[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Parc de Salut Mar\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":595},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,51,80,111,138,171,202,229,256,276,306,331,359,383,408,436,460,483,508,536,567],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100639928","postnatal-debriefing-after-adverse-obstetric-events-100639928",false,"NCT07579273","Postnatal Debriefing After Adverse Obstetric Events","Effect of a Structured Postnatal Debriefing on Psychological Outcomes and Birth Experience in Women After Adverse or Unexpected Obstetric Events","DBIRTH","Inclusion Criteria:\n\n* Women aged 18 years or older.\n* Women who have experienced an adverse or unexpected obstetric event during labor or the immediate postpartum period.\n* Admitted to the maternity unit of Hospital del Mar and clinically stable within the first 24 hours postpartum.\n* Able to understand and communicate in Spanish, Catalan, or English.\n* Willing to participate and able to provide written informed consent.\n* Access to an email account for follow-up assessments.\n\nExclusion Criteria:\n\n* Inability to communicate verbally.\n* Maternal-neonatal separation due to social reasons.\n* Unstable or severe psychiatric condition.\n* Immediate perinatal loss (intrapartum fetal death or early neonatal death).\n* Admission to intensive care within the first 24 hours postpartum.","FEMALE","18 Years",{"count":20,"type":21},142,"ESTIMATED","INTERVENTIONAL",[24],"NA","Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress. However, structured postnatal debriefing is not routinely implemented in clinical practice, and evidence regarding its effectiveness remains limited.\n\nThis study aims to evaluate the effect of a structured postnatal debriefing conducted within the first 24 hours after childbirth in women who have experienced an adverse or unexpected obstetric event.\n\nThis quasi-experimental pretest-posttest study will include two consecutive groups: a control group receiving usual postpartum care during the pre-implementation phase and an intervention group receiving structured postnatal debriefing during the implementation phase.\n\nThe primary outcome is childbirth-related trauma at 6 weeks postpartum. Secondary outcomes include birth satisfaction, early post-traumatic stress symptoms, satisfaction with information and emotional support received after childbirth, and clinical maternal and neonatal outcomes.\n\nThis study will provide evidence on whether structured postnatal debriefing improves psychological outcomes and contributes to more patient-centered obstetric care.",[27,28,29,30],"Stress Disorders, Post-Traumatic","Psychological Trauma","Obstetric Labor Complications","Postpartum Period",[32,33,34,35,36,37,38],"Traumatic Birth","Birth Experience","Postpartum PTSD","Postnatal Debriefing","Obstetric Debriefing","Patient-Centered Care","Maternal Mental Health","NOT_YET_RECRUITING","2026-06-22",{"date":42,"type":43},"2026-06-25","ACTUAL",{"date":45,"type":21},"2026-10",{"date":47,"type":21},"2029-01",{"name":49,"class":50},"Parc de Salut Mar","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100635595","an-extended-cohort-study-to-investigate-suicidal-behavior-in-spain-the-survive-2-study-100635595","NCT07554729","AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN (THE SURVIVE 2 STUDY)","THE SURVIVE 2 PROJECT: AN EXTENDED COHORT STUDY TO INVESTIGATE SUICIDAL BEHAVIOR IN SPAIN AND THE EFFICACY OF SECONDARY PREVENTION STRATEGIES","SURVIVE 2","Inclusion Criteria:\n\n* Individuals (above 12 years old) who present to participating Spanish hospital emergency departments after a suicide attempt, as defined by self-injurious behavior with at least some intent to die.\n* Able to understand the study procedures and provide informed consent (or assent with parental\u002Fguardian consent for minors, according to local regulations)\n* Sufficient proficiency in Spanish to complete study assessments\n\nExclusion Criteria:\n\n* Suicide attempts clearly judged as accidental or without suicidal intent\n* Severe cognitive impairment, intellectual disability, or neurological condition that, in the opinion of the clinical team, prevents valid assessment or informed consent\n* Acute medical instability that makes participation in research procedures unsafe.\n* Any condition or circumstance that, in the opinion of investigators, would seriously interfere with participation or follow-up in the cohort.","ALL","12 Years",{"count":62,"type":21},3600,"OBSERVATIONAL","The goal of this observational study is to learn more about people who come to emergency departments in Spain after a suicide attempt and to find ways to prevent another attempt. The main questions are whether some personal, social, biological, and clinical factors are linked to a higher risk of trying again, and whether different follow-up strategies can help lower this risk over time.\n\nResearchers will follow a total of about 3,600 people who attempted suicide: around 1,800 who were already recruited in a previous study and about 1,800 new participants who will be added in this project, in several hospitals across Spain.\n\nSome participants may also be invited to give blood samples, answer online questionnaires, or use smartphone-based tools to understand better changes in mood and suicidal thoughts in daily life. A subset of participants may be invited to join separate clinical trials that test different follow-up programs to prevent another suicide attempt; these trials will be registered and described in their own study records.",[66],"Suicidal Behaviors",[68,69],"suicide","cohort study","RECRUITING","2026-04-23",{"date":73,"type":43},"2026-04-28",{"date":75,"type":43},"2024-09-01",{"date":77,"type":21},"2026-12-01",{"name":49,"class":50},2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100563160","zn-supplementation-in-hiv-immunological-non-responders-100563160","NCT06612554","Zn Supplementation in HIV Immunological Non Responders","Role of Zinc Supplementation in Immunological Non-responders HIV Individuals: Exploring Pathways for Persistent Inflammation","VIHZn","Inclusion Criteria:\n\n* confirmed HIV infection;\n* 18 years or older\n* Serum zinc levels less than 150ug\u002Fdl (normal range considered 75-150 ug\u002Fdl)\n* HIV-1 infection on stable ART for at least 3 months with cumulative ART duration of at least 6 months\n* Undetectable (less than 50copies\u002Fml) persistently (isolated transient increases in viremia of less than 1000 copies\u002Fml will be accepted)\n* Persistent less than 500CD4+ T-cells\u002Fmm3 at enrolment or an increase of less than 80 cells\u002Fmm3 after one year of viral undetectability\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Active infectious or inflammatory condition\n* Uncontrolled diabetes\n* Serum Zinc levels more than 150ug\u002Fdl",{"count":89,"type":21},120,[24],"Zinc is an essential micronutrient crucial for the normal functioning of the human immune system. Zinc deficiency impairs immune function and increases infection risk, especially in vulnerable populations like people living with HIV. This project aims to study the role of zinc supplementation in improving immune response in HIV-infected individuals who are Immunological Non-Responders (INRs)-people who have not restored Cluster of differentiation 4 (CD4) T-cell counts despite receiving antiretroviral therapy (ART). INRs face a higher risk of opportunistic infections, non-HIV comorbidities due to high inflammation, and generally have a poorer prognosis. Zinc supports immune function by aiding in immune cell development, cytokine production, and maintaining mucosal barrier integrity.