[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,86,0,25,[9,43,86,120,131,162,192,225,258,293,320,346,374,401,422,450,473,493,518,542,588,626,648,672,690],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053793","phase-2-study-of-disc-0974-201-in-participants-with-ibd-and-anemia-100053793",false,"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.","ALL","18 Years",{"count":20,"type":21},21,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","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.",[27,28,29],"Inflammatory Bowel Disease (IBD)","Anemia","Inflammatory Bowel Disease (IBD); Anemia","RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-02-20",{"date":38,"type":21},"2027-03",{"name":40,"class":41},"Disc Medicine, Inc","INDUSTRY",13,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100053679","delayed-versus-immediate-cord-clamping-in-preterm-birth-100053679","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":53,"type":21},200,[55],"NA","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.",[58,59,60,61,28,62,63,64],"Preterm Birth Complication","Neonatal Morbidity and Mortality","Cord Clamping","Delayed Cord Clamping","NEC - Necrotizing Enterocolitis","Intraventricular Hemorrhage Neonatal","Respiratory Distress Neonatal",[66,67,68,69,70,71,72,73,74,75],"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":33,"type":34},{"date":79,"type":34},"2025-10-02",{"date":81,"type":21},"2026-12-31",{"name":83,"class":84},"Faculty of Medicine of Tunis","OTHER",1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":98,"conditions":99,"keywords":104,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":85},"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":95,"type":21},236,[97],"PHASE1","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",[100,101,102,28,103],"Cardiogenic Shock","Extracorporeal Membrane Oxygenation","Transfusion Related Complication","Oxygen Delivery",[105,106,107,108,109,110],"ECMO","ECLS","Refractory cardiogenic shock","Transfusion","ScVO2","Outcome","2026-06-30",{"date":113,"type":34},"2026-07-02",{"date":115,"type":34},"2023-09-18",{"date":117,"type":21},"2028-12-18",{"name":119,"class":84},"University Hospital, Lille",{"id":121,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":25,"conditions":124,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":128,"leadSponsor":129,"locationsCount":130},"100621311",{"count":20,"type":21},[24],[27,28,29],"2026-06-29",{"date":111,"type":34},{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},11,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":85},"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":140,"type":21},900,[55],"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.",[144,145,28,146],"Cardiac Surgery","Blood Transfusion","Cardiopulmonary Bypass",[148,149,150,151,152],"restrictive transfusion","hemoglobin trhreshold","oxygen delivery","cardiac surgery","ICU","NOT_YET_RECRUITING","2026-06-26",{"date":111,"type":34},{"date":157,"type":21},"2026-09-14",{"date":159,"type":21},"2030-03-15",{"name":161,"class":84},"Yan Mia Min",{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":170,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":85},"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.",true,"10 Years","26 Years",{"count":174,"type":21},275,[55],"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.",[178,179,180,181,28,182,183],"Adolescent Idiopathic Scoliosis","Neuromuscular Scoliosis","Perioperative\u002FPostoperative Complications","Iron Deficiencies","Spinal Fusion","Postoperative Cognitive Dysfunction","2026-06-25",{"date":154,"type":34},{"date":187,"type":34},"2024-01-11",{"date":189,"type":21},"2028-02-01",{"name":191,"class":84},"Columbia University",{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":199,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100490331","phase-2-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","Key Inclusion Criteria:\n\n* Adult participant≥ 18 years with documented diagnosis of A-Thal HbH disease with Transfusion dependence defined as:.\n\n  1. TD participant: ≥ 6 RBC units during the 24 weeks prior to randomization.\n  2. 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  1. 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  2. 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  3. Participant has Karnofsky (age ≥16 years) or Lansky (age \\\u003C 16 years) performance status score ≥ 50 at screening.\n\nKey Exclusion 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.