[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anemia":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,40,72,105,137,169,196,222,247,268,289,313,335,361,392,431,461,491,520,550,586,612,640,662,691],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100652115","study-evaluating-multifaceted-support-for-the-implementation-of-recommendations-for-the-prevention-and-management-of-anemia-in-intensive-care-units-100652115",false,"NCT07771192","Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units","STOP-A _ Multicenter, Prospective, Randomized, Stepped-wedge Study Evaluating Multifaceted Support for the Implementation of Recommendations for the Prevention and Management of Anemia in Intensive Care Units","STOP-A","Inclusion Criteria:\n\n* Length of stay in intensive care is ≥ 2 days\n* The patient has at least one organ failure lasting 24 hours or more (catecholamine infusion and\u002For mechanical ventilation (invasive or NIV \\> 6 hours\u002Fday))\n* No objection to data collection (patient or relative)\n\nExclusion Criteria:\n\n* Terminally ill patient with limited active treatment options within 72 hours of admission.","ALL","18 Years",{"count":21,"type":22},5760,"ESTIMATED","OBSERVATIONAL","STOP-A is a prospective, multicenter data study aimed at demonstrating the impact of multifaceted support for the implementation of recommendations on the prevention and management of anemia in intensive care, compared to previous practices, on hospital mortality in adult patients hospitalized in intensive care for ≥2 days. The timing of implementation in each center is determined randomly by stepped-wedge randomization.\n\nAs such, this is a pragmatic study that meets the international PRECIS-2 criteria.",[26],"Anemia","NOT_YET_RECRUITING","2026-08-13",{"date":30,"type":31},"2026-08-18","ACTUAL",{"date":33,"type":22},"2026-09-01",{"date":35,"type":22},"2028-03-01",{"name":37,"class":38},"University Hospital, Angers","OTHER_GOV",27,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100559133","restrictive-versus-liberal-thresholds-for-rbc-transfusion-in-ecmo-100559133","NCT06560164","Restrictive Versus Liberal Thresholds for RBC Transfusion in ECMO","Restrictive Versus Liberal Thresholds for Red Blood Cell Transfusion in ExtraCorporeal Membrane Oxygenation - the TREC Study","TREC","Inclusion Criteria:\n\n* Patient is aged 18 years or older;\n* Is receiving ECMO;\n* (Deferred) informed consent.\n\nExclusion Criteria:\n\n* Not expected to survive for 24 hours when assessed;\n* Inability to receive blood products;\n* (Known) decline to blood transfusions (e.g., Jehovah's Witnesses);\n* Extracorporeal carbon dioxide removal (ECCO2R) using low blood flow devices or pumpless devices (i.e., MINILUNG ®, PrismaLung+);\n* Received ECMO over 48h before screening for eligibility.",{"count":49,"type":22},526,"INTERVENTIONAL",[52],"NA","Rationale: In patients supported with extracorporeal membrane oxygenation (ECMO), transfusion of red blood cells (RBC) is very common. This is possibly due to the application of liberal thresholds and the lack of evidence-based guidelines. Although RBC transfusion can be lifesaving, it is also a risk-bearing intervention with substantial risk for morbidity and mortality in this critically ill population. Also, with increasing scarcity, RBC transfusions are becoming more expensive. Furthermore, in the past decades it has been shown in several critically ill patient populations - not on ECMO - that maintaining a restrictive hemoglobin (Hb) threshold for RBC transfusion is non-inferior, including in cardiothoracic surgery, acute myocardial infarction and septic shock. Therefore, the investigators hypothesize that a restrictive transfusion threshold for RBC is safe to apply in patients on ECMO in comparison with a liberal transfusion threshold.\n\nObjective: The primary objective of this trial is to study in a prospective randomized comparison whether a restrictive RBC transfusions strategy is non-inferior compared to a liberal strategy in patients on ECMO with respect to 90-day mortality.\n\nStudy design: Prospective multi-center randomized controlled non-inferiority trial.\n\nStudy population: Patients, 18 years or older, receiving ECMO.\n\nIntervention: Restrictive RBC transfusion threshold: in case the Hb transfusion trigger of 7.0 g\u002FdL (4.3 mmol\u002FL) is reached, 1 RBC unit at a time will be transfused. The aimed Hb target range of the restrictive\u002Fintervention group will be 7.1 - 9.0 g\u002FdL (4.3 - 5.6 mmol\u002FL). Liberal RBC transfusion threshold: in case the Hb transfusion trigger of 9.0 g\u002FdL (5.6 mmol\u002FL) is reached, 1 RBC unit at a time will be transfused. Target range of the liberal group is defined as Hb 9.1 - 11.0 g\u002FdL\n\nMain study parameters\u002Fendpoints: The primary outcome parameter is 90-day all-cause mortality.\n\nSecondary outcomes include: 1) proportion of patients on ECMO exposed to allogeneic RBC transfusion; 2) RBC volume infused per patient during ECMO; 3) reasons for RBC transfusion other than Hb triggers; 4) transfusion reactions; 5) time on ECMO; 6) length of hospital- and ICU-stay; 7) in-ICU morbidity; 8) quality of life (QoL), iMTA Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ) at 3, 6, 9, and 12 months; 9) costs related to a) transfusion, b) hospital admission and c) transfusion-related sequelae.",[55,56,57,26,58],"Transfusion","Red Blood Cell","Extracorporeal Membrane Oxygenation","ECMO",[55,56,57,26,58],"RECRUITING","2026-08-12",{"date":63,"type":31},"2026-08-14",{"date":65,"type":31},"2024-11-26",{"date":67,"type":22},"2028-10-01",{"name":69,"class":70},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",14,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":50,"phases":81,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100463861","phase-1-study-of-disc-0974-rally-mf-in-participants-with-myelofibrosis-or-myelodysplastic-syndrome-and-anemia-100463861","NCT05320198","Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","RALLY-MF: A Phase 1b\u002F2 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of DISC-0974 in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia","Inclusion Criteria for Participants with MF and Anemia:\n\nParticipants are eligible for the study if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the informed consent form (ICF).\n2. For Phase 1b: Dynamic International Prognostic Scoring System (DIPSS) score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and\u002For post ET MF, as confirmed in the most recent local bone marrow biopsy report, according to World Health Organization (WHO) 2016 criteria.\n\n   For Phase 2: In addition to the criteria above, DIPSS score of ≥2 (intermediate 1 risk) may also be included.\n3. Washout of at least 28 days prior to Screening of the following treatments:\n\n   1. Androgens\n   2. EPO\n   3. Cladribine\n   4. Immunomodulators (lenalidomide, thalidomide)\n   5. Luspatercept\u002Fsotatercept\n   6. Systemic corticosteroids are permitted for non-hematological conditions if stable or decreasing dose for ≥28 days prior to Screening and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening.\n\n   Screening can begin before the 28 day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   For Phase 1b: Hgb \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically but not meeting criteria for TD participant as defined for the TD cohort. The baseline Hgb value for these participants is the lowest Hgb level during the 84 days prior to Screening, or RBC transfusion dependence, defined as an RBC transfusion frequency of ≥6 units PRBC over the 84 days immediately prior to Screening. There must not be any consecutive 42-day period without an RBC transfusion in the 84-day period, and the last transfusion must be within 28 days prior to Screening.\n\n   For Phase 2:\n\n   TD high transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 3 to 12 PRBC units over the 84 days immediately prior to Screening TD low transfusion burden cohort: RBC transfusion dependence, defined as an RBC transfusion requirement of 1 to 2 PRBC units over the 84 days immediately prior to Screening nTD Cohort: Non-transfusion dependence, baseline Hgb \\\u003C10 g\u002FdL as defined on ≥3 assessments over 84 days prior to Screening, without RBC transfusion\n5. Stable dosing of MF-directed therapy:\n\n   1. Hydroxyurea, or, if taking any other treatment for MF, stable for at least 28 days prior to Screening.\n   2. Interferon alpha stable dosing for at least 12 weeks prior to Screening.\n   3. JAK inhibitors require 12 weeks of stable dosing prior to Screening. For the TD high, TD low, and nTD cohorts, JAK inhibitors allowed include momelotinib, pacritinib, fedratinib, and ruxolitinib.\n   4. If the participant discontinues JAK inhibitor (including momelotinib\u002Fpacritinib\u002Fruxolitinib\u002Ffedratinib) and\u002For hydroxyurea prior to Screening, a 60-day washout period is required.\n6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2.\n7. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening.\n8. TSAT \\\u003C75% (local lab acceptable) at or within 2 weeks of Screening.\n9. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review. Required for TD high participants only.\n10. Serum ferritin ≥50 µg\u002FL at Screening.\n11. Platelet count ≥25,000\u002FµL and \\\u003C1,000,000\u002FµL; neutrophils ≥1,000\u002FµL; and total white blood cell (WBC) count \\\u003C50,000\u002FµL at Screening.\n12. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.\n13. Aspartate aminotransferase (AST) and ALT \\\u003C3.0x upper limit of normal (ULN) at Screening.\n14. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis or Gilbert's syndrome, with approval from Sponsor.\n15. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n16. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n17. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n18. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n19. Able to comply with all study procedures.\n\nInclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:\n\nParticipants are eligible for the MDS exploratory cohort if all of the following criteria apply:\n\n1. Age 18 years or older at the time of signing the ICF.\n2. Molecular International Prognostic Scoring System (IPSS-M) classification of very low, low, or intermediate (ie, lower risk) MDS-ringed sideroblasts (RS) negative, MDS\u002FMPN with ringed sideroblasts and thrombocytosis (RS-T), Chronic Myelomonocytic Leukemia (CMML), Atypical Chronic Myeloid Leukemia (aCML), or Myelodysplastic\u002FMyeloproliferative Neoplasms, Unclassifiable (MDS\u002FMPN-U) as confirmed in the most recent local bone marrow biopsy report according to WHO criteria.\n3. Washout of at least 28 days is required for prior anemia\u002Fneutropenia-directed therapies, including:\n\n   1. Androgens\n   2. EPO-stimulating agents\n   3. Luspatercept\n   4. Sotatercept (ACE-011)\n   5. Imetelstat\n   6. Granulocyte colony-stimulating factor (G CSF) OR granulocyte-macrophage CSF (GM CSF).\n   7. Systemic corticosteroids (except for participants on a stable or decreasing dose for ≥28 days prior to randomization for non-hematological conditions and receiving an equivalent to ≤10 mg prednisone for the 28 days immediately prior to Screening) Screening can begin before the 28-day washout is completed, but the washout period must be completed prior to collection of Screening blood samples.\n4. Anemia:\n\n   1. Baseline Hgb of \\\u003C10 g\u002FdL on ≥3 assessments over 84 days prior to Screening, without RBC transfusion, or Hgb \\\u003C10 g\u002FdL and receiving RBC transfusions periodically during the 84 days prior to Screening\n   2. Medical history of ≤24 units of PRBC for MDS and anemia\n5. ECOG performance score ≤2\n6. Infusion of hematopoietic stem cell transplant not anticipated within 8 months after Screening\n7. TSAT \\\u003C75% (local lab acceptable) at or within 2 weeks of Screening\n8. Liver iron concentration by MRI \\\u003C7 mg\u002Fg dry weight within 3 months of eligibility confirmation by central review\n9. Serum ferritin ≥50 μg\u002FL at Screening\n10. Platelet count ≥25,000\u002FμL and \\\u003C1,000,000\u002FμL, and total WBC count \\\u003C50,000\u002FμL at Screening or otherwise approved by Sponsor.