[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypoalbuminemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypoalbuminemia":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,39,71,111,155,193],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100626460","evaluate-recombinant-human-serum-albumin-from-oryza-sativa-in-patients-with-hypoalbuminemia-andor-hypovolemia-requiring-urgent-treatment-100626460",false,"NCT07435922","Evaluate Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment","Recombinant Human Serum Albumin From Oryza Sativa In Patients With Hypoalbuminemia and\u002For Hypovolemia Requiring Urgent Treatment: A ReaL World Observational Study","Inclusion Criteria:\n\n* Age ≥ 18 years, male or female.\n* Hypoalbuminemia and\u002For hypovolemia requiring urgent treatment.\n* Agree to participate in this study and sign a written informed consent form by the subject themselves or their legal representative (guardian).\n* In real-world clinical practice, the attending physician has decided and planned to administer at least one dose of human albumin injection.\n\nExclusion Criteria:\n\n* Known allergy to the active ingredients or any excipients of this product.\n* Any medical condition that, in the investigator's judgment, may significantly increase the subject's risk or interfere with their participation in and completion of this study.\n* Participation in any other clinical trial of a drug at the time of enrollment in this study.","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","OBSERVATIONAL","This study is a post-marketing, multicenter, prospective, open-label observational study. It plans to enroll approximately 2,000 patients with hypoalbuminemia and\u002For hypovolemia requiring urgent treatment who are scheduled to receive at least one dose of Recombinant Human Albumin from Oryza Sativa. The study does not interfere with clinical diagnosis and treatment; the use of the study drug is solely determined by the attending physician based on the patient's condition and clinical guidelines.\n\nStudy data will be collected during the patient's participation in the study, including baseline characteristics, medical history, concomitant medications, records of study drug administration and reasons for use, serum albumin levels (baseline and end of treatment), adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs), and adverse events of special interest (AESIs). The follow-up period will primarily be conducted via telephone.\n\nThe primary endpoint of the study is the incidence of all adverse drug reactions (ADRs). Secondary endpoints include the incidence of all adverse events (AEs), the incidence of AEs by severity, the incidence of serious adverse events (SAEs), the incidence of adverse events of special interest (AESIs), and the incidence of AEs leading to dose interruption, dose reduction, discontinuation, or death related to Recombinant Human Albumin Injection from Oryza Sativa. Efficacy evaluations include changes in serum albumin concentration before and after treatment and assessment of volume restoration.",[24,25],"Hypoalbuminemia","Hypovolemia","NOT_YET_RECRUITING","2026-02-26",{"date":29,"type":30},"2026-03-02","ACTUAL",{"date":32,"type":20},"2026-02-24",{"date":34,"type":20},"2026-12-31",{"name":36,"class":37},"Healthgen Biotechnology Corp.","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100601879","edoxaban-steady-state-pkpd-in-adults-with-nephrotic-syndrome-100601879","NCT07116239","Edoxaban Steady-State PK\u002FPD in Adults With Nephrotic Syndrome","Steady-state Pharmacokinetics and Pharmacodynamics of Edoxaban in Adults With Nephrotic Syndrome: A Non-randomized Open-label, Parallel Arm and Single-center Study","Inclusion Criteria:\n\n1. Nephrotic syndrome Group:\n\n   * Age between 18-70 years old\n   * Diagnosed with nephrotic syndrome: proteinuria≥3.5 g\u002F24h or morning urine protein\u002Fcreatinine ratio ≥3.0g\u002Fg), with serum albumin \\\u003C30g\u002FL present at the time of enrollment, with or without edema or hyperlipidemia\n   * Calculated creatinine clearance (CrCl) \\>50ml\u002Fmin using the Cockcroft-Gault formula\n   * Actual body