\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":201,"type":21},189,[24],"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.",[28],[206,207,208,209,210,211,212,213,214],"Luspatercept","BMS-986346","ACE-536","α-thalassemia","Alpha Thalassemia","Reblozyl","Transfusions","Non-transfusion dependent","RBC transfusion dependent","2026-06-23",{"date":217,"type":34},"2026-06-24",{"date":219,"type":34},"2022-12-09",{"date":221,"type":21},"2034-08-14",{"name":223,"class":41},"Bristol-Myers Squibb",36,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":232,"minAge":233,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":237,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":85},"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","15 Years","19 Years",{"count":236,"type":21},60,[238],"PHASE3","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.",[28],[242,243,244,245,246,247,248,249],"Anaemia","iron deficiency anemia","adolescent girls","goat liver supplementation","food-based intervention","precision nutrition","gut microbiome","dietary intervention","2026-06-22",{"date":184,"type":34},{"date":253,"type":21},"2026-07",{"date":255,"type":21},"2026-11",{"name":257,"class":84},"Southern Medical University, China",{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":292},"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":267,"type":21},528,[269],"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).",[272,28,273,274],"Hip Fracture","Iron","Placebo - Control",[276,28,277,278,279,280,281,282,283],"Hip fracture","iron","Intravenous iron","mobility","fatigue","hemoglobin","RCT","Placebo","2026-06-19",{"date":217,"type":34},{"date":287,"type":21},"2026-10-01",{"date":289,"type":21},"2028-09-30",{"name":291,"class":84},"University of Aarhus",5,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":319},"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":302,"type":21},300,[238],"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.",[306,28],"Myelodysplastic Syndrome",[308,309],"TAK-226","Drug therapy","2026-06-12",{"date":312,"type":34},"2026-06-15",{"date":314,"type":34},"2026-05-21",{"date":316,"type":21},"2033-10-01",{"name":318,"class":41},"Takeda",154,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":85},"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":329,"type":21},72,[331],"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.",[28,181,334],"Chronic Kidney Disease",[336,273,28,337],"Red blood cells","Chronic kidney disease","2026-06-10",{"date":310,"type":34},{"date":341,"type":21},"2026-06",{"date":343,"type":21},"2026-12-30",{"name":345,"class":41},"Cajal Therapeutics Inc.",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"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":53,"type":21},[55],"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",[360,28],"Prematurity Complications",[362,363,364],"Cord Blood red blood cells","transfusion","preterm newborns","2026-06-09",{"date":367,"type":34},"2026-06-11",{"date":369,"type":21},"2026-11-01",{"date":371,"type":21},"2029-11-01",{"name":373,"class":84},"University of Parma",{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":383,"phases":4,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":85},"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":53,"type":21},"OBSERVATIONAL","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.",[386,387,388,389,28,390,391],"Primary Myelofibrosis","Secondary Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Myelofibrosis; Anemia","Myelofibrosis","2026-06-03",{"date":394,"type":34},"2026-06-05",{"date":396,"type":34},"2026-02-19",{"date":398,"type":21},"2031-09",{"name":400,"class":41},"iOMEDICO AG",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":414,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":4},"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":410,"type":21},324,[238],"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.",[391,28],[308,309],"2026-05-29",{"date":392,"type":34},{"date":418,"type":21},"2026-08-25",{"date":420,"type":21},"2034-03-30",{"name":318,"class":41},{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":430,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":449},"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":432,"type":21},210,[269],"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.",[272,28],[276,28,437,438,439,440],"IV Iron","Mobility","Perioperative optimisation","Randomized Controlled Trial",{"date":442,"type":34},"2026-06-01",{"date":444,"type":34},"2025-06-09",{"date":446,"type":21},"2027-09-14",{"name":448,"class":84},"Soren Overgaard",3,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":85},"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":459,"type":21},400,[55],"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",[28,463,464,108,144],"Iron Deficiency Anemia","Perioperative",{"date":466,"type":34},"2026-06-02",{"date":468,"type":34},"2025-01-04",{"date":470,"type":21},"2028-03-31",{"name":472,"class":84},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":22,"phases":482,"briefSummary":483,"conditions":484,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":491,"locationsCount":85},"100500772","phase-2-iron-replacement-to-reduce-anemia-during-neoadjuvant-chemotherapy-100500772","NCT05800600","Iron Replacement to Reduce Anemia During Neoadjuvant Chemotherapy","Iron-RANC","Inclusion Criteria:\n\n* Male or female patients \\> 18 years\n* Patients undergoing neoadjuvant chemotherapy, including radiation and\u002For immunotherapy, with intent for curative surgical resection for breast, thoracic, gastrointestinal (GI) or genitourinary (GU) malignancies.