[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto de Investigación Sanitaria y Biomédica de Alicante\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100576667","aerobic-exercise-induced-effect-on-endothelial-function-in-patients-with-ischaemic-heart-disease-100576667",false,"NCT06788275","Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease","Effect of Different Aerobic Exercise Methods in Cardiac Rehabilitation on Endothelial Function in Patients With Ischaemic Heart Disease and Study of the Associated Physiological Mechanisms (ENDO-R)","ENDO-R","Inclusion Criteria:\n\n* Men and women aged between 45 and 75 years.\n* Diagnosed with acute myocardial infarction, unstable or stable angina.\n* Treated with percutaneous coronary intervention, coronary artery bypass grafting, or conservative treatment.\n* Event or intervention within 3 to 12 months prior to participation in the study.\n* Fluency in speaking and reading Spanish.\n* Residing in Elche or surrounding areas and able to attend evaluations and the exercise programme (not planning to be absent for more than one week during the programme).\n* Functional Class I-II according to the New York Heart Association (NYHA) classification.\n* No physical limitations for exercise.\n* Stable optimal medical treatment.\n* Physically inactive, defined as 1) not meeting the World Health Organization recommendations for both aerobic and strength exercise, and 2) not participating in a structured exercise programme at least 3 days per week for more than 3 months. Both conditions must be met for inclusion. Note: Casual walking is not considered grounds for exclusion.\n\nExclusion Criteria:\n\n* Use of walking assistive devices.\n* Treatment with chemotherapy for any type of cancer in the past 2 years.\n* Hospitalisation in an intensive care unit in the past 6 months for reasons other than the ischaemic event.\n* Acute myocardial infarction group IV Killip-Kimball.\n* Obesity grade III (≥40.0 kg\u002Fm²).\n* Medical contraindication for inclusion in an exercise programme.\n* Diabetes with uncontrolled blood glucose levels.\n* Poorly controlled hypertension: resting blood pressure \\> 180\u002F110 mmHg.\n* Chest pain with exertion or ST-segment changes suggestive of residual ischemia during ergometry. Residual ischemia.\n* Severely reduced functional capacity on initial ergometry (\\<5 metabolic equivalent of task).\n* Left ventricular ejection fraction less than 50%.\n* Severe stenosis of the left main coronary artery (\\>50% significant disease).\n* Severe aortic stenosis, left ventricular outflow tract obstruction (e.g., obstructive hypertrophic cardiomyopathy) or aortic dissection.\n* Severe valvulopathy.\n* Acute pulmonary embolism or deep vein thrombosis.\n* Severe pulmonary hypertension.\n* Acute heart failure.\n* Acute endocarditis, myocarditis, or pericarditis.\n* Acute or chronic renal insufficiency (estimated glomerular filtration rate \\<30 ml\u002Fmin).\n* Pulmonary fibrosis or interstitial disease (severe respiratory insufficiency or confirmed chronic obstructive pulmonary disease).\n* Uncontrolled cardiac arrhythmias\u002Fhemodynamically unstable.\n* Permanent or persistent\u002Fparoxysmal atrial fibrillation with episodes in the past 6 months.\n* High-grade cardiac block.\n* Presence of implantable devices: cardiac resynchronization therapy pacemaker, implantable cardioverter defibrillators, or pacemaker.\n* Presence of ischaemic symptoms during the incremental exercise test performed before the intervention.\n* Severe autonomic or peripheral neuropathy.\n* Use of nitrates in pharmacological treatment.\n* Any planned surgical or medical intervention during the study period.\n* Plans to participate in or current participation in other studies that may interfere with this study.\n* Current pregnancy or intention to become pregnant during the study period.","ALL","45 Years","75 Years",{"count":21,"type":22},132,"ESTIMATED","INTERVENTIONAL",[25],"NA","Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD. Within the aerobic exercise methods, there is evidence showing that high-intensity interval training (HIIT) increases FMD to a greater extent than moderate-intensity training (MIT) in these patients. Notably, in a recent review, our research group found that only studies performing long bouts of HIIT (long HIIT: higher than 1 min) found a greater effect on FMD, while no differences were found in those studies using short bouts of HIIT (short HIIT: ≤ 1 min) and MIT. However, no experimental studies comparing the effect of long HIIT, short HIIT, and MIT on endothelial function, as well as other predictors of mortality, such as cardiorespiratory fitness, brain-derived neurotrophic factor (BDNF) levels or parasympathetic branch activity, have been performed. Therefore, the main objective of this project will be to compare the effect of the three aerobic exercise methods on endothelial function, as measured by FMD, in patients with IHD. Complementarily, the effect of aerobic exercise, depending on the exercise method, on different mortality predictors will be compared. For this purpose, a multicentre randomised study will be carried out (2 hospitals in Elche and one in Alicante). Assessors will be blinded to the patients allocation. Participants will be aware about their allocation in the experimental groups due to the nature of the study. A total of 132 men and women with IHD (66 per sex), diagnosed between three and 12 months before the start of the intervention, aged between 45 and 75 years, and without limitations for the practice of exercise training, will be recruited. All patients will train 3 days a week for 12 weeks. Participants will be assessed before the intervention (i.e., pre), at 6 weeks of training (i.e., mid) and after the intervention (i.e., post). Physiological and psychological variables will be registered in the assessment periods. Training intensity will be individually prescribed based on the cardiopulmonary exercise test (CPET). Intensity exercise will be adapted after the first part of the intervention. Analysis of covariance will be used to compare the values of the three groups after the intervention for the continuous variables, including