\n11. eGFR ≥30 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI formula\n12. AST and ALT \\\u003C3x ULN at Screening\n13. Direct bilirubin \\\u003C2x ULN at Screening. Higher levels are acceptable if these can be attributed by the Investigator to ineffective erythropoiesis.\n14. If male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner)\n    2. Intrauterine device in place for at least 3 months (female partner)\n    3. Surgically sterile hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    4. Confirmed successful vasectomy\n15. If female, then EITHER postmenopausal (defined as 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum FSH levels \\>40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) on Day 1 (or earlier) and for at least 8 weeks after the last dose of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months)\n    2. Intrauterine device in place for at least 3 months\n    3. Tubal ligation or single male partner with vasectomy\n16. Negative urine pregnancy test (females of childbearing potential) at Screening (Days 28 to 2).\n17. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n18. Able to comply with all study procedures.\n\nExclusion Criteria for Participants with MF and Anemia:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical History, Participants with MF and Anemia\n\n1. Hereditary hemochromatosis\n2. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n3. Total splenectomy\n4. Hematopoietic cell transplant within the past 2 years, or graft vs host disease requiring immunosuppression\n5. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n6. Active immune-mediated hemolytic anemia\n7. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n8. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n9. Malignancy within the past 3 years, other than primary MF, post ET, or post PV MF. The following history or concurrent conditions are allowed:\n\n   1. basal or squamous cell carcinoma of the skin\n   2. carcinoma in situ of the cervix or the breast\n   3. histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n10. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 3 months prior to Screening\n11. Known allergic reaction to any study drug excipient\n12. A history of anti-drug antibody formation\n13. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n14. Hepatitis B or C, or human immunodeficiency virus (HIV) with detectable viral load\n15. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Participants with MF and Anemia\n16. Iron chelation therapy in the 28 days prior to Screening\n17. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Participants with MF and Anemia\n18. Peripheral blood myeloblasts ≥10% of WBC differential at most recent evaluation prior to Screening\n19. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Participants with MF and Anemia\n20. Pregnant or lactating\n21. Condition or concomitant medication that would confound the ability to interpret study data\n22. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening\n\nExclusion Criteria for Exploratory Cohort of Participants with MDS and Anemia:\n\nParticipants are excluded from the MDS exploratory cohort if any of the following criteria apply:\n\nMedical History, Participants with MDS and Anemia\n\n1. Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and\u002For radiation from other diseases\n2. Peripheral blasts ≥5%\n3. Current treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy or planned use within 6 months after Screening\n4. Prior treatment with \\>3 anemia-directed therapies (unless otherwise approved by Sponsor) including:\n\n   1. Luspatercept\n   2. Sotatercept (ACE-011)\n   3. EPO-stimulating agent\n   4. Imetelstat\n5. Hereditary hemochromatosis\n6. Hemoglobinopathy or intrinsic RBC defect associated with anemia\n7. Total splenectomy\n8. Hematopoietic cell transplant within the past 10 years\n9. Current anemia from iron deficiency, vitamin B12 or folate deficiency, infection, or bleeding\n10. Active immune-mediated hemolytic anemia\n11. Symptomatic bleeding, unrelated to surgery, in a critical area or organ and\u002For bleeding causing a decrease in Hgb of ≥2 g\u002FdL or leading to transfusion of ≥2 units of RBCs in the 6 months prior to Screening\n12. Major surgery within 8 weeks prior to Screening or incomplete recovery from any previous surgery\n13. Malignancy within the past 3 years, other than MDS or MDS\u002FMPN without excess blasts. The following history or concurrent conditions are allowed:\n\n    1. Basal or squamous cell carcinoma of the skin\n    2. Carcinoma in situ of the cervix or the breast\n    3. Histologic finding of prostate cancer (T1a or T1b using the TNM clinical staging system) A history of completed treatment (medical or surgical) of stage 1-2 cancers may be permitted with prior Sponsor agreement\n14. Stroke, deep vein thrombosis, or pulmonary or arterial embolism within 6 months prior to Screening\n15. Known allergic reaction to any study drug excipient\n16. A history of antidrug antibody formation\n17. Inadequately controlled heart disease (New York Heart Association Classification 3 or 4) and\u002For known to have left ventricular ejection fraction \\\u003C35%\n18. Active hepatitis B or C, or HIV with detectable viral load\n19. Uncontrolled fungal, bacterial, or viral infection (ongoing signs\u002Fsymptoms related to the infection, without improvement despite appropriate treatment)\n\n    Treatment History, Participants with MDS and Anemia\n20. Iron chelation therapy in the 28 days prior to Screening\n21. Change in anticoagulant therapy regimen within 8 weeks prior to Screening\n\n    Laboratory Exclusions, Participants with MDS and Anemia\n22. Positive direct antiglobulin test in conjunction with a reactive RBC eluate at Screening\n\n    Miscellaneous, Participants with MDS and Anemia\n23. Pregnant or lactating\n24. Condition or concomitant medication that would confound the ability to interpret study data\n25. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at unacceptable risk or otherwise preclude the participant from participating in the study\n26. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days prior to Screening",{"count":80,"type":22},150,[82,83],"PHASE1","PHASE2","This phase 1b\u002F2a open-label study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of DISC-0974 as well as categorize the effects on hematologic response in participants with myelofibrosis or myelodysplastic syndrome and anemia.",[86,26,87,88,89,90,91],"Myelofibrosis; Anemia","Myelofibrosis","Myelofibrosis Due to and Following Polycythemia Vera","Primary Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Myelodysplastic Syndromes",[93,94],"Myeloproliferative Neoplasm","Myeloproliferative Disorders","2026-08-10",{"date":61,"type":31},{"date":98,"type":31},"2022-06-06",{"date":100,"type":22},"2027-06",{"name":102,"class":103},"Disc Medicine, Inc","INDUSTRY",30,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":50,"phases":115,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100651347","phenotyping-acute-non-severe-anemia-in-the-emergency-department-100651347","NCT07761104","Phenotyping Acute Non-Severe Anemia in the Emergency Department","A Prospective Interventional Physiological Study for Comprehensive Phenotyping of Adults With Non-Life-Threatening Anemia Presenting to the Emergency Department","PHENOEMEMIA","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Presentation to the emergency department.\n* Blood hemoglobin concentration \\\u003C10 g\u002FdL.\n* Non-life-threatening clinical condition at presentation.\n* Able to understand the study information and provide written informed consent.\n* Affiliated with a health insurance system.\n\nExclusion Criteria:\n\n* Glasgow Coma Scale score \\\u003C15.\n* Shock Index \\>0.9.\n* Acute clinically significant gastrointestinal, gynecological or other active bleeding within the previous 24 hours.\n* Oxygen saturation \\\u003C92% on room air.\n* Suspected acute myocardial ischemia.\n* Carbon monoxide poisoning.\n* Pregnancy or breastfeeding.\n* Adults lacking legal capacity to provide consent.\n* Individuals deprived of liberty by judicial or administrative decision.\n* Individuals under psychiatric care without consent.\n* Individuals under legal protection (guardianship or curatorship).\n* Individuals not affiliated with a health insurance system.",{"count":114,"type":22},59,[52],"Anemia is traditionally diagnosed and managed using circulating hemoglobin concentration (\\[Hb\\]). However, \\[Hb\\] is influenced by plasma volume and may not accurately reflect the total amount of hemoglobin available for oxygen transport. Total hemoglobin mass (Hbmass), measured using the optimized carbon monoxide rebreathing method, provides a direct assessment of the body's oxygen-carrying capacity but has never been extensively investigated in patients presenting to the emergency department with non-life-threatening anemia.\n\nThe hypothesis of the PHENOEMEMIA study is that routine blood hemoglobin concentration is only moderately correlated with Hbmass and therefore does not fully reflect the physiological severity of anemia.\n\nPHENOEMEMIA is a prospective single-center interventional physiological study including adults presenting to the emergency department with non-life-threatening anemia. Each participant undergoes routine clinical assessment, standardized symptom questionnaires, additional blood sampling for biological and hemorheological analyses, focused transthoracic echocardiography, near-infrared spectroscopy assessment of tissue oxygenation, and Hbmass measurement using the optimized carbon monoxide rebreathing technique.\n\nThe primary objective is to evaluate the correlation between blood hemoglobin concentration and Hbmass normalized to body weight. Secondary objectives include describing the relationships between Hbmass, biological markers of anemia, clinical symptoms, cardiac adaptation, blood rheology, tissue oxygenation, and physiological phenotypes of anemia.",[26],[26,119,120,121,122,123,124,125,126,127],"Hemoglobin Mass","Carbon Monoxide Rebreathing","Emergency Medicine","Blood Volume","Hemorheology","Tissue Oxygenation","Near Infrared Spectroscopy","Echocardiography","Physiological Phenotyping","2026-08-07",{"date":61,"type":31},{"date":131,"type":22},"2026-12",{"date":133,"type":22},"2028-12",{"name":135,"class":70},"Hospices Civils de Lyon",1,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":18,"minAge":144,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":50,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100490331","a-study-to-determine-the-efficacy-and-safety-of-luspatercept-in-adult-participants-and-to-evaluate-the-safety-and-pharmacokinetics-in-and-adolescent-participants-with-alpha--thalassemia-100490331","NCT05664737","A Study to Determine the Efficacy and Safety of Luspatercept in Adult Participants and to Evaluate the Safety and Pharmacokinetics in and Adolescent Participants With Alpha (α)-Thalassemia","A Phase 2, Study for the Treatment of Anemia With Alpha (α)-Thalassemia to Determine the Efficacy and Safety of Luspatercept (BMS-986346\u002FACE-536) in Adults and Evaluate the Safety and Pharmacokinetics in Adolescents","Inclusion Criteria:\n\n* Adult participant≥ 18 years with documented diagnosis of A-Thal HbH disease with Transfusion dependence defined as:.\n\n  i) TD participant: ≥ 6 RBC units during the 24 weeks prior to randomization. ii) NTD participant:\\\u003C 6 RBC units during the 24 weeks prior to randomization(transfusion due to conditions other than A-Thal will not be considered)and, RBC transfusion-free during at least 8 weeks prior to randomization(unless transfusion was required to treat an acute medical condition other than A-Thal) and, mean baseline Hb ≤ 10 g\u002FdL, based on a minimum of 2 measurements ≥ 1 week apart within 4 weeks prior to randomization; hemoglobin values within 21 days post-transfusion will be excluded.\n* Adult participant has Eastern Cooperative Oncology Group (ECOG) 34 score of 0 or 1.