\n* Anemia defined as Hgb \\\u003C10.5 g\u002FdL during chemotherapy.\n* Iron storage levels of ferritin \\\u003C500 ng\u002FmL and iron saturation \\\u003C35%\n* Ability to understand and willingness to sign a written informed consent and HIPAA consent document\n\nExclusion Criteria:\n\n* Diagnosis of anemia at the time of cycle 1 day 1 of neoadjuvant chemotherapy, Hgb \\\u003C 11.0 g\u002FdL, uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic new\u002Fexacerbated congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Prior parenteral iron infusion in the past 4 weeks\n* The use of erythropoietin stimulating agents within 4 weeks unless chronic needs due to CKD\n* Concurrent systemic infection at the time of enrollment.\n* Known hypersensitivity to Iron sucrose\n* Pregnant or breast feeding. Refer to section 4.4 for further detail.\n* Anemia from another established etiology (i.e MDS, Myeloma)",{"count":481,"type":21},34,[24],"This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.",[28],"2026-05-20",{"date":487,"type":34},"2026-05-22",{"date":489,"type":34},"2023-03-15",{"date":189,"type":21},{"name":492,"class":84},"Fox Chase Cancer Center",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":22,"phases":502,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":7},"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: 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 WHO 2016 criteria.55\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 (see Section 6.3). 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).\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 \\\u003C3x 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 by 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)\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 Exclusion 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 with the past 3 years, other than primary MF, post ET MF, or post PV MF. The following history or concurrent conditions are allowed:\n\n   1. basal or squamous cell carcinoma\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, Medical 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, Medical History, 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, Medical History, 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. Prior treatment with hypomethylating agent or other acute myeloid leukemia (AML)-like combination chemotherapy\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\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":501,"type":21},150,[97,24],"This phase 1b\u002F2a open-label study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis or myelodysplastic syndrome and anemia.",[390,28,391,505,386,389,506],"Myelofibrosis Due to and Following Polycythemia Vera","Myelodysplastic Syndromes",[508,509],"Myeloproliferative Neoplasm","Myeloproliferative Disorders","2026-05-12",{"date":512,"type":34},"2026-05-13",{"date":514,"type":34},"2022-06-06",{"date":516,"type":21},"2026-09",{"name":40,"class":41},{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":525,"maxAge":18,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":527,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":85},"100636276","efficacy-of-oral-sucrosomial-iron-supplementation-in-children-with-celiac-disease-and-iron-deficiency-or-anemia-100636276","NCT07563582","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency anemia.\n2. Age at diagnosis of CD between 8 and 18 years (inclusive).\n3. Absence of oral martial supplementation in the 30 days before the diagnosis and intravenous martial supplementation in the 90 days prior to the diagnosis of CD.\n4. Patients who have not already started GFD before diagnosis.\n5. Exclusion of other causes of anemia.\n6. Patients (and parents\u002Flegal guardian) able to understand and willing to participate in the study, with collaborative attitude.\n7. Informed consent release by both parents\u002Flegal guardian.\n\nExclusion Criteria:\n\n1. Potential celiac disease.\n2. Hb \\\u003C 8 g\u002FdL at screening\n3. Other causes of anemia, hemoglobinopathies or coagulopathies.\n4. Active bleeding or surgery or major trauma in the last 6 months.