[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundacion Clinic per a la Recerca Biomédica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":505},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,39,63,87,108,130,152,184,207,232,256,282,306,330,353,385,414,438,457,481],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100605506","phase-1-first-in-human-pilot-study-to-assess-the-safety-and-efficacy-of-dendritic-cells-loaded-with-frameshift-derived-neopeptides-for-the-prevention-of-cancer-in-of-lynch-syndrome-carriers-100605506",false,"NCT07163403","First in Human Pilot Study to Assess the Safety and Efficacy of Dendritic Cells Loaded With Frameshift Derived Neopeptides for the Prevention of Cancer in of Lynch Syndrome Carriers","DELAY","Inclusion Criteria:\n\n1. Individuals that are carriers of a pathogenic or likely pathogenic germline variant in one of the mismatch repair genes (MLH1, MSH2, MSH6).\n2. Participants must have no evidence of active or previous invasive cancer.\n3. Participants must have endoscopically accessible colon.\n4. Participants must consent to follow the standard of care surveillance with colonoscopy and biopsies every 1-2 years.\n5. Age ≥ 18 years\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 (Karnofsky ≥70%).\n7. Haemoglobin ≥10 g\u002FdL or haematocrit ≥30%; Leukocyte count ≥3.0x109\u002Fl; Platelet count ≥100x109\u002Fl; Absolute neutrophil count ≥1.5x109\u002Fl; Absolut lymphocyte count ≥0.8x109\u002Fl.\n8. Creatinine clearance (calculated if measured is not available) ≥60mL\u002Fmin\u002F1.73m2.\n9. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\] ≤2 times the institutional upper limit of normal (ULN).\n10. Total bilirubin ≤ 1.5 the ULN; participants with Gilbert's disease may be enrolled with higher total bilirubin if their direct bilirubin is ≤1.5 times the ULN.\n11. Written informed consent.\n12. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods until one year following the las immunization dose. Highly effective contraceptive methods will include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence. \\* A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient.\n\nExclusion Criteria:\n\n1. Individuals that are carriers of a pathogenic or likely pathogenic germline variant in PMS2.\n2. Individuals with active malignancy or previous malignancy (excluding non-melanoma skin cancer)\n3. Participants who cannot be removed from their baseline medication for the duration of the trial to administer the investigational treatment. This includes the daily use of \\>100 mg aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX) inhibitors.\n4. Any serious uncontrolled and \u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures.\n5. Patients with active systemic bacterial, viral or fungal infections or known to have human immunodeficiency virus (HIV) or to test positive for HIV antibody at screening.\n6. Positive hepatitis B surface antigen or hepatitis C antibody tests at screening.\n7. History of organ allograft or other history of immunodeficiency\n8. Individuals with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.\n9. Pregnant or breastfeeding or planning to become pregnant during the first year after the completion of the study treatment.\n10. Men attempting or planning to conceive children during the first year after the completion of the study treatment.\n11. Participants cannot receive any other investigational agents in the last month before its inclusion.\n12. Participants unable to refrain to receive any type of vaccination during the first 12 weeks of the trial.\n13. Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).\n14. Any other problem that according to the investigator could interfere with the evaluation of the objectives","ALL","18 Years",{"count":5,"type":19},"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","Tha aim of this clinical trial is to evaluate safety and tolerability of autologous peripheral blood differentiated and matured adult dendritic cells. Immunogenicity of the prduct(DC-DELAY) will be evaluated also.",[25],"Lynch Syndrome","RECRUITING","2026-04-10",{"date":29,"type":30},"2026-04-13","ACTUAL",{"date":32,"type":30},"2025-09-04",{"date":34,"type":19},"2028-09-20",{"name":36,"class":37},"Fundacion Clinic per a la Recerca Biomédica","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":38},"100627860","phase-1-cd5car-nk-cells-for-refractory-invasive-mold-disease-100627860","NCT07454122","CD5CAR-NK Cells for Refractory Invasive Mold Disease","Off-the-shelf CD5CAR-NK Cells for Refractory Invasive Mold Disease: Phase I Clinical Trial.","CD5CAR-NK","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of probable or proven fungal infection according to EORTC criteria20, who have been treated with the best available antifungal strategy and present at least one of the following criteria indicating inadequate response to antifungal therapy: Increase in fungal infection biomarker levels (serum or bronchoalveolar lavage galactomannan, or serum β-D-glucan) after at least one week of antifungal therapy:\n\n   1. Persistence of positive cultures despite having received ≥2 weeks of appropriate antifungal treatment.\n   2. Radiological worsening of lesions suggestive of fungal infection despite having received ≥2 weeks of appropriate antifungal treatment, and when at least 2 weeks have passed since the previous imaging study.\n   3. Clinical deterioration and microbiological isolation of a fungus resistant to all available antifungal treatments (including cases in which a specific antifungal cannot be administered due to the risk of unacceptable toxicity).\n   4. Rapidly progressive clinical deterioration despite the implementation of all available antifungal measures, conferring a poor prognosis for the patient.\n3. Signing the informed consent form to participate in the clinical trial and to receive CD5CAR-CBNK therapy. If the patient is not in a condition to sign the informed consent form, consent will be requested from the family and patient consent for the study continuation will be obtained as soon as deemed possible.\n\nExclusion Criteria:\n\n1. An expected survival of less than four weeks due to a cause unrelated to the current fungal infection.\n2. Patients with positive HIV serology.\n3. Pregnant or breastfeeding women.\n4. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.","65 Years",{"count":49,"type":19},10,[22],"CD5CAR-NK is a first-in-human, pilot, dose-escalation, and single-site study to evaluate the safety of CD5CAR-CBNK in patients with invasive mold diseases (IMD).\n\nThe study population consists of patients aged ≥18 years with refractory mold infections.\n\nThe number of patients treated will be 10. This is a dose-escalation study including 3 cohorts.",[53],"Fungal Infection","NOT_YET_RECRUITING","2026-03-02",{"date":57,"type":30},"2026-03-06",{"date":59,"type":19},"2026-05",{"date":61,"type":19},"2029-12",{"name":36,"class":37},{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":16,"minAge":17,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":81,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":38},"100627858","phase-4-application-of-radiomics-for-diagnosis-and-follow-up-of-cardiovascular-device-infections-predict-study-100627858","NCT07454096","Application of Radiomics for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study","Application of Radiomics in Molecular Imaging (18F-FDG-PET\u002FCT) for Diagnosis and Follow-up of Cardiovascular Device Infections: PREDICT Study","PREDICT","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Implanted cardiovascular device (prosthetic valve, TAVI, CIED, vascular graft\u002Fendograft).