\n* Adolescent participant 12 years to \\\u003C 18 years with documented diagnosis of A-Thal HbH disease with transfusion dependence defined as:.\n\n  i) TD participant: ≥ 4 RBC events during the 24 weeks prior to enrollment and, no transfusion-free period for \\> 56 days during the 24 weeks prior to enrollment. Participants must have a history of regular transfusions for at least 2 years.\n\nii) NTD participant:\\\u003C 4 RBC events during the 24 weeks prior to enrollment and RBC transfusion-free during at least 8 weeks prior to enrollment and, mean baseline Hb ≤ 10 g\u002FdL, based on a minimum of 2 measurements ≥ 1 week apart within 4 weeks prior to enrollment, hemoglobin values within 21 days post-transfusion will be excluded.\n\niii) Participant has Karnofsky (age ≥16 years) or Lansky (age \\\u003C 16 years) performance status score ≥ 50 at screening.\n\nExclusion Criteria:\n\n* Medical Conditions: Diagnosis of A-ThalTrait, Hb Bart hydrops, ATRx A-Thal, hemoglobin S\u002Fβ-thalassemia, myelodysplasia subtype anemia, or with HbE homozygous beta gene mutation. Anemia related to nutritional deficiency, anemia of chronic disease, autoimmune hemolytic anemia, or any other hemolytic anemias. Undergone episodes of hemolysis not related to A-Thal within the 8 weeks prior to randomization. Applicable for the EU only: Bleeding disorders manifested by frequent bleeding episodes (eg, menorrhagia, epistaxis, clotting disorders).\n* Participant has deep vein thrombosis (DVT), stroke or other thromboembolic event(s) (except clogged indwelling catheter) requiring medical intervention ≤ 24weeks prior to randomization.\n* Participant has uncontrolled hypertension. Controlled hypertension for this protocol is considered: blood pressure value corresponding to ≤Grade 1 according to NCI CTCAE Version 5.0. with or without pharmacological treatment.\n* Reproductive Status: Women who are pregnant, plan to get pregnant during the study, or who are breastfeeding.\n* Prior\u002FConcomitant: Undergone HSCTs or gene therapy (candidates for HSCT or gene therapy with waiting period of ≥ 12 months are eligible).\n* Use of hydroxyurea treatment ≤ 12 weeks prior to enrollment for NTD participants and ≤ 24 weeks for TD participants.\n* Participant who has extramedullary hematopoiesis (EMH) complications requiring treatment to control the growth of EMH mass(es) during the screening period.\n* Any medical or psychiatric condition (including active infections, recent surgery, sequelae of diseases or interventions, clinically significant laboratory abnormalities or concurrent treatment) that in the opinion of the investigator would put the participant at unacceptable risk of participating in the study or that could affect interpretability of data.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","12 Years",{"count":146,"type":22},189,[83],"The purpose of the study is to evaluate the efficacy and safety of luspatercept plus best supportive care (BSC) vs placebo plus BSC on anemia in adult participants with α-thalassemia hemoglobin H (HbH) disease and determine the safety and drug levels in adolescent participants.",[26],[151,152,153,154,155,156,157,158,159],"Luspatercept","BMS-986346","ACE-536","α-thalassemia","Alpha Thalassemia","Reblozyl","Transfusions","Non-transfusion dependent","RBC transfusion dependent","2026-08-06",{"date":95,"type":31},{"date":163,"type":31},"2022-12-09",{"date":165,"type":22},"2034-08-14",{"name":167,"class":103},"Bristol-Myers Squibb",36,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":50,"phases":179,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":178,"type":22},324,[180],"PHASE3","The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[87,26],[184,185],"TAK-226","Drug therapy","2026-08-04",{"date":188,"type":31},"2026-08-05",{"date":190,"type":22},"2026-08-25",{"date":192,"type":22},"2034-03-30",{"name":194,"class":103},"Takeda",194,{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":203,"maxAge":204,"enrollmentInfo":205,"targetDuration":4,"studyType":50,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":136},"100556614","phase-2-choline-and-iron-deficiency-100556614","NCT06527391","Choline and Iron Deficiency","Supplemental Choline to Prevent and Treat Learning and Memory Deficits of Early Iron Deficiency: the SupCHO Study","Inclusion Criteria:\n\n* Age 6 months +\u002F- 28 days\n* Hb \\\u003C 11.0 g\u002FdL\n* ZPP \\> = 80\n* T\\\u003C37.5°C\n* Malaria-negative based on Rapid Diagnostic Test (RDT)\n* Mother is HIV-negative.\n\nExclusion Criteria:\n\n* Developmental disorder\n* Severe malnutrition (severe wasting or bipedal edema)\n* Known sickle cell disease\n* Neurologic disorder, brain injury, or other condition affecting brain development\n* Not currently breastfeeding\n* Birthweight \\\u003C 2000 g","5 Months","7 Months",{"count":206,"type":22},300,[83,180],"BACKGROUND:\n\nIron deficiency limits the neurodevelopmental potential of more than 200 million children each year. Iron therapy is typically started when iron deficiency anemia is first diagnosed after screening for anemia or detection of clinical symptoms of iron deficiency anemia at 12 months of age. But iron started at this time does not fully correct earlier iron-deficiency-mediated brain dysfunction, underscoring the need for low-cost, easily implementable adjunct therapies to iron to treat or prevent this dysfunction in high-risk populations.\n\nGAP Supplementation with the nutrient choline lessens damage to the hippocampus from early-life iron deficiency in pre-clinical models and improves hippocampus-mediated memory in children with Fetal Alcohol Spectrum Disorders. Choline has not been tested in children with iron deficiency anemia, despite strong pre-clinical and clinical evidence supporting a benefit to brain development.\n\nHYPOTHESIS:\n\nInfants with iron deficiency anemia who receive iron and nine months of daily choline supplements will have better scores on specific neurobehavioral tests of recognition memory than infants who receive iron and placebo.\n\nMETHODS:\n\nThis randomized, double-blinded, placebo-controlled clinical trial will randomize 300 6-month-old infants with iron deficiency anemia at Mulago Hospital, Kampala, Uganda, to iron plus choline or iron plus placebo to test the effect of choline on hippocampus-specific and global neurobehavioral outcomes after nine months.\n\nRESULTS: Pending\n\nIMPACT:\n\nIf our hypothesis is correct, choline could be added immediately to standard-of-care treatment for iron deficiency anemia. This intervention could safely mitigate the brain dysfunction of early-life iron deficiency that is often undiagnosed until the hippocampal critical window is closing. This simple, low-cost nutrient could thus have life-long benefit for both individuals and the economic and social prosperity of entire regions.",[210,26],"Pediatric Iron Deficiency",[212,213,214],"iron deficiency","choline","anemia",{"date":188,"type":31},{"date":217,"type":31},"2025-08-11",{"date":219,"type":22},"2027-09-21",{"name":221,"class":70},"University of Minnesota",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":229,"sex":18,"minAge":230,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":50,"phases":234,"briefSummary":235,"conditions":236,"keywords":237,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":136},"100630907","multiple-micronutrient-supplementation-with-digital-layering-among-adolescents-in-tanzania-100630907","NCT07493772","Multiple Micronutrient Supplementation With Digital Layering Among Adolescents in Tanzania","MMSDigitalTZ","Inclusion Criteria:\n\n* Aged 15-19 years at enrollment.\n* Resident in the Dar es Salaam HDSS coverage area.\n* Has access to at least one phone (own or shared within the household; feature phone or smartphone).\n* Demonstrates basic literacy skills sufficient to understand simple written messages.\n* Has capacity to provide informed consent (for those ≥18 years) or assent (for those \\\u003C18 years, with parental\u002Fguardian consent).\n\nExclusion Criteria:\n\n* Currently pregnant.\n* Enrolled in the ARISE-NUTRINT trial.\n* Currently taking iron and folic acid or multiple micronutrient tablets for anemia outside this study.\n* Known to have HIV infection at the time of screening.\n* More than one eligible adolescent per household: if multiple adolescents meet criteria in a household, one will be randomly selected to participate.",true,"15 Years","19 Years",{"count":233,"type":22},1200,[52],"This study is a three-arm, individually randomized controlled trial evaluating the impact of digitally delivered nutrition education, layered onto multiple micronutrient supplementation (MMS), on anemia and related health behaviors among adolescents in Dar es Salaam, Tanzania. A total of 1,200 adolescents aged 15-19 years with access to a phone (own or shared) will be enrolled from the Dar es Salaam Health and Demographic Surveillance System and followed for 9 months, with assessments at baseline, 4 months, and 9 months.\n\nAll participants will receive a brief in-person nutrition education session, printed brochures on adolescent nutrition and anemia, and a 2-month supply of daily MMS tablets with instructions and access to refills (Control arm). In Intervention Arm I, participants will receive the same package plus weekly one-way SMS\u002FWhatsApp messages reinforcing key nutrition content and adherence to MMS and refills. In Intervention Arm II, participants will receive all components of Arm I plus fortnightly, in-person group digital nutrition education sessions that include interactive content and opportunities to co-create and share digital nutrition messages with peers. All participants will receive information on replenishing the tablets. Participants in Intervention Arm I and Intervention Arm II will receive additional nutrition, diet, and physical activity-related messages along with reminders and motivational encouragement to replenish their supplement stocks.\n\nThe primary outcome is anemia prevalence, assessed using hemoglobin concentration and WHO age- and sex-specific cutoffs. Secondary outcomes include moderate\u002Fsevere anemia, hemoglobin levels, adherence to MMS pick-up and consumption, nutrition literacy, dietary diversity, fruit and vegetable intake, physical activity, underweight\u002Foverweight\u002Fobesity, and digital literacy. The trial also includes a mixed-methods process evaluation of feasibility, acceptability, reach, engagement with the digital components, and a cost estimation of the digital strategies.",[26],[238],"Adolescents, multiple micronutrient supplements, RCT, Tanzania","2026-08-03",{"date":188,"type":31},{"date":242,"type":22},"2026-07-07",{"date":244,"type":22},"2027-03-31",{"name":246,"class":70},"Harvard School of Public Health (HSPH)",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":50,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":71},"100621311","phase-2-study-of-disc-0974-201-in-participants-with-ibd-and-anemia-100621311","NCT07368972","Study of DISC-0974-201 in Participants With IBD and Anemia","RALLY-IBD: A Phase 2 Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of DISC-0974 in Participants With Inflammatory Bowel Disease and Anemia of Inflammation","Inclusion Criteria:\n\nParticipants must meet all the following criteria at screening (unless otherwise specified) to be eligible for enrollment in the study:\n\n1. Aged ≥18 years at the time of signing informed consent.\n2. Established diagnosis of IBD (CD, UC, or IBD-unclassified) based on documented findings on both endoscopy and histopathology.\n3. Baseline endoscopy at screening with modified Mayo Score for UC and CDAI for Crohn's Disease to include mild disease as defined below:\n\n   a. CDAI of \\\u003C220 and SES-CD of 0 to 6 (CD\u002FIBD-unclassified) modified Mayo Score of \\\u003C5 points and Mayo endoscopic subscore of 0 to 1 (UC\u002FIBD-unclassified).\n4. Are symptomatic from anemia as assessed by the Investigator despite optimized, stable conventional IBD-directed therapy for 3 months.\n5. Hgb ≥7 AND \\\u003C12 g\u002FdL for females and ≥7 AND \\\u003C13 g\u002FdL for males (local lab) at screening.