\n5. Other inflammatory diseases, neoplasms or IgE mediated food allergies\n6. Syndromes or presence of vascular malformations\n7. Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\\*\n8. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.\n9. Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis.\n10. Use of other investigational drug(s) within 30 days before study entry or during the study.\n11. Any other condition, illness or treatment that in the Investigator's opinion does not make the patient suitable for the study.\n\n    * Self-certification of non-pregnancy status is considered sufficient given that the product under study is a safe and well-tolerated dietary supplement that has already been tested in pregnant women.","8 Years",{"count":236,"type":21},[55],"Celiac disease in children is frequently associated with iron deficiency and\u002For iron deficiency anemia due to intestinal malabsorption and chronic inflammation. Although a gluten-free diet is the standard treatment and can restore iron balance over time, there is currently no clear evidence or consensus on the role and timing of iron supplementation in pediatric patients at diagnosis.\n\nGiven the potential impact of anemia on growth and neurodevelopment, strategies that enable a faster correction of iron deficiency are clinically relevant. Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability compared to conventional oral iron in adult celiac patients.\n\nThis study aims to evaluate whether Sucrosomial® iron supplementation, in addition to a gluten-free diet, is more effective and safe than diet alone in achieving a faster normalization of hemoglobin and iron stores in children with newly diagnosed celiac disease.\n\nThe primary objective of this randomized, double-blind, placebo-controlled, parallel-group study is to assess whether oral supplementation with Sucrosomial® iron, when added to a gluten-free diet (GFD), accelerates the normalization of iron stores and hemoglobin levels compared with GFD alone in school-age children and adolescents newly diagnosed with celiac disease presenting with hypoferritinemia and\u002For iron deficiency anemia.\n\nTarget Study Population: Children and adolescents with celiac disease and iron deficiency or anemia due to iron deficiency.\n\nStudy Duration Total study duration (per patient) will be about 6 months; total treatment duration (per patient) will be 6 months.\n\nNumber of Patients: 60 planned Two typologies of patients will be included: with hypoferritinemia and with anemia due to iron deficiency.\n\nThe randomization process will be stratified, so that:\n\n* 15 patients with hypoferritinemia receive active treatment and 15 patients receive placebo;\n* 15 patients with anemia due to iron deficiency receive active treatment and 15 patients receive placebo.\n\nThe age of patients will also be considered for the randomization (to assign the correct number of product bottles).",[530,28,181],"Celiac Disease in Children",[532],"Iron deficiency\u002Fanemia due to iron deficiency in CD children and adolescents","2026-04-29",{"date":535,"type":34},"2026-05-04",{"date":537,"type":34},"2025-12-23",{"date":539,"type":21},"2027-09",{"name":541,"class":84},"Istituto Giannina Gaslini",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":232,"minAge":199,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":571,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":584,"leadSponsor":586,"locationsCount":85},"100636706","improved-child-nutrition-and-development-through-social-transfers-100636706","NCT07569172","Improved Child Nutrition and Development Through Social Transfers","Taabo Enhanced Nutrition and Development Through Economic Rewards","TENDER","Inclusion Criteria:\n\n1. Are enrolled in the Taabo multigenerational birth cohort (MGC)\n2. Completed the postpartum interview of the Taabo MGC\n3. Have a child who is within two weeks of their 12-month birthday,\n4. are breastfeeding at time of recruitment,\n5. live in the Taabo HDSS, Côte d'Ivoire\n6. have no illnesses that contraindicates breastfeeding,\n7. had a healthy singleton infant with a birth weight of at least 2500 grams, and\n8. agree to participate and sign an informed consent; if underage (12-17 years), a legal representative will also have to agree to sign the informed consent\n\nExclusion Criteria:\n\n1. Plans to move permanently outside study area\n2. Has a medical, intellectual or psychological disability\n3. Contraindication for breastfeeding\n4. Children born with \\\u003C 2500 grams",{"count":551,"type":21},1040,[55],"The goal of this clinical trial is to learn if a conditional social transfer works to improve rates of complementary breastfeeding. It will also learn about the impacts of social transfers on maternal and child health and development. The main questions it aims to answer are:\n\n* Does the social transfer increase complementary breastfeeding rates at 24-months postpartum?