[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Armenia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":688},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,47,78,103,131,155,183,203,225,245,282,303,333,355,373,396,419,444,474,510,534,561,599,626,647],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":7},"100566774","phase-2-a-phase-2-efficacy-and-safety-study-of-gal-101-2-ophthalmic-solution-in-non-foveal-geographic-atrophy-secondary-to-non-neovascular-amd-100566774",false,"NCT06659549","A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD","A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study","eDREAM","Inclusion Criteria:\n\n* ≥55 years of age\n* Willing and able to provide written informed consent\n* Willing and able to comply with the study schedule and study assessments\n* Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution\n* BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20\u002F100 Snellen equivalent). Criterion will be confirmed at Baseline\n* Refractive error between +3 and -6 diopters spherical equivalent in the study eye\n* Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline\n* Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center\n\n  1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2\n  2. If GA is multifocal, at least 1 lesion ≥1.25 mm2\n  3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \\[RPE\\] and outer retina)\n  4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea\n  5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \\>300 µm from image edges\n  6. GA lesions must be \\>300 µm from the optic disc and\u002For peripapillary atrophy\n  7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2\n\nExclusion Criteria:\n\n1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline\n2. History of laser therapy in the macular region, regardless of indication\n3. History of herpes zoster\n4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period\n5. GA with cumulative area \\\u003C1.25 mm2\n6. Any GA lesion within 100 µm radius from the center point of the fovea\n7. Axial length \\>26 mm\n8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)\n9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period\n10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period\n11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period\n12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period\n\n    Non-study Eye:\n13. BCVA of \\\u003C5 letters using ETDRS chart (i.e., 20\u002F800 Snellen equivalent)\n\n    Either Eye:\n14. History of uveitis\n15. GA secondary to any condition other than non-neovascular AMD\n16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline\n17. Underwent investigational treatment for AMD within 6 months before Visit 1a\n\n    General Exclusion Criteria:\n18. History of therapeutic radiation to the cranium\n19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients\n20. History of malignant disease\n21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period\n22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period\n23. Use of lutein \\>10 mg per day or zeaxanthin \\>2 mg per day within 1 month before Visit 1a, or planned use during the study period\n24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data\n25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation\n26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline\n27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP","ALL","55 Years",{"count":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.",[28],"Geographic Atrophy of the Macula",[30,31,32,33,34],"AMD","Geographic Atrophy","Age Related Macular Degeneration","Amyloid-Beta","Eye-drops","RECRUITING","2026-08-19",{"date":38,"type":39},"2026-08-20","ACTUAL",{"date":41,"type":39},"2025-01-10",{"date":43,"type":22},"2027-05-30",{"name":45,"class":46},"Galimedix Therapeutics Inc","INDUSTRY",{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100543874","phase-3-study-of-iv-human-plasma-derived-c1-esterase-inhibitor-concentrate-in-patients-with-congenital-c1-inh-deficiency-for-treatment-and-pre-procedure-preventing-of-acute-hereditary-angioedema-attacks-100543874","NCT06361537","Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks","Prospective, Multicenter, Randomized, Double-blind, Parallel Group, Placebo- Controlled, Efficacy and Safety Phase 3 Study of an Intravenous Human Plasma- Derived C1 Esterase Inhibitor (C1-INH) Concentrate in Participants With Congenital C1-INH Deficiency for the Treatment and Pre-procedure Prevention of Acute Hereditary Angioedema Attacks","Inclusion Criteria:\n\n1. Is at least 18 years of age (applicable for 1st study phase) or is at least 2 years of age (applicable for 2nd study phase)\n2. Has confirmed diagnosis of HAE type I or II\n3. Has had at least 3 moderate or severe HAE attacks (excluding extremity attacks) in the last 3 months before the Screening Visit. For participants ≥2 and ≤12 years of age, has had at