\n6. Have symptomatic anemia defined as:\n\n   1. Hgb ≤10 g\u002FdL and symptomatic as assessed by Investigator (fatigue, shortness of breath at rest or on minimal exertion, palpitations, tachycardia, orthostatic hypotension or dizziness), or\n   2. Hgb \\>10 g\u002FdL and a minimum score of 4 on the Numeric Rating Scale for Fatigue.\n7. Serum ferritin ≥75 μg\u002FL at screening (local lab).\n8. AST and ALT \\\u003C2× upper limit of normal (ULN) at screening.\n9. Total and direct bilirubin \\\u003CULN at screening.\n10. Estimated glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula.\n11. If female, then EITHER postmenopausal (defined as at least 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \\>40 mIU\u002FmL, or at least 6 weeks following surgical bilateral oophorectomy with or without hysterectomy), surgically sterile, OR agreeable to use 1 of the following highly effective contraception methods (listed below) during the study and for at least 8 weeks after the last dose of study drug:\n\n    * Stable hormonal contraceptive (≥3 months)\n    * Intrauterine device in place for at least 3 months\n    * Tubal ligation or single male partner with vasectomy\n12. If a male with female sexual partner(s) of childbearing potential, agrees to use 1 of the following highly effective methods of contraception during the study and for at least 8 weeks after the last study drug dose:\n\n    * Stable hormonal contraceptive (≥3 months; female partner)\n    * Intrauterine device in place for at least 3 months (female partner)\n    * Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner)\n    * Confirmed successful vasectomy\n13. Able to understand and provide written informed consent.\n14. Able to comply with all study procedures.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria at screening are not eligible for study enrollment:\n\n1. Treatment within 2 days prior to screening with oral iron or iron-containing supplements. Participants may be considered for the study if they undergo a 2-day washout period prior to screening labs for oral iron or iron-containing supplements. Between screening and 2 days prior to Day 1 visit, participants may continue oral iron or iron-containing supplements at the discretion of the Investigator, but any study-related lab draws will require a 48-hour washout from oral iron.\n2. Treatment within 30 days prior to screening with any of the following anemia treatments: blood transfusion, EPO-stimulating agent (ESA), or IV iron. Participants may be considered for the study if they undergo a 30-day washout period for ESAs or IV iron prior to screening labs.\n3. Planned change in IBD directed therapy within 3 months of screening.\n4. Moderate or severe IBD assessed during screening period. Defined as:\n\n   1. CD\u002FIBD-unclassified: participants with a CDAI score ≥220 or SES-CD ≥7\n   2. UC\u002FIBD-unclassified: modified Mayo Score of ≥6 or endoscopic subscore of 3\n   3. Fever, tachycardia, or anticipated need for surgery in the next 3 months\n5. Hospitalization within 30 days prior to screening.\n6. Positive direct antiglobulin test with reactive eluate at screening or medical history at screening of active hemolytic anemia.\n7. Gross gastrointestinal blood loss (eg, visible rectal bleeding, hematochezia, melena) within 4 weeks prior to screening.\n8. Active gastrointestinal bleeding requiring hospitalization, blood transfusion, or endoscopy hemostasis within 8 weeks prior to screening.\n9. Current use of Janus kinase (JAK) inhibitor.\n10. History of hereditary hemochromatosis.\n11. History of Primary Sclerosis Cholangitis.\n12. History of hemoglobinopathy or intrinsic RBC defect associated with anemia.\n13. History of total splenectomy.\n14. Hematopoietic stem cell or solid organ transplant within the past 10 years.\n15. Medical history of anemia from Vitamin B12 or folate deficiency or infection in the 3 months prior to screening.\n16. Stroke, myocardial infarction, deep venous thrombosis, pulmonary or arterial embolism within 6 months prior to screening.\n17. Medical history of clinically significant thrombotic disorder.\n18. If female, pregnant or breastfeeding.\n19. Any major surgery within 8 weeks before screening or incomplete recovery from any previous surgery.\n20. Current or recent systemic corticosteroid use (within 3 months of screening).\n21. Endoscopic abnormalities concerning for colon cancer on baseline endoscopy.\n22. History of malignancy within the last 3 years. The following history\u002Fconcurrent conditions are allowed: basal or squamous cell carcinoma skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis clinical staging system). A history of completed treatment (medical or surgical) of Stage 1-2 cancers may be permitted with prior Sponsor agreement.\n23. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and\u002For therapeutic devices within 30 days of screening.\n24. A history or known allergic reaction to any investigational product excipients.\n25. History of ADA formation with anaphylaxis.\n26. History of inadequately controlled heart failure (New York Heart Association Classification 3 or 4) and\u002For have a history of left ventricular ejection fraction \\\u003C35%.\n27. Uncontrolled fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement, despite appropriate treatment).\n28. Active infectious gastroenteritis including clostridium difficile colitis or viral enteritis (eg, cytomegalovirus).\n29. HIV positive, active hepatitis B virus surface antigen (HBV), or active hepatitis C virus antibody (HCV).\n30. Significant medical condition, laboratory abnormality, or psychiatric condition that would prevent the patient from participating in the study.\n31. Any condition or concomitant medication that would confound the ability to interpret data from the study.",{"count":255,"type":22},21,[83],"This is a Phase 2, multicenter, randomized, double-blind placebo-controlled study of DISC-0974 to evaluate safety, tolerability, and efficacy in participants with IBD and anemia of inflammation.",[259,26,260],"Inflammatory Bowel Disease (IBD)","Inflammatory Bowel Disease (IBD); Anemia","2026-07-31",{"date":239,"type":31},{"date":264,"type":31},"2026-02-20",{"date":266,"type":22},"2027-03",{"name":102,"class":103},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":50,"phases":277,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":287,"locationsCount":4},"100649804","phase-2-evaluate-ofirnoflast-in-adults-with-very-low--to-intermediate-risk-myelodysplastic-syndromes-requiring-transfusions-100649804","NCT07738510","Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Transfusions","A Phase 2b, Multicenter, Open-label, Randomized, Dose Optimization Study of Ofirnoflast (HT-6184) for the Treatment of Anemia in Adults With Very Low- to Intermediate-Risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions","Inclusion Criteria:\n\n1. At least 18 years of age at the time of signing informed consent.\n2. Capable of giving signed informed consent\n3. Documented diagnosis of very low-, low-, or intermediate-risk MDS\n4. Documented diagnosis of anemia\n5. Relapsed or refractory disease after 1 to 3 prior lines of therapy for lower-risk MDS\n6. Willing to provide a bone marrow aspirate at Screening.\n7. Life expectancy of more than 6 months at screening.\n8. Participants of childbearing potential must have a negative pregnancy test at screening (serum) and Day 1 (urine).\n9. Participants and partners must use contraception consistent with local regulations and protocol-defined criteria during the intervention period and for at least 30 days after the last dose; periodic abstinence and withdrawal are not acceptable methods.\n\nExclusion Criteria:\n\n1. Anemia due to other causes (e.g., iron deficiency).\n2. Known clinically significant anemia due to iron, vitamin B12, or folate deficiency; autoimmune or hereditary hemolytic anemia; or gastrointestinal bleeding.\n3. History of hemoglobinopathies, intrinsic RBC membrane\u002Fenzyme defects, or hemolytic anemia.\n4. Prior history of AML, secondary MDS, or other malignancy (except non-melanoma skin cancer or in situ cervical\u002Fbreast carcinoma) unless disease-free for \\>1 year.\n5. Diagnosis of MPN, CMML, or overlap MDS\u002FMPN per WHO classification.\n6. Any condition or concomitant treatment that may impair absorption of orally administered study intervention.\n7. Uncontrolled infection or severe organ dysfunction.\n8. Concomitant intercurrent illness or condition that, per investigator judgment, would compromise safe participation (e.g., uncontrolled hypertension, uncontrolled seizure, unstable angina, new-onset\u002Fexacerbated cardiac arrhythmia).\n9. Prior treatment with disease-modifying agents (e.g., hypomethylating agents) or immunosuppressive therapy, except prior lenalidomide (permitted).\n10. Treatment with cytotoxic chemotherapy or experimental agents within 4 weeks prior to first dose.\n11. History of stem cell, bone marrow, or solid organ transplant.\n12. Known hypersensitivity to ofirnoflast or its excipients.\n13. Severe renal or hepatic impairment\n14. Inability to swallow tablets.\n15. Participation in another interventional clinical study within 90 days prior to first dose.\n16. QTcF \\>480 ms.\n17. Prior treatment with ofirnoflast.",{"count":276,"type":22},50,[83],"The primary objective of this study is to evaluate the efficacy and safety of ofirnoflast administered orally once daily in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who are transfusion-dependent and have failed one to three prior therapies, in order to identify the optimal dose for continuation into a Phase 3 study.\n\nThe secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during the dose-selection phase, and to evaluate hematologic improvement with ofirnoflast treatment.",[91,26],[281],"Ofirnoflast, HT-6184, Myelodysplastic syndromes, MDS","2026-07-29",{"date":261,"type":31},{"date":285,"type":22},"2026-10",{"date":133,"type":22},{"name":288,"class":103},"Halia Therapeutics, Inc.",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":50,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100648807","phase-2-a-study-of-luspatercept-in-people-with-anemia-100648807","NCT07725497","A Study of Luspatercept in People With Anemia","A Multicenter Phase 2 Study of Luspatercept in Patients With Anemia Due to Chronic Kidney Disease","Inclusion Criteria:\n\nDocumentation of Anemia due to CKD\n\n* Patients must have a Hb ≤ 9.5 g\u002FdL on two separate occasions within 4 weeks prior to enrollment.\n* Do not anticipate red cell transfusion within the following 4 weeks and no history of red cell transfusion in three weeks prior to enrollment.\n* Ferritin ≥100 ng\u002FmL and iron transferrin saturation (TSAT) ≥ 20%.\n* Serum folate \\> 4 ng\u002FmL\n* Serum vitamin B12 \\> 250 pg\u002FmL\n* Patients may have received iron, B12 and folic acid repletion if initiated \\> 6 weeks prior to enrollment. Patients who are already on iron, B12 and folic acid repletion can continue throughout the trial.\n* TSH, T4 within institutional normal limits. Documentation of Chronic Kidney Disease\n* Chronic kidney disease defined as a GFR between 30-60 mL\u002Fmin\u002F1.73m2 for ≥ 3 months calculated by the 2021 CKD-EPI creatinine equation for eGFR, the 2021 CKD-EPI creatinine-cystatin C equation, or creatinine clearance measured by a 24-hour urine collection.\n\nPrior Treatment with Erythrocyte Stimulating Agents (ESA)\n\n* Eligible patients will not have had recent (within past 3 weeks) erythrocyte stimulating agents (ESA) prior to enrollment unless they are hyporesponsive to ESA therapy.\n* Patients are eligible if they are either hyporesponsive to ESA therapy or unwilling to accept ESAs. defined by the Kidney Disease Outcomes Quality Initiative (KDOQI) as the inability to achieve\u002Fmaintain a desired hemoglobin (herein defined as a hemoglobin of \\> 9.0 g\u002FdL) using a maximum dose of erythropoietin (450 units\u002Fkg\u002Fweek IV or 300 units\u002Fkg\u002Fweek SQ or the darbepoetin equivalent using the conversion of 45,000 units\u002Fweek of epoetin = 100 mcg\u002Fweek of darbepoetin).