\n* For infected cohorts: patients studied by FDG-PET with definitive diagnosis of CVDI based on multidisciplinary evaluation.\n* For control group: no clinical suspicion of infection at time of inclusion.\n* Written Informed consent provided (prospective cohort and control group).\n* Women of child-bearing potential must have a negative pregnancy test in serum or urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence (only if refraining from heterosexual intercourse during the period of twelve months of duration of the study).\n\nExclusion Criteria:\n\n* Inability to undergo FDG-PET due to contraindications (e.g., allergies, claustrophobia).\n* Pregnancy or breastfeeding.\n* Incomplete clinical data or lack of access to imaging studies.\n* Refusal or withdrawal of informed consent (for control and prospective cohort).",true,"84 Years",{"count":74,"type":19},200,[76],"PHASE4","Single center, open-label, phase IV clinical trial to study the application of radiomics in molecular imaging for diagnosis and follow-up of CVDIs. The study will include three populations:\n\n* Retrospective cohort (2018-2025)\n* Prospective cohort (2026-2027)\n* Control group (prospective)",[79,80],"Cardiac Disease","Device Related Infection",{"date":57,"type":30},{"date":83,"type":19},"2026-04-30",{"date":85,"type":19},"2028-04-30",{"name":36,"class":37},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":20,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":5},"100469889","phase-4-oral-antimicrobial-treatment-vs-outpatient-parenteral-for-infective-endocarditis-100469889","NCT05398679","Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis","OraPAT-IEGAMES","Inclusion Criteria:\n\n* Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group.\n* Male or female 18 years old or older.\n* 10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery.\n* Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to \\\u003C25% of peak value or \\\u003C20 mg\u002Fl, and white blood cell count \\\u003C15x10\\^9\u002Fl during antibiotic treatment\n* Transthoracic \u002F transesophageal echocardiography performed within 48 hours of randomization\n\nExclusion Criteria:\n\n* Body mass index \\>40\n* Concomitant infection requiring intravenous antibiotic therapy\n* Inability to give informed consent to participation\n* Suspicion of reduced absorption of oral treatment due to abdominal disorder\n* Microorganisms with no oral combinations for treatment (two active antibiotics of different families)\n* Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy\n* No family or appropriate home support\n* Reduced compliance\n* Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period\n* Women in lactancy period",{"count":95,"type":19},360,[76],"Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis",[99],"Endocarditis Infective","2026-02-23",{"date":102,"type":30},"2026-02-25",{"date":104,"type":30},"2022-08-17",{"date":106,"type":19},"2027-12-30",{"name":36,"class":37},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":20,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":129,"locationsCount":38},"100624687","phase-4-study-on-sexual-health-and-self-perceived-quality-of-life-proms-in-patients-treated-for-cervical-cancer-100624687","NCT07412873","Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer","Prospective Randomized Study on Sexual Health and Self-perceived Quality of Life (PROMs) in Patients Treated for Cervical Cancer","PROVIDENCE","Inclusion Criteria:\n\n* Women of legal age.\n* Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous.\n* Patients treated for cancer with surgery and\u002For radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain.\n* Complete response after oncospecific treatment was obtained.\n* Signature of the informed consent (IC) by the patient or responsible family member.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Pregnancy or breastfeeding.\n* Partial response after completion of oncospecific treatment.\n* Patients with premalignant pathology.\n* Diagnosis of a tumor of non-cervical origin or atypical histologies.\n* Impossibility of completing the questionnaires included in the protocol autonomously.\n* Contraindications to the use of vaginal estrogens.\n* Patients undergoing fertility-sparing treatment (trachelectomy or conization).\n* Patients undergoing palliative treatment.","FEMALE",{"count":118,"type":19},120,[76],"To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.",[122],"Cervical Cancer","2026-02-09",{"date":125,"type":30},"2026-02-17",{"date":55,"type":19},{"date":128,"type":19},"2029-06-30",{"name":36,"class":37},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":20,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":38},"100511298","sentinel-node-detection-with-technetium-99m-albumin-nanocolloid-and-icg-in-patients-with-epithelial-ovarian-cancer-100511298","NCT05937620","Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer","Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study","Melisa-II","Inclusion Criteria:\n\n* Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.\n* Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.\n* Signing of informed consent by the patient or relative in charge.\n* Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years\n* Pregnancy or breastfeeding\n* Epithelial ovarian tumors stage FIGO III or IV.\n* Impossibility to obtain a biopsy from the tumor.\n* History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.\n* Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.\n* Patient not able to undergo surgery.\n* Hypersensitivity to active principle, to sodium iodide or iodine allergy.\n* Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland",{"count":139,"type":19},62,[141],"NA","Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.",[144],"Ovarian Epithelial Cancer","2026-02-05",{"date":123,"type":30},{"date":148,"type":30},"2023-09-01",{"date":150,"type":19},"2026-10",{"name":36,"class":37},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":71,"sex":16,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":20,"phases":164,"briefSummary":165,"conditions":166,"keywords":170,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":183,"locationsCount":38},"100623243","pharmacokinetic-characterization-of-tartaric-acid-in-humans-100623243","NCT07394101","Pharmacokinetic Characterization of Tartaric Acid in Humans","Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability","TARBIO","Inclusion Criteria:\n\n* Healthy non-smoking adults aged 20-40 years.\n* Body mass index (BMI) between 23 and 27 kg\u002Fm².\n* No history of cardiovascular, hepatic, or renal disease.\n* No adherence to any special diet for at least 4 weeks prior to the study.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Current smokers or recent ex-smokers.\n* History of cardiovascular, hepatic, or renal disorders.\n* Current adherence to any special diet or nutritional supplementation that could affect study outcomes.\n* Any condition or medication that could interfere with absorption, metabolism, or excretion of tartaric acid.\n* Participation in another clinical trial within the past 3 months.