\n* Does the social transfer increase complementary breastfeeding duration?\n* Does the social transfer impact child health and development?\n* Does the social transfer impact maternal physical and mental health?\n\nResearchers will compare a conditional social transfer to a control group that only receives education about breastfeeding recommendations to see if a conditional social transfers works to increase complementary breastfeeding.\n\nParticipants will:\n\nReceive a pamphlet explaining the current recommendations of breastfeeding Receive instructions that if they meet the recommendation to breastfeed until 24-months postpartum they receive a social transfer or receive no additional information Complete home visits at 12- and 24-months postpartum Complete detailed questionnaire",[555,556,557,558,559,560,561,28,562,563,564,565,566,567,568,569,570],"Breastfeeding","Breastfeeding Education","Breastfeeding Duration","Breastfeeding Continuation","Child Growth","Stress","Infectious Diseases","Child Development","Weight Loss","Blood Pressure","Mental Health","Diarrhea","Coughing","Eczema","Allergies","Antibiotic Use",[572,573,574,575,576,577,578,579],"breastfeeding","cash transfer","child health","maternal health","mental health","child growth","child development","education","2026-04-28",{"date":582,"type":34},"2026-05-06",{"date":442,"type":21},{"date":585,"type":21},"2028-02-28",{"name":587,"class":84},"Swiss Tropical & Public Health Institute",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":383,"phases":4,"briefSummary":599,"conditions":600,"keywords":611,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":620,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":85},"100506981","prevalence-incidence-and-risk-signature-of-chronic-kidney-disease-in-sub-saharan-africa-100506981","NCT05881447","Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa","Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in a Primary Care Setting in Semirural Sub-Saharan Africa","RenalTWO","Inclusion Criteria:\n\nall adult patients (≥18 years) attending the outpatients department of the Bagamoyo district hospital (BDH) or the associated Fukayosi and Yombo dispensary\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* not living in the BDH catchment area\n* not of African decent\n* not willing to come back for follow-up visits","99 Years",{"count":598,"type":21},1200,"Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.",[601,602,603,604,605,606,28,607,608,609,610],"Chronic Kidney Diseases","Type 2 Diabetes Mellitus","Arterial Hypertension","Obesity","Cardiovascular Diseases","HIV Infections","Underweight","Infections","Albuminuria","Dyslipidemias",[612,613,614,28,615,616,617,618,619],"CKD","Risk factors","Cardiovascular disease","Point of care diagnostics","Albumin creatinine ration (ACR)","Estimated glomerular filtration rate (eGFR)","Kidney Disease: Improving Global Outcomes (KDIGO)","HbA1c","2026-04-23",{"date":533,"type":34},{"date":623,"type":34},"2023-06-21",{"date":81,"type":21},{"name":587,"class":84},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":633,"targetDuration":4,"studyType":383,"phases":4,"briefSummary":634,"conditions":635,"keywords":637,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":639,"lastUpdatePostDateStruct":640,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":85},"100065664","diamond-blackfan-anemia-registry-dbar-100065664","NCT00106015","Diamond Blackfan Anemia Registry (DBAR)","DBAR","Inclusion Criteria:\n\n* Patients must meet the diagnostic criteria for DBA which include the following:\n\n  1. Normochromic, usually macrocytic and occasionally normocytic anemia developing early in childhood\n  2. Reticulocytopenia\n  3. Normocellular bone marrow with a selective deficiency of red cell precursors\n  4. Normal or slightly decreased leukocyte count\n  5. Normal or often increased platelet count\n  6. Or, a confirmed mutation in one of the identified DBA genes\n\nExclusion Criteria:\n\n* Any subject identified as having another bone marrow failure syndrome (eg. Fanconi anemia, dyskeratosis congenita, Shwachman Diamond syndrome, etc.) will be excluded.",{"count":140,"type":21},"The purpose of this study is to maintain a comprehensive registry of patients with the rare inherited bone marrow failure syndrome Diamond Blackfan anemia (DBA).",[28,636],"Blood Disease",[638],"inherited pure red cell aplasia","2026-04-13",{"date":641,"type":34},"2026-04-16",{"date":643,"type":34},"2004-09",{"date":645,"type":21},"2030-04",{"name":647,"class":84},"Northwell Health",{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":170,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":22,"phases":657,"briefSummary":658,"conditions":659,"keywords":660,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":671},"100498694","phase-1-a-study-to-evaluate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-apg-5918-100498694","NCT05773586","A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of APG-5918.","A Phase 1, Ascending Dose Study to Evaluate Safety and Tolerability, Pharmacokinetics and Preliminary Efficacy of APG-5918 in Healthy Volunteers and Patients With Anemia.","Inclusion Criteria:\n\n1. Healthy Subjects:\n\n1\\. Age: 18 to 55 years. 