\n\nSeveral studies have investigated zinc supplementation in HIV-infected individuals, showing significant increases in CD4 counts and a reduction in opportunistic infections. However, the doses used vary, and the results are sometimes contradictory. Our objective is to study whether zinc supplementation in INRs improves immune function, specifically by increasing CD4 counts, decreasing inflammation, and affecting other immune parameters.\n\nThis project involves a clinical trial where INRs will be randomly assigned to receive 75mg of elemental zinc daily (in the form of 3 zinc acetate tablets) along with their usual treatment or to continue their treatment without zinc supplements. We will assess whether zinc supplementation increases CD4 lymphocytes, reduces inflammation in INRs, and induces immune system changes. We will also investigate immune system functionality by measuring the presence of the Torque Teno Virus (TTV), a harmless virus, and see how zinc supplementation impacts its control by monitoring viral load changes.\n\nRecent research by our group has demonstrated that zinc has both antiviral and anti-inflammatory effects. Zinc supplementation is generally safe and well-tolerated, with few adverse effects. Zinc is available in various forms, including gluconate, acetate, and sulfate. Although the recommended daily dose is 40mg, studies have shown that doses exceeding 80mg have been safely administered for over 10 years without side effects.\n\nWe have selected a 75mg daily dose of elemental zinc for several reasons. Studies that showed no effect used lower doses (15-20mg\u002Fday), and our research found that 75mg\u002Fday improved outcomes in acute viral infections like Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV2). We believe previous failures to show zinc's efficacy were due to insufficient dosing. After extensive literature review, we concluded that 75mg daily is safe and likely to produce the desired effects.\n\nOur goal is to demonstrate the efficacy of zinc as an immunomodulatory agent. If successful, this could be a simple and cost-effective way to improve the quality of life for many people. We would recommend its widespread use under medical supervision, particularly at the doses being studied.",[93,94,95],"HIV","Zinc Status","HIV Infection",[97,98,99,100,101],"Zinc Supplementation","HIV Immunological Non-Responder","Immune response","immune activation","Inflammation","2026-04-13",{"date":104,"type":43},"2026-04-16",{"date":106,"type":43},"2025-01-02",{"date":108,"type":21},"2026-12",{"name":49,"class":50},1,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":136,"locationsCount":137},"100631763","spanish-validation-of-koquss-40-questionnaire-assessing-qol-of-gastric-cancer-patients-after-gastrectomy-spquss-41-100631763","NCT07504913","Spanish Validation of KOQUSS-40 Questionnaire: Assessing QoL of Gastric Cancer Patients After Gastrectomy: SPQUSS-41","SPQUSS-41: Validación Del Cuestionario de Calidad de Vida KOQUSS-40 Para Los Pacientes Con gastrectomía Por cáncer gástrico [SPQUSS-41]","SPQUSS-41","Inclusion Criteria:\n\n* Patients operated on for gastric cancer with curative intent from 1 month postoperatively up to the last 5 years\n* Adult patients over 18 years old\n* No recurrence of the disease\n* Patients who have given their informed consent to participate in the Spanish EURECCA Registry of Esophagogastric Cancer and have signed the specific consent for the SPQUSS-4 study\n\nExclusion Criteria:\n\n* First 30 days after surgery and\u002For patients with postoperative complications requiring more than 30 days of hospitalization.\n* Patients who do not give their consent to participate in the study will be excluded.\n* Patients with a history of other neoplasms.\n* Patients with disseminated gastric cancer or candidates for palliative surgery, as well as those patients who do not give their consent to participate.",{"count":120,"type":21},505,"The main objective of this study is the translation, linguistic adaptation into Spanish, and validation of the Korean quality of life questionnaire KOQUSS-40. This tool will allow us to objectively measure the quality of life of patients in clinical trials.",[123,124],"Stomach Neoplasms","Validation Study",[126,127,128,129],"Stomach neoplasms","Validation study","Surveys and questionnaires","Quality of life","2026-03-26",{"date":132,"type":43},"2026-04-01",{"date":134,"type":43},"2025-05-03",{"date":77,"type":21},{"name":49,"class":50},6,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":149,"conditions":150,"keywords":157,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":110},"100612468","prospective-evaluation-of-atrial-fibrillation-related-stroke-patients-in-rehabilitation-program-pearl-an-observational-cohort-study-100612468","NCT07253974","Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study","Prospective Evaluation of Atrial Fibrillation-Related Stroke Patients in Rehabilitation Program (PEARL), an Observational Cohort Study. TARGET: Health Virtual Twins for the Personalised Management of Stroke Related to Atrial Fibrillation\".","PEARL","Inclusion Criteria:\\> 18 a, first-ever intracerebral ischemic stroke\n\n\\-\n\nExclusion Criteria:\n\n* intracranial haemorrhage, symptomatic hemorrhagic transformation, new infarcts after the initial stroke or other neurological or psychiatric conditions.","99 Years",{"count":148,"type":21},213,"The goal of this observational study is to determine if rehabilitation program intensity impacts functional recovery and specific needs in adult ischemic stroke patients who require inpatient rehabilitation. The main questions it aims to answer are:\n\nDo patients with stroke of Atrial-related subtypes (AFRS) have distinct rehabilitation needs and functional outcomes compared to non-AFRS patients? Does higher-intensity inpatient rehabilitation (3-5 sessions\u002Fday) result in better functional recovery at six months (measured by the Barthel Index) than moderate-intensity programs (1 