\n* Age ≥ 18\n* ECOG Performance Status of ≤ 2\n* Not Pregnant and Not Nursing Required Organ Function\n* Adequate hematologic function defined as follows:\n* Absolute neutrophil count (ANC) ≥ 1,000 cells\u002Fmm3\n* Platelets ≥ 75,000 cells\u002Fmm3\n* Adequate hepatic function defined as follows:\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n* AST and ALT ≤3 x institutional ULN\n* Comorbid Conditions\n* Patients with a history of a solid organ malignancy can be included if they have been in remission for at least 12 months.\n\nExclusion Criteria:\n\n* Evidence of recent (within previous 4 weeks) bleeding including gastrointestinal to explain anemia.\n* Evidence of hemolysis (LDH ≥ 2 x ULN and haptoglobin below lower limit of normal)\n* Known diagnosis of myelodysplastic syndrome or any known hematologic malignancy \\[not including monoclonal of undetermined significance (MGUS) or monoclonal b-cell lymphocytosis (MBL)\\] not in remission\n* GFR \\\u003C 30 mL\u002Fmin\u002F1.73m2 or on dialysis (no available data for luspatercept on HD)\n* Acute kidney injury ( ≤ 3 months)\n* Uncontrolled hypertension: repeated elevations of SBP ≥ 150 mmHg and\u002For DBP ≥ 100 mmHg despite adequate treatment\n* Known hemoglobinopathy.\n* Known inherited or acquired thrombophilia.\n* History of venous thromboembolism within past 2 years\n* Cerebral vascular accident within past 2 years\n* Recent (within 2 years) myocardial infarction\n* Allergy to luspatercept components",{"count":104,"type":22},[83],"The researchers are doing this study to test whether luspatercept works to improve hemoglobin levels in people with anemia caused by chronic kidney disease (CKD). The researchers will also test whether luspatercept is a safe treatment that causes few or mild side effects in participants.",[26,300],"Chronic Kidney Disease",[151,302],"26-194","2026-07-21",{"date":305,"type":31},"2026-07-24",{"date":307,"type":31},"2026-07-20",{"date":309,"type":22},"2029-07",{"name":311,"class":70},"Memorial Sloan Kettering Cancer Center",7,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":50,"phases":322,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100625426","phase-3-a-study-to-compare-elritercept-with-epoetin-alfa-to-treat-anemia-in-adults-with-very-low-low-or-intermediate-risk-myelodysplastic-syndromes-mds-who-need-regular-blood-transfusions-100625426","NCT07422480","A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept Versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions","ELRiSE MDS","Inclusion Criteria\n\n1. Male or female participants aged ≥ 18 years or older at time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF prior to any trial-related procedures being conducted and authorization to use protected health information and personal data in accordance to national and local privacy regulations.\n3. Documented diagnosis of myelodysplastic syndrome(s) (MDS) according to WHO 2016 classification that meets International Prognostic Scoring System - Revised (IPSS-R) classification of very low-, low-, or intermediate-risk disease, confirmed by central laboratory independent reviewer prior to randomization. Hemoglobin (Hgb), platelet, and absolute neutrophil count (ANC) values should be collected greater than (\\>) 14 days after red blood cell (RBC) transfusion or greater than (\\>) 7 days after platelet transfusion, unless otherwise considered to be pretransfusion values.\n4. Bone marrow less than (\\\u003C) 5% blasts in an evaluable bone marrow collected at screening and confirmed by central pathology independent reviewer.\n5. Endogenous serum erythropoietin s (EPO) level of \\\u003C500 U\u002FL. Should be results from blood samples collected \\>14 days following an RBC transfusion to evaluate for eligibility unless considered pretransfusion values.\n6. Participant requires RBC transfusion, as documented by the following criteria. A transfusion requirement of 2 to 6 pRBCs units\u002F8 weeks confirmed for a minimum of 8 weeks immediately preceding randomization.\n\n   • Hgb levels at the time of or within 3 days prior to administration of a RBC transfusion must have been less than or equal to (≤) 9.0 grams per deciliter (g\u002FdL) (5.6 millimoles per liter (mmol\u002FL)) with symptoms of anemia (or ≤7 g\u002FdL \\[4.3 mmol\u002FL\\] in the absence of symptoms) in order for the transfusion to be counted towards meeting eligibility criteria.\n\n   • RBC transfusions administered when hemoglobin (Hgb) levels were \\>9.0 g\u002FdL (or \\>7 g\u002FdL in the absence of symptoms) and\u002For RBC transfusions administered for elective surgery, infections or bleeding events will not qualify as a required transfusion for the purpose of meeting eligibility criteria or stratification.\n7. Hgb \\\u003C11.0 g\u002FdL (6.8 mmol\u002FL) after last RBC transfusion preceding randomization. Local laboratory is acceptable to facilitate randomization.\n8. Eastern Cooperative Oncology Group score of 0, 1, or 2. Exclusion Criteria\n\n\u003C!-- -->\n\n1. Prior therapy with any of the following:\n\n   1. Epoetin alfa\n\n      • At the investigator's discretion in consultation with the medical monitor, may be allowed if received no more than 2 doses of only epoetin alfa ≥8 weeks prior to randomization. No other erythropoiesis-stimulating agent (ESA) agent is allowed.\n   2. Darbepoetin\n   3. Granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor administered ≤8 weeks (56 days) prior to randomization unless given for treatment of febrile neutropenia.\n   4. Immunomodulatory drug (IMiDs) including lenalidomide\n\n      • At the investigator's discretion in consultation with the medical monitor may be allowed if received ≤1 week of an IMiD ≥8 weeks prior to randomization.\n   5. Hypomethylating agent\n\n      • At the investigator's discretion, in consultation with the medical monitor may be allowed if received no more than 2 doses ≥8 weeks prior to randomization.\n   6. Luspatercept, sotatercept, imetelstat, or elritercept\n   7. Immunosuppressive therapy\n   8. Hematopoeitic cell transplant\n   9. Iron chelation if administered ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed Vitamin B12 or folate therapy initiated within 4 weeks prior to randomization. Participants on stable replacement doses for ≥4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n   10. Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed\n   11. High-dose corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥ 4 weeks are allowed. Other disease modifying treatments for autoimmune diseases may be allowed upon medical monitor review.\n   12. Investigational agent or any other agent intended for treatment MDS treatment\n2. Diagnosed to have MDS associated with del(5q) cytogenetic abnormality or MDS unclassifiable according to WHO 2016 classification or secondary MDS.\n3. Known history of diagnosis of acute myeloid leukemia (AML).\n4. Anemia due to any other known cause including but not limited to thalassemia; hypothyroidism; due to iron, vitamin B12, vitamin B6, zinc, or folate deficiencies; autoimmune or hereditary hemolytic anemia; any type of known clinically significant bleeding or sequestration or drug induced anemia, hemolytic anemia, or bleeding events.\n5. Clinically significant cardiovascular disease defined as:\n\n   1. New York Heart Association heart disease class III or IV\n   2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during screening\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening\n6. Known ejection fraction \\\u003C35%, confirmed by a local echocardiogram performed during screening, or a previously performed echocardiogram if collected within 6 months before screening.\n7. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (DVT; including proximal and distal), pulmonary or arterial embolism, arterial thrombosis or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Prior history of malignancies, other than MDS. Participants who are free of other malignant disease for ≥3 years and have completed treatment, including maintenance are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n   1. Basal or squamous cell carcinoma of the skin;\n   2. Carcinoma in situ of the cervix;\n   3. Carcinoma in situ of the breast;\n   4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n10. History of solid organ or bone marrow transplantation.\n11. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 14 days before randomization.\n12. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B virus (HBV), or active infectious hepatitis C virus (HCV). Participants without known positive history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n13. Body mass index ≥ 40 kilograms per square meter (kg\u002Fm\\^2).\n14. Major surgery within 28 days before randomization.\n15. New-onset seizures or poorly controlled seizures within 12 weeks prior to randomization are excluded from trial participation.\n16. History of allergy\u002Fanaphylaxis to investigational product (including epoetin alfa) excipients (refer to the current elritercept investigator's brochure for a list of excipients) or recombination proteins.\n17. History of pure red cell aplasia and\u002For antibody against erythropoietin (EPO).\n18. Any of the following laboratory abnormalities:\n\n    1. ANC \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002FL).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or ≥450,000\u002FμL (450×109\u002FL).\n    3. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3× upper limit of the normal (ULN).\n    4. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin \\\u003C3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    5. Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m\\^2 as determined by the Chronic Kidney Disease Epidemiology (CKD-EPI) collaboration equation.\n    6. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    7. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    8. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n19. Ongoing participation in another interventional clinical trial.\n20. Participant is unwilling or in the opinion of the investigator the participant is unable to comply with the requirements of the protocol.\n21. Is a participant of childbearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of trial intervention.\n22. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n23. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire trial intervention period until at least 60 days after the last dose of trial intervention.\n24. For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":206,"type":22},[180],"The main aim of this study is to assess how elritercept works in lowering the need for RBC (red blood cell) transfusions and how safe elritercept is when compared with epoetin alfa. Other aims are to learn if elritercept improves tiredness as reported by participants without needing RBC transfusion compared with epoetin alfa, the RBC transfusion burden and quality of life compared with epoetin alfa. The study also aims to find out the extent of the immune response to elritercept. The study will also check on the medical problems (safety) of elritercept.",[325,26],"Myelodysplastic Syndrome",[184,185],{"date":328,"type":31},"2026-07-22",{"date":330,"type":31},"2026-05-21",{"date":332,"type":22},"2033-10-01",{"name":194,"class":103},156,{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":341,"maxAge":19,"enrollmentInfo":342,"targetDuration":4,"studyType":50,"phases":344,"briefSummary":345,"conditions":346,"keywords":347,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":359,"locationsCount":4},"100647950","phase-2-efficacy-and-safety-of-spironolactone-in-pediatric-hemodialysis-patients-with-anemia-100647950","NCT07715318","Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.","Inclusion Criteria:\n\n1. Male or female patients with ages 6-18 years old undergoing regular hemodialysis (3 sessions per week for at least 6 months)\n2. Pediatric patients weighing between 25 kg and 50 kg.\n3. Patients with potassium level less than 5.5 mmol\u002FL and produce urine.