2. Body Mass Index (BMI): 18-28 kg\u002Fm² (inclusive). 3. Hemoglobin value: 120 g\u002FL-160 g\u002FL (inclusive). 4. Normal body iron stores. 2. Anemic Subjects:\n\n1. Age: ≥ 18 years.\n2. Including beta-thalassemia and other related anemias, with screening Hb ≤ 100.0 g\u002FL.\n3. Body weight ≥ 40 kg.\n4. Serum folate and vitamin B12 levels above the lower limit of normal (LLN).\n5. ALT, AST ≤ 2×ULN, and direct (unconjugated) total bilirubin (DBIL) ≤ 2×ULN. Higher levels may be accepted after excluding other diseases based on investigator judgment.\n6. No active or chronic bleeding.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n\n3\\. For female subjects of childbearing potential, a negative blood or urine pregnancy test within 7 days prior to the first dose.\n\n4\\. Subjects and their partners must voluntarily agree to use effective contraceptive measures as required by the protocol during the treatment period and for at least 3 months after the last dose of study drug.\n\n5\\. Ability to understand and voluntarily sign a written informed consent form, which must be signed before any trial-specific procedures are performed.\n\nExclusion Criteria -\n\n1\\. Healthy Subjects:\n\n1. History of any disease or clinical condition that, in the investigator's opinion, may confound the study results or pose additional risk to the subject with administration of the study drug.\n2. ALT or AST \\> 2×ULN, or TBIL \\> 1.5×ULN at screening.\n3. Undergone surgery (excluding minor cosmetic or dental procedures) within 3 months prior to screening.\n4. Blood donation or blood loss exceeding 400 mL within 3 months prior to screening, or planned donation of blood or blood components during the study period.\n5. Use of another investigational product within 30 days or 5 half-lives (whichever is longer) prior to dosing, or current participation in a prospective study of an investigational product or medical device.\n6. History of substance abuse within 6 months prior to screening.\n7. Positive alcohol breath test.\n\n2\\. Anemic Subjects:\n\n1. Presence of clinically significant or uncontrolled ongoing autoimmune disease.\n2. Severe cardiac disease.\n3. Severe renal disease, defined as estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73m², or dependence on dialysis.\n4. Active malignancy, history of cancer, or presence of a known or suspected familial cancer syndrome in linealrelatives.\n5. A history of persistent hemolysis or hemolytic syndrome due to causes other than the study diseases.\n6. A history of thrombosis or newly developed thrombus within 4 weeks prior to screening.\n7. Receipt of intravenous iron supplementation within 28 days prior to first dosing.\n8. Any active infection requiring systemic antibiotic therapy (including oral, intravenous, or intraperitoneal administration) within 14 days prior to first dosing.\n9. A history of organ transplantation.\n10. Any condition that may affect drug absorption.\n11. Participation in another clinical study and still using another investigational products, or without completion of a washout period of at least 5 half-lives within 4 weeks prior to first dosing.\n12. Receipt of cytotoxic agents, high-dose systemic corticosteroids, immunosuppressive agents, or anticoagulant therapy such as warfarin within 28 days prior to first dosing.\n\n3\\. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody at screening.\n\n4\\. A history of regular alcohol consumption within 6 months prior to screening, defined as an average daily intake of ≥30 grams (for males) or ≥20 grams (for females) of ethanol.\n\n5\\. Standard 12-lead ECG with QTcB \\> 450 ms for males or QTcB \\> 470 ms for females.\n\n6\\. Female subjects who are pregnant, planning to become pregnant, or breastfeeding; or male subjects whose partners are planning to become pregnant.