weight \\>60kg, and body mass index within the range of 18.5-28kg\u002Fm2\n   * Signed informed consent form\n2. Healthy volunteer Group:\n\n   * Age between 18-70 years old\n   * Serum albumin ≥40g\u002FL\n   * Calculated CrCl \\>50ml\u002Fmin using the Cockcroft-Gault formula\n   * Actual body weight \\>60kg, and body mass index within the range of 18.5-28kg\u002Fm2\n   * Signed informed consent form\n\nExclusion Criteria:\n\n* Serun albumin \\\u003C30 g\u002FL for other reasons in patients with nephrotic syndrome as judged by the investigator\n* Prolonged PT, INR, APTT at baseline (defined as greater than the upper limit of normal values)\n* Platelet count \\\u003C100×109\u002FL or ≥300×109\u002FL due to hematological diseases confirmed by laboratory tests\n* History of: gastrointestinal bleeding, intracranial hemorrhage, hemoptysis, or other clinically documented bleeding from internal organs within the last 3 months; surgery (except \\>3 days after renal biopsy without bleeding complications) or trauma. Bleeding complications after renal biopsy are defined as: ① bleeding (hematuria, perirenal hematoma, or arteriovenous fistula) that occur after renal biopsy requiring transfusion, resulting in altered hemodynamics, or requiring surgery or interventional treatment; ② symptomatic perirenal hematoma; and ③visible hematuria that persist for \\>3 days postoperatively.\n* A lesion or condition with a significant risk of major bleeding, such as current or recent gastrointestinal ulcer, malignant tumors with a high risk of bleeding, esophageal varices, arteriovenous malformations, vascular aneurysms, or major intravertebral or intracerebral vascular malformations.\n* Serious bleeding disorders as judged by the investigator\n* Systemic lupus erythematosus with or without renal damage\n* Bleeding or thrombophilia disorders as judged by the investigator\n* History of stroke\n* History of congestive heart failure (New York grade II or above) at the time of screening\n* Liver dysfunction (cirrhosis or bilirubin \\>2×, and serum transaminases \\>3×, upper limit of normal)\n* Use of (but not limited to) the prescription medications that are inhibitors or inducers of CYP3A4 and\u002For P-gp within the past 14 days:\n\n  * CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, etc.) ②CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin, etc.)\n\n    * P-gp inducers (e.g., apalutamide, rifampicin, etc.) ④ P-gp inhibitors (e.g., dronedarone, cyclosporine, erythromycin, ketoconazole, quinidine, verapamil, amiodarone, etc.) ⑤Selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)\n* Use of antiplatelet and\u002F or anticoagulant agents within 5 half-lives (at least 7 days): including but not limited to heparin, heparin derivatives, aspirin, clopidogrel, prasugrel, nonsteroidal anti-inflammatory drugs, warfarin, rivaroxaban, dabigatran, apixaban, etc.\n* Pregnant or breastfeeding women or women of childbearing age without contraception\n* Uncontrolled severe hypertension (SBP≥180mmHg, DBP≥110mmHg)\n* Conditions considered unsuitable for inclusion in this study, judged by investigator\n* Patients with hypersensitivity to the active ingredient or other excipients of the Edoxaban and enoxaparin sodium\n* History of immune-mediated heparin-induced thrombocytopenia (HIT) or presence of circulating antibodies within the previous 100 days.\n* Spinal or epidural anesthesia or local anesthesia within 24 hours prior to the administration of enoxaparin sodium and Edoxaban",true,"70 Years",{"count":49,"type":20},60,"INTERVENTIONAL",[52],"NA","A study to evaluate the impact of nephrotic syndrome on the steady state pharmacokinetics and pharmacodynamics of edoxaban compared to health volunteers, and whether edoxaban can provide an equivalent anticoagulant effect to enoxaparin sodium.",[55,24],"Nephrotic Syndrome",[57,58,59,60],"edoxaban","nephrotic syndrome","hypoalbuminemia","enoxaparin","2025-08-04",{"date":63,"type":30},"2025-08-11",{"date":65,"type":20},"2025-09",{"date":67,"type":20},"2026-02",{"name":69,"class":70},"Peking University People's