\n* Pregnancy or lactation.","20 Years","40 Years",{"count":163,"type":19},30,[141],"The goal of this clinical trial is to characterize the pharmacokinetics (absorption, distribution, metabolism, and excretion; ADME) and oral bioavailability of tartaric acid in humans after its administration through different food matrices (red wine, fresh grapes, and grape juice). The study aims to determine whether the pharmacokinetic behavior of tartaric acid is matrix-dependent and dose-dependent in healthy adult volunteers.\n\nThe main questions it aims to answer are:\n\nDoes the food matrix (wine, grapes, or grape juice) influence the oral bioavailability of tartaric acid?\n\nAre there differences in key pharmacokinetic parameters of tartaric acid, including maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), total exposure (AUC), half-life (t1\u002F2), and urinary excretion, depending on the matrix of intake?\n\nResearchers will compare the pharmacokinetic profiles of tartaric acid after consumption in red wine, grapes, and grape juice to evaluate differences in absorption, systemic exposure, and elimination attributable to the source of intake.\n\nParticipants will:\n\nFollow a polyphenol-restricted diet prior to the study, including avoidance of grapes, wine, and related products.\n\nConsume a single standardized dose of tartaric acid administered as red wine, fresh grapes, or grape juice after an overnight fast.\n\nProvide blood samples at multiple time points over a 24-hour period to determine plasma tartaric acid concentrations.\n\nCollect urine samples over 24 hours for assessment of tartaric acid excretion.\n\nConsume standardized low-polyphenol meals under controlled conditions during the study day.",[167,168,169],"Healthy Adult Participants","Non-smoking, Healthy Adults","Normal Weight Adults",[171,172,173,174,175,176],"Tartaric acid","Pharmacokinetics","Bioavailability","Food matrix effect","Wine","Healthy volunteers","2026-02-02",{"date":179,"type":30},"2026-02-06",{"date":181,"type":19},"2026-04",{"date":59,"type":19},{"name":36,"class":37},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":20,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100613767","phase-4-study-to-evaluate-the-efficacy-of-intravenous-administration-of-human-albumin-versus-saline-solution-in-patients-with-descompnsate-cirrhosis-grade-1b-or-higher-renal-failure-100613767","NCT07270874","Study to Evaluate the Efficacy of Intravenous Administration of Human Albumin Versus Saline Solution in Patients With descompénsate Cirrhosis Grade 1B or Higher Renal Failure","LIVER AKI: A Randomized, Open-label Trial to Evaluate the Efficacy of Intravenous Human Albumin Administration Versus Saline Solution (NaCl 0.9%) in Patients With descompénsate Cirrhosis and AKI 1B or Grater","LIVER-AKI","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Cirrhosis defined by standard clinical criteria, ultrasonographic findings and\u002For histology. (Cirrhosis of any etiology may be included).\n3. Patients with AKI 1B or greater, defined according to EASL guidelines (EASL. J Hepatol 2018).\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function\n\nExclusion Criteria:\n\n1. Time since AKI diagnosis \\> 24 hours.\n2. Patients with AKI due to pure hypovolemia. According to guidelines, these patients should receive crystalloid solutions (i.e. NaCl 0.9%) and will be excluded from the study. Fluid losses will be specifically assessed by an accurate anamnesis and physical examination. If patient's diuretic treatment has been increased recently (within prior 2 weeks), or the patient had diarrhea before admission, patient will be considered that the AKI phenotype is pre-renal and will be excluded from the analysis. Patients will be excluded when clear evidence of hypovolemia is present, based on clinical history (e.g, recent fluid losses, diuretic escalation, diarrhea) and corroborating physical findings (e.g, dry mucous membranes, reduced skin turgor, sunken eyes, or low jugular venous pressure)\n3. Patients with AKI due to gastrointestinal bleeding with AKI 1B or greater, and hemoglobin \\\u003C 7.0 g\u002FdL. These patients can be included after 48 hours without rebleeding and Hb ≥ 8.0 g\u002FdL, and still present AKI 1B or greater.\n4. Patients who had already received albumin at the time of inclusion\u002Fexclusion criteria assessment.\n5. Patients with Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate \\\u003C60ml\u002Fmin for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate \\> 30 mg\u002F24h; Albumin-to-creatinine ratio \\> 30 mg\u002Fg), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.\n6. Patients under renal replacement therapy, or with urgent criteria of RRT.\n7. Patients with hepatocellular carcinoma beyond Milan criteria.\n8. Patients with severe extrahepatic comorbidities, including congestive heart failure New York Heart Association Grade III\u002FIV, chronic obstructive pulmonary disease Global Initiative for Chronic Obstructive Lung Disease group 2 or higher.\n9. Previous liver and\u002For kidney transplantation.\n10. Patients with current extra hepatic malignancies including solid tumors and hematologic disorders.\n11. Patients included in other clinical trials in the month before inclusion.\n12. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.\n13. Refusal to give informed consent.",{"count":193,"type":19},114,[76],"This is a phase IV, unicentric, open-label. Patients eligible for this study will be patients with AKI 1B or greater and decompensated cirrhosis from the hospital participating in the study",[197,198],"Decompensated Cirrhosis","AKI - Acute Kidney Injury","2025-12-16",{"date":201,"type":30},"2025-12-18",{"date":203,"type":19},"2026-01",{"date":205,"type":19},"2028-02",{"name":36,"class":37},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":20,"phases":218,"briefSummary":220,"conditions":221,"keywords":223,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":38},"100605984","phase-3-darbepoetin-in-patients-candidates-for-liver-transplant-epo-lt-trial-100605984","NCT07169643","Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)","Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)","EPO-LT","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Patients on the official liver transplant waiting list\n3. Hemoglobin (Hb) level ≤ 11.5 g\u002FdL\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.\n\n   * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. \\*\\* Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects' usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception.\n\nExclusion Criteria:\n\n* 1\\. Acute\u002Fsubacute liver failure (see appendix 7) 2. Patients with acute-on-chronic liver failure grade III and\u002For MELD \\> 35 3. History of thrombosis, including portal vein thrombosis 4. Significant coronary artery disease (requiring angioplasty and\u002For coronary stent) 5. Serum ferritin \\> 800 ng\u002FmL and SAT \\> 50% 6. Anticoagulant\u002Fantiplatelet therapy 7. History of seizures 8. Uncontrolled hypertension (requiring ≥2 antihypertensive drugs) 9. Active infection\u002Fsepsis (see appendix 8) 10. Lack of patient consent. 11. Pregnancy or breastfeeding. 12. Patients included in other clinical trials in the month before inclusion. 13. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.","70 Years",{"count":217,"type":19},140,[219],"PHASE3","This is a national multicenter, randomized clinical trial to evaluate the the efficacy and safety of DP administration in patients on the liver transplant waiting list to reduce intraoperative red blood cell concentrate transfusion.",[222],"Liver Transplant; Complications",[224],"living kidney trasplant","2025-12-11",{"date":201,"type":30},{"date":228,"type":30},"2025-11-25",{"date":230,"type":19},"2027-06",{"name":36,"class":37},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":20,"phases":241,"briefSummary":242,"conditions":243,"keywords":246,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":4},"100585334","continuous-renal-replacement-therapy-doses-in-critically-ill-patients-with-acute-kidney-injury-100585334","NCT06901011","Continuous Renal Replacement Therapy Doses in Critically Ill Patients With Acute Kidney Injury","CRRIT1","Inclusion Criteria:\n\n* Patients 18 years of age or older\n* Acute renal failure (AKIN 3) requiring Continuous Renal Replacement Therapy\n* Requirement of vasoactive drugs (norepinephrine \\> 0.1 mcg\u002Fkg\u002Fmin)\n* Written informed consent (patient or family)\n\nExclusion Criteria:\n\n* Lack of informed consent.\n* Possibility of using plasma exchange or MARS therapy at the at the time of inclusion.\n* Baseline renal function with an estimated glomerular filtration rate (CKD-EPI) less than 30 ml\u002Fmin.",{"count":240,"type":19},100,[141],"Acute kidney injury in critically ill patients admitted to the ICU is a common complication associated with high mortality or long-term chronic kidney damage. Some of these patients require continuous renal replacement therapy (low-intensity hemodialysis for 24 hours) until renal function recovery is achieved.\n\nContinuous Renal Replacement Therapy (CRRT) is a crucial treatment for ICU patients with acute renal failure. It offers continuous toxin removal and prevents fluid accumulation in the patient's body. The therapy not only eliminates toxins but also physiological substances, including micronutrients and essential elements for cellular metabolism and organ function.\n\nCurrently, there is limited information available to adjust the renal therapy dose and avoid or balance the loss of these substances without causing toxin accumulation. Some studies suggest that high doses of therapy do not provide benefits and increase complications.\n\nThe objective of this study is to evaluate two doses of continuous renal therapy in terms of internal environment control (sodium, potassium, and acids and bases), micronutrient loss, and toxin elimination. After 48 hours of therapy, patients will be assigned to continue with a dose equal to the initial dose or a decrease in the initial dose. These two options are part of the current standard practice in our center.\n\nPatients participating in the study will be randomly assigned one of the continuous renal therapy doses. The study is open, so treating physicians will always know the therapy the patient is receiving and can freely adjust it if deemed necessary.\n\nThe intervention duration is 96 hours, after which the dose will be at the discretion of the treating medical team. A follow-up will be conducted through medical records or phone calls approximately 90 days after starting therapy.\n\nThe risks for the patient are minimal, as toxin elimination monitoring will be even more intensive than usual. The study plans to include approximately 100 patients.",[244,245],"Renal Replacement Therapy for Acute Kidney Injury in ICU","Continuous Renal Replacement Therapy (CRRT)",[245,244,247],"dialytrauma","2025-07-14",{"date":250,"type":30},"2025-07-17",{"date":252,"type":19},"2025-08-01",{"date":254,"type":19},"2027-08",{"name":36,"class":37},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":262,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":20,"phases":266,"briefSummary":268,"conditions":269,"keywords":271,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},"100594400","phase-2-study-to-evaluate-the-efficacy-and-safety-of-atezolizumab-and-bevacizumab-as-neoadjuvant-plus-adjuvant-treatment-in-hcc-100594400","NCT07018947","Study to Evaluate the Efficacy and Safety of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in HCC","A Phase II, Randomized, Open-label, National, Multicenter Study Evaluating the Efficacy and Safety of the Combination of Atezolizumab and Bevacizumab as Neoadjuvant Plus Adjuvant Treatment in Hepatocellular Carcinoma (ASPIRE)","ASPIRE","Inclusion Criteria:\n\n1. Signed Informed Consent Form.\n2. Age ≥ 18 years at the time of signing Informed Consent Form.\n3. Ability to fully comply with the protocol, in the investigator's judgment.\n4. Diagnosis of HCC confirmed by histology.\n5. HCC that is amenable to R0 surgical resection with curative intent in the opinion of the surgeons and oncologists or hepatologists involved in the care of the participant.\n6. HCC at high-risk of recurrence defined by either multifocality, large tumor diameter (\\>5cm), AFP (alpha-fetoprotein) ≥400ng\u002FmL, poor tumor differentiation, or the presence of microvascular invasion.\n\n   \\- For patients with tumors between 3-5 cm, a predefined nomogram will be applied, indicating a high prevalence of microvascular invasion with a score \\>200 points. (Lie et al., 2016).\n7. Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0.\n9. Child-Pugh Class A.\n10. No evidence of clinically significant portal hypertension (CSPH) or minor CSPH (HVPG \\\u003C12 mmHg) in candidates for minor resection (fewer than 3 segments). (Galle et al., 2018) Clinically significant portal hypertension (CSPH) can be defined either by its gold standard measurement, a hepatic venous pressure gradient (HVPG) ≥10 mmHg, or by the presence of surrogate markers such as a platelet count \\\u003C100,000 × 10³\u002FµL combined with splenomegaly.\n11. Willing to undergo a tumor biopsy at screening visit.\n\n    \\- Baseline tumor tissue samples will be collected from all participants by means of a core-needle biopsy performed at study entry. A minimum of two core-needle biopsies are required. If a fresh biopsy is not deemed feasible by the investigator, archival tumor tissue may be submitted, provided the tissue was obtained from a biopsy performed within 3 months prior to enrollment and the patient has not received any anti-cancer therapy, including locoregional liver-directed therapy, since the time of the biopsy. Tumor and normal adjacent tissue specimen will be collected at surgery as fresh snap-frozen and formalin-fixed, paraffin-embedded (FFPE) format. FFPE tissue blocks are preferred, or a minimum of 20 slides must be submitted.\n12. No prior locoregional or systemic treatment for HCC.\n13. Adequate hematologic and end-organ function, defined by the following laboratory test results:\n\n    * ANC ≥ 1.5 × 109\u002FL (1500\u002FµL) without granulocyte colony-stimulating factor (G-CSF) support.\n    * Lymphocyte count ≥ 0.5 × 109\u002FL (500\u002FµL).\n    * Platelet count ≥ 75 × 109\u002FL (75,000\u002FµL) without transfusion.\n    * Hemoglobin ≥ 90 g\u002FL (9.0 g\u002FdL) without transfusion. Participants must not have required transfusion during screening or within 2 weeks prior to screening to meet this criterion.\n    * AST, ALT, and ALP ≤ 5 × upper limit of normal (ULN).\n    * Bilirubin ≤ 3 × ULN.\n    * Adequate renal function: creatinine clearance by estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease Study (MDRD) formula ≥ 50 mL\u002Fmin. Participants with creatinine clearance by estimating eGFR by MDRD formula of ≥ 30 mL\u002Fmin and ≤ 50 mL\u002Fmin may be enrolled if renal function was stable for ≥ 28 days prior to randomization.\n    * Albumin ≥ 28 g\u002FL (2.8 g\u002FdL) without transfusion.