[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":304},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,57,95,136,176,203,224,256,278],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100551404",false,"NCT06459648","Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies","Prediction Study or Response to Treatment With Anti-CGRP Monoclonal Antibodies in Migraine","PREDI-CGRP","Inclusion Criteria:\n\n* Patients aged between 18 and 65 years.\n* Caucasian ethnicity.\n* Patients diagnosed with migraine with and without high-frequency episodic aura (more than 8 days of migraine per month) or chronic by a neurologist expert in headaches and according to the criteria proposed in the International Classification of Headache Diseases, 3rd edition (ICHD- 3).\n* Have at least one year of history of migraine.\n* Patients must maintain stable preventive treatment in the previous month and not have received botulinum toxin in the month prior to starting the monoclonal antibody.\n* Patients able to describe their clinical situation and the characteristics of their headache.\n* Grant your informed consent.\n\nExclusion Criteria:\n\n* Patients who present with another type of non-migraine headache, with the exception of headache due to excessive use of analgesic medication.\n* Neurological focus in the examination.\n* Pregnancy or breastfeeding period.\n* Patients with cognitive deficiency or pathology that may prevent or hinder the correct completion of the study.\n* Patients who require changes in preventive treatment during the first 6 months after starting treatment with monoclonal antibodies.\n* Patients who present any significant adverse effect that requires withdrawal or change of anti-CGRP drug.","ALL","18 Years","65 Years",{"count":20,"type":21},350,"ESTIMATED","18 Months","OBSERVATIONAL","Being able to predict each patients response to a specific treatment can mean a significant improvement in socioeconomic costs, but above all in their quality of life. With the present study, the investigators aim to analyze in a combined way different clinical, biological and neuroimaging variables, which allow the clinical staff to anticipate the response to treatment with anti-CGRP monoclonal antibodies in patients with migraine.",[26],"Migraine",[26,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"headache","antibodies","antibody","monoclonal antibody","anti-cgrp","anti cgrp","cgrp","prediction","treatmen","migraine treatment","treatment with anti-CGRP monoclonal antibodies","anti-cgrp antibodies","anti-cgrp antibody","anti-cgrp monoclonal antibodies","migraine and antibodies","migraine and cgrp","RECRUITING","2026-06-30",{"date":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2023-04-26",{"date":52,"type":21},"2026-07",{"name":54,"class":55},"Fundación de Investigación Biomédica - Hospital Universitario de La Princesa","OTHER",7,{"id":58,"slug":4,"hasResults":10,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":65,"targetDuration":67,"studyType":23,"phases":4,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":93,"locationsCount":94},"100551403","NCT06459635","Migraine Attack Pain Phase Prediction Study","Prediction Study of the Pain Phase of Migraine Attacks in Patients With Episodic Migraine","PREDI-CRISIS","Inclusion Criteria:\n\n* Age between 15 years and 69 years.\n* Diagnosed with migraine by a headache neurologist and according to the criteria proposed by ICHD-3.\n* History of migraine of at least 1 year of evolution.\n* Normal neurological examination.\n* Have given your informed consent.\n* Be able to describe your clinical situation and the characteristics of your headache.\n* Have an average of 10 to 14 migraine days per month in the three months prior to inclusion (high-frequency episodic migraine).\n* User-level management capacity of \"smartphone\" type electronic devices.\n* Be able to complete two months of study follow-up.\n\nExclusion Criteria:\n\n* Presence of another type of headache, with the exception of headache due to excessive use of analgesic medication.\n* Cognitive deficiency or any other pathology that may prevent or make it difficult for the patient to perform the study correctly.\n* Neurological focus in the examination.\n* Pregnancy or breastfeeding period.\n* Patients with known heart disease or bronchopathy, Sjögren\\'s syndrome, diabetes mellitus, or hypo\u002Fhyperthyroidism.\n* Carriers of pacemakers, neurostimulators or any other electronic device that is considered to make the interpretation of biometric records difficult.\n* Anatomical problem that makes the use of the device impossible.