least 1 moderate or severe HAE attack (excluding extremity attacks) in the last 6 months before Screening Visit\n4. Has a documented congenital C1-INH functional activity \\\u003C50% with or without C1-INH deficiency and C4 antigen level below the laboratory reference range\n5. Participant or the participant's legally authorized representative(s) has signed informed consent (as required by local law), with the assent of participants legally capable of providing it, as applicable\n6. States willingness to comply with all study procedures and availability for the duration of the study\n7. If the participant is of childbearing potential (CBP), has a negative pregnancy test and must have been using a highly effective method of contraception and continue to do so until at least 2 weeks after their last dose (for both blinded and open-label doses of IMP). Not of CBP is defined as surgically sterilized (hysterectomy, bilateral oophorectomy) or who are postmenopausal (defined as women with no menses for 12 months without an alternative medical cause). Highly effective methods of contraception:\n\n   * Combined hormonal contraception (estrogens and progesterone) methods such as oral, implantable, intravaginal, injectable, or transdermal contraceptives at a stable dose for a minimum of 1 full cycle (hormonal contraceptives must inhibit ovulation) and for at least 4 weeks before screening\n   * Progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n   * Intrauterine device\n   * Intrauterine hormone-releasing system inserted at least 4 weeks before screening\n   * Bilateral tubal ligation\u002Focclusion or vasectomized partner (with surgical success confirmed by medical assessment) OR Agrees to abstain from heterosexual intercourse during study participation and to use a highly effective contraceptive (as described above) as backup if they become sexually active during the study. Abstinence is only acceptable if this is the participant's usual lifestyle. Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method are not acceptable methods of contraception\n   * Note: If a participant of CBP has a positive or suspected positive urine pregnancy test within 72 hours prior to treatment, a serum pregnancy test will be required\n   * Male participants must not plan to father a child or donate sperm for 90 days after their last dose of study drug (for both blinded and open-label doses of the IMP). However, there are no official contraception requirements for male participants during the study.\n\nInclusion Criteria for IMP Dosing for QAT:\n\n1. Has confirmed QAT per definition criteria\n2. Has a swelling episode that is new and not the continuation of a previous HAE attack\n\nExclusion Criteria:\n\n1. Has a history of clinically relevant antibody development against C1-INH\n2. Has a medical history consistent with Type 3 HAE (i.e., onset at age above 40 year, no family history, no known HAE mutation, low C1q level in plasma)\n3. Has a history of allergic reaction to C1-INH or other blood\u002Fplasma product\n4. Has a history of B-cell malignancy that was unresolved in the past 5 years\n5. Has a narcotic and\u002For alcoholic addiction\n6. Has participated in any other investigational drug evaluation within 30 days before screening\n7. Is pregnant or breastfeeding\n8. Has any clinically significant medical or psychiatric condition that, in the investigator's opinion would interfere with the participant's ability to participate in the study\n9. Has a history of thromboembolic events (TEEs), myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebrovascular accident, transient ischemic attack, severe peripheral vascular disease, or disseminated intravascular coagulation within one year before screening\n10. (applicable until IDMC review of the interim preliminary safety and efficacy data): has clinically significant derangement in measurements of cardiovascular status (i.e. uncontrolled arterial hypertension, cardiac insufficiency New York Heart Association (NYHA) class III-IV), pulmonary status (i.e., COPD GOLD classification 3 and 4, severe asthma) and renal status (i.e., eGFR below 90 ml\u002Fmin per 1.73 m2)\n\nExclusion Criteria for IMP Dosing for QAT:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. started or changed hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) within 14 days before IMP dosing\n3. Started or changed androgen therapy (e.g. testosterone, dehydro- epiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) within 14 days before IMP dosing or is not willing to maintain a stable dose throughout the study\n4. Started or changed the dose of monoclonal antibodies e.g. lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing for a QAT\n6. Has received OCTA-C1-INH within 14 days before IMP dosing\n\nExclusion Criteria for IMP Dosing for PK:\n\n1. Has received blood or a blood product for prophylactic or acute treatment with any C1-INH (Berinert®, Cinryze®, HAEgarda®, Ruconest®, etc.), non-biological