\n    * For participants not receiving anticoagulation: INR or aPTT ≤ 1.5 × ULN.\n14. Documented virology status of hepatitis, as confirmed by screening tests for hepatitis B virus (HBV) and\u002For hepatitis C virus (HCV):\n\n    * Patients with active HBV must have HBV DNA \\\u003C 500 IU\u002FmL during screening, must have initiated anti-HBV treatment at least 14 days prior treatment initiation, and must be willing to continue anti-HBV treatment during the study (per local standard of care, e.g., entecavir).\n    * Patients with HCV, either with resolved infection (as evidenced by detectable antibody) or chronic infection (as evidenced by detectable HCV RNA), are eligible.\n    * For patients with detectable HCV RNA and for whom HCV treatment is considered appropriate by the investigator, treatment should begin no sooner than 6 months following liver resection consistent with AASLD guidelines.\n15. Negative HIV test at screening with the following exception:\n\n    \\- Individuals with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FmL, and have an undetectable viral load.\n16. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.\n17. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Presence of extrahepatic disease or macrovascular invasion.\n2. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC, or other rare variants of HCC.\n3. History of hepatic encephalopathy if clinically significant within one year prior to screening.\n4. CSPH in candidates for major resection (more than 3 segments).\n5. Moderate or severe ascites.\n6. Active co-infection with HBV and HCV (defined as detectable HCV RNA plus positive HBV surface antigen or HBV DNA). Patients with a history of HCV infection but who are negative for HCV RNA by Polymerase Chain Reaction (PCR) will be considered non-infected with HCV.\n7. Known active co-infection with HBV and hepatitis D viral infection (HDV).\n8. Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.\n9. Treatment with investigational therapy within 28 days prior to screening.\n10. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding. Participants must undergo an esophagogastroduodenoscopy (EGD), and all size of varices (small to large) must be assessed and treated per local standard of care prior to enrollment. Participants who have undergone an EGD within 6 months prior screening do not need to repeat the procedure.\n11. A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to screening.\n12. Inadequately controlled hypertension, defined as systolic blood pressure (BP) \\> 150 mmHg and\u002For diastolic BP \\> 100 mmHg (average of at least three readings at two or more sessions).\n\n    \\- Anti-hypertensive therapy to achieve these parameters is allowed.\n13. History of hypertensive crisis or hypertensive encephalopathy.\n14. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to screening.\n15. History of hemoptysis (≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening.\n16. Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n17. Current or recent (≤ 10 days prior to screening) use of aspirin (\\> 325 mg\u002Fday) or treatment with clopidogrel, dipyramidole, ticlopidine, or cilostazol.\n\n    \\- Chronic use of low dose aspirin (\\\u003C 325 mg\u002Fday) for cardioprotection is allowed.\n18. Current or recent (≤ 10 days prior to screening) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose.\n\n    * Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity of the agent results in an INR \\\u003C 1.5 × ULN and aPTT is within normal limits within 14 days prior to screening.\n    * Prophylactic use of low-molecular-weight heparin (LMWH; i.e., enoxaparin 40 mg\u002Fday) is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) are not recommended due to potential bleeding risk. Benefits and risks should be assessed, and caution exercised for use of direct oral anticoagulants.\n\n    The investigator should consider switching to other approved anticoagulants due to the risk of upper GI (gastrointestinal) bleeding in patients with HCC.\n\n    \\- For prophylactic use of anticoagulants or thrombolytic therapies, the approved dose as described on the local label may be used.\n19. History of abdominal or tracheoesophageal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to screening.\n20. History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction, including subocclusive or occlusive syndrome related to the underlying disease, or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding prior to screening.\n21. Evidence of abdominal free air that is not explained by paracentesis or recent (\\\u003C 3 months) abdominal surgical procedure.\n22. Serious, non-healing, or dehiscing wound, active ulcer, or untreated bone fracture.\n23. Grade ≥ 2 proteinuria, as demonstrated by ≥ 2+ protein on dipstick urinalysis and ≥ 1.0 g of protein in a 24-hour urine collection.\n\n    * All patients with ≥ 2+ protein on dipstick urinalysis at screening must undergo a 24-hour urine collection (or an alternative method such as protein\u002Fcreatinine ratio, per local guidance) for protein and must demonstrate \\\u003C 1 g of protein in 24 hours.\n    * Patients with \\\u003C 2+ protein on dipstick urinalysis are eligible for the study.\n24. History of intra-abdominal inflammatory process within 6 months prior to screening, including but not limited to peptic ulcer disease, diverticulitis, or colitis.\n25. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to screening; or abdominal surgery, abdominal interventions or significant abdominal traumatic injury within 60 days prior to screening; or anticipation of need for major surgical procedure, other than potentially curative liver resection, during the study; or non-recovery from side effects of any such procedure.\n26. Complete healing from minor surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days before screening.\n27. Chronic daily treatment with a non-steroidal anti-inflammatory drug (NSAID).\n\n    \\- The occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed.\n28. Serious infection requiring oral or IV antibiotics and\u002For hospitalization within 4 weeks prior to screening, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact participant safety.\n29. Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study.\n30. History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n\n    * Patients with localized prostate cancer (defined as Stage ≤ pT2c, Gleason score ≤ 7, and prostate-specific antigen (PSA) at prostate cancer diagnosis ≤ 20 ng\u002FmL) treated with curative intent and without PSA recurrence are eligible.\n    * Patients with pre-existing low-risk prostate cancer (defined as Stage cT1\u002FT2a, Gleason score ≤ 6, and PSA ≤ 10 ng\u002FmL) who are treatment-naive and undergoing active surveillance are eligible.\n    * Patients with malignancies associated with a negligible risk of metastasis or death (e.g., risk of metastasis or death \\\u003C 5% at 5 years) are eligible provided they meet all of the following criteria:\n\n      * Malignancy treated with expected curative intent (e.g., adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent)\n      * No evidence of recurrence or metastasis by follow-up imaging and any disease-specific tumor markers.\n31. Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n    * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n    * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n      * Rash must cover \\\u003C 10% of body surface area.