session\u002Fday)? The study is non-invasive, does not interfere with usual care. The investigators' ultimate goal is to enhance the understanding of recovery after following different rehabilitation usual programs.",[151,152,153,154,155,156],"STROKE","Rehabilitation Outcome","Brain Disease","Cardiovascular Disease Acute","Hemiplegia and\u002For Hemiparesis Following Stroke","Disability Physical",[158,159,160,161,162],"functional outcomes","stroke","disability","rehabilitation","high intensity rehabilitation program","2025-12-11",{"date":165,"type":43},"2025-12-15",{"date":167,"type":43},"2024-11-11",{"date":169,"type":21},"2027-12-01",{"name":49,"class":50},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":59,"minAge":179,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":22,"phases":182,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100589287","phase-3-pharmacogenomics-of-antivegf-in-patients-with-age-associated-macular-degeneration-amd-100589287","NCT06952452","Pharmacogenomics of antiVEGF in Patients With Age-Associated Macular Degeneration (AMD)","Multicentre, Randomised, Double-blind, Parallel-group, Phase III Study to Evaluate the Genetic Polymorphism Influence in the Response to Ranibizumab and Bevacizumab Treatment in Patients With Age-Associated Macular Degeneration.","AMD","Inclusion Criteria:\n\n* Patients diagnosed with neovascular Age-related Macular Degeneration\n* Age of 50 years or older.\n* That at the discretion of the ophthalmologist has an indication of receiving treatment with an anti-VEGF agent as usual in clinical practice.\n* Without previous treatment in the eye under study (no previous treatment for AMD).\n\nExclusion Criteria:\n\n* Participate or have participated in another clinical trial with an experimental drug in the last 6 months.\n* Patients with other eye diseases, p. eg, advanced glaucoma or visually significant cataracts, which are likely to require surgery during the follow-up period in the eye under study.\n* Concomitant, ocular or systemic, administration of drugs up to 3 months before the treatment with another anti-VEGF in the contralateral eye.\n* High cardiovascular risk: poorly controlled arterial hypertension, history or risk of arterial thromboembolic events, history of stroke or acute myocardial infarction, anticoagulant treatment, proteinuria or major elective surgery within 3 months.\n* Ophthalmological risk with the intraocular injection (all intravitreal treatments): active or suspected ocular or periocular infection, severe blepharitis, history of endophthalmitis, history of retinal detachment, myopathy, glaucoma.\n* Hypersensitivity to the active substance or to the excipients.\n* Diabetic retinopathy documented.\n* Pregnant or nursing (lactating) women.\n\nPatients who meet elegibility criteria and decline participation due to treatment randomization, will participate in an observational follow-up, collecting saliva for the analysis of genetic polymorphisms and clinical data related to antiVEGF received out of the clinical trial and AV, OCT results and adverse events registered in medical records at 6m, 12m, 24m, 36m.","50 Years",{"count":181,"type":21},630,[183],"PHASE3","This is a phase III, multicenter, randomized double-blinded clinical trial with two parallel groups (ranibizumab and bevacizumab) and an observational follow-up of patients who meet elegibility criteria and decline participation due to treatment randomization. It will be performed involving 630 eyes from patients with wet age-related macular degeneration (wAMD) diagnosis without another eye disease. This clinical trial compares the treatment response for 3 years, considering genetic variants already studied between the eyes treated with one of the first options of anti-VEGF used in patients with wAMD, (ranibizumab) and the most cost-effective anti-VEGF (bevacizumab; off-label use)",[186],"Wet Age-related Macular Degeneration",[188,189,190,191,177,192],"wAMD","antiVEGF","BVZ","RBZ","pharmacogenomics","2025-11-19",{"date":195,"type":43},"2025-11-20",{"date":197,"type":43},"2022-11-18",{"date":199,"type":21},"2026-07",{"name":49,"class":50},4,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":228,"locationsCount":110},"100604640","pilot-study-of-tscs-for-improving-upper-limb-function-in-people-with-multiple-sclerosis-100604640","NCT07152145","Pilot Study of tSCS for Improving Upper Limb Function in People With Multiple Sclerosis","Transcutaneous Electrical Spinal Stimulation (tSCS) for Improving Upper Limb Function in People With MS","tSCS-MS","Inclusion Criteria:\n\n* Age between 18 and 70 years.\n* Diagnosis of Multiple Sclerosis (according to revised McDonald criteria).\n* Upper limb dysfunction (9-Hole Peg Test score ≥ 20% slower than normative values).\n* Stable disease-modifying treatment for ≥ 6 months before enrollment.\n* Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Relapse or corticosteroid treatment within the last 3 months.\n* Severe spasticity of the upper limb (Modified Ashworth Scale \\> 3).\n* Implanted electrical devices (pacemaker, spinal cord stimulator).\n* Epilepsy or uncontrolled seizures.\n* Severe psychiatric disorders or cognitive impairment interfering with study procedures.\n* Pregnant or breastfeeding women.\n* Participation in another interventional clinical trial within the last 3 months.","70 Years",{"count":212,"type":21},60,[24],"The goal of this clinical trial is to evaluate whether non-invasive spinal cord neuromodulation with the SCONE™ device can improve upper limb function in people with multiple sclerosis. The study will investigate if combining SCONE™ therapy with rehabilitation exercises leads to improvements in arm and hand movement, and whether the therapy is safe and well tolerated in this patient population. Participants will receive non-invasive spinal cord stimulation with the SCONE™ device and perform rehabilitation exercises specifically focused on the upper limb.",[216],"Multiple Sclerosis",[218,219,220,221],"Spinal Cord Neuromodulation","Non-invasive neuromodulation","Upper limb function","Neurorehabilitation","2025-08-28",{"date":224,"type":43},"2025-09-03",{"date":226,"type":21},"2025-10",{"date":108,"type":21},{"name":49,"class":50},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100528627","efficacy-of-a-mobile-application-and-semi-attendance-program-in-bariatric-surgery-100528627","NCT06163235","Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery","Efficacy of a Mobile Application and Semi-attendance Program in Bariatric Surgery: a Randomized Clinical Trial","Inclusion Criteria:\n\n* BMI between 35-50kg\u002Fm2\n* Bariatric surgery candidates\n\nExclusion Criteria:\n\n* Non-controlled psychiatric disorder\n* Pregnancy desire in the next 12 months\n* Do not have mobile devices (smartphone)\n* Language barrier with Spanish.","65 Years",{"count":238,"type":21},72,[24],"BACKGROUND: Applications for mobile devices in patients with obesity offer a great opportunity to improve the quality of care and the monitoring of patients in bariatric surgery programs. This is especially pressing in the context of an increasing prevalence of obesity, and longer waiting lists in bariatric surgery programs.