\n* Patients in whom it is expected that a change in migraine preventive treatment or other usual treatment will be possible during the study period.",true,{"count":66,"type":21},70,"2 Months","The study of the ability to predict pain in a migraine attack, through premonitory symptoms and through an ambulatory monitoring device through real-time recording of hemodynamic variables, is one of the strategic lines of research of the unit. of Headaches at the Hospital de La Princesa since 2013 together with the Complutense and Polytechnic University of Madrid. Their results have been reflected in various publications (Pagán J, et al. Sensors 2015; Gago-Veiga AB, et al. J Pain Res 2018) and have promoted the creation of several invention patents.",[26,70,71,72,73],"Migraine Headache","Migraine Disorders","Migraine Without Aura","Migraine With Aura",[26,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Headache","Predict","Prediction","headache prediction","predict headache","migraine prediction","predict migraine","migraine attacks","migraine attack","headache attack","migraine attack prediction","predict migraine attack","prediction algorithm","algorithm",{"date":47,"type":48},{"date":91,"type":48},"2023-10-09",{"date":52,"type":21},{"name":54,"class":55},1,{"id":96,"slug":4,"hasResults":10,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":10,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":94},"100625176","NCT07419230","Evaluation of a Digital Tool to Improve Aeroallergen Immunotherapy Adherence. NavigAITme Project","Pragmatic Randomized Prospective Clinical Study to Evaluate the Effectiveness of a Digital Application to Improve Aeroallergen Immunotherapy Adherence in Real Life. The NavigAITme Project","NavigAIT","Inclusion Criteria:\n\n* Patients of any age and sex\n* Patients who have received their first prescription for a new aeroallergen immunotherapy treatment as part of their routine care for allergic rhinitis with or without asthma\n* Patients who have been prescribed only a single immunotherapy product\n* Patients who have been prescribed a commercially available product, from any company, for sublingual or subcutaneous administration\n* Patients who have provided the first photograph of the product for which they are entering the study\n\nExclusion Criteria:\n\n* Patients receiving AIT prescription for asthma only, and do not suffer allergic rhinitis\n* Administration routes other than subcutaneous or sublingual\n* Patients receiving AIT prescription for other indications, e.g., food or hymenoptera allergies\n* Patients who have received immunotherapy in the last 3 years or are currently undergoing treatment with an AIT product other than the one being studied in the current project.\n* Patients who have received prescription for two or more different immunotherapy products simultaneously",{"count":103,"type":21},880,"INTERVENTIONAL",[106],"NA","Aaeroallergen Immunotherapy (AIT) is indicated in the treatment of allergic rhinitis and asthma, and has shown efficacy to control symptoms and induce immunomodulatory changes that support post discontinuation efficacy. Data from clinical trials provides founding for its efficacy and safety profile, but the therapy needs to be withheld for a minimum of 3 years, with modalities that imply daily or near daily administration of a sublingual extract, or subcutaneous injections, every 4 to 6 weeks. This treatment regimen often faces other limitations such as cost, patient´s lack of knowledge regarding efficacy\u002Fsafety, or potentiality of adverse reactions. These factors have been pointed out as main reasons for a reported low level of treatment adherence in real life.\n\nWhile overall literature data on treatment adherence ranges widely, from 6% to 93% of patients finalising the minimum of 3 years, current data from precise German registries inform of persistence at 3 years being very low, varying from 5.2% to 18.2% with differences depending on extract, route and patient´s age.\n\nSurprisingly, even if the Scientific community acknowledges patient adherence as a very relevant weak point, there´s paucity of structured strategies to tackle this issue, and those available, have mostly been developed in single centers, for periods below the 3 years of AIT recommended duration. In the era of technology, and with the spreading of mobile applications (App), new approaches are currently ongoing to counteract this important drawback . In this landscape, this study aims at creating a new App that will be thoroughly tested in a prospective long-term randomized trial, to improve AIT persistence.",[109],"Allergic Rhinitis",[111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"allergen immunotherapy","Respiratory allergy","Allergic rhinitis","Adherence","Implementation","Persistance","AIT","Mobile App","Real life study","mites","grass","pollen","animal dander","sublingual","subcutaneous","SLIT","SCIT","2026-03-18",{"date":130,"type":48},"2026-03-23",{"date":132,"type":48},"2026-03-11",{"date":134,"type":21},"2030-03-11",{"name":54,"class":55},{"id":137,"slug":4,"hasResults":10,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":10,"sex":16,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":104,"phases":147,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":94},"100625177","NCT07419243","Tolerance