\n      * Disease is well controlled at baseline and requires only low-potency topical corticosteroids.\n      * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months.\n32. Pregnancy or breastfeeding, or intention of becoming pregnant during the study.\n\n    \\- Female participants of childbearing potential must have a negative serum pregnancy test result at screening.\n33. Left ventricular ejection fraction (LVEF) \\\u003C 50% assessed by either transthoracic echocardiogram (TTE) or multiple-gated acquisition (MUGA) scan (TTE preferred test) within 6 months prior to screening.\n34. History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.\n35. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n\n    \\- History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n36. Prior allogeneic stem cell or solid organ transplantation.\n37. Active tuberculosis.",{"count":265,"type":19},90,[267],"PHASE2","Study to evaluate the efficacy and safety of the combination of Atezolizumab and Bevacizumab as neoadjuvant plus adjuvant treatment in Hepatocellular Carcinoma.",[270],"Resectable Hepatocellular Carcinoma",[272],"resectable HCC with high risk of recurrence","2025-06-05",{"date":275,"type":30},"2025-06-13",{"date":277,"type":19},"2025-11",{"date":279,"type":19},"2030-11",{"name":36,"class":37},13,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":290,"enrollmentInfo":291,"targetDuration":4,"studyType":20,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100579933","phase-2-study-to-evaluate-the-safety-and-efficacy-of-ari0002h-for-the-initial-treatment-of-patients-with-primary-plasma-cell-leukaemia-100579933","NCT06830733","Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia","Phase II, Multicenter, Open-label, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of ARI0002h, a CAR-T Cell Against BCMA, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia","GEM-PLASMACAR","Inclusion Criteria:\n\n1. Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG).\n2. Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the \"International Myeloma Working Group\".\n3. ECOG Performance Status from 0 to 2\n4. Life expectancy greater than 3 months.\n5. Adequate venous access and absence of contraindications for lymphoapheresis.\n6. Patients who, after being informed, give their consent by signing the Informed Consent Document.\n7. Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion.\n\nExclusion Criteria:\n\n1. No previous treatments, except for induction therapy for primary plasma cell leukemia.\n2. Administration of any anti-BCMA therapy as part of induction\n3. Not having achieved at least a minimal response with induction treatment (IMWG criteria)\n4. Absolute lymphocyte count \\\u003C0.1x109\u002FL\n5. Active immunosuppressive therapy except for prednisone 10 mg\u002Fday (or equivalent).\n6. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.\n7. Active infection requiring treatment.\n8. Active HIV, HBV, or HCV infection.\n9. Uncontrolled medical illness\n10. Severe organ impairment that meets any of the following criteria: EF\\\u003C40%, DLCO \\\u003C40%, GFR \\\u003C30 ml\u002Fmin, bilirubin \\>3 times the upper limit of normality (unless due to Gilbert syndrome)\n11. Previous diagnosis of symptomatic AL amyloidosis,\n12. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase.\n13. Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\\* from the beginning of the study to completion of the study.\n14. Men who are unable or unwilling to use highly effective contraceptive methods\\* from the beginning of the study to completion of the study.\n15. Contraindication to receive lymphodepletive chemotherapy.","75 Years",{"count":292,"type":19},25,[267],"Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL).\n\nThe study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months.\n\nThe primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.",[296],"Leukemia, Plasma Cell","2025-04-24",{"date":299,"type":30},"2025-04-25",{"date":301,"type":19},"2025-04",{"date":303,"type":19},"2027-12",{"name":36,"class":37},7,{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":71,"sex":116,"minAge":17,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":20,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":38},"100584996","phase-4-impact-of-the-presence-of-the-corpus-luteum-on-pregnancies-obtained-through-frozen-embryo-transferfet-100584996","NCT06896617","Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET)","Impact of the Presence of the Corpus Luteum on Pregnancies Obtained Through Frozen Embryo Transfer(FET): a Prospective Randomized Controlled Study","LUTI","Inclusion Criteria:\n\n* Female patients 18- 37 years old (both included) at the time of oocyte retrieval and less than 41 years of age at the time of embryo transfer.\n* Regular menstrual cycles between 24 and 35 days.\n* Availability of cryopreserved blastocysts from own gametes\n* Indication for single embryo transfer.\n* Patients who will be included in the LUTI study are candidates for either of the two procedures under study, and will have no contraindications for either procedure.\n\nExclusion Criteria:\n\n* Recurrent pregnancy loss (3 or more).\n* Recurrent implantation failure in previous IVF treatments (3 or more unsuccessful embryo transfers). .\n* Diagnosis of polycystic ovarian syndrome, diabetes mellitus, chronic arterial hypertension, maternal heart disease and autoimmune diseases (Systemic Lupus Erythematosus (SLE) or Antiphospholipid syndrome (APS)).\n* Active treatment with aspirin, heparin or other anticoagulant therapy, antihypertensives or other drugs used to treat circulation or coagulation disorders .\n* Indication for PGT (Preimplantation Genetic Testing).\n* Multiple pregnancy.","41 Years",{"count":316,"type":19},334,[76],"In pregnancies achieved through programmed frozen embryo transfer cycle (PC-FET) and modified natural frozen embryo transfer (mNC-FET), to determine whether there are differences in endothelial and placental function, maternal cardiovascular function, fetal growth and fetal cardiovascular and cerebral programming and to assess whether there is an association between these differences and the plasma concentrations of the main secretion products of the Corpus Luteum (CL) with vasoactive and angiogenic action.",[320,321],"Infertilities","Embryo Transfer","2025-03-28",{"date":324,"type":30},"2025-04-02",{"date":326,"type":30},"2025-02-01",{"date":328,"type":19},"2026-12-20",{"name":36,"class":37},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":338,"enrollmentInfo":339,"targetDuration":4,"studyType":20,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":38},"100465902","validation-of-a-microrna-based-fecal-mirfec-test-for-colorectal-cancer-screening-surveillance-and-diagnosis-100465902","NCT05346757","Validation of a microRNA-based Fecal (miRFec) Test for Colorectal Cancer Screening, Surveillance and Diagnosis","Prospective, Multicenter, Comparative, Paired Study to Validate a microRNA-based Fecal Test for Colorectal Cancer Screening. The miRFec Study","miRFec","Inclusion Criteria:\n\n* Male or female aged 50 to 75 (average-risk) referred to colonoscopy-based CRC screening.\n* Male or female aged 30 to 80 with family history of CRC (moderate-risk) referred to colonoscopy-based CRC screening.\n* Male and female aged 18 or older with personal history of colorectal polyps referred to colonoscopy surveillance.\n* Male and female aged 18 or older with personal history of CRC referred to colonoscopy surveillance.