring a thickened, high-calorie, high-protein ONS, as determined by medical assessment in routine clinical practice.\n* Voluntary written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment that interferes with the correct interpretation of the study or its requirements.\n* Diagnosis of advanced dementia, severe psychiatric illness, or any other central nervous system condition that impairs the patient's comprehension of the study.\n* Sociocultural, linguistic, intellectual, or other factors that hinder the patient's proper understanding of the study.\n* Diagnosis of galactosemia.\n* Intolerance or refusal (for any reason) of oral nutritional supplements.\n* Requirement for parenteral nutrition or contraindication to oral intake.\n* Severe active renal, hepatic, or gastrointestinal diseases that contraindicate the use of ONS","99 Years",{"count":354,"type":22},15,[25],"Dysphagia is a common complication in patients who have suffered a cerebrovascular accident (CVA), with an incidence ranging from 29% to 81%. Rehabilitation improves dysphagia in 47% of cases within the first few weeks and in 17% within 2-4 months. However, dysphagia can lead to nutritional and respiratory complications, affecting recovery and increasing healthcare costs due to the need for prolonged hospitalizations and readmissions.\n\nMalnutrition is a frequent consequence of CVA, with its prevalence increasing from 12% to 50% in patients with prolonged hospital stays. This condition worsens the vital prognosis, as it increases the incidence of complications and slows down functional recovery.\n\nPost-stroke dysphagia causes unsafe swallowing and increases the risk of aspiration, pneumonia, and other respiratory infections, worsening the patient's prognosis. Impaired swallowing efficiency leads to oral and pharyngeal residue, aggravating nutritional complications. On the other hand, swallowing safety is characterized by the presence of aspirations, manifesting as coughing, wet voice, and oxygen desaturation during the Volume-Viscosity Swallow Test (V-VST).\n\nThe dietary management of these patients includes modifying food textures and using thickened liquids, strategies that have been shown to reduce the incidence of aspiration pneumonia. However, adherence to these diets is often low due to dissatisfaction with the texture and taste of thickening agents.\n\nIn this context, the development of oral nutritional supplements (ONS) with stimulating flavors has been proposed to improve the perception of swallowing safety. Stimulation of the oropharyngeal sensory nerves, through activation by cold and chemical agents such as menthol, enhances swallowing by increasing oral sensitivity and improving the pharyngeal swallowing reflex response. The European Society for Swallowing Disorders (ESSD) recommends sensory stimulation as a therapeutic strategy to compensate for oropharyngeal sensory loss in patients with dysphagia.\n\nPrevious studies have shown that sensory stimulation activates the swallowing center in the brainstem, accelerating the swallowing response and protecting the airway. In clinical trials with transient receptor potential (TRP) receptor agonists, observed benefits include faster closure of swallowing sphincters, improved swallowing reflex sensitivity, a 50% reduction in microaspirations, and a 67% decrease in pharyngeal residue.\n\nBased on this evidence, a new thickened ONS with stimulating flavors such as mango-mint and lemon-mint has been designed to enhance the perception of freshness and swallowing safety. This supplement is already used in clinical practice, but its effect on the perception of patients with post-stroke dysphagia has not yet been evaluated.",[358],"Neuromotor Dysphagia After Acute Stroke",[360,361,362],"dysphagia","cerebrovascular accident","oral nutritional supplements","2025-06-30",{"date":180,"type":34},{"date":366,"type":34},"2025-05-19",{"date":368,"type":22},"2026-03-30",{"name":40,"class":41},{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":214,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":42},"100559007","pectin-intervention-study-and-long-term-follow-up-in-lipid-transfer-proteins-allergic-patients-100559007","NCT06558526","Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients","Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up","PI23\u002F00820","Inclusion Criteria:\n\n* Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and\u002For systemic symptoms) and with or without clinical history of food allergy with peanut.