\n\nOBJECTIVES: The main objective is to evaluate the efficacy of a digital platform on mobile devices in obesity and bariatric surgery programs. Investigators will compare weight loss at 12 months after surgery in patients in the standard of care program and those in a semi-attendance program with digital support through a mobile application. As secondary objectives, it will be compared: (1) the number medical complications, the quality of life and satisfaction, physical activity, diet and attrition at 12 months after surgery. Investigators will also study the patient interaction with the platform and social networks.\n\nTRIAL DESIGN: Randomized, non-inferiority clinical trial with a 12-month follow-up.\n\nMETHODS: 72 patients will be randomized (1: 1) to standard of care program and to semi-attendance program with digital support from the bariatric surgery program waiting list. Inclusion criteria: age between 18 and 60 years, body mass index between 35-50kg\u002Fm2, candidates for the sleeve gastrectomy technique, and possession of a mobile device. Participants will be evaluated before and 12 months after surgery. Variables: anthropometric measurements, medical complications during follow-up, quality of life, diet and physical activity questionnaires. Primary endpoint: weight loss 12 months after surgery.",[242,243],"Obesity","Bariatric Surgery Candidate",[245,246,247],"Bariatric surgery","Telemedicine","Weight loss","2025-08-17",{"date":250,"type":43},"2025-08-21",{"date":252,"type":21},"2025-09-25",{"date":254,"type":21},"2027-12-31",{"name":49,"class":50},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":110},"100551026","shock-wave-therapy-for-lower-limb-lymphedema-100551026","NCT06454734","Shock Wave Therapy for Lower Limb Lymphedema","Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial","Inclusion criteria\n\n* Patients with lower limb lymphedema\n* Lymphedema of at least 6 months of evolution\n* The lymphedema must affect at least the knee to the foot\n* Moderate or severe lymphedema (grades 2 or 3)\n* Sign the informed consent\n\nExclusion criteria\n\n* Under 18 years of age\n* Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)\n* Current or previous deep vein thrombosis of the lower extremity\n* Pregnancy\n* Electronic implantable medical devices as pacemaker implants, medication pumps, etc\n* Having received treatment with complex decongestive therapy or shock waves during the last 6 months\n* Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks\n* Active oncological disease in the area to be treated\n* Active infectious-inflammatory process in the area to be treated\n* Cognitive or sensory deficits that prevent collaboration\n* Inability to walk independently or inability to attend therapy",{"count":264,"type":21},30,[24],"This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.",[268],"Lymphedema, Lower Limb","2025-07-30",{"date":271,"type":43},"2025-07-31",{"date":273,"type":43},"2024-05-28",{"date":108,"type":21},{"name":49,"class":50},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":210,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":110},"100369013","augmentation-of-emdr-with-tdcs-in-the-treatment-of-fibromyalgia-100369013","NCT04084795","Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia","Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 70 years old\n* Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial\n* Presence of one or more traumatic events causing current trauma-related symptoms\n* Current clinical symptoms of depression and\u002For anxiety\n* 2 weeks of stable medication\n\nExclusion Criteria:\n\n* Comorbid autoimmune or chronic inflammatory disease\n* Neurological or serious medical diseases\n* Bipolar disorder, schizoaffective disorder and schizophrenia\n* Suicidal ideation\n* Previous EMDR therapy in the past two years\n* Substance abuse\u002Fdependency within 1 month prior to participation (except for nicotine abuse\u002Fdependency),\n* Pending FM-related litigation or disability\n* Metallic implants in the head\n* Positive test for pregnancy\n* Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)",{"count":284,"type":21},96,[24],"Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.",[288,28,289,290],"Fibromyalgia","Depressive Symptoms","Anxiety",[288,292,293,294,295,296,297],"Psychological trauma","Posttraumatic stress disorder","Major depressive disorder","Anxiety disorder","Eye Movement Desensitization and Reprocessing","transcranial Direct Current Stimulation","2025-07-29",{"date":300,"type":43},"2025-08-03",{"date":302,"type":43},"2025-01-21",{"date":304,"type":21},"2026-12-31",{"name":49,"class":50},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":59,"minAge":4,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":110},"100600776","comparative-study-between-the-use-of-trapeziometacarpal-prostheses-and-the-usual-resection-tenosuspension-arthroplasty-for-the-treatment-of-rhizarthrosis-focusing-on-changes-in-pain-measured-with-the-vas-scale-and-function-with-the-quick-dash-100600776","NCT07101887","Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis, Focusing on Changes in Pain (Measured With the VAS Scale) and Function (With the Quick-DASH).","Comparative Study Between the Use of Trapeziometacarpal Prostheses and the Usual Resection-tenosuspension Arthroplasty for the Treatment of Rhizarthrosis.","Inclusion Criteria:\n\n* Rizarthrosis grade I, II, III\n\nExclusion Criteria:\n\n* Rizarthrosis grade IV\n* Severe osteoporosis\n* Metals allergy\n* Previous surgical interventions related\n* Malformations in the articular zones that difficult the implant placement",{"count":314,"type":21},61,[24],"It is a randomized, prospective, single-blind study of two treatment techniques for rhizarthrosis. The patients are divided into two groups: one in which a Maia trapeziometacarpal prosthesis is implanted, and the other in which the standard technique of trapeziectomy and tenosuspension plasty is performed according to the Burton-Pellegrini technique.The follow-up of the patients is one year, and functionality (measured with the Quick Dash test) and pain (measured with the VAS scale) are compared throughout this period.This study has a sample size of 62 patients, 31 per group. Other secondary variables are also evaluated, such as strength and mobility of the thumb trapeziometacarpal joint (measured with the Kapandji index).",[318],"Rizarthrosis",[320,321,322,323],"Thumb","osteoarthritis","prosthesis","trapeziectomy","2025-07-28",{"date":300,"type":43},{"date":327,"type":43},"2022-06-01",{"date":329,"type":21},"2025-11-01",{"name":49,"class":50},{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":59,"minAge":210,"maxAge":339,"enrollmentInfo":340,"targetDuration":342,"studyType":63,"phases":4,"briefSummary":343,"conditions":344,"keywords":348,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":110},"100555087","frailty-in-outpatient-digestive-endoscopy-100555087","NCT06507527","Frailty in Outpatient Digestive Endoscopy","ASSESSMENT OF THE ADEQUACY IN CARE OF THE FRAGILE PATIENT IN A DIGESTIVE ENDOSCOPY UNIT FRIEND Study (FRailty In ENDoscopy) Estudi FRIEND (FRailty In ENDoscopy)","FRIEND","Inclusion Criteria:\n\n* It will include all patients over 70 years of age who are indicated to undergo an ambulatory upper or lower endoscopy.