\n* Male and female aged 18 or older with colorectal symptoms referred to diagnostic colonoscopy.\n\nExclusion Criteria:\n\n* Lack of informed consent to participate\n* Personal history of Lynch syndrome\n* Personal history of adenomatous or hamartomatous polyposis\n* Personal history of serrated polyposis syndrome\n* Personal history of inflammatory bowel disease\n* Personal history of total colectomy for any reason\n* Family history of Lynch syndrome\n* Family history of adenomatous or hamartomatous polyposis\n* Family history of serrated polyposis syndrome","80 Years",{"count":340,"type":19},5390,[141],"The present study aims to compare effectiveness and cost-effectiveness of the miRFec test with respect to fecal immunochemical test (FIT) for the detection of advanced colorectal neoplasm among individuals participating in colorectal cancer (CRC) screening, surveillance and diagnosis.",[344],"Colorectal Cancer","2025-03-11",{"date":347,"type":30},"2025-03-13",{"date":349,"type":30},"2022-03-23",{"date":351,"type":19},"2027-01-31",{"name":36,"class":37},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":361,"targetDuration":4,"studyType":363,"phases":4,"briefSummary":364,"conditions":365,"keywords":368,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":38},"100562842","precision-medicine-for-lgcmn-and-melanoma-1-100562842","NCT06608420","Precision Medicine for L\u002FGCMN and Melanoma 1","Precision Medicine for L\u002FGCMN and Melanoma 1 (Precis-mel 1)","Precis-mel 1","Inclusion Criteria:\n\n\\- Melanoma patients of any age with histopathological confirmed melanoma\n\nExclusion Criteria:\n\n* Not having a melanoma diagnosis\n* Not having signed the informed consent\n* Records prior to the year 2012 (as data might not accurately reflect current practices and treatment outcomes)",{"count":362,"type":19},6000,"OBSERVATIONAL","The primary objective of this study is to create a highly multidimensional and multicentric database for melanoma that encompasses cohorts of children, adolescent and young adults. This database will be used to perform survival analysis and evaluate sentinel lymph node (SLNB) positivity in CAYA. The secondary objectives to be met are the following:\n\n* Adaptation and optimization of algorithms: work on optimizing existing precision medicine algorithms, which are currently being used in adult patient care, for their application within pediatric and young adult populations.\n* Implementation of transfer learning: given the limitations associated with pediatric and young adult data, the investigators intend to utilize transfer learning techniques. The study will employ a sequential waterfall methodology, whereby machine learning models trained on adult patient data will be fine-tuned using the more limited data from younger cohorts.\n* Integration of expert medical opinion: to integrate physician's scientific domain knowledge into the decision support system. This will be facilitated through the comprehensive examination of existing literature, as well as the evaluation of variable risk contributions within each patient group.\n* AI-based prognostic models: to develop artificial intelligence-based models for the quantitative prognosis of melanoma across the three age groups: adults, young adults, and children.",[366,367],"Melanoma (Skin Cancer)","Nevi and Melanomas",[369,370,371,372,373,374,375,376],"Melanoma","Artificial intelligence","Patient stratification","Machine learning","Children","Adolescents","Young Adults","Survival analysis","2025-02-26",{"date":379,"type":30},"2025-02-28",{"date":381,"type":30},"2024-03-01",{"date":383,"type":19},"2026-11-30",{"name":36,"class":37},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":363,"phases":4,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100562613","precision-medicine-for-lgcmn-and-melanoma-2-100562613","NCT06605443","Precision Medicine for L\u002FGCMN and Melanoma 2","Precision Medicine for L\u002FGCMN and Melanoma 1 (Precis-mel 2)","Precis-mel 2","Inclusion Criteria:\n\n* Be over 18 years old\n* Have a histopathological confirmed melanoma diagnosis (stage II, III or IV AJCC)\n\nExclusion Criteria:\n\n* Not signing the informed consent form\n* Present other cancers or chronic diseases (such as diabetes, asthma, etc.), which may affect the volatile organic compound profiles",{"count":240,"type":19},"The primary objective is to evaluate the possibility of using minimally and non-invasive technologies (skin patch and breath analyzer) based on the detection of volatile organic compounds (VOCs) for the early identification of metastases. The secondary objective is to evaluate the usability of these technologies in the follow up of high-risk melanoma patients.",[366,367,396],"Congenital Melanocytic Nevus",[398,399,400,369,401,402,403,404],"Volatilomics","Breath analyzer","Skin patch","L\u002FGCMN","Liquid biopsy","cfDNA","Non-invasive diagnostics","2025-02-25",{"date":407,"type":30},"2025-02-27",{"date":409,"type":30},"2025-01-01",{"date":411,"type":19},"2026-12-01",{"name":36,"class":37},3,{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":363,"phases":4,"briefSummary":423,"conditions":424,"keywords":427,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":436,"locationsCount":437},"100562611","understanding-the-transition-from-normal-melanocytes-to-nevus-to-melanoma-100562611","NCT06605417","Understanding the Transition from Normal Melanocytes to Nevus to Melanoma","Understanding the Transition from Normal Melanocytes to Nevus to Melanoma (NevustoMel)","NevustoMel","Inclusion criteria:\n\n* Congenital nevus with estimated size of 20 cm\n* Be over 18 years of age\n\nExclusion criteria:\n\n* No available biological material\n* Not having signed the informed consent",{"count":240,"type":19},"The primary objective of this study is to identify the molecular identity profiles of all cellular states that characterize the progression from benign nevi to malignant melanoma in CAYA patients with L\u002FGCMN. The secondary objectives are:\n\n* To longitudinally characterize the cell-free DNA (cfDNA) from CAYA patients.\n* To improve the early diagnosis and treatments for intermediate conditions such as L\u002FGCMN through evidence-based interpretation of personal risk from endogenous or exogenous sources.\n* To test pre-clinical strategies to best model and improve patient response.",[425,426,367],"Congenital Melanocytic Nevi","Melanoma, Skin",[428,369,402,403,429,401,430,431],"Congenital melanocytic nevi","Methylomics","RNAseq","Molecular profiles",{"date":407,"type":30},{"date":434,"type":30},"2024-01-01",{"date":383,"type":19},{"name":36,"class":37},2,{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":445,"targetDuration":4,"studyType":20,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":305},"100581616","phase-1-autologous-tolerogenic-dendritic-cells-atdc-for-highly-sensitized-kidney-transplant-recipients-100581616","NCT06852625","Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients","ATDC-PICI","Inclusion Criteria:\n\n1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.\n2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.\n3. Adequate venous access and absence of contraindications for leukoapheresis.\n4. Women of childbearing age must take contraceptive measures.\n5. Must have given written informed consent\n\nExclusion Criteria:\n\n1. Subjects with active TB.\n2. Patients on the waiting list multiple organ transplants.