Results and Immune Mechanisms in Cow´s Milk and\u002For Hen´s Egg Allergic Children Following Natural Evolution or Oral Immunotherapy","Identification of Mechanisms and Biomarkers Predictive of Tolerance in Children With Food Allergies: Comparison Between Treatment With Oral Immunotherapy and Natural Evolution. alerITO Study","alerITO","Inclusion Criteria:\n\nNAT-cohort:\n\n* Cow´s Milk and\u002For Hen´s Egg allergic patients 4 to 10 years old\n* sIgE levels to milk OR egg extracts between 0.35 to 35kUA\u002FL\n* Positive entry Open food challenge with milk\u002Fegg with oFASS5 classification ≥2 with a maximum cumulative dose of up to 4193.7 mg of milk protein or 3110.8 mg of egg white protein\n* Having a mild to moderate food allergy severity per the Definition of Food Allergy Severity (DEFASE) score (\\\u003C13 points)\n* Having signed the informed consent\n\nOIT-cohort:\n\n* Patients in the compITO study (NCT06976775) who are undergoing OIT and have achieved full desensitization to the food by month 7 of the study (end of study)\n* Patients in the compITO study who are undergoing OIT and have achieved partial desensitization (tolerating a dose lower than the total dose, and a minimum of 3 doses above the entry challenge threshold) to the food by month 7 of the study (end of study)\n* Having signed the informed consent\n\nExclusion Criteria:\n\nNAT-cohort:\n\n* Positive reaction in the entry open oral food challenge with a baseline Eliciting Dose (ED) 20 below the target ED20 for food. For milk, 23.1 mg (35.7 mg cumulative) of protein, or for egg, 19.5 mg (29.4 mg cumulative) of protein.\n* Patient desire or medical indication to initiate OIT at any time within 29 months of study entry.\n* No allergic reaction greater than oFASS5 grade 1 in the baseline challenge for the maximum cumulative programmed doses of 4193.7 mg of milk protein, or 3110.8 mg of egg white protein.\n* Immunological diseases, immunomodulatory\u002Fblocking therapies.\n* Severe atopic dermatitis according to the SCORing Atopic Dermatitis (SCORAD) classification\n* Severe allergy, according to a DEFASE score ≥13\n* Spirometry values with moderate-to-severe airflow obstruction (FEV1 \\\u003C70%)\n* Poorly controlled asthma according to clinical criteria\n* Previous OIT for another food\n* Within the first 3 months of treatment with Subcutaneous Aeroallergen Immunotherapy\n* Within the first week of treatment with Sublingual Aeroallergen Immunotherapy\n* Presence or suspicion of Eosinophilic Esophagitis\n* Non-IgE-mediated allergy to milk or egg\n* Pregnancy\n* Significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers)\n* Inability to provide informed consent\n* Communication or cognitive barriers that prevent adherence to the protocol\n\nOIT-cohort:\n\n* Patients enrolled in the compITO study who have failed or withdrawn from the study for any reason.\n* Patients with uncontrolled Atopic Dermatitis or Asthma at the time of enrolment, or who have developed Eosinophilic Esophagitis.\n* Patients with confirmed pregnancy at the time of enrolment.\n* Patients who have developed significant medical comorbidities (renal, hepatic, or cardiac insufficiency, active infectious diseases, previous or concurrent cancers) at the time of enrolment.\n* Inability to provide informed consent.\n* Communication or cognitive barriers that prevent adherence to the protocol.","4 Years","17 Years",{"count":146,"type":21},68,[148,149],"PHASE1","PHASE2","Allergy to Cow's milk and hen´s egg proteins are the most common causes of food allergies in early childhood and are associated with the occurrence of adverse events that may be life-threatening, quality of life impairment and negative nutritional and health economic impact.\n\nHowever, contrarily to other food allergy models such as nuts\u002Fpeanut allergy, milk and egg allergy have greater chances of natural resolution. While around 50% of children may outgrow milk or egg allergy by the age of 5 years old, only 22% of peanut allergic children at the age of 4 years can tolerate this food. However, it is also documented that, at 14 years of age, the persistence of milk and egg allergy still affects around 30% of these children.\n\nStandard of care relies on food avoidance and treatment of accidental reactions, but this approach is unsatisfactory because adverse events and quality of life limitations still remain. Milk and egg Oral Immunotherapy (OIT) is the most promising therapeutic alternative and showed good results to induce Desensitization (ability to tolerate the food while it is regularly taken) but insufficient efficacy to achieve Sustained Unresponsiveness (SU) (ability to tolerate the food after a period of avoidance).