\n\nExclusion Criteria:\n\n* Age below 70 years\n* Non-ambulatory endoscopies\n* Assessment of test contraindications by the endoscopist\n* Non-acceptance to enter the study","100 Years",{"count":341,"type":21},1474,"16 Months","The increase in our society of the proportion of frail people who suffer from disability and dependency forces us to detect modifiable factors and therefore subject to intervention that can adapt health care for frail patients in order to increase the effectiveness and safety of medical treatments and procedures.\n\nA geriatric assessment should be performed on all patients likely to present frailty prior to a digestive endoscopy to assess the risk-benefit of the indication and to improve patient preparation by avoiding adverse effects of endoscopic examinations, increasing the safety and profitability of the tests There are no data in our medium on the prevalence of frailty in patients referred for endoscopy, nor on the incidence in these patients of adverse effects, inadequate preparations, or incomplete examinations, so a frailty study is needed to elaborate multidisciplinary protocols that improve circuits and care in these patients and prevent complications.\n\nThe questions we want to try to answer are:\n\n* Prevalence and severity of fragility in digestive endoscopy.\n* Specific problems related to fragility in digestive endoscopy, mainly the profitability of the examination and the incidence of adverse effects, in order to create protocols for improving care in this group of patients.",[345,346,347],"Frailty","Comorbidities and Coexisting Conditions","Complication",[349,350,351,352],"Endoscopy","Indication","Bowell Preparation","Adverse effects",{"date":271,"type":43},{"date":355,"type":43},"2024-06-10",{"date":357,"type":21},"2025-09-30",{"name":49,"class":50},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":368,"conditions":369,"keywords":371,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":110},"100427536","intraoperative-radiotherapy-in-patients-with-brain-metastases-100427536","NCT04847284","Intraoperative Radiotherapy in Patients With Brain Metastases","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Karnofsky Performance Status ≥ 70\n* Newly diagnosed cerebral or cerebellar lesion (contrast enhancing on a T1-weighted MRI scan) amenable to total resection with no dural attachment\n* Frozen section confirming a metastasis of an extracranial ( Central Nervous System i.e. non-CNS) tumor\n* Adequate distance to optic nerve(s), chiasm and brainstem (organs at risk for radiotherapy)\n* Adequate birth control\n\nExclusion Criteria:\n\n* Leptomeningeal spread and dural attachment (assessed pre- and intraoperatively)\n* Frozen section reveals primary CNS tumor, lymphoma, SCLC (Small-cell lung cancer) or germinoma\n* More than one brain metastasis\n* Psychiatric or social condition potentially interfering with compliance\n* Contraindication against anesthesia, surgery, MRI and\u002For contrast agents\n* Pregnant or breast-feeding women",{"count":366,"type":21},25,[24],"Intraoperative radiotherapy (IORT) is a new alternative for local radiotherapy with the advantages of dose escalation, reduced overall treatment time, and enhanced patient convenience, however the degree of efficacy is unknown, as well as and which is the most efficient dose.\n\nThe objective of this study is to evaluate the efficacy and safety of IORT in patients with surgical excision of brain metastases at a dose of 20 Gy is at least as effective and safe as other forms of radiation therapy in patients with resection of brain metastases.",[370],"Brain Metastases",[372,373,374],"Brain metastases","Intraoperative radiotherapy","Intrabeam","2025-06-05",{"date":377,"type":43},"2025-06-06",{"date":379,"type":43},"2021-05-05",{"date":381,"type":21},"2025-12",{"name":49,"class":50},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":391,"sex":59,"minAge":236,"maxAge":392,"enrollmentInfo":393,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":110},"100590327","the-cohorfes-a-prospective-study-of-frailty-and-dependence-100590327","NCT06965972","The CohorFES: a Prospective Study of Frailty and Dependence","Prospective Cohort for the Study of Phenotypic Clusters, Progression Paths and Outcomes of Frailty and Dependence: The Spanish CohorFES","COHORFES","Inclusion Criteria:\n\n* women and men 65 years old or above visited in the outpatient clinics of participant centers\n* Signed informed consent\n\nExclusion Criteria:\n\n* Patients in a critical situation of end of live or Barthel scale \\\u003C60.",true,"120 Years",{"count":394,"type":21},1500,"Background Frailty has become a major problem for the health system, but also a window of opportunity to fight against disability through preventive strategies focused on the detection and treatment of frailty in all settings. However, no systematic strategies of screening and early detection are available in clinical settings. This project aims to identify clinical and biological phenotypic clusters that drive through the different stages of frailty and to describe the underlying mechanisms of the trajectories leading to disability and the potential for treatment. Moreover, validation of Frailty Trait Scale 5 (FTS5) will be performed as an easy model to be implemented in primary care and hospital scope.\n\nMethods\u002Fdesign A prospective population-based cohort will be stablished for frailty phenotyping (CohorFES). Creation of a CIBERFES Biobank where blood and urine samples from participants of CohortFES are stored for future researches. Demographic and clinical history data, anthropometric measurements, predimed questionnaire, peripheral blood biochemical variables and metabolomics were collected for each participant at baseline and every year until become frailty.