bradykinin and kallikrein pathway inhibitors (e.g., ecallantide, icatibant, berotralstat), or treatment with tranexamic acid within 14 days before dosing with the IMP (or is not willing to abstain from these medications throughout the study)\n2. Is receiving hormone replacement therapy or selective estrogen receptor modulators (e.g., tamoxifen) and has had their dose changed within 14 days before IMP dosing\n3. Is receiving or has received androgen therapy (e.g., testosterone, dehydroepiandrosterone\u002Fandrostenedione, oxandrolone, danazol, stanozolol) IN ANY DOSE within 14 days before dosing\n4. Started or changed the dose of monoclonal antibodies e.g lanadelumab within 11 weeks before dosing or not willing to maintain a stable dose throughout the study\n5. Has used narcotic pain medications or non-opioid analgesics within 7 days before IMP dosing\n6. Has received IMP within 14 days before IMP dosing\n7. Has planned dental, medical, or surgical procedures during the PK Period that will require pre-procedural prevention","2 Years",{"count":56,"type":22},124,[58],"PHASE3","Prospective, multicenter, randomized, double-blind, parallel group, placebo- controlled, efficacy and safety phase 3 study of an intravenous human plasma- derived C1 esterase inhibitor (C1-INH) concentrate in participants with congenital C1-INH deficiency for the treatment and pre-procedure prevention of acute hereditary angioedema attacks",[61],"Acute Hereditary Angio Edema",[63,64,65,66,67],"Edema","Swelling","Angio Edema","Hereditary","Congenital Angioedema","2026-08-04",{"date":70,"type":39},"2026-08-06",{"date":72,"type":39},"2024-04-30",{"date":74,"type":22},"2027-06",{"name":76,"class":46},"Octapharma",23,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100484459","phase-1-safety-and-pharmacokinetics-study-of-naldemedine-in-paediatric-participants-receiving-opioids-100484459","NCT05588323","Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids","A Phase 1\u002F2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment With Opioids","Inclusion Criteria:\n\nDisease Characteristics\n\n* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.\n* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.\n* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.\n\nWeight\n\n* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.\n* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.\n* Inability to eat\u002Fswallow or have need of a nasogastric tube.\n* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).\n* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.\n* Participants who need mechanical ventilation.\n* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.\n* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.\n\nPrior\u002FOngoing Medications\n\n* Currently receiving the first cycle of chemotherapy.\n* Previously received naldemedine.\n\nOther Exclusions\n\n\\- Positive pregnancy test for females of childbearing potential.\n\nNote: Other protocol-defined Inclusion\u002FExclusion criteria may apply.","18 Years",{"count":87,"type":22},24,[89,25],"PHASE1","The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.",[92],"Opioid-Induced Constipation (OIC)","2026-07-25",{"date":95,"type":39},"2026-07-28",{"date":97,"type":39},"2023-01-04",{"date":99,"type":22},"2028-06-15",{"name":101,"class":46},"Shionogi",16,{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":7},"100580086","phase-1-invobenitug-also-known-as-procizumab-pcz-ak1967-in-critical-cardiovascular-care-100580086","NCT06832722","Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care","Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b\u002F2a Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of Invobenitug Also Knows as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations","PROCARD 2a","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Diagnosis of CS based on the following entry criteria:\n\n   1. Need for ongoing vasopressors and\u002For inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg\n   2. Lactate ≥ 2.0 mmol\u002FL\n   3. High cDPP3 concentration ≥ 30 ng\u002FmL\n3. Etiology of CS must be one of the following: ACS, septic or adHF origin\n\n   Exclusion Criteria:\n4. Patients who will be receiving vasopressors and\u002For inotropes for more than 16 hours prior to receiving the IMP.\n5. Patients being longer than 24 hours in the ICU at the time of randomization.\n6. Patients below the age of 18 or above 80 years.\n7. Patients receiving Ang II and\u002For levosimendan.\n8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication.\n9. Stroke or transient ischemic attack within the last 3 months.\n10. SCAI Shock Stage E.\n11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset).\n12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death.\n13. Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and\u002For ECMO but have no evidence of hemolysis during screening can be enrolled in the trial.