\n4. Anemic patients \"have Hb values between 9.5 and 12.5 g\u002Fdl, transferrin saturation (TSAT) less than 20%)\n5. patients have been receiving stable rHuEpo therapy administered intravenously (IV) or subcutaneously (SC) for at least 8 weeks prior to randomization\n6. Patients suffering from iron- restricted erythropoiesis -\n\nExclusion Criteria:\n\n1. Patients with acute renal insufficiency.\n2. Patients with hyperkalemia (≥5.5 mmol\u002FL) and hyponatremia (blood level less than135 mEq\u002FL)\n3. Patients with liver disease (AST \\& ALT greater than 3times upper limit normal)\n4. Patients with hypersensitivity to spironolactone.\n5. Patients scheduled for a living donor kidney transplant within 6 weeks following consent.\n6. Current or recently enrolled in another investigational drug study (within 30 days).\n7. Uncontrolled pre-dialysis supine diastolic blood pressure greater than the 95th percentile for height, gender, and age on more than two occasions in the 2 weeks prior to screening.\n\n   \\-","6 Years",{"count":343,"type":22},40,[83],"The goal of this clinical trial is to learn if Spironolactone drug works to treat anemia in hemodialysis pediatric patients. It will also learn about the safety of Spironolactone drug. The main questions it aims to answer are:\n\nIn pediatric patients with anemia undergoing maintenance hemodialysis, does treatment with spironolactone, compared with standard care alone, reduce erythropoietin dose requirements while maintaining an acceptable safety profile? Researchers will compare Spironolactone drug to a standard therapy ((IV iron according to serum iron deficiency and patient's weight, epoetin after each session of dialysis according to the patient's weight) to see if Spironolactone drug works to treat anemia.\n\nParticipants will:\n\n* Take Spironolactone drug daily for 12 weeks in addition to standard care.\n* Continue their scheduled maintenance hemodialysis sessions.\n* Undergo regular monitoring during dialysis visits, including clinical assessment and laboratory tests (e.g., hemoglobin, potassium, renal profile)\n* Record any symptoms or side effects during the study period.",[26],[348,349,350,351,214,352,353],"Spironolactone","pediatric hemodialysis","chronic kidney disease","end stage renal disease","erythropoietin","hemodialysis patients","2026-07-15",{"date":307,"type":31},{"date":357,"type":22},"2026-12-01",{"date":35,"type":22},{"name":360,"class":70},"Ain Shams University",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":371,"conditions":372,"keywords":373,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":136},"100645702","validation-of-non-invasive-hemoglobin-measurement-using-optical-method-for-anemia-screening-among-adults-in-jakarta-100645702","NCT07701499","Validation of Non-Invasive Hemoglobin Measurement Using Optical Method for Anemia Screening Among Adults in Jakarta","Validation of Non-Invasive Hemoglobin Measurement (Using Optical Method) Compared With Point-of-Care Testing and Hematology Analyzer Among Adult in Jakarta","SPECTRO-Hb","Inclusion Criteria:\n\n* Adults aged 18 years and older.\n* Residents or community members participating in community health screening activities in Kelurahan Kota Bambu, Jakarta.\n* Willing to undergo non-invasive hemoglobin measurement.\n* Willing to undergo capillary blood hemoglobin testing using point-of-care testing (POCT).\n* Willing to undergo venous blood collection for hematology analyzer examination.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Active bleeding at the time of examination.\n* Severe acute illness requiring urgent medical attention.\n* Refusal to undergo finger-prick or venous blood sampling.\n* History of severe anxiety, syncope, or adverse reactions related to blood collection procedures.\n* Visible infection, wound, or skin lesion at the measurement site.\n* Severe hand deformity preventing proper non-invasive measurement.\n* Nail polish or artificial nails that cannot be removed before examination.\n* Markedly cold hands or poor peripheral perfusion that may interfere with optical measurements.\n* Incomplete hemoglobin measurement data from any of the study methods.",{"count":370,"type":22},200,"Anemia remains a major public health concern and is commonly diagnosed through hemoglobin measurement using capillary or venous blood samples. Although laboratory-based and point-of-care testing methods are widely used, they require blood collection, trained personnel, and may cause discomfort to participants. Non-invasive spectrophotometric technology has emerged as a potential alternative for rapid hemoglobin assessment without blood sampling.\n\nThis study aims to evaluate the validity and diagnostic performance of a non-invasive hemoglobin using optical method compared with capillary point-of-care testing (POCT) and venous blood hemoglobin measured using an automated hematology analyzer as the reference standard. A total of 150 adults from Kelurahan Kota Bambu, Jakarta, will undergo non-invasive hemoglobin measurement, capillary blood testing, and venous blood testing during a single study visit.\n\nThe study will assess agreement between methods, diagnostic accuracy for anemia detection, and factors that may influence measurement performance. Findings from this study are expected to support the development of convenient, community-based anemia screening strategies and provide evidence for future implementation of non-invasive hemoglobin assessment technologies.",[26],[26,374,375,376,377,378,379,380,381,382,383],"Hemoglobin","Point-of-Care Testing","Hematology Analyzer","Diagnostic Validation'","Diagnostic Accuracy","Anemia Screening","Community Screening","Optical Hemoglobin Measurement","Non-Invasive Hemoglobin Measurement","optical method","2026-07-13",{"date":354,"type":31},{"date":387,"type":22},"2026-07-11",{"date":389,"type":22},"2028-07-30",{"name":391,"class":70},"Tarumanagara University",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":400,"maxAge":4,"enrollmentInfo":401,"targetDuration":4,"studyType":50,"phases":402,"briefSummary":403,"conditions":404,"keywords":412,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":136},"100645772","delayed-versus-immediate-cord-clamping-in-preterm-birth-100645772","NCT07699666","Delayed Versus Immediate Cord Clamping in Preterm Birth","Early Neonatal Outcomes After Delayed Versus Immediate Cord Clamping in Preterm Birth: A Comparative Study From A Tunisian Tertiary Maternity Center","PREM-CORD","Inclusion Criteria:\n\n* Preterm neonates born at gestational age between 32 and 37 weeks\n* Live-born infants delivered in the study center\n* Singleton pregnancies\n* Parental consent obtained when applicable according to institutional ethical requirements\n\nExclusion Criteria:\n\n* Major congenital malformations or chromosomal abnormalities\n* Need for immediate advanced resuscitation at birth\n* Severe fetal distress requiring emergency obstetric intervention incompatible with protocol allocation\n* Placental conditions contraindicating delayed cord clamping (e.g., placental abruption with maternal instability, placenta previa bleeding, Placenta accreta spectrum)\n* Intra Uterin Growth Restriction with abnormal umbilical artery Doppler velocimetry","0 Days",{"count":370,"type":22},[52],"The goal of this study is to evaluate whether delayed cord clamping improves early neonatal outcomes compared with immediate clamping in preterm birth.\n\nPreterm infants are at higher risk of neonatal complications, and the timing of cord clamping may influence placental transfusion and neonatal adaptation after birth. Delayed cord clamping may increase blood volume, improve iron stores, and reduce some neonatal morbidities, while immediate cord clamping is still commonly practiced in many settings.\n\nIn this study, preterm newborns are assigned to either delayed or immediate cord clamping according to a predefined protocol. Early neonatal outcomes, including respiratory status, need for resuscitation, hemoglobin levels, and early morbidity and mortality, will be assessed.\n\nThe study is conducted in a tertiary maternity center in Tunisia.",[405,406,407,408,26,409,410,411],"Preterm Birth Complication","Neonatal Morbidity and Mortality","Cord Clamping","Delayed Cord Clamping","NEC - Necrotizing Enterocolitis","Intraventricular Hemorrhage Neonatal","Respiratory Distress Neonatal",[413,414,415,416,417,418,419,420,421,422],"Delayed cord clamping","Immediate cord clamping","Preterm infants","Preterm birth","Umbilical cord clamping","Neonatal outcomes","Placental transfusion","Neonatal morbidity","Neonatal mortality","Tunisia","2026-07-08",{"date":384,"type":31},{"date":426,"type":31},"2025-10-02",{"date":428,"type":22},"2026-12-31",{"name":430,"class":70},"Faculty of Medicine of Tunis",{"id":432,"slug":433,"hasResults":12,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":50,"phases":441,"briefSummary":442,"conditions":443,"keywords":447,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":136},"100492965","phase-1-individualized-or-conventional-transfusion-strategies-during-peripheral-va-ecmo-100492965","NCT05699005","Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO","Comparison of an Individualized Transfusion Strategy to a Conventional Strategy in Patients Undergoing Peripheral Veno-arterial ECMO for Refractory Cardiogenic Shock: a Randomized Controlled Trial - ICONE","ICONE","Inclusion Criteria:\n\n* Age of 18 and older,\n* supported by peripheral VA-ECMO\n* for cardiogenic shock\n* Life expentency \\>90 days\n* Central venous line available ScVO2 measurement\n\nExclusion Criteria:\n\n* Pregnancy,\n* Lack of health insurance,\n* Opposition to blood transfusion,\n* Known congenital hemoglobin disease or disorder,\n* Metabolic alcaloosis with pH\\>7.8,\n* eCPR,\n* Legally incapacitated adults",{"count":440,"type":22},236,[82],"This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock.\n\nAn individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness",[444,57,445,26,446],"Cardiogenic Shock","Transfusion Related Complication","Oxygen Delivery",[58,448,449,55,450,451],"ECLS","Refractory cardiogenic shock","ScVO2","Outcome","2026-06-30",{"date":454,"type":31},"2026-07-02",{"date":456,"type":31},"2023-09-18",{"date":458,"type":22},"2028-12-18",{"name":460,"class":70},"University Hospital, Lille",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":50,"phases":471,"briefSummary":472,"conditions":473,"keywords":477,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":136},"100644603","personalized-blood-transfusion-protocol-for-cardiac-patients-100644603","NCT07671469","Personalized Blood Transfusion Protocol for Cardiac Patients","Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients","PerP","Inclusion Criteria:\n\n* Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures\n* Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)\n* Allogeneic red blood cell transfusion is considered likely\n* Able to provide informed consent and understand randomization to different transfusion thresholds\n* Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first\n\nExclusion Criteria:\n\n* Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program\n* Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)\n* Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion\n* Off-pump bypass or other procedures not using cardiopulmonary bypass\n* Severe preoperative anemia (e.g., hemoglobin \\\u003C 8 g\u002FdL) or chronic transfusion-dependent anemia\n* Conditions preventing protocol adherence (e.g., anticipated massive hemorrhage, known bleeding disorder, very low platelets, uninterruptible dual antiplatelet\u002Fanticoagulant therapy)\n* Chronic dialysis dependence or established end-stage renal disease (eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² or on maintenance renal replacement therapy) prior to surgery.