\n\nUsing cluster partition models (k-means and hierarchical clustering) will group together individuals with similar deficits and characteristics (frailty phenotypes). Then, by using pre-established criteria (gap and silhouette), the proposed clustering solution (belonging to given clusters) will be evaluated. Further, investigators will assess, in a longitudinal fashion, the appearance and accumulation of deficits during the study period and identifying the clusters subgroups with more rapid progression. Results will be applied to establish and compare clusters and trajectories. Finally, frailty phenotypes and patient clusters will be correlated with health outcomes such as the use of health services (both primary and secondary care), hospital admissions, and mortality.\n\nDiscussion Information about clinical and biological phenotypic clusters that drive through the different stages of frailty can lead to identify potential targets that could improve the therapeutic management of these patients.\n\nIn summary, from a research perspective the project aims to better understanding of the interindividual variability in clinical events that lead to frailty, dependence and finally, to death.",[397],"Frailty Syndrome",[389,345,399],"FTS5","2025-05-02",{"date":402,"type":43},"2025-05-11",{"date":404,"type":43},"2022-12-01",{"date":406,"type":21},"2035-12-31",{"name":49,"class":50},{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":414,"eligibilityCriteria":415,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":416,"targetDuration":4,"studyType":22,"phases":418,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":435,"locationsCount":110},"100570470","left-septal-pacing-or-left-bundle-branch-pacing-to-avoid-left-ventricle-systolic-dysfunction-100570470","NCT06707662","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction","Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators","STAY II","Inclusion Criteria:\n\n1. Age of 18 years or more.\n2. Preserved or mild deteriorated LVEF (Simpson \\>40%) assessed by a recent (\\\u003C1 month before implantation) transthoracic echocardiography.\n3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\\>80%).\n4. Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.\n\nExclusion Criteria:\n\n1. Patients with indication for implantable cardioverter defibrillator device.\n2. Patients with indication for a CRT device, with LVEF \\\u003C40%.\n3. Patients with previous severe LVD (Simpson LVEF \\\u003C30%) and a recovered LVEF.\n4. History of myocardial infarction\u002Frevascularization or cardiac surgery within 6 months before randomization.\n5. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.",{"count":417,"type":21},150,[24],"Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial).\n\nCriteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.",[421],"AV Block",[423,424,425,426,427,428],"Conduction System Pacing","Left bundle branch area pacing","Right ventricle apical pacing","Left septum pacing","Left ventricle ejection fraction","Heart failure","2025-02-10",{"date":431,"type":43},"2025-02-11",{"date":433,"type":43},"2025-01-01",{"date":77,"type":21},{"name":49,"class":50},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":4,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":445,"briefSummary":446,"conditions":447,"keywords":449,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":457,"leadSponsor":459,"locationsCount":110},"100578036","balneotherapy-for-breast-cancer-patients-undergoing-endocrine-therapy-100578036","NCT06806072","BALNEOTHERAPY FOR BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY","EFFECTS OF BALNEOTHERAPY IN BREAST CANCER PATIENTS UNDERGOING ENDOCRINE THERAPY","Inclusion Criteria:\n\nPremenopausal women diagnosed with early-stage hormonal receptor (HR+) breast cancer (stages I-III) undergoing ovarian suppression and aromatase inhibitor therapy (i.e., endocrine therapy) for at least three months.\n\n\\- Reported musculoskeletal pain (VAS score ≥2) associated with the initiation of the endocrine therapy.\n\nExclusion Criteria\n\n* Chronic musculoskeletal conditions predating the initiation of endocrine therapy and\u002For unrelated to effects derived from the endocrine therapy (i.e. fibromyalgia)\n* Anxiety-depression syndrome predating the initiation of endocrine therapy that is treated with drugs.\n* Fear of water\n* Fecal and\u002For urinary incontinence\n* Severe venous insufficiency\n* Epilepsy and physical disabilities that may hinder the performance of Balneotherapy (BT)\u002Faquatic exercises.","55 Years",{"count":284,"type":21},[24],"Endocrine therapy is the mainstay of adjuvant therapy in premenopausal women with hormone receptive-positive (HR+) breast cancer as it has been demonstrated that it reduces long-term recurrences and increases survivial. However, this therapy, which suppresses estrogen production and estrogen-induced effects, is associated with the development of joint pain which can significantly reduce quality of life and lead to treatment discontinuation.\n\nThe main question the study aims o answer is:\n\nCan balneotherapy (BT) alleviate muscle-skeletal pain (primary objective) derived from endocrine therapy and improve quality of life (secondary objective) in young women with HR+ breast cancer?",[448],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[450,451,452],"breast cancer","balneotherapy","endocrine therapy","2025-01-30",{"date":455,"type":43},"2025-02-03",{"date":429,"type":21},{"date":458,"type":21},"2027-05-31",{"name":49,"class":50},{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":475,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":481,"leadSponsor":482,"locationsCount":110},"100574286","impact-of-mediterranean-diet-in-cardiovascular-risk-among-people-with-hiv-100574286","NCT06757309","Impact of Mediterranean Diet in Cardiovascular Risk Among People With HIV","Randomized Study to Evaluate the Impact of Dietary Optimization on Metabolic Profile, Immunoactivation and Cardiovascular Risk in HIV Population on ART","VIHMED","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Confirmed diagnosis of HIV infection.\n* On stable antiretroviral therapy (ART) with an undetectable viral load for at least 12 months.\n* LDL cholesterol levels \\>140 mg\u002FdL.\n* Low adherence to the Mediterranean diet, defined by a MEDAS score \\\u003C9.\n* Must be able to swallow tablets\n* Willingness and ability to provide informed consent.\n\nExclusion Criteria:\n\n* Use of lipid-lowering medications.\n* Chronic use of anti-inflammatory drugs.\n* Active hepatitis B or hepatitis C infection.\n* Other chronic inflammatory conditions (e.g., autoimmune diseases).\n* Familial hypercholesterolemia.\n* Uncontrolled metabolic conditions, such as hypothyroidism or diabetes mellitus.\n* Pregnancy or breastfeeding.\n* Cognitive or psychological conditions impairing the ability to comply with the study protocol.