the pre-intervention value as a covariate, while a logistic regression model will be used for the categorical variables.",[28,29,30,31,32,33],"Percutaneous Coronary Intervention (PCI)","Acute Myocardial Infarction","Angina (Stable)","Unstable Angina Pectoris","Cardiorespiratory Fitness","Ischaemic Heart Diseases",[35,36,37,38,39,40,41,42],"Aerobic exercise","High-intensity interval training","Cardiac rehabilitation","Multicenter study","Coronary artery disease","Flow-mediated dilation","Nitroglycerin-mediated dilation","Mortality predictors","RECRUITING","2026-02-25",{"date":46,"type":47},"2026-02-27","ACTUAL",{"date":49,"type":47},"2024-11-01",{"date":51,"type":22},"2027-11",{"name":53,"class":54},"Instituto de Investigación Sanitaria y Biomédica de Alicante","NETWORK",2,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100593427","one-year-outcomes-by-index-treatment-in-elderly-patients-with-acute-cholecystitis-100593427","NCT07006298","One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis","One-year Outcomes by Index Treatment in Elderly Patients With Acute Cholecystitis: Protocol of the International, Prospective, Observational GOLDENEYE Study","GOLDENEYE","Inclusion Criteria:\n\n* patients ≥70 years\n* diagnosed with acute cholecystitis, as per the Tokyo guidelines\n\nExclusion Criteria:\n\n* prior episodes of cholecystitis or pancreatitis\n* terminal illness\n* concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy","70 Years",{"count":66,"type":22},376,"OBSERVATIONAL","Background: The GOLDENEYE study is an international, multicenter, prospective observational investigation designed to compare the outcomes of various management strategies for acute cholecystitis in patients aged 70 years and older. This research is driven by the increasing prevalence of gallstones and biliary tract diseases in the elderly, alongside a recognition that the burden of comorbidity in this population may necessitate tailored treatment approaches to optimize outcomes.\n\nPatients and Methods: The primary aims of the study are to evaluate the efficacy of different treatments -supportive care, percutaneous gallbladder drainage, early or delayed cholecystectomy, and EUS-guided gallbladder drainage- on patient-centric outcomes, including one-year additional treatment modalities, hospital readmissions, outpatient encounters, quality of life, and survival rates. The study adopts a robust design incorporating propensity score matching analysis to account for the non-randomized allocation of treatment modalities, thereby minimizing selection bias and enhancing the comparability of treatment groups. Inclusion criteria are centered on patients ≥70 years diagnosed with acute cholecystitis, as per the Tokyo guidelines, while key exclusion criteria include prior episodes of cholecystitis or pancreatitis, terminal illness, and concurrent diagnosis of acute pancreatitis, cholangitis, bile duct disease, or digestive malignancy. Data collection will leverage the REDCap platform for systematic and secure data management, facilitating real-time data entry and monitoring across participating centers.\n\nDiscussion: This comprehensive approach ensures the integrity and reliability of data collected on demographics, gender, clinical outcomes, and quality of life measures. Through its innovative design and methodology, the GOLDENEYE study aims to generate evidence-based insights that will significantly influence the management of acute cholecystitis in the elderly, ultimately improving patient outcomes and healthcare practices in this growing demographic population.",[70],"Acute Cholecystitis",[72,73,74,75,76,77],"laparoscopic cholecystectomy","Conservative Treatment","drainage","Endosonography","Propensity Score","Retrospective Studies","2025-06-06",{"date":80,"type":47},"2025-06-08",{"date":82,"type":47},"2025-05-15",{"date":84,"type":22},"2027-05-15",{"name":53,"class":54},1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":55},"100556695","phase-3-clinical-trial-evaluating-the-efficacy-and-safety-of-dexamethasone-compared-to-placebo-in-patients-with-severe-influenza-100556695","NCT06528444","Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza","Randomized, Double-blind, Multicenter, Phase III Clinical Trial Evaluating the Efficacy and Safety of Dexamethasone Compared to Placebo in Patients With Severe Influenza","FLUDEX","Inclusion Criteria:\n\n1. Aged ≥ 18 years.\n2. Diagnosis of influenza A or B virus infection by antigen or RT-PCR (local laboratory) at the time of entry or at 48 hours prior to randomization in respiratory specimens (nasopharyngeal swab or bronchoalveolar lavage).\n3. Hospitalized patients with an estimated hospital stay of more than 24 hours.\n4. In previous treatment or concomitant start of treatment with oseltamivir.\n5. For women of childbearing age, use of contraceptive methods until day 30 after completion of treatment.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients with bronchial hyperresponsiveness that requires systemic corticosteroids for more than 24 hours.\n\n  2\\. Pre-inclusion treatment with corticosteroids for more than 24 hours at a dose equal to or higher than 1 mg\u002Fkg methyl-prednisolone (0.2 mg\u002Fkg dexamethasone or 1.25 mg\u002Fkg prednisone).\n\n  3\\. Inability to administer oral oseltamivir. 4. Patients on ECMO (extracorporeal membrane oxygenation). 5. Pre-existing condition or use of medication that, in the opinion of the local investigator, may pose a risk for the administration of corticosteroids.\n\n  6\\. Patients with severe comorbidity with life expectancy of less than six months in the opinion of the investigator.\n\n  7\\. Patients co-infected with SARS-CoV-2 or RSV.",true,"18 Years","100 Years",{"count":99,"type":22},42,[101],"PHASE3","Clinical trial with an active ingredient of a pharmaceutical specialty marketed in Spain vs. placebo.\n\nRandomized, double-blind, multicenter phase III clinical trial that evaluates the efficacy and safety of dexamethasone compared to placebo in patients with severe influenza.",[104],"Influenza","2025-02-17",{"date":107,"type":47},"2025-02-19",{"date":109,"type":47},"2024-10-01",{"date":111,"type":22},"2028-10-31",{"name":53,"class":54},""]