\n14. Patients exceeding a maximum body weight of 120 kg (US: 150 kg).\n15. CPR lasting more than 15 minutes and\u002For the patient is not conscious at randomization.\n16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease.\n17. Pericardial constriction\n18. Sustained SBP \\> 120 mmHg during the hour prior to randomization.\n19. Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score \\>30), known severe chronic pulmonary disease (including COPD classification GOLD4 and\u002For chronic oxygen therapy and\u002For restrictive chronic pulmonary disease and\u002For severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR \\\u003C 20 ml\u002Fmin\u002F1.73 m2 or chronic dialysis.\n20. Patients with untreated sepsis.\n21. Patients with valvular heart diseases as the primary cause of cardiogenic shock.\n22. Other known causes of shock, namely\n\n    1. Hypovolemia\n    2. Hemorrhage\n    3. Anaphylaxis\n    4. Intoxication (e.g., drug-induced shock)\n    5. Dynamic left ventricular outflow tract obstruction\n    6. Isolated right heart failure, including cardiac tamponade and\u002For pulmonary embolism\n    7. Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture\n    8. Inappropriate pacing or shock resulting from ICD malfunction\n23. Patients who have severe immune suppression such as recent (\\\u003C3 months) chemotherapy and\u002For severe neutropenia (neutrophil count \\\u003C500 cells\u002Fmm3) and\u002For chronic high glucocorticoid dose (≥0.5 mg\u002Fkg per day of prednisone equivalent) and\u002For recent (\\\u003C3 months) organ transplantation\n24. Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed.\n25. Women who are pregnant or breastfeeding.\n26. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization\n27. US only: Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures","80 Years",{"count":113,"type":22},90,[89,25],"The objective of this Phase 1b\u002F2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.",[117],"Shock, Cardiogenic",[119,120,121],"Cardiogenic shock","Procizumab","invobenitug","2026-07-08",{"date":124,"type":39},"2026-07-09",{"date":126,"type":39},"2025-07-13",{"date":128,"type":22},"2026-12-31",{"name":130,"class":46},"4TEEN4 Pharmaceuticals GmbH",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":154},"100557107","clinical-epidemiology-in-contemporary-patients-with-myelofibrosis-100557107","NCT06533813","Clinical Epidemiology in Contemporary Patients With Myelofibrosis.","Clinical Epidemiology in Contemporary Patients With Myelofibrosis (ERNEST-3): A European LeukemiaNet (ELN) Observational Study","ERNEST-3","Inclusion Criteria:\n\n* Diagnosis of primary myelofibrosis (PMF) or secondary (i.e., post-ET\u002FPV MF) myelofibrosis according to 2016- or 2022-WHO criteria ascertained between 01\u002F01\u002F2018 and 31\u002F12\u002F2027\n* Age ≥ 18 years\n* Signed informed consent where applicable, in line with current European General Data Protection Regulation (GDPR) directives\n\nExclusion Criteria:\n\n* Diagnosis of early\u002Fprefibrotic primary myelofibrosis\n* Concurrent participation to interventional clinical trials in MF","100 Years",{"count":141,"type":22},617,"OBSERVATIONAL","Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from 01\u002F01\u002F2018 to 31\u002F12\u002F2027 will be enrolled into the study. Yearly follow-up updates will be scheduled until the end of data collection on 31\u002F12\u002F2028 or until the last available patient visit, whichever comes first. At least 1 year of follow-up will be ensured from the last patient enrolled.",[145],"Myelofibrosis",{"date":124,"type":39},{"date":148,"type":39},"2024-10-14",{"date":150,"type":22},"2028-12-31",{"name":152,"class":153},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS","OTHER",27,{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":180,"locationsCount":182},"100546993","coloseal-icd-system-safety-and-feasibility-study-100546993","NCT06402188","ColoSeal™ ICD System Safety and Feasibility Study","European ColoSeal™ ICD System Safety and Feasibility Study","Inclusion Criteria:\n\n* Subject is 18-65 years of age at screening, or subject is 66-70 years of age at screening with up to one cardiovascular, metabolic or pulmonary comorbidity for which medication is prescribed.\n* Subject is diagnosed with rectosigmoid or rectal cancer\n* Subject is scheduled for elective resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach) which will require the creation of an anastomosis and protective ostomy (anastomosis maximally 15 cm from the anal verge).\n* The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).\n* Subject must be willing and able to comply with study follow-up requirements.\n\nExclusion Criteria:\n\n* Subject with a life expectancy \\\u003C 1 year\n* Subjects with ASA classification \\> 3\n* Albumin \\\u003C 30 g\u002Fliter\n* Subject has local or systemic infection at the time of intervention.