\n* Inability to provide informed consent.",{"count":469,"type":21},64,[24],"This study (VIHMET) aims to explore how dietary changes, specifically the adoption of a Mediterranean diet, can improve health outcomes in people living with HIV (PLWH) who are on antiretroviral therapy (ART). PLWH often experience chronic inflammation, metabolic disturbances, and elevated cardiovascular risk due to the virus, immune activation, and ART-related side effects. By examining dietary interventions, this study seeks strategies to reduce these risks and enhance quality of life.\n\nThe VIHMET study is a randomized clinical trial involving 64 participants at Hospital del Mar, Barcelona, randomized into control and intervention groups (1:2 ratio). The intervention group will receive personalized nutritional counseling to improve adherence to the Mediterranean diet, focusing on food selection and meal preparation. The control group will follow standard dietary recommendations. Assessments will occur at baseline, week 24, and week 48.\n\nKey health indicators include lipid profiles, markers of inflammation, immune activation, and cardiovascular health, assessed through non-invasive techniques like arterial stiffness and subclinical atherosclerosis measurements. Participants will complete questionnaires on diet adherence, physical activity, and quality of life, alongside anthropometric evaluations.\n\nEligible participants are adults with HIV, undetectable viral loads for 12+ months, and elevated LDL cholesterol with low Mediterranean diet adherence. Exclusion criteria include lipid-lowering drugs, chronic anti-inflammatory therapy, or other active inflammatory\u002Fmetabolic conditions.\n\nThis study aims to improve lipid levels, reduce inflammation, decrease arterial stiffness, and assess diet adherence's impact on quality of life and subclinical atherosclerosis. Results may inform dietary recommendations to reduce cardiovascular risks and enhance holistic care for PLWH.",[95,101,473,474],"Cardiovascular Risk","Mediterranean Diet",[93,101,476],"Coronary Artery","2024-12-31",{"date":479,"type":43},"2025-01-03",{"date":477,"type":43},{"date":199,"type":21},{"name":49,"class":50},{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":59,"minAge":491,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":110},"100568467","testing-pulse-stimulation-to-improve-motor-function-in-people-with-als-a-pilot-study-100568467","NCT06681610","Testing Pulse Stimulation to Improve Motor Function in People With ALS: A Pilot Study","Modulation of the Motor Pathway by Transcranial Pulse Stimulation in People With ALS: a Pilot Randomized Trial","TPS4ALS","Inclusion Criteria:\n\n* Patients with diagnosis of sporadic ALS (definite or clinically probable) as defined by the World Federation of Neurology revised El Escorial criteria\n* SVC of 50% or greater of estimated measure and presence of measurable motor evoked potential\n* 21 to 80 years old and male or female\n\nExclusion Criteria:\n\n* patients with fALS (based on medical history) that are unable to tolerate TMS and MRI studies or have a contraindication as described below","21 Years","80 Years",{"count":494,"type":21},50,[24],"The goal of this clinical trial is to assess the efficacy of TPS of the motor cortex on biomarkers and clinical endpoints in patients with ALS. The main questions it aims to answer are:\n\n* Stage 1: Is there a change in the short intracortical inhibition (SICI) of the motor cortex from baseline to week 8?\n* Stage 2: Is there a change from baseline to month 6 in the ALS functional rating scale-revised (ALSFRS-R) total score?\n\nIn stage 2, researchers will compare the group receiving the stimulation vs the group receiving a sham stimulation to see if there is a difference in motor cortex activity and in the ALSFRS-R score\n\nParticipants will receive either:\n\n* the TPS treatment\n* a sham TPS treatment",[498],"Amyotrophic Lateral Sclerosis (ALS)",[500,498],"Transcranial Pulse Stimulation (TPS)","2024-11-07",{"date":503,"type":43},"2024-11-08",{"date":505,"type":43},"2024-10-24",{"date":108,"type":21},{"name":49,"class":50},{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":11,"sex":59,"minAge":179,"maxAge":516,"enrollmentInfo":517,"targetDuration":4,"studyType":22,"phases":519,"briefSummary":520,"conditions":521,"keywords":526,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":110},"100557796","atrial-anomalies-predict-silent-atrial-fibrillation-detected-by-implantable-cardiac-monitor-in-cryptogenic-stroke-100557796","NCT06542770","Atrial Anomalies Predict Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Cryptogenic Stroke","Subtle Ultrasound Atrial Anomalies Predicts the Early Diagnosis of Silent Atrial Fibrillation Detected by Implantable Cardiac Monitor in Patients With Cryptogenic Stroke. A Randomized Trial","CRIPTO-FAST","Inclusion Criteria:\n\n* Acute ischemic stroke or transient ischemic attack (TIA) from January 2022 to July 2023\n* Age between 50 and 89 years;\n* Undetermined origin at hospital admission according to the SSS-TOAST criteria (2):\n\n  1. Absence of major structural heart disease by cardiac ultrasound (normal global and segmental left ventricle contraction, absence of valvular\u002Frheumatic disease, absence of intracardiac shunts)\n  2. Absence of AF during 48h ECG-monitoring\n  3. Absence of major anomalies in the supra-aortic trunks ultrasound.\n\nExclusion Criteria:\n\n1. Patients with a history of hemorrhagic stroke;\n2. Presence with prior atrial fibrillation or atrial flutter;\n3. Permanent contraindication or indication for OAC for other reasons;\n4. Recent (\\\u003C1 month) major surgery or cardiac events;\n5. Presence of severe cardiac abnormalities;\n6. Patients with life expectancy \\\u003C1 year or severe stroke (modified Rankin Scale \\> 4).","89 Years",{"count":518,"type":21},100,[24],"Cryptogenic stroke (CS) causes about 30% of admissions to a stroke unit. Silent paroxysmal atrial fibrillation (PAF) is believed to be the underlying cause of a significant proportion of patients. The use of implantable cardiac monitors (ICM) early after the CS has demonstrated benefits in the diagnostic yield, but the indication for ICM in the current guidelines remains unclear. Atrial contraction strain (ACS) evaluated by cardiac ultrasound could be of help to select the patients more prone to suffer from silent PAF.