Hospital","OTHER",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":50,"phases":82,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":38},"100590008","brief-title-the-role-of-nutrition-in-the-rehabilitation-of-patients-with-eating-disorders-after-a-vascular-stroke-100590008","NCT06961825","Brief Title: The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke.","The Role of Nutrition in the Rehabilitation of Patients With Eating Disorders After a Vascular Stroke: A Randomized Controlled Trial Investigating the Effect of Protein Supplementation on Functional Recovery, Sarcopenia, Osteopenia, and Nutritional Status in Stroke Patients With Hypoalbuminemia.","Nutristroke","Inclusion Criteria:\n\n* Age range: Adults aged 18 to 85 years\n* Diagnosis: Patients diagnosed with a stroke (cerebrovascular accident) within the last 4 to 6 weeks\n* Serum albumin levels: Patients with low serum albumin levels (\\\u003C 3.5 g \u002F dL)\n* Nutritional intervention requirement: Patients who require nutritional intervention to support rehabilitation and nutrition\n* Informed consent: Patients who have completed the consent form for participation in the study and acceptance of the intervention\n\nExclusion Criteria:\n\n* Severe infections or serious cardiopulmonary conditions: Patients with severe infections or serious cardiopulmonary conditions requiring immediate medical intervention, which may affect nutrition and rehabilitation\n* Comorbidities: Patients with comorbid conditions such as renal or liver disease\n* History of stroke or neurological conditions: Patients with a history of stroke or other neurological conditions who do not meet the criteria for rehabilitation\n* Severe mental or psychological conditions: Patients with severe mental or psychological conditions who are unable to understand or consent to participation in the study","85 Years",{"count":81,"type":20},100,[52],"Brief Summary: The main objective of this thesis is to investigate the role of nutrition - specifically the administration of protein supplements (single dose and double dose) - in the rehabilitation of stroke patients with low albumin levels in relation to sarcopenia, osteopenia and functional recovery indices. The study will follow a randomized controlled trial design, incorporating clinical observation, analysis of biochemical markers, and assessment of physical and functional parameters. Participants will be randomly assigned to one of the three groups: (1) Group 1, receiving no protein supplementation (control group), (2) Group 2, receiving a single dose of protein supplement and (3) Group 3, receiving a double dose of protein supplement. The intervention will last for at least six weeks or until the biochemical markers of albumin normalize and the patient resumes regular oral intake. Biochemical assessment with be conducted through regular nutritional evaluations including measurement of serum albumin, prealbumin, C - reactive protein, creatinine, blood glucose and glycosylated hemoglobin (HbA1c), urea, electrolytes, urine albumin and additional inflammatory markers. Bone density will be assessed using DEXA, MBSR and hip measurements to determine the potential improvements resulting from the intervention. Muscle mass will be evaluated using whole - body DEXA analysis, while muscle strength and mobility will be assessed through grip strength tests and fine gait assessments. Functional recovery will be evaluated usings standardized tools for activities of daily living (Barthel Index), mental state (Geriatric Depression Scale) and quality of life (SF - 36), as well as mobility and walking tests such as the Timed Up and Go Test and 6 - Minute Walk Test. The collected data will be analyzed using appropriate statistical tools, including comparison models (ANOVA, Mann - Whitney U test) and correlation models (Pearson - Spearman). This research is expected to enhance theoretical knowledge regarding the relationship between nutrition, biochemical markers and rehabilitation outcomes in stroke patients with hypoalbuminemia. More specifically, it aims to explore the underlying mechanisms through which nutrition affects recovery - a field that remains unexplored. Additionally, the anticipated finding may