[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fresenius Kabi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":94},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100629790","glycaemic-index-measurement-of-an-oral-nutritional-supplement-with-biomarker-assessment-and-lifestyle-monitoring-in-healthy-participants-100629790",false,"NCT07479251","Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants","Inclusion Criteria:\n\n* Aged ≥18 and ≤60 years, adult healthy Caucasian or Chinese participants\n* Stable body weight within the Body Mass Index between 18.5 kg\u002Fm2 and 27.9 kg\u002Fm2 (inclusive)\n* Glycated hemoglobin \\\u003C 6%\u002F\\\u003C 42 mmol\u002Fmol\n\nExclusion Criteria:\n\n* Pregnant or lactating,\n* Body fat percentage exceeding 30%,\n* Known history of metabolic diseases or diabetes mellitus,\n* Major medical or surgical event requiring hospitalization within the preceding 3 months\n* Medical condition(s) or medication(s) or herbal effects known to affect glucose regulation, tolerance or appetite and\u002For which influence digestion and absorption of nutrients (excluding oral contraceptives),\n* Use of steroids, protease inhibitors, amphetamines or antipsychotics",true,"ALL","18 Years","60 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical trial evaluates the postprandial glycaemic response to an Oral Nutritional Supplement (ONS), a Food for Special Medical Purposes (FSMP), in healthy adults. The study uses a crossover design comparing the ONS to the reference product glucose.\n\nEach participant will consume both test and reference products on three separate occasions each, overall on six test days.",[27],"Healthy Participants","NOT_YET_RECRUITING","2026-03-19",{"date":31,"type":32},"2026-03-23","ACTUAL",{"date":34,"type":21},"2026-03",{"date":36,"type":21},"2026-12",{"name":38,"class":39},"Fresenius Kabi","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100519909","phase-4-safety-study-of-smoflipid-to-evaluate-the-risk-of-developing-efad-andor-pnac-in-pediatric-and-adult-patients-100519909","NCT06049680","Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and\u002For PNAC in Pediatric and Adult Patients","A Single-arm Open-label Safety Study of SMOFlipid to Evaluate the Risk of Developing Essential Fatty Acid Deficiency (EFAD) and\u002For Parenteral Nutrition-associated Cholestasis (PNAC) in Pediatric Patients 1 Month to 17 Years of Age and in Adult Patients, Who Are Anticipated to Need 8 Weeks or Longer of Parenteral Nutrition Treatment","Age Limits: and Adults\n\nInclusion Criteria:\n\n1. Male or female patients, at least 1 month of age.\n2. Patients who require PN for at least 5 days\u002Fweek.\n3. Patients who receive 80% or more of their total energy requirements as PN at enrollment and who are expected to receive 80% or more of their total energy requirements as PN for at least 56 days.\n4. Written informed consent. In case of pediatric patients, informed consent must be obtained from parent(s) or legal representatives. If possible, the assent of the pediatric patient must also be obtained (according to local law).\n\nExclusion Criteria:\n\n1. Use of any other lipid injectable emulsion than SMOFlipid within 6 months prior to study participation\n2. Known hypersensitivity to fish, egg, soybean, or peanut proteins, or to any of the active ingredients or excipients of SMOFlipid.\n3. Hyperlipidemia or disorders of lipid metabolism characterized by hypertriglyceridemia (serum triglyceride concentration \\>250 mg\u002FdL in infants or \\>400 mg\u002FdL in older pediatric and adult patients).\n4. Inborn errors of amino acid metabolism.\n5. Cardiopulmonary instability (including pulmonary edema, cardiac insufficiency, myocardial infarction, acidosis and hemodynamic instability requiring significant vasopressor support).\n6. Hemophagocytic syndrome.\n7. Liver enzymes (either AST, or ALT, or GGT) exceeding 2 x upper limit of normal range\n8. Direct bilirubin exceeding 2 x upper limit of normal range\n9. INR exceeding 2 x upper limit of normal range and patient not receiving oral anticoagulants.\n10. Any known hepatic condition outside of IFALD that will increase direct bilirubin ≥2.0 mg\u002FdL.\n11. Clinically significant abnormal levels of any serum electrolyte (sodium, potassium, magnesium, calcium, chloride, phosphate).