\n\n7\\. Any subject deemed unsuitable for participation in this study based on the investigator's judgment.",{"count":656,"type":21},105,[97],"The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of APG-5918 in Healthy Subjects or Anemic Patients.",[28],[661,28],"APG-5918","2026-04-12",{"date":664,"type":34},"2026-04-15",{"date":666,"type":34},"2023-03-13",{"date":668,"type":21},"2028-07-15",{"name":670,"class":41},"Ascentage Pharma Group Inc.",2,{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":677,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":678,"enrollmentInfo":679,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":681,"conditions":682,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":85},"100590555","long-term-outcomes-sub-study-of-preoperative-combined-iron-therapy-100590555","NCT06968936","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy","Long-term Outcomes Sub-Study of Preoperative Combined Iron Therapy in Anemic Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial","85 Years",{"count":459,"type":21},[55],"This is a sub-study of the Preoperative Combined Iron Therapy trail in which some participants will be additionally randomized to combined iron supplementation or standarded treatment control to evaluate the impact on long-term outcomes.",[28,181,144],"2026-04-07",{"date":639,"type":34},{"date":686,"type":34},"2026-03-27",{"date":688,"type":21},"2029-06-30",{"name":472,"class":84},{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":22,"phases":700,"briefSummary":701,"conditions":702,"keywords":704,"overallStatus":153,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":711,"completionDateStruct":712,"leadSponsor":714,"locationsCount":4},"100632681","phase-2-dapagliflozin-for-anemia-in-lower-risk-myelodysplastic-syndromes-100632681","NCT07516847","Dapagliflozin for Anemia in Lower-Risk Myelodysplastic Syndromes","A Phase II, Prospective, Open-Label Study to Evaluate the Efficacy and Safety of Dapagliflozin for Anemia in Patients With Lower-Risk Myelodysplastic Syndromes","DAPA-MDS1","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diagnosis of myelodysplastic syndromes (MDS) according to WHO or ICC criteria\n* Revised International Prognostic Scoring System (IPSS-R) very low, low, or intermediate risk\n* Hemoglobin ≤10 g\u002FdL at screening\n* Transfusion independent or low transfusion burden (Defined as ≤2 units of red blood cell transfusion within 8 weeks prior to enrollment)\n* If receiving erythropoiesis-stimulating agents (ESA) or other anemia-directed therapy, on a stable dose for at least 8 weeks prior to enrollment\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) ≥0.75 ×10⁹\u002FL\n* Platelet count ≥50 ×10⁹\u002FL\n* Adequate organ function:\n\nCreatinine clearance ≥30 mL\u002Fmin AST or ALT ≤3 × upper limit of normal\n\nExclusion Criteria:\n\n* IPSS-R intermediate-high or high-risk MDS\n* Transformation to acute myeloid leukemia or ≥20% blasts\n* Initiation or dose change of MDS- or anemia-directed therapy (e.g., ESA, luspatercept, hypomethylating agents) within 8 weeks prior to screening\n* Red blood cell transfusion \\>2 units within 8 weeks prior to enrollment\n* Current use of SGLT2 inhibitors or history of serious adverse reaction to SGLT2 inhibitors\n* Uncontrolled diabetes mellitus (e.g., HbA1c \\>10%) or history of diabetic ketoacidosis\n* Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* Active or uncontrolled infection\n* Absolute neutrophil count (ANC) \\\u003C0.75 ×10⁹\u002FL or platelet count \\\u003C50 ×10⁹\u002FL\n* Pregnant or breastfeeding women\n* Any condition that, in the investigator's judgment, would make participation inappropriate",{"count":699,"type":21},37,[24],"This study is a prospective, single-arm, phase II clinical trial designed to evaluate the efficacy and safety of dapagliflozin in improving anemia in patients with lower-risk myelodysplastic syndromes (MDS).\n\nAnemia is the most common clinical problem in patients with lower-risk MDS and often leads to fatigue, reduced quality of life, and the need for repeated blood transfusions. Current treatment options, including erythropoiesis-stimulating agents and other therapies, are not effective in all patients, and additional treatment options are needed.\n\nDapagliflozin is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that is widely used for the treatment of diabetes, heart failure, and chronic kidney disease. Previous studies have shown that SGLT2 inhibitors can increase hemoglobin levels, possibly by stimulating erythropoiesis.\n\nIn this study, eligible patients will receive dapagliflozin 10 mg orally once daily for 24 weeks. The primary objective is to evaluate the hemoglobin response rate during the study period. Secondary objectives include changes in hemoglobin levels, transfusion requirements, and safety outcomes.\n\nThis study aims to explore whether dapagliflozin can serve as a potential treatment option for anemia in patients with lower-risk MDS.",[703,28],"Myelodysplastic Syndromes (MDS)",[506,28,705,706,707],"SGLT2 inhibitor","Dapagliflozin","Lower-risk MDS","2026-04-01",{"date":710,"type":34},"2026-04-08",{"date":516,"type":21},{"date":713,"type":21},"2029-09",{"name":715,"class":84},"Seug yun Yoon, MD"]