contribute to the development of clinical guidelines and therapeutic approaches for the nutritional management of patients with low albumin levels, promoting personalized nutritional strategies that support effective post - stroke rehabilitation.",[85,24,86,87,88,89,90],"Stroke","Sarcopenia","Osteopenia","Malnutrition (Calorie)","Protein-energy Malnutrition","Functional Decline",[92,93,94,95,96,97,98,99,100,101],"protein supplementation","nutritional intervention","albumin levels","stroke","stroke rehabilitation","eating disorders","malnutrition","nutritional assessment","sarcopenia","osteopenia","2025-04-29",{"date":104,"type":30},"2025-05-08",{"date":106,"type":20},"2025-05-05",{"date":108,"type":20},"2030-05-05",{"name":110,"class":70},"University of Ioannina",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":46,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":118,"targetDuration":120,"studyType":21,"phases":4,"briefSummary":121,"conditions":122,"keywords":130,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":4},"100576988","biomarkers-and-outcome-predictors-of-pediatric-nephrotic-syndrome-a-genetic-transcriptomic-and-secretome-multiomics-study-100576988","NCT06792448","Biomarkers and Outcome Predictors of Pediatric Nephrotic Syndrome: A Genetic, Transcriptomic, and Secretome Multiomics Study","PRECISE","Inclusion Criteria:\n\n* Clinical diagnosis of idiopathic nephrotic syndrome (INS) with nephrotic range proteinuria (uPr\u002FuCr ratio \\> 2 mg\u002Fmg).\n* Hypoalbuminemia with serum albumin \\\u003C 3.0 g\u002FdL.\n* Presence of edema.\n* No prior treatment for idiopathic nephrotic syndrome.\n* Age between 1 and 18 years at the time of enrollment.\n* igned informed consent by a parent or legal guardian.\n\nExclusion Criteria:\n\n* Diagnosis of congenital or infantile nephrotic syndrome (age \\\u003C 1 year).\n* Diagnosis of secondary nephrotic syndrome.\n* Presence of glomerulonephritis, autoimmune diseases, or vasculitis.\n* Lack of signed informed consent by a parent or legal guardian.\n* Previous treatment with prednisone or prednisolone for nephrotic syndrome.",{"count":119,"type":20},350,"1 Year","Idiopathic Nephrotic Syndrome is a rare disease of the kidneys, which typically affects children. For most affected children there is the need of a prolonged treatment with drugs reducing the activity of the immune system, also resulting in many side effects. Those patients, who do not respond to treatment, are at risk of kidney damage and of dialysis or kidney transplantation. It is currently impossible to predict the response to treatment, leading to unnecessary therapies with side effects as well as unclear prognosis in the affected children. The response of the idiopathic nephrotic syndrome to medications acting on the immune system explains its important role in the occurrence of the disease.\n\nWith this study we aim to obtain predictors of the response to treatment right at the beginning of the disease, to adapt the therapy avoiding needless side effects. This will be done evaluating the blood and urine of affected children using state of the art molecular characterisation. We will evaluate the genetic predisposition, the cell trait changes and the presence of molecules in blood and urine that may affect the interaction between the immune system and the kidneys. We expect that the findings will improve treatment of children with idiopathic nephrotic syndrome and reduce the number of children suffering from unnecessary drugs related side effects.",[123,124,125,126,127,24,128,129],"Nephrotic Syndrome Steroid-Dependent","Nephrotic Syndrome Steroid-Resistant","Nephrotic Syndrome in Children","Glomerulonephritis","Proteinuria","Kidney Diseases","Chronic Kidney Disease",[131,132,133,134,135,136,137,138,139,140,141,142,143,144,145],"Pediatric nephrotic syndrome","Idiopathic nephrotic syndrome","Steroid-resistant nephrotic syndrome","Steroid-sensitive nephrotic syndrome","Biomarkers discovery","Genetic risk factors","Epigenetic analysis","Adaptive immune system profiling","Liquid biopsy","Serum and urine proteomics","Multiomics approach","Personalized treatment","Disease progression