\n12. Active bloodstream infection demonstrated by positive blood culture at screening.\n13. Severe renal failure (eGFR \\\u003C15 ml\u002Fmin per 1.73 m2) including patients on renal replacement therapy.\n14. Abnormal blood pH, oxygen saturation, or carbon dioxide.\n15. Pregnancy or lactation.\n16. Participation in another interventional clinical study.\n17. Unlikely to survive longer than 56 days.","1 Month","17 Years",{"count":50,"type":21},100,[52],"PHASE4","Evaluate the risk of developing EFAD and\u002For PNAC in adult and pediatric patients 1 month of age and older, who are anticipated to need 8 weeks or longer of parenteral nutrition treatment with SMOFlipid.",[55,56,57,58],"Malnutrition, Child","Malnutrition","Essential Fatty Acid Deficiency (EFAD)","Parenteral Nutrition Associated Cholestasis","RECRUITING","2025-12-03",{"date":62,"type":32},"2025-12-04",{"date":64,"type":32},"2024-10-28",{"date":66,"type":21},"2026-09",{"name":38,"class":39},5,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":48,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100537204","safety-study-to-evaluate-the-occurrence-of-efad-in-pediatric-patients-with-pnac-who-require-more-than-eight-weeks-of-omegaven-treatment-100537204","NCT06274788","Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment","Title: A Single-arm, Open-label, Prospective, Multicenter Safety Study to Evaluate the Occurrence of Essential Fatty Acid Deficiency (EFAD) in Pediatric Patients With Parenteral Nutrition-associated Cholestasis (PNAC) Who Require More Than Eight Weeks of Omegaven Treatment","Inclusion Criteria:\n\n1. Patient's parent(s) or legal guardian(s) has provided a signed and dated Informed Consent Form (ICF).\n2. Pediatric patient (\\\u003C18 years) has been diagnosed with PNAC, defined as direct or conjugated bilirubin (DBil) ≥ 2.0 mg\u002FdL with no other known cause of liver dysfunction at the time of enrollment and is expected to require Omegaven treatment for at least eight weeks.\n3. Patient has oral or enteral feeding intolerance or at least one gastrointestinal disorder requiring PN.\n\nExclusion Criteria:\n\n1. Patient has received Omegaven within four weeks before inclusion in the study\n2. Patient has any other known cause of chronic liver disease such as hepatitis C, cystic fibrosis, biliary atresia, alpha-1-antitrypsin deficiency, passive hepatic congestion due to heart failure, etc.\n3. Patient has known cirrhosis (liver biopsy is not required under this protocol).\n4. Patient has been previously diagnosed with, or has prior evidence of, portal vein thrombosis.\n5. Patient has previously received a liver-only or liver-inclusive transplant.\n6. Patient has hemodynamic instability due to any major cardiac anomaly.\n7. Patient has a major life-threatening disease (e.g., sepsis requiring high-dose vasopressors, acute respiratory distress syndrome, veno-occlusive disease, cancer).\n8. Patient has multi-organ failure, septic shock, hypotension requiring pressor therapy, persistent pulmonary hypertension requiring inhaled nitric oxides, or requires extracorporeal membrane oxygenation (ECMO) or similar intervention.\n9. Patient has renal failure and requires renal replacement therapy.\n10. Patient has a severe hemorrhagic disorder.\n11. Patient has severe hyperlipidemia or a severe disorder of lipid metabolism characterized by hypertriglyceridemia (i.e., serum triglyceride level \\> 1,000 mg\u002FdL).\n12. Patient has a record of EFAD before inclusion in the study\n13. Patient has been diagnosed with or is suspected to have an inborn error of metabolism.\n14. Patient has a known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients of Omegaven.\n15. Patient is subject to treatment limitation.\n16. Patient is enrolled in any other study with an investigational medicinal product during the course of the current study.","1 Day",{"count":78,"type":21},40,"OBSERVATIONAL","This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population",[82,83,56,84],"Parenteral Nutrition Associated Liver Disease (PNALD)","Essential Fatty Acid Deficiency","Pediatric ALL","2025-08-28",{"date":87,"type":32},"2025-09-05",{"date":89,"type":32},"2024-12-15",{"date":91,"type":21},"2027-03-01",{"name":38,"class":39},10,""]