\n* Pregnancy or lactation\n* Enrollment in another interventional trial affecting transfusion practice or hemoglobin thresholds\n* Unable to provide informed consent (e.g., severe cognitive impairment without a legally authorized representative)",{"count":470,"type":22},900,[52],"This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.",[474,475,26,476],"Cardiac Surgery","Blood Transfusion","Cardiopulmonary Bypass",[478,479,480,481,482],"restrictive transfusion","hemoglobin trhreshold","oxygen delivery","cardiac surgery","ICU","2026-06-26",{"date":452,"type":31},{"date":486,"type":22},"2026-09-14",{"date":488,"type":22},"2030-03-15",{"name":490,"class":70},"Yan Mia Min",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":229,"sex":18,"minAge":499,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":50,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":136},"100519373","kids-with-iron-deficiency-and-scoliosis-100519373","NCT06042699","Kids With Iron Deficiency and Scoliosis","Kids With Iron Deficiency and Scoliosis (KIDS) Study","KIDS","Inclusion Criteria:\n\n1. 10-26 years old;\n2. diagnosis of scoliosis or kyphosis;\n3. self-reported ability to swallow a tablet;\n4. spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work;\n5. serum ferritin less than or equal to 25 µg\u002FL.\n\nExclusion Criteria:\n\n1. taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;\n2. taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;\n3. Hg \\\u003C10mg\u002FdL if post-menarchal, Hg \\\u003C 11 if premenarchal or male\n4. C-reactive protein \\> 10 mg\u002FL\n5. receiving nutritional support by report in the medical chart;\n6. self-reported history of hypersensitivity reaction to iron-containing supplements;\n7. self-reported history of or suspected non-iron deficient hematologic disorder;\n8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;\n9. objection to receiving red blood cell transfusions;\n10. current pregnancy (by self-report);\n11. prisoners;\n12. patient or parent decides against study participation.","10 Years","26 Years",{"count":502,"type":22},275,[52],"This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery.\n\nResearch Question(s)\u002FHypothesis(es):\n\nPrimary\n\n* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.\n\nSecondary\n\n* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion.\n* Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.",[506,507,508,509,26,510,511],"Adolescent Idiopathic Scoliosis","Neuromuscular Scoliosis","Perioperative\u002FPostoperative Complications","Iron Deficiencies","Spinal Fusion","Postoperative Cognitive Dysfunction","2026-06-25",{"date":483,"type":31},{"date":515,"type":31},"2024-01-11",{"date":517,"type":22},"2028-02-01",{"name":519,"class":70},"Columbia University",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":527,"minAge":230,"maxAge":231,"enrollmentInfo":528,"targetDuration":4,"studyType":50,"phases":530,"briefSummary":531,"conditions":532,"keywords":533,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":136},"100642268","phase-3-how-precision-diets-through-gut-bacteria-affect-anemia-in-nepalese-adolescent-100642268","NCT07661602","How Precision Diets, Through Gut Bacteria, Affect Anemia in Nepalese Adolescent","Gut Microbiota-Mediated Effects of Precision Dietary Interventions on Anemia Among Nepalese Adolescents","Inclusion Criteria:\n\n* Female adolescents aged 15-19 years\n* Enrolled in selected schools\n* Resident in Kathmandu for at least 6 months\n* Provision of written informed assent and parental consent\n\nExclusion Criteria:\n\n* Current pregnancy\n* Known genetic blood disorders (thalassemia, sickle cell disease)\n* Chronic metabolic, inflammatory, or infectious diseases affecting hematological parameters\n* Acute illness at time of screening\n* Use of iron, folic acid, vitamin B12 supplements, antibiotics, or probiotics within the past 3 months\n* History of helminth infection or deworming treatment within the past 6 months\n* Participation in other nutrition intervention studies","FEMALE",{"count":529,"type":22},60,[180],"This study aims to evaluate whether a food-based nutrition intervention using goat liver can improve anemia among adolescent girls in Kathmandu, Nepal, and compare its effectiveness with the current standard iron and folic acid supplementation. It will also investigate how diet and the gut microbiota (the community of beneficial microorganisms living in the intestine) may influence iron absorption and response to treatment.\n\nAnemia is a major public health problem among adolescent girls in Nepal. During adolescence, rapid growth and the onset of menstruation increase the body's need for iron and other nutrients involved in blood formation. If left untreated, anemia can impair physical growth, reduce learning ability and concentration, decrease work capacity, weaken immunity, and negatively affect future reproductive health. Although weekly iron-folic acid supplementation programs are widely implemented, anemia remains common, suggesting that additional strategies may be needed.\n\nRecent research indicates that gut microbiota may affect iron metabolism by influencing nutrient absorption, inflammation, and overall intestinal health. Dietary habits can alter the composition of gut bacteria, which may partly explain why individuals respond differently to iron interventions. However, little is known about these relationships among Nepalese adolescents. This study seeks to fill that knowledge gap and explore whether a locally available food-based intervention can provide a practical and sustainable alternative or complement to conventional supplementation.\n\nThe research will be conducted among adolescent girls aged 15 to 19 years enrolled in selected schools in Kathmandu. The study has two phases. In the first phase, you will undergo screening to determine the prevalence and types of anemia. Blood samples will be collected to measure hemoglobin, iron status, vitamin B12, folate, and inflammation-related biomarkers. Stool samples will be collected to analyze gut microbiota composition. Information on dietary intake, food frequency, dietary diversity, and other relevant characteristics will also be obtained through structured questionnaires.\n\nGirls identified with anemia and meeting the eligibility criteria will be invited to participate in the randomized intervention phase. You will be randomly assigned to receive either the standard iron-folic acid supplementation recommended by national programs or a goat liver-based dietary intervention for 12 weeks. Random assignment ensures a fair comparison between interventions and minimizes bias.\n\nGoat liver was selected because it is rich in highly bioavailable heme iron as well as vitamin B12, folate, vitamin A, and other nutrients important for blood production. As a commonly available food in Nepal, it may represent a culturally acceptable and sustainable nutrition-based strategy for improving anemia.\n\nDuring the intervention, you will be monitored regularly to assess adherence and wellbeing. At the end of the 12-week period, blood and stool samples will be collected again to evaluate changes in hemoglobin levels, iron-related biomarkers, nutritional status, and gut microbiota composition. The study will compare improvements between intervention groups and examine whether changes in gut microbiota are associated with better anemia outcomes.\n\nParticipation is entirely voluntary. Written informed consent from parents or guardians and informed assent from adolescent participants will be obtained before enrollment. You may withdraw from the study at any time without penalty. All personal information and laboratory results will remain confidential and will be stored using coded identifiers to protect privacy.\n\nBlood collection will be performed by trained healthcare professionals using standard safety procedures, and stool samples will be collected using appropriate collection kits and instructions. Participants found to have severe anemia or other important medical conditions during the study will be referred for appropriate medical care according to national guidelines.\n\nThe findings from this study are expected to provide important evidence on whether a locally available food-based intervention can effectively improve anemia among adolescent girls while also enhancing understanding of the relationship between diet, gut microbiota, and iron metabolism. The results may help inform future nutrition policies, school health programs, and precision nutrition strategies for anemia prevention and treatment in Nepal and other similar settings.",[26],[534,535,536,537,538,539,540,541],"Anaemia","iron deficiency anemia","adolescent girls","goat liver supplementation","food-based intervention","precision nutrition","gut microbiome","dietary intervention","2026-06-22",{"date":512,"type":31},{"date":545,"type":22},"2026-07",{"date":547,"type":22},"2026-11",{"name":549,"class":70},"Southern Medical University, China",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":18,"minAge":557,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":50,"phases":560,"briefSummary":562,"conditions":563,"keywords":567,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":585},"100642134","phase-4-ironcare-iron-treatment-in-older-patients-with-hip-fractures-100642134","NCT07659184","IRONCARE: Iron Treatment in Older Patients With Hip Fractures","IRONCARE: Iron Treatment in Older Patients With Hip Fractures - A Double-blinded Placebo-controlled Randomized Trial","Inclusion Criteria:\n\n* Hip fracture (ICD-10 codes: DS720, DS721 and DS722)\n* Low energy trauma\n* Age ≥ 75 years\n* Hemoglobin ≤7.0 mmol\u002FL (11 g\u002FdL) during hospital admission\n\nExclusion Criteria:\n\n* Pathological fracture\n* Periprosthetic fracture\n* Inability to understand or speak Danish\n* Dysphagia and thus inability to swallow study medication\n* Signs of iron overload, hemochromatosis, or hemosiderosis\n* Liver disease (cirrhosis or hepatitis) and transaminase levels \\>3 times upper limit of normal\n* Known allergy to iron formulations\n* Severe asthma\n* Severe hypophosphatemia: \\\u003C0.35 mmol\u002FL\n* Patients already receiving iron supplementation that cannot be paused for the study period\n* Cognitive impairment that results in either memantine-treatment or a Short Portable Mental Status Questionnaire (SPMSQ) score \\> 4","75 Years",{"count":559,"type":22},528,[561],"PHASE4","The aim of this study is to investigate the effects of intravenous (IV) iron therapy compared to alternate-day oral iron treatment and no supplementation in older patients with hip fractures. This study will examine the impact of iron treatment on fatigue, functional decline, fear of falling, cognitive impairment, and quality of life, as well as its effects on iron stores and hemoglobin levels, with the overall goal of improving postoperative rehabilitation.