\n\nIn the day-to-day practice, families and allergists of milk and egg allergic children frequently face the following dilemma: what is the best approach? Keep waiting for natural resolution or embarking in OIT? At the moment, there are only very limited data to guide this decision, specially in children with mild to moderate allergy, that still after 6 years of age withhold relevant chances of naturally outgrowing their allergy.\n\nOur objective is conducting a longitudinal cohort-study of children undergoing food avoidance and children undergoing OIT to assess biomarkers of natural allergy resolution\u002Fpersistence and OIT Desensitization\u002FSustained Unresponsiveness trajectories.",[152],"Food Allergy in Children",[154,155,156,157,158,159,160,161,162,163,164,165,166,167],"Oral immunotherapy","Food allergy","Children","Hen´s egg allergy","Cow´s milk allergy","Desensitization","Sustained Unresponsiveness","Biomarkers","Natural evolution","Microbiota","OIT","Quality of Life","FAQLQ","Burden of treatment","2026-02-25",{"date":170,"type":48},"2026-02-27",{"date":172,"type":48},"2026-02-18",{"date":174,"type":21},"2030-07-30",{"name":54,"class":55},{"id":177,"slug":4,"hasResults":10,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":183,"targetDuration":4,"studyType":104,"phases":185,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100550717","NCT06450704","Cerebral and Anti-inflammatory Response Through Exercise - Mechanisms In Depressive Disorders","Inflammatory and Brain Mechanisms and Clinical and Cognitive Effects of an Exercise Intervention in Major Depressive Disorder: a Randomised Longitudinal Clinical Trial.","CARE-MIND","Inclusion Criteria:\n\n* A diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria (through the Mini International Neuropsychiatric Interview (MINI)\n* Severity of depression according to the Hamilton Depression Rating Scale 17 items (HAM-D17): minimum of 14 cut-off score of moderate depression.\n* Outpatient clinical care.\n* Current antidepressant treatment that will be maintained during the 12 weeks of the physical exercise intervention.\n\nExclusion Criteria:\n\n* Diagnosis of any axis I diagnosis except for MDD;\n* Contraindications for Magnetic Resonance Imaging.\n* Antiinflammatory treatments or antibiotics within the week before randomisation.\n* Vaccines within the month before randomisation.\n* Fever (\\>38ºC) at the moment of study entry.\n* Pregnant women.\n* Alcohol or drug abuse.",{"count":184,"type":21},124,[106],"The goal of this clinical trial is to study how physical exercise works when applied to patients diagnosed with Major Depressive Disorder (MDD). The main questions it aims to answer are:\n\n* What are the antiinflammatory and oxidative stress and neural mechanisms involved in the antidepressant effects of exercise?\n* How effective is a physical exercise program in MDD patients in real-life conditions?\n\nThe experimental group will receive an exercise intervention as an add-on to their usual treatment (antidepressant treatment prescribed by the attending specialist). Researchers will compare to a control group, which will only receive standard treatment (antidepressant treatment prescribed by the attending specialist) and will be instructed to not change their usual physical activity. The aim is to see if a physical exercise intervention would induce a significant improvement in depressive symptoms and which mechanisms are responsible for this result.",[188,189],"Major Depressive Disorder","Inflammatory Response",[188,191,192,193],"Physical Exercise","Inflammation","Neuroimaging","2026-01-05",{"date":196,"type":48},"2026-01-06",{"date":198,"type":48},"2025-04-21",{"date":200,"type":21},"2026-12-31",{"name":54,"class":55},5,{"id":204,"slug":4,"hasResults":10,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":10,"sex":209,"minAge":17,"maxAge":210,"enrollmentInfo":211,"targetDuration":143,"studyType":23,"phases":4,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":94},"100542030","NCT06337565","Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes","Safety of IBD Drugs During Pregnancy and Breasfeeding: Mothers and Babies' Outcomes (DUMBO 2 Registry)","Inclusion Criteria:\n\n* Patients over 18 years of age diagnosed with IBD.\n* Confirmed pregnancy.\n* \\- Treatment with non-anti-TNF biologics or other advanced therapies (i.e JAK inhibitors, S1P receptor modulators and molecules approved in the forthcoming years).