\n\nThe purpose of this investigation is to conduct a randomized prospective unicentric study to evaluate the usefulness of ICM for early detection of silent PAF episodes in patients with CS. Clinical and ultrasound predictors of PAF occurrence (ACS) will be studied in order to define patients needing a closer follow-up.",[522,523,524,525],"Paroxysmal Atrial Fibrillation","Cardiac Rhythm Disorder","Left Atrial Dilatation","Cryptogenic Stroke",[527],"Atrial strain. Implantable cardiac monitor","2024-08-02",{"date":530,"type":43},"2024-08-07",{"date":532,"type":43},"2021-01-01",{"date":534,"type":21},"2024-12",{"name":49,"class":50},{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":22,"phases":546,"briefSummary":547,"conditions":548,"keywords":553,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":110},"100537032","implementing-proms-and-prems-in-routine-clinical-care-assessment-of-requirements-and-impact-100537032","NCT06272552","Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact","Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact.","PROMs & PREMs","Inclusion Criteria:\n\n* Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service\n* In possession of an email account and having basic knowledge of how to manage emails\n* In possession of a smartphone, computer, or tablet with access to the Internet\n* Fluent and able to read in Spanish\n\nExclusion Criteria:\n\n\\- Under 18 years of age",{"count":545,"type":21},1440,[24],"There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.\n\nObjective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.\n\nDesign: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.\n\nParticipants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.\n\nIntervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).\n\nMain outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).\n\nExpected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\\' and health professionals\\' experiences on health care, as well as improve patients\\' health.",[549,550,551,552],"PROMs","PREMs","Implementation Research","Impact Evaluation",[554,551,555,549,550,556,557,558],"PRMs Implementation","Implementation evaluation","Impact evaluation","RCT","Health Services Research","2024-02-21",{"date":561,"type":43},"2024-02-22",{"date":563,"type":43},"2023-10-25",{"date":565,"type":21},"2027-10",{"name":49,"class":50},{"id":568,"slug":569,"hasResults":11,"nctId":570,"briefTitle":571,"officialTitle":572,"acronym":573,"eligibilityCriteria":574,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":580,"conditions":581,"keywords":584,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":594,"locationsCount":4},"100535978","phase-4-restoration-of-vitamin-d-in-pulmonary-arterial-hypertension-100535978","NCT06258850","REstoration of VItamin D in Pulmonary Arterial Hypertension","REstoration With Calcifediol of VItamin D Deficiency in Pulmonary Arterial Hypertension Patients","REVIDAH","Inclusion Criteria:\n\n1. Male and female patients aged 18 -75 years.\n2. Patients with diagnosis of PAH of the following types according to 2022 ERS\u002FESC guidelines: idiopathic, hereditary, drug and toxin-induced PAH or associated to connective tissues disease.\n3. Patients who are stable and treated with standard medications for PAH on monotherapy or with combinations of drugs, including calcium channel blockers, phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERA), prostacyclin analogues or selexipag or with stable dose of diuretics who had no treatment modification for at least 6 weeks before randomization.\n4. Patients with an intermediate-low and intermediate-high risk score according to 2022 ERS\u002FESC guidelines.\n5. Patients with severe deficiency of vitamin D, defined herein as plasma or serum 25(OH)vitamin D levels equal to or lower than 12 ng\u002Fml\n6. Patients who can understand and follow instructions, and who are able to participate in the study for the entire study.\n7. Patients must have given their written informed consent to participate in the study after having received adequate previous information and before any study-specific procedures.\n\nExclusion Criteria:\n\n1. Participation in another interventional clinical study within 30 days before screening.\n2. Previous randomisation to treatment during this study (no re-randomisation).\n3. Pregnant women or breastfeeding women, or women with childbearing potential not using a effective contraception method throughout the study.\n4. Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate in or complete this study, in the opinion of the investigator.\n5. Patients with substance abuse (eg, alcohol or drug abuse) within the previous 3 months before and at randomisation.\n6. Patients with underlying medical disorders with an anticipated life expectancy \\\u003C2 years.\n7. Patients with a history of severe allergies or multiple drug allergies or with hypersensitivity to the investigational drug or any of the excipients.\n8. Patients unable to perform a valid 6MWD test (eg, orthopaedic disease or peripheral artery occlusive disease that affects the patient's ability to walk).\n9. Excluded medication\u002Ftreatment: active treatment with digoxin.","75 Years",{"count":577,"type":21},102,[579],"PHASE4","Background. Pulmonary arterial hypertension (PAH) is a heterogeneous pathophysiological condition characterized by progressive pulmonary vascular narrowing that ultimately results in right-sided heart failure and eventually death or lung transplantation. The effectiveness of current pharmacological treatments is suboptimal and a large proportion of patients still had events or died despite receiving combination therapy. Vitamin D deficiency has been found to be much more frequent in PAH patients than in the general population or even compared to patients with other severe cardiovascular diseases. Moreover, vitamin D deficiency has a negative prognostic impact in PAH. Animal studies support that vitamin D deficiency worsens PAH.\n\nHypothesis. In patients with PAH and vitamin D deficiency, restoration of vitamin D status with calcifediol improves their symptomatology and prognosis.\n\nDesign: Multicenter clinical trial with the participation of 9 hospitals, placebo-controlled, randomized (1:1 ratio), in two parallel groups (without crossover), triple blind, and add-on on existing treatments (add-on). It will include at least 102 subjects (51 in the calcifediol group and 51 in the placebo group) followed for 24 weeks of treatment.\n\nInclusion criteria: Patients of both sexes (18-75 years) with hemodynamic diagnosis of PAH and severe vitamin D deficiency (25-OHvitD \\\u003C= 12 ng\u002Fml) and without previous diagnosis of osteoporosis or osteomalacia.\n\nTreatments: 1) Calcifediol Hydroferol® 0.266 mg once every 10 days for the first 12 weeks and once every two weeks for the following 12 weeks. 2) Placebo.\n\nMain objective: A composite endpoint of clinical improvement without clinical worsening at week 24.\n\nExpected outcome: Restoration of vitamin D status is an unexpensive measure, very easily implantable and that could improve the evolution of the disease as well as other aspects such as bone or immune health and that has few side effects.",[582,583],"Pulmonary Artery Hypertension","Vitamin d Deficiency",[585,586],"Clinical improvement","Clinical worsening","2024-02-06",{"date":589,"type":43},"2024-02-14",{"date":591,"type":21},"2024-07-01",{"date":593,"type":21},"2027-12",{"name":49,"class":50},""]