prediction","Molecular characterization","Pediatric kidney disease","2025-01-28",{"date":148,"type":30},"2025-01-30",{"date":150,"type":20},"2025-02-15",{"date":152,"type":20},"2028-06-01",{"name":154,"class":70},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":164,"studyType":21,"phases":4,"briefSummary":165,"conditions":166,"keywords":174,"overallStatus":183,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":38},"100500545","comparing-the-diagnostic-sensitivity-and-specificity-of-pleural-fluid-n-terminal-pro-b-type-natriuretic-peptide-nt-probnp-and-other-biochemical-gradient-criteria-in-distinguishing-heart-failure-and-non-heart-failure-related-pleural-effusions-centre-study-100500545","NCT05797649","Comparing the Diagnostic Sensitivity and Specificity of Pleural Fluid N-Terminal Pro B-type Natriuretic Peptide (NT-proBNP) and Other Biochemical Gradient Criteria in Distinguishing Heart Failure and Non-heart Failure Related Pleural Effusions (CENTRE Study)","Comparing N-terminal-proB-type Natriuretic Peptide with Other Diagnostic Criteria in Discriminating Heart Failure-associated from Non-heart Failure-associated Pleural Effusions","Inclusion Criteria:\n\n* Patients hospitalized for heart failure and pleural effusion\n* Pleural tapping indicated for pleural fluid analysis.\n* Aged 18 years old or above\n\nExclusion Criteria:\n\n* History of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space.\n* History of surgical decortication or pleurodesis in the ipsilateral pleural space.\n* Ipsilateral thoracic or cardiac surgery in the past 3 months.\n* Failure to obtain informed consent due to the patient's refusal or cognitive impairment.",{"count":163,"type":20},120,"24 Months","To assess the discriminative properties of pleural fluid (PF) N-terminal-proB-type-natriuretic-peptide (NTproBNP) levels in identifying heart failure (HF)-associated pleural effusions (PE).",[167,168,169,170,24,171,172,173],"Pleural Effusion","Heart Failure","Malignant Neoplasm","Fluid Overload","Renal Failure","Cirrhosis","Infections",[175,176,177,178,179,180,181,182],"pleural fluid","heart failure","malignancy","cancer","echocardiography","infection","tuberculosis","respiratory medicine","RECRUITING","2024-11-11",{"date":186,"type":30},"2024-11-13",{"date":188,"type":30},"2023-07-01",{"date":190,"type":20},"2025-11-30",{"name":192,"class":70},"Chinese University of Hong Kong",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":17,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":203,"conditions":204,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100559358","hypoalbuminemia-in-critically-sick-children-100559358","NCT06563089","Hypoalbuminemia in Critically Sick Children","Hypoalbuminemia in Critically Sick Children at Assiut University Children's Hospital","Inclusion Criteria:\n\n1. Patients with an albumin level of less than 3.4 g\u002FdL for patients 7 months or older and less than 2.5 g\u002FdL for patients younger than 7 months.\n2. Patients with Severe sepsis, Respiratory diseases, Neurological diseases, Cardiac diseases, Blood diseases and gastrointestinal diseases with low albumin level .\n\nExclusion Criteria:\n\n1. Immune deficiency patients\n2. Malabsorption syndrome patients\n3. Celiac disease patients\n4. Protein loosing enteropathy patients\n5. Nephrotic syndrome patients\n6. Chronic liver disease patients","1 Month",{"count":202,"type":20},110,"The primary outcome in this Hospital-based study is to correlate the significance of hypoalbuminemia with different prognosis and outcome of different pediatric diseases.\n\nThe secondary outcomes of this study are i) to investigate the frequency of occurrence of hypoalbuminemia ii) to evaluate whether hypoalbuminemia on admission is a marker of adverse outcome in this population iii) whether correction of albumin by Human Albumin infusion or FFP helps in decreasing the length of stay in pediatric care unit, morbidity (e.g., duration of ventilator use) or mortality of the sick child.",[24],"2024-08-23",{"date":207,"type":30},"2024-08-26",{"date":209,"type":20},"2024-09-15",{"date":211,"type":20},"2026-03-31",{"name":213,"class":70},"Assiut University"]