\n\nExclusion Criteria:\n\n* Patients who do not accept to participate in the study","FEMALE","70 Years",{"count":212,"type":21},1000,"This is an observational study where pregnant women treated with non-anti-TNF agents or targeted small molecules approved for IBD treatment will be included. Although it is a multicentre, nationwide study, the number of patients to be included is expected to be relatively low (in DUMBO 1, during 5 years of recruitment, 88 patients treated with ustekimunab, 34 treated with vedolizumab, and 2 exposed to tofacitinib were included); however, this registry involved over 60 Spanish centres and it is a paramount study providing with data on the safety of drugs during pregnancy, as patients with this condition are excluded from clinical trials. In this regard, no sample size estimation was made, as we plan to include all patients who meet the inclusion criteria and consent their enrolment.",[215],"Drusgs for IBD","2025-09-22",{"date":218,"type":48},"2025-09-25",{"date":220,"type":48},"2024-05-20",{"date":222,"type":21},"2030-05-20",{"name":54,"class":55},{"id":225,"slug":4,"hasResults":10,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":104,"phases":231,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":94},"100463355","NCT05313620","Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events","Inclusion Criteria:\n\nEX VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Over 18 years old.\n* Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).\n* Previous treatments are allowed, provided they have remained stable for the past 3 months.\n* In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nINDIVIDUALS WITHOUT UC:\n\n* Over 18 years old.\n* Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases.\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nIN VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Over 18 years old.\n* Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO).\n* Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib.\n* Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action.\n* Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2).\n* Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nINDIVIDUALS WITHOUT UC:\n\n* Over 18 years old.\n* Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases.\n* Women of childbearing age using contraceptive methods with an error rate \\\u003C1% per year. Examples of contraceptive methods whose error rate is \\\u003C1% per year are:\n\n  1. Intrauterine device (IUD).\n  2. Bilateral tubal occlusion.\n  3. Couple with vasectomy.\n  4. Sexual abstinence.\n\nExclusion Criteria:\n\nEX VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Under 18 years old.\n* Immune-mediated disease, neoplasm or active infection.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Abdominal surgery in the last 6 months.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nINDIVIDUALS WITHOUT UC:\n\n* Under 18 years of age.\n* Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Abdominal surgery in the last 6 months.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nIN VIVO STUDY IN PATIENTS WITH UC\n\nPATIENTS WITH UC:\n\n* Under 18 years old.\n* Immune-mediated disease.\n* Neoplasm or active infection.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Ostomy.\n* Colectomy.\n* Active infection with hepatitis B, C or HIV virus.\n* Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC.\n* Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors)\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n\nINDIVIDUALS WITHOUT UC:\n\n* Under 18 years of age.\n* Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study.\n* Pregnancy or lactation.\n* Alcohol or drug abuse.\n* Active infection with hepatitis B, C or HIV virus.\n* Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy.\n* Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.\n* Medical history of thromboembolic events.\n* Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation.\n* Use of combined hormonal contraceptives or hormone replacement therapy.\n* Hereditary coagulation disorders.\n* Refusal to give consent for participation in the study.\n* Abdominal surgery in the last 6 months.",{"count":230,"type":21},30,[232],"PHASE4","Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and\u002For vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.",[235,236],"Ulcerative Colitis","Thromboembolism",[238,239,240,241,242,243,244,245,246,247],"ulcerative colitis","Tromboembolism","Coagulation","Platelet Function","Tofacitinib","JAK inhibitors","anti-TNF","Infliximab","Adalimumab","Golimumab","2025-03-12",{"date":250,"type":48},"2025-03-17",{"date":252,"type":48},"2022-04-01",{"date":254,"type":21},"2025-12",{"name":54,"class":55},{"id":257,"slug":4,"hasResults":10,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":269,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100564670","NCT06632197","Non-invasive Monitoring of Mixed Venous Oxygen Saturation Using the Capnodynamic Method in Adults","CAPNO-SVO2","Inclusion Criteria:\n\n* Age \\> 18 years\n* Not participating in any other interventional study at the time of the study.\n* Patients under controlled mechanical ventilation in passive conditions.