\n* Sensitization to Pru p 3 by positive skin prick test (SPT wheal area \\>7 mm2) and specific IgE (sIgE \\>0.35 kUA\u002FL)\n* Positive DBPCFC with peach juice.\n* If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE \\>0.35 kUA\u002FL to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Food allergy to corn.\n* Food allergy to peanut due to sensitization to storage proteins.\n* Previous\u002Factive treatment with sublingual immunotherapy to Pru p 3.\n* Pregnancy\u002Flactation.\n* Active infections.\n* Inflammatory, autoimmune, and\u002For oncological diseases.\n* Severe immunodeficiency.\n* Metabolic syndrome.\n* Increased liver parameters and\u002For any liver disease.\n* Alcohol disorder.\n* Mental illness.\n* Mast cell activation syndrome.\n* Severe atopic dermatitis.\n* FEV1 \\\u003C 70%\n* Treatment with immunomodulators in the last five years.\n* Vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.\n* Any clinical condition contraindicating performance of DBPCFC.",{"count":379,"type":22},62,[25],"Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.",[383],"Food Allergy",[385,386,387,388,389,390],"nsLTP allergy","Dietary intervention","Pectin","Microbiome","Immunomodulation","Food allergy treatment","2025-06-11",{"date":393,"type":34},"2025-06-15",{"date":395,"type":34},"2025-01-13",{"date":397,"type":22},"2026-11-30",{"name":40,"class":41},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":42},"100592437","optimize-risk-prediction-after-myocardial-infarction-the-oracle-study-100592437","NCT06993415","Optimize Risk Prediction After Myocardial Infarction: The ORACLE Study","Optimize Risk Prediction After Myocardial Infarction Through Artificial Intelligence and Multidimensional Evaluation: The ORACLE Study","ORACLE","Inclusion Criteria:\n\n* Patients with Myocardial Infarction (i.e. hospitalization for ST- segment elevated, non-ST-segment elevated myocardial infarction or unstable angina) undergoing invasive management and at high risk of clinical events (i.e. presence of at least two of these high risk criteria: age \\>65 years, diabetes mellitus, multivessel disease, peripheral artery disease, chronic kidney disease, prior stroke anytime or prior TIA in the last 6 months, prior MI, complex PCI, Prior PCI\u002FCABG, heart failure, BMI\\>27, anticipated long term use of an oral anticoagulant, haemoglobin less than 11g\u002Fdl, spontaneous bleeding requiring hospitalization or transfusion in the past 12 months, bleeding diathesis\\* active malignancy other than skin, previous spontaneous intracranial hemorrhage).\n\n  * Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count \\\u003C100,000\u002Fmm3 (\\\u003C100 x 10\\^9\u002FL), or any known coagulation disorder associated with increased bleeding risk.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Low life expectancy (\\\u003C1 year)\n* Pregnant or breastfeeding women\n* Evidence at coronary angiography of non-significant coronary artery disease (\\\u003C30% in the left main stem or \\\u003C50% in the other coronary segments)\n* Subject belongs to a vulnerable population (per investigator's judgment), subject unable to read or write, or other conditions that unable the patient to fully comprehend and comply to the study procedures as per investigator's judgement",{"count":408,"type":22},750,"Background. Myocardial infarction (MI) is a leading cause of death worldwide. After MI, longterm antithrombotic therapy is crucial to prevent recurrent events, but increases bleeding, that also impacts morbidity and mortality. Giving these competing risks prediction tools to forecast ischemic and bleeding are of paramount importance to inform clinical decisions, but their current precision is limited. Improve events prediction, by discovering novel and innovative markers of risk would have a tremendous impact on therapeutic decisions and patients' outcome.\n\nObjectives. Discover novel \"computational biomarkers\" of risk and improve current standards of risk prediction by using innovative multidimensional information from wearable devices, biomarkers, behavioural patterns and non-invasive imaging, integrated through artificial intelligence computation.