\n* Major surgical or interventional procedures within 30 days prior to this study or planned major surgical or interventional procedures within 1 month of entry into this study\n* Patient has received systemic chemotherapy or radiation to the pelvis within 30 days prior to the planned procedure\n* Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diverticulitis, or extensively spread inflammatory bowel disease\n* Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function\n* Subjects has a diagnosis of coagulopathy, thrombocytopenia, immune suppression\n* BMI ≥ 40\n* Subject is scheduled for a concurrent major surgical procedure during the surgery (e.g., liver resection)\n* Subject has been taking regular systemic\u002F steroid medication in the last 3 months\n* Subjects is taking antimetabolites or antiplatelet agents (with the exception of aspirin)\n* Subject has undergone a prior pelvic anastomosis\n* Subject requires an end-to-end anastomosis smaller than 31 mm in diameter\n* Inadequate bowel preparation prior to the procedure\n* Anastomotic leak detected during intraoperative leak testing\n* Known allergy to any component of the device\n* Known allergy to iodine or iodine-based contrast unless subject can be adequately premedicated prior to leak test\n* Subject has unresolved alcohol abuse or illegal drug use\n* Any condition or abnormality which in the opinion of the investigator may jeopardize the subject's safe participation or the quality of the data\n* Subject is pregnant or planning to become pregnant. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure\n* Subject is unable or unwilling to provide informed consent\n* Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints","70 Years",{"count":113,"type":22},[165],"NA","The purpose of this clinical investigation is to evaluate the safety and feasibility of the ColoSeal ICD System in a prospective, multicenter, single-arm study. The ColoSeal ICD System is intended to be used to protect a damaged segment of colon such as a surgical anastomosis, anastomosis leak, or perforation from contact with fecal flow for up to 14 days. The device will be evaluated in adult patients with rectal and rectosigmoid cancer undergoing a resection with a colorectal anastomosis.",[168],"Colorectal Cancer",[170,171,172,173],"Colon anastomosis","Rectosigmoid cancer resection","Ostomy","Colon diversion","2026-06-19",{"date":176,"type":39},"2026-06-23",{"date":178,"type":39},"2023-06-05",{"date":128,"type":22},{"name":181,"class":46},"Averto Medical, Inc.",3,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":200,"locationsCount":202},"100493053","integrated-molecular-and-clinical-profiling-to-improve-disease-characterization-and-outcome-prediction-in-nodal-marginal-zone-lymphoma-100493053","NCT05700149","Integrated Molecular and Clinical Profiling to Improve Disease Characterization and Outcome Prediction in Nodal Marginal Zone Lymphoma","Inclusion Criteria:\n\n1. Male or female adults 18 years or older\n2. Diagnosis of NMZL on lymph node histology after Jan 1st, 2000\n3. Availability of tumor material from lymph node (either frozen or FFPE) collected when the patient was treatment naïve\n4. Availability of the baseline and follow-up annotations\n\nExclusion Criteria:\n\n1\\. Nodal spread of a clinically occult extranodal MZL (this must have been ruled out by carefully evaluating the extranodal tissues draining to the involved lymph nodes by imaging or endoscopy)",{"count":190,"type":22},300,"International retrospective observational cohort study aimed to describe a molecular classification for NMZL.",[193],"Nodal Marginal Zone Lymphoma","2026-06-18",{"date":196,"type":39},"2026-06-22",{"date":198,"type":39},"2024-04-11",{"date":128,"type":22},{"name":201,"class":153},"International Extranodal Lymphoma Study Group (IELSG)",50,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100507779","phase-2-assessment-of-the-safety-and-efficacy-of-balstilimab-for-the-treatment-of-relapsedrefractory-lymphomas-immonc0001-100507779","NCT05891821","Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed\u002FRefractory Lymphomas (IMMONC0001)","Inclusion Criteria:\n\n1. Voluntarily agree to participate by giving written informed consent\n2. ≥ 18 years of age\n3. Have a histologically confirmed diagnosis of a relapsed\u002Frefractory classical Hodgkin lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) for which no standard therapy is available or standard therapy has failed or the patient does not have access to it.\n4. Has a life expectancy of at least 3 months and an ECOG performance status of ≤1 as determined by study Investigator\n5. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated\n6. Has adequate organ function defined as the following laboratory values within 7 days of C1D1:\n\n   1. Neutrophils ≥ 1500\u002FμL (Must be stable and off any growth factor within 4 weeks of first study treatment administration)\n   2. Platelets ≥ 75 × 103\u002FμL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   3. Hemoglobin ≥ 8.0 g\u002FdL (transfusion to achieve this level is not permitted within 2 weeks of first study treatment administration)\n   4. Creatinine clearance ≥ 30 mL\u002Fmin as measured or calculated per local institutional standards\n   5. AST\u002FALT ≤ 3 × upper limit of normal (ULN)\n   6. Total bilirubin ≤ 1.5 × ULN (except patients with Gilbert syndrome who must have a total bilirubin level of ≤ 3.0 × ULN)\n7. Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 7 days before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):\n\n   1. ≥ 50 years of age and has not menstruated for greater than 1 year\n   2. Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation\n   3. WOCP must be willing to use highly effective methods of contraception (defined in the informed consent form \\[ICF\\]) throughout the study, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n8. Male patients with a female partner(s) of childbearing potential must agree to use highly effective contraceptive measures throughout the study starting with the screening visit through 90 days after the last dose of study treatment is received. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner.\n9. Is willing and able to comply with the requirements of the protocol\n\nExclusion Criteria:\n\n1. Has an inadequate period of time prior to first dose of study treatment that is defined as:\n\n   1. Received systemic cytotoxic chemotherapy within 3 weeks before initiation of study treatment\n   2. Received biological therapy or investigational therapy within 4 weeks or 5 circulating halve-lives, whichever is shorter\n   3. Received small molecule\u002Ftyrosine kinase inhibitors within 2 weeks or 5 circulating half-lives, whichever is shorter\n   4. Received radiation therapy within 3 weeks before initiation of study treatment, except for palliative radiation therapy, which can be received 2 weeks prior to initiation of study treatment\n   5. Had major surgery within 4 weeks before initiation of study treatment\n2. Has gone through disease progression after receiving prior therapy with:\n\n   a. Any antibody\u002Fdrug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-PD-1 and anti-PD-L1 antibodies\n3. Has persisting AEs related to prior immunotherapy of NCI-CTCAE v5.0 Grade ≥ 2 severity.\n4. Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent, radiation therapy, and\u002For surgical resection)\n5. Has known allergy or hypersensitivity to any component of balstilimab, any history of anaphylaxis, or uncontrolled asthma\n6. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.\n7. Patients with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.\n8. Has had an allogeneic tissue\u002Fsolid organ transplant\n9. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.\n\n   a. QTcF (QTc interval corrected using Fridericia's formula) of \\> 480 ms.\n10. Any evidence of current interstitial lung disease (ILD) or pneumonitis, or prior history of ILD or non-infectious pneumonitis requiring glucocorticoids.\n11. Has known untreated hepatitis B\u002Fhepatitis C virus (HBV\u002FHCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined by a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay\n12. Uncontrolled infection with human immunodeficiency virus (HIV). Patients on stable highly active antiretroviral therapy with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required.\n13. Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and\u002For interpretation of the current study\n14. Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the study\n15. Is legally incapacitated or has limited legal capacity\n16. Is pregnant or breastfeeding\n17. Has received a live\u002Fattenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment\n18. Has other co-morbidities that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)\n19. Is receiving other therapy that would alter risk-benefit of providing balstilimab (determined by treating physician's assessment)",{"count":210,"type":22},20,[25],"The goal of this study is to see if the drug balstilimab is safe and effective in participants with relapsed\u002Frefractory lymphomas.\n\nParticipants will receive balstilimab every 3 weeks and their outcomes will be assessed periodically.",[214],"Lymphoma","2026-06-04",{"date":217,"type":39},"2026-06-08",{"date":219,"type":39},"2023-09-01",{"date":221,"type":22},"2029-09",{"name":223,"class":153},"Immune Oncology Research Institute",1,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":231,"targetDuration":233,"studyType":142,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100472368","blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-international-registry-100472368","NCT05430971","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) International Registry","Inclusion Criteria:\n\n* Diagnosis of BPDCN\n* Signed informed consent form for prospective patients\n\nExclusion Criteria:\n\n\\-",{"count":232,"type":22},