\n* Situations where the responsible physician deems that, for the benefit of clinical management and therapeutic decision-making, the patient would benefit from the placement of a pulmonary artery catheter (Swan-Ganz) and\u002For monitoring of central or mixed venous saturation.\n* Obtaining informed consent.\n\nExclusion Criteria:\n\n* Failure to obtain informed consent.\n* No need for invasive mechanical ventilation.",{"count":263,"type":21},25,"The objective of this study is to compare the accuracy and correlation of the capnodynamic method for measuring mixed venous oxygen saturation (SvO2) with the standard reference method (pulmonary artery catheter), with the potential for the capnodynamic method to replace the traditional method in selected cases.",[266,267,268],"Ventilatory Failure","Cardiac Failure","Mechanical Ventilation Pressure High","NOT_YET_RECRUITING","2024-10-08",{"date":272,"type":48},"2024-10-10",{"date":274,"type":21},"2024-12",{"date":276,"type":21},"2025-08",{"name":54,"class":55},{"id":279,"slug":4,"hasResults":10,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":285,"targetDuration":287,"studyType":23,"phases":4,"briefSummary":288,"conditions":289,"keywords":292,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":301,"leadSponsor":303,"locationsCount":94},"100510526","NCT05927584","Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment","Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).","LORENA","Inclusion Criteria:\n\n* Patients age 18 years or older.\n* Histologic proof of infiltrating rectal adenocarcinoma. or\n* Preoperative biopsy compatible with rectal adenoma or intramucous adenocarcinoma with endoscopic or radiological suspicion of infiltrating adenocarcinoma.\n\n  1. Endoscopic criteria: Kudo´s crypt pattern of V or higher, despite non confirmatory preoperative histology. endoscópicos: patrón de criptas V o superior según la clasificación de Kudo, que define lesiones infiltrantes, a pesar de que la histología preoperatoria no sea confirmatoria .\n  2. Ultrasonographic criteria: hipoecogenic rectal tumor invading the intermediate hyperecogenic layer (submucosal), but does not infiltrate the hypoecogenic outer layer (muscularis propia).\n  3. Radiological criterio in MR: tumor invades the submucosal layer without infiltration of the rectal muscularis propia. The usual low signal submucosal image is substituted with an aberrant signal, meaning the loss of the zebra pattern in a normal rectal wall.\n* Rectal neoplasm with an inferior limit no further than 2cm proximal to the anorectal verge, both in digital rectal examination and in radiology examinations, ideally magnetic resonance (MR).\n* Rectal neoplasms up to 3 cm of major diameter.\n* Clinical preoperative staging of cT1N0M0, based on endoscopy, MR, +\u002F- endorectal ultrasound.\n* Cases in which LE as exclusive treatment with curative intent is prescribed after MDT discusión, regardless of the approach both via flexible endoscopy and transanal endoscopic microsurgery and its variations.\n* Neoplasms with low risk histologic criteria known preoperatively or lack of information regarding this aspect:\n\n  1. Submucosal infiltration of less than 1000µm (sm1 in the Kikuchi classification) .\n  2. Tumor budding absent.\n  3. En bloc resection in patients with a previous endoscopic resection.\n  4. Vascular, lymphatic and perineural invasión absent.\n  5. Low histologic grade.\n\nExclusion Criteria:\n\n* Patients younger than 18 years old.\n* Rectal neoplasms different from adenocarcinoma.\n* Neoplasms in which the inferior edge is farther than 2cm proximal to the anorectal verge in the preoperative MR.\n* Any other clinical stage other than cT1N0M0 (any T\\>1, N+, or M+).\n* Neoplasms larger than 3cm.\n* Preoperatively demonstration of PPHF:\n\n  1. Submucosal infiltration deeper than 1000µm (sm2 and sm3 in the Kikuchi classification)\n  2. Tumor budding present.\n  3. Piecemeal resection in cases with previous endoscopic resection.\n  4. Vascular, lymphatic and perineural invasión presence.\n  5. High histologic grade.\n* Any patient with planned systemic treatment with RTQT combined with the LE after MDT discusión, regardless of the preoperative clinical or postoperative pathological stage.",{"count":286,"type":21},145,"36 Months","Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE).\n\nA radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure.\n\nThe goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer.\n\nThe main question it aims to answer are:\n\n• How frequently does LE allow for rectum preservation?\n\nParticipants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.",[290,291],"Rectal Cancer","Rectum Neoplasm",[293,294,295,296],"Early rectal cancer","Local excision","Total Mesorectal Excision","Organ preservation","2024-05-13",{"date":299,"type":48},"2024-05-14",{"date":297,"type":48},{"date":302,"type":21},"2027-05-01",{"name":54,"class":55},""]