\n\nOutcomes. The primary outcomes of interest for this analysis are bleeding and ischemic events occurring in or outside the hospital at longest available follow-up. Bleeding will be categorised according to the Bleeding Academic Research Consortium (BARC) definition. The occurrence of major adverse cardiovascular events (MACE), a composite of cardiovascular death, MI, definite stent thrombosis and stroke will be collected according to the Academic Research Consortium-2 classification.",[411],"Myocardial Infarction (MI)",[411,413,414,415,416,417,418,419],"Risk prediction","Artificial Intelligence","ORACLE study","Computational Biomarkers","Ischemic Events","Bleeding Events","Prospective Observational Study","2025-06-04",{"date":422,"type":34},"2025-06-10",{"date":424,"type":22},"2025-06",{"date":426,"type":22},"2028-02",{"name":40,"class":41},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":23,"phases":437,"briefSummary":438,"conditions":439,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":4},"100593805","in-search-of-the-correct-diagnosis-of-beta-lactam-allergy-from-the-validation-of-a-risk-stratification-tool-to-accurate-endotyping-100593805","NCT07011212","In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping","Allergy","Inclusion Criteria:\n\n* signed informed consnet\n\nExclusion Criteria:\n\n* Use of immunomodulators, antihistamines and corticosteroids",{"count":436,"type":22},332,[25],"Testing a clinical decision tool (BL-Predictor)",[440],"Drug Allergy","2025-05-30",{"date":443,"type":34},"2025-06-08",{"date":445,"type":22},"2025-07",{"date":343,"type":22},{"name":40,"class":41},{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":19,"enrollmentInfo":455,"targetDuration":4,"studyType":243,"phases":4,"briefSummary":457,"conditions":458,"keywords":459,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":466,"locationsCount":42},"100592745","endophenotyping-for-plant-based-food-allergy-diagnosis-tolerance-biomarkers-and-mechanisms-in-microneedle-immunotherapy-100592745","NCT06997432","Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy","Study of the Clinical and Immunological Implications of Maintaining in the Diet the Maximum Tolerated Dose Identified in a Controlled Food Exposure Test According to the Sensitization Profile to LTPs","Inclusion Criteria:\n\n* Women and men\n* 14-65 years-old\n* Peach allergy due to sensitization to LTP confirmed by skin tests and\u002For IgEe positive to Pru p 3.\n* Sign informed consent.\n\nExclusion Criteria:\n\n* Pregnant of lactating women.\n* Patients with immunological diseases, mental illness or severe atopic dermatitis.\n* Patients treated with immunomodulators and\u002For β-blockers\n* Patients with forced expiratory volume (FEV1)\\\u003C70%.",{"count":456,"type":22},32,"In relation to the prognosis of vegetable FA (VFA), in contrast to other food allergies (FA), which disappear naturally with time, VFA tends to persist into adulthood and to the appearance of new sensitizations to other vegetables. The paradigm of early intervention in patients with risk factors for developing FA has changed in recent years, with evidence that maintaining a controlled diet with foods with potential allergic risk in a population of children at risk has shown efficacy in early intervention. An important aspect would be the selection of the dose of the food to be included in the diet. In this sense, recent studies on the standardization of the double-blind placebo-controlled oral challenge test (DBPCFC) in allergic patients to Lipid Transfer Proteins (LTP) with known amounts of Pru p 3 (peach LTP), have observed that the maximum tolerated dose (MTD) was equivalent to 40 grams of peach with skin. Based on these results and those obtained in the pediatric population, this study aims to evaluate whether the maintenance in the diet of a DMT evaluated in a DBPCFC could influence tolerance (desensitization) to the food at both clinical and immunological levels.",[301],[460,307,461],"Vegetable food allergy","Lipid Transfer Proteins","2025-05-21",{"date":441,"type":34},{"date":424,"type":22},{"date":182,"type":22},{"name":40,"class":41},{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":50,"sex":475,"minAge":18,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":42},"100580150","the-role-of-breast-milk-neutrophils-from-mothers-with-metabolic-diseases-after-nutritional-intervention-impact-on-infant-development-and-response-to-pulmonary-infections-100580150","NCT06833554","The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections","The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases and Impact on Infant Development and Response to Pulmonary Infections","PI2222\u002F01813","Inclusion Criteria:\n\n* full term pregnancy (\\>37 weeks)\n* mother age 18-50 years\n* intention to practice exclusive breastfeeding for at least 3 