\n\nThe trial will be conducted on five different hospitals in the Central Region of Denmark (Region Midtjylland).",[564,26,565,566],"Hip Fracture","Iron","Placebo - Control",[568,26,569,570,571,572,573,574,575],"Hip fracture","iron","Intravenous iron","mobility","fatigue","hemoglobin","RCT","Placebo","2026-06-19",{"date":578,"type":31},"2026-06-24",{"date":580,"type":22},"2026-10-01",{"date":582,"type":22},"2028-09-30",{"name":584,"class":70},"University of Aarhus",5,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":229,"sex":18,"minAge":19,"maxAge":593,"enrollmentInfo":594,"targetDuration":4,"studyType":50,"phases":596,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":136},"100642082","early-phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-ctx001-in-healthy-adults-100642082","NCT07577817","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.","A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Agrees to use effective contraception\n* Body Mass Index (BMI) between 18.0 and 32.0 kg\u002Fm2\n* Healthy by medical evaluation and medical history\n* Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20%\n* Can swallow tablets and has suitable venous access for blood sampling\n\nExclusion Criteria:\n\n* Has dietary requirements that may be difficult to accommodate\n* Is a regular user of cannabis or has a history of illicit drug abuse within 1 year\n* Has a history of alcohol abuse or binge drinking within 6 months\n* Is a regular user of tobacco or nicotine-containing products\n* Unwilling or unable to comply with the lifestyle guidelines described in the protocol\n* Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator\n* Has any concurrent disease or condition or physical, psychological, mental, and\u002For social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study\n* Has received a blood transfusion within 1 year\n* Has donated whole blood within 6 months or plasma within 30 days\n* Requires prescription medication or regular use of non-prescription medication\n* Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study","55 Years",{"count":595,"type":22},72,[597],"EARLY_PHASE1","This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and\u002For food.",[26,509,300],[601,565,26,602],"Red blood cells","Chronic kidney disease","2026-06-10",{"date":605,"type":31},"2026-06-12",{"date":607,"type":22},"2026-06",{"date":609,"type":22},"2026-12-30",{"name":611,"class":103},"Cajal Therapeutics Inc.",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":620,"maxAge":621,"enrollmentInfo":622,"targetDuration":4,"studyType":50,"phases":623,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":631,"lastUpdatePostDateStruct":632,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":4},"100643567","personalizing-preterm-neonatal-transfusions-with-fetal-hemoglobin-enriched-cord-blood-100643567","NCT07636473","Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","Advancing Neonatal Health: Personalizing Preterm Neonatal Transfusions With Fetal Hemoglobin-Enriched Cord Blood","ANH-Prestige","Inclusion Criteria:\n\n* Preterm neonates born between 24+0 and 31+6 weeks of gestational age;\n* Requirement for at least one red blood cell transfusion during hospitalization, according to current Italian transfusion thresholds;\n* Written informed consent obtained from parents or legal guardians prior to any study procedure.\n\nExclusion Criteria:\n\n* Gestational age \\> 32+0 weeks;\n* Pregnancy complicated by maternal-fetal alloimmunization (e.g., hemolytic disease of the newborn);\n* Pregnancy complicated by fetal hydrops;\n* Major congenital anomalies or genetic syndromes;\n* Previous red blood cell transfusions (prior to enrollment);\n* Perinatal hemorrhage at delivery;\n* Documented congenital infections (TORCH).","24 Weeks","31 Weeks",{"count":370,"type":22},[52],"Long-term morbidities among very low birth weight infants remain a significant challenge. Oxidative stress is a key factor in the pathogenesis of 'free radical (FR) diseases of prematurity,' including retinopathy of prematurity, bronchopulmonary dysplasia, necrotizing enterocolitis, and intraventricular hemorrhage. Red blood cell (RBC) transfusions are recognized as a contributing factor to FR-related diseases. RBCs contain adult hemoglobin (HbA), which has a lower affinity for oxygen. This characteristic increases oxygen delivery and tissue uptake, leading to a potentially harmful state of hyperoxia and over-generation of FRs. The strategy employs a multidisciplinary approach to evaluate the impact of cord blood transfusions in anemic newborns. Results will be assessed in relation to short- and long-term neonatal outcomes to determine the effectiveness of this new preventive strategy. Improving the current data are critical for setting action priorities for and monitoring progress",[626,26],"Prematurity Complications",[628,629,630],"Cord Blood red blood cells","transfusion","preterm newborns","2026-06-09",{"date":633,"type":31},"2026-06-11",{"date":635,"type":22},"2026-11-01",{"date":637,"type":22},"2029-11-01",{"name":639,"class":70},"University of Parma",{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":649,"conditions":650,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":136},"100591168","research-platform-myelofibrosis-and-anemia-100591168","NCT06976918","Research Platform Myelofibrosis and Anemia","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Primary and Secondary Myelofibrosis and Anemia Who Are JAK Inhibitor Treatment-naïve or JAK Inhibitor Treatment-experienced (RHODOLITE)","RHODOLITE","Inclusion Criteria:\n\n* Confirmed diagnosis of primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) (Note: diagnosis according to WHO-2017, ICC-2022 or WHO-2022 or IWG-MRT criteria, respectively).\n* Diagnosis of anemia at the time of enrollment as per individual, clinical assessment by the local physician.\n* Start of first or subsequent systemic treatment for MF.\n* Informed consent and registration for the GSG-MPN Bioregistry.\n* Willingness and capability to participate in PRO assessment.\n* Signed and dated informed consent form for RHODOLITE at the latest six weeks after start of the respective systemic MF treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for diagnosed primary or secondary MF.\n* Planned allogenic stem cell transplantation (allo-SCT) or active participation in an interventional clinical trial.",{"count":370,"type":22},"The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor research platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease and to collect patient-reported outcomes for patients with primary and secondary myelofibrosis and anemia in Germany.",[89,651,652,90,26,86,87],"Secondary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","2026-06-03",{"date":655,"type":31},"2026-06-05",{"date":657,"type":31},"2026-02-19",{"date":659,"type":22},"2031-09",{"name":661,"class":103},"iOMEDICO AG",{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":670,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":50,"phases":673,"briefSummary":674,"conditions":675,"keywords":676,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":690},"100585165","phase-4-the-effects-of-intravenous-iron-on-mobility-in-elderly-patients-following-hip-fracture-surgery-100585165","NCT06898814","The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery","The Effects of Intravenous Iron on Mobility in Elderly Patients Following Hip Fracture Surgery: a Multicentre, Parallel Group, Randomised Controlled Trial","IronHip","Inclusion Criteria:\n\n1. 65 years of age or older\n2. Acute proximal femur fracture surgery\n3. A hemoglobin measurement ≤6.5 mmol\u002FL (10.5 g\u002FdL) on day 1 to 5 postoperatively\n4. Independent prefracture indoor walking ability, indoor NMS ≥ 2\n5. Ability to speak and understand Danish\n6. Able to provide informed consent on the participants own behalf\n\nExclusion Criteria:\n\n1. Known allergy to intravenous iron\n2. Residing permanently at a nursing home\n3. Hematological conditions with a risk of iron overload e.g. haemochromatosis, hemosiderosis, or where alternative treatments are necessary e.g. haematological malignancies\n4. Other contraindication to iron treatment, e.g. severe liver cirrhosis and hepatitis\n5. Severe uncontrolled infection as assessed by the responsible clinician (e.g. bacteraemia or sepsis)\n6. Plasma sodium levels below 125 or above 150 mmol\u002FL on the day of inclusion\n7. Renal replacement therapy\n8. Severe dementia assessed by physician\n9. Recent intravenous iron injection, 4 weeks prior to surgery\n10. Patient declared terminally ill\n11. Pathologic Fracture","65 Years",{"count":672,"type":22},210,[561],"The primary aim of this clinical trial is to investigate the effects of intravenous iron on recovery in mobility compared to the pre-fracture level in patients with a hip fracture\n\nThe main questions it aims to answer are:\n\nIt is hypothesize that intravenous iron will enhance gains in mobility and hereby recovery of mobility, increase hemoglobin (Hgb), lower fatigue, have a positive effect on skeletal muscles in the weeks and months after administration.\n\nThe primary objective is to compare the effect of a single dose of ferric derisomaltose (FDI) (20 mg\u002Fkg body weight) relative to placebo on patients' recovery of functional mobility, measured as the change from baseline in the New Mobility Score.\n\nParticipants will:\n\n\\- Receive either a single dose of intravenous FDI (20 mg\u002Fkg body weight) (and saline) or placebo (saline) at 1-5 days after surgery.\n\nThis trial will be conducted at three hospitals in Denmark, involving an anticipated 210 participants.",[564,26],[568,26,677,678,679,680],"IV Iron","Mobility","Perioperative optimisation","Randomized Controlled Trial","2026-05-29",{"date":683,"type":31},"2026-06-01",{"date":685,"type":31},"2025-06-09",{"date":687,"type":22},"2027-09-14",{"name":689,"class":70},"Soren Overgaard",3,{"id":692,"slug":693,"hasResults":12,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":697,"eligibilityCriteria":698,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":699,"targetDuration":4,"studyType":50,"phases":701,"briefSummary":702,"conditions":703,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":706,"startDateStruct":708,"completionDateStruct":710,"leadSponsor":712,"locationsCount":136},"100517070","the-effect-of-combined-iron-protocols-on-perioperative-allogeneic-transfusion-100517070","NCT06012760","The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion","Effect of Iron Sucrose Combined With Human Erythropoietin and Vitamin C on Perioperative Allogeneic Red Blood Cell Infusion in Major Cardiac Surgery","CIPAT","Inclusion Criteria:\n\n1. Participants must be at least 18 years of age.\n2. Major cardiac surgery should encompass procedures such as coronary artery bypass grafting (CABG), valve surgery, or a combination of both.\n3. Iron deficiency anemia is defined as having a ferritin level below 100 μg\u002FL or a ferritin level below 300 μg\u002FL accompanied by a transferrin saturation below 25%. Additionally, hemoglobin levels should range between 90 and 130 g\u002FL for men or between 90 and 120 g\u002FL for women.\n4. The American Society of Anesthesiologists (ASA) classification should fall within Grade 1-3.\n5. Prior to participation, the patient or their legal representative must provide informed consent.\n\nExclusion Criteria:\n\n1. Contraindications for the administration of iron sucrose, ascorbic acid, or rHuEPO.\n2. Presence of a temperature exceeding 37.5 °C or the utilization of non-prophylactic antibiotics.\n3. Individuals with a weight equal to or less than 50kg.\n4. Individuals with a family history of haemochromatosis or thalassaemia, or those with a transferrin saturation level exceeding 50% or a documented history of iron overload.\n5. Presence of other known haematological disorders such as folic acid or vitamin B12 deficiency, haemolytic anaemia, haemoglobinopathies, iron granulocytic anaemia, G6PD deficiency, etc.\n6. Requirement for emergency surgical intervention.\n7. Severe hepatic or renal impairment, ALT \\>3 times the upper limit of normal value or AST \\>3 times the upper limit of normal value, creatinine \\>1.5 times the upper limit of normal value\n8. Pregnant or lactating women\n9. history of blood transfusion, intravenous iron or ascorbic acid use within 12 weeks prior to surgery\n10. Acute blood loss, gastrointestinal bleeding, etc. in the preoperative period.",{"count":700,"type":22},400,[52],"The goal of this clinical trial is to learn if a combined iron supplementation regimen can reduce the need for blood transfusions in adults with iron-deficiency anemia undergoing major elective cardiac surgery. The trial will also look at whether this regimen is safe and well tolerated. The main questions it aims to answer are:\n\nDoes the combined regimen lower the amount of allogeneic red blood cell transfusion needed during and after surgery?\n\nAre there any side effects or safety concerns associated with the regimen?\n\nResearchers will compare the combined iron supplementation (sucrose iron, erythropoietin, and vitamin C) to standard care to see if it helps reduce blood transfusions.\n\nParticipants will:\n\nReceive either the combined regimen or standard care before surgery\n\nUndergo major elective cardiac surgery under general anesthesia\n\nBe monitored for blood transfusion needs and recovery up to 90 days after surgery",[26,704,705,55,474],"Iron Deficiency Anemia","Perioperative",{"date":707,"type":31},"2026-06-02",{"date":709,"type":31},"2025-01-04",{"date":711,"type":22},"2028-03-31",{"name":713,"class":70},"Second Affiliated Hospital, School of Medicine, Zhejiang University"]