\n3. A significantly abnormal general serum screening lab result defined as WBC\\\u003C3.0x103\u002Fml, Hgb\\\u003C8.0 g\u002FdL, platelet count \\\u003C100x103\u002Fml, SGOT\\>3x upper limit.\n4. HIV-positive subjects.\n5. Subjects who test positive for HBV infection \\[positive HBVsAg or HBVeAg\u002FDNA\\] or HCV infection \\[RNA+\\].\n6. Subjects with active CMV or EBV infection as defined by positive PCR.\n7. Subjects with a known history of previous myocardial infarction within one year of screening.\n8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.\n9. Patients with a kidney disease with high risk of recurrence and\u002For complement-associated kidney disease (aHUS, etc).\n10. Pregnant and lactating women.",{"count":163,"type":19},[22],"The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.",[449],"Kidney Transplant Rejection","2025-02-24",{"date":379,"type":30},{"date":453,"type":19},"2025-05",{"date":455,"type":19},"2028-03",{"name":36,"class":37},{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":20,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":38},"100555670","antibody-mediated-lgi1-encephalitis-symptoms-biomarkers-and-mechanisms-of-the-chronic-phase-of-the-disease-100555670","NCT06515106","Antibody-mediated LGI1 Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Chronic Phase of the Disease","Inclusion Criteria:\n\n* Patients with Antibody-mediated LGI-1 encephalitis in the post-acute stage of the disease;\n* Patients has been discharged from hospital (acute phase).\n\nExclusion Criteria:\n\n* Inability to obtain informed consent;\n* Inability to travel to the center.",{"count":5,"type":19},[141],"The encephalitis mediated by antibodies against Leucine-rich, glioma inactivated 1 protein (anti-LGI1 encephalitis) predominantly affects men (M:F, 6:4) and mostly older than 60 years. The disease has two distinct clinical phases: The acute phase in which the majority of patients develop severe short-term memory deficits (unable to remember events or experiences that occurred a few minutes earlier). This memory impairment can be preceded or accompanied by one or more of the following: hyponatremia (60% of patients), a highly distinctive type of seizures called facio-brachial dystonic seizures (\\~40% of patients), along with confusion, irritability and other types of focal seizures or less frequently, generalized seizures. In addition, many patients at this stage have symptoms of REM sleep behavior disorder. In this stage, the CSF may show pleocytosis or mild increase of proteins, the EEG is usually abnormal, and in \\~60% of the patients the MRI shows typical increased FLAIR signal in medial temporal lobes (11). There is a clinical sub-phenotype (\\~13% of patients) in which the disease presents as a rapidly progressive cognitive decline without the indicated FLAIR MRI changes. About 70% of patients improve rapidly with corticosteroids and immunotherapy (eg, intravenous immunoglobulins and\u002For plasma exchange), but the improvement is often partial. After the acute phase, there is a chronic or residual phase which represents the interval from improvement of initial symptoms until the disease is considered no longer active and the remaining symptoms are thought to be irreversible. This chronic phase may take several months (it has been less well studied), and is characterized by the absence of CSF pleocytosis and inflammatory MRI changes (albeit this may show residual hippocampal atrophy), and very low or undetectable titers of serum antibodies. Most patients are unable to return to their job or previous activities due to residual (irreversible) memory or cognitive deficits accompanied by signs of moderate brain atrophy. In addition, we and others have shown that about 27-35% of patients have relapsing symptoms after improving from the acute phase (. Although acute symptomatic seizures (facio-brachial dystonic and others) occur in \\~90% of patients during the acute phase of the disease, less than 10% of patients develop chronic epilepsy often associated with hippocampal sclerosis. Therefore, the prevailing concept on this disease suggests a syndrome and clinical course in which the acute phase shows rapid, albeit partial, response to immunotherapy, and the symptoms of the chronic phase represent a burnout or irreversible process, in which the disease is no longer active, and the potential improvement of remaining symptoms is uncertain.\n\nHere investigators postulate that a better knowledge of this stage will improve treatment decisions and outcome.\n\nIn Aim 1, the post-acute stage will be clinically characterized.\n\nIn Aim 2, the impact of cognitive rehabilitation will be assessed.\n\nIn Aim 3, a mouse model of anti-LGI1 encephalitis will be used to determine the underlying mechanisms and treatment of the postacute stage.",[467],"Limbic Encephalitis With LGI1 Antibodies",[469,470,471,472],"Cognitive Impairment","Encephalitis","Autoimmune","Cognitive rehabilitation","2024-07-18",{"date":475,"type":30},"2024-07-23",{"date":477,"type":30},"2023-12-18",{"date":479,"type":19},"2026-12-31",{"name":36,"class":37},{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":20,"phases":491,"briefSummary":493,"conditions":494,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":305},"100523574","early-phase-1-first-in-human-study-of-the-infusion-of-ari0003-cells-in-relapsedrefractory-to-treatment-b-cell-aggressive-lymphoma-100523574","NCT06097455","First in Human Study of the Infusion of ARI0003 Cells in Relapsed\u002FRefractory to Treatment B-cell Aggressive Lymphoma","First in Human, Pilot, Open-label, Prospective, Multicentre, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of ARI0003 (CART CD19\u002F CD269 Cells) in Patients With Relapsed\u002FRefractory B-cell Aggressive Lymphoma","CARTD-BG-1","Inclusion Criteria:\n\n* 1\\. Diagnosis of CD19+ or CD269+ relapsed\u002Frefractory (R\u002FR) aggressive B-cell lymphoma in one of the following circumstances:\n\n  * Burkitt's lymphoma;\n  * Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or\n  * Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.\n\n    2\\. Age older than 18 years. 3. ECOG performance status of 0-2. 4. Estimated life expectancy of at least 3 months. 5. Adequate venous access and absence of contraindications for lymphapheresis. 6. Signature of informed consent. 7. In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion\n\nExclusion Criteria:\n\n* 1\\. Any experimental or non-commercialized therapy in the previous 4 weeks. 2. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.\n\n  3\\. Active immunosuppressive therapy except for prednisone 10 mg\u002Fday (or equivalent).\n\n  4\\. Active infection requiring systemic medical therapy. 5. Active HBV or HCV infection. 6. Positive serology for HIV. 7. Any concomitant and uncontrolled medical disease. 8. Severe organic impairment defined by cardiac ejection fraction \\\u003C40%, DLCO \\\u003C40%, GFR \\\u003C30 ml\u002Fmin or bilirubin \\>3 times the upper limit of normality (unless due to Gilbert's syndrome).\n\n  9\\. Lactating or pregnant women. 10. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.\n\n  11\\. CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed",{"count":490,"type":19},40,[492],"EARLY_PHASE1","ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study.",[495,496],"Refractory Non-Hodgkin Lymphoma","Relapsed Non-Hodgkin Lymphoma","2023-10-24",{"date":499,"type":30},"2023-10-26",{"date":501,"type":19},"2024-01-15",{"date":503,"type":19},"2027-01-15",{"name":36,"class":37},""]