months\n\nExclusion Criteria:\n\n* preterm pregnancy (\\\u003C37 weeks)\n* multiple delivery\n* delivery complications that compromise the well-being of the newborn\n* congenital abnormalities of the baby\n* pathologies of the mother such as hypertension, HELLP syndrome, thyroids alterations or nephropathies - drugs or alcohol abuse record\n* occurrence of mastitis during the study\n* mothers practicing tandem nursing","FEMALE","50 Years",{"count":478,"type":22},80,[25],"This project aims at identifying variations in breast milk neutrophils among lactating mothers with gestational diabetes or obesity (objective 1), and to describe how a dietary intervention with Omega-3 fatty acids affects these changes (objective 2). The occurrence of respiratory infections on the progeny will be analysed, as well as its development and the impact on gut microbiota and epigenetic changes (objective 3). The involvement of breast milk on the neonate's microbiota (sub-objective 1) and epigenetic variations (sub-objective 2) will be depicted. In addition, the direct engagement of milk neutrophils in the ability of the progeny to react against lung infections will be studied (sub-objective 3).\n\nTo attain these mother milk and blood samples will be obtained from three groups of lactating mothers: control, obesity or gestational diabetes, upon a dietary intervention with Omega-3 fatty acids. Neutrophil populations of maternal blood and milk samples will be studied by flow cytometry and in vitro assays. The microbiome and miRNA content of infant's saliva and tool samples will be characterized by 16s rRNA gene sequencing and PCR. The occurrence of respiratory infections and the development the infants participating in the study will be tracked during the first 2 years of life by telephone surveys.\n\nTo study the impact of the presented maternal variables on the progeny upon a respiratory inflammation on a systemic level, mouse models will be employed. The offspring of lactating dams with gestational diabetes or obesity will be subjected to an artificial acute lung infection. The progression of the lung disease will be studied by histology and the neutrophil profile in the organs of the litter by flow cytometry. The response to acute lung injury after fecal transplantation with infant's microbiota intro germ-free mice as well as of wild type pups breastfeed by neutropenic dams will complement the animal studies.",[482],"Gestational Diabetes Mellitus (GDM)","2025-02-17",{"date":485,"type":34},"2025-02-18",{"date":487,"type":34},"2023-01-01",{"date":489,"type":22},"2025-12-31",{"name":40,"class":41},{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":502,"conditions":503,"keywords":507,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":4},"100535392","phase-2-proof-of-concept-to-evaluate-the-efficacy-and-safety-of-prednisone-in-idiosyncratic-hepatotoxicity-100535392","NCT06251232","Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity","Proof-of-concept Phase II Study to Evaluate the Efficacy and Safety of Prednisone in the Treatment of Idiosyncratic Hepatotoxicity and Its Mechanistic Pathways Through an Integrative Analysis: the DILI-CORT Clinical Trial","DILICORT","Inclusion Criteria:\n\n1. Female and male patients, aged ≥ 18 years.\n2. Patients who have been diagnosed with DILI by the expert committee.\n3. Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg\u002FdL).\n4. Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.\n\nExclusion Criteria:\n\n1. No clear DILI diagnosis after an expert committee DILI assessment.\n2. DILI due to immune-checkpoint inhibitors.\n3. Presence of active infection as evidenced by positive urine or blood culture.\n4. Acute liver failure (international normalized ratio (INR) \\> 1.5 and hepatic encephalopathy).\n5. Model for End-Stage Liver Disease (MELD) ≥ 30.\n6. Known hypersensitivity to prednisone or placebo components.\n7. Pregnant or nursing mothers.\n8. Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).\n9. Patients already receiving systemic steroids or other immunosuppressants.\n10. Inability to provide informed consent.\n11. Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.",{"count":116,"type":22},[501],"PHASE2","This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.",[504,505,506],"Hepatotoxicity","Idiosyncratic Drug Effect","Prednisone",[506,508],"Idiosyncrasic hepatotoxicity","2024-04-04",{"date":511,"type":34},"2024-04-05",{"date":513,"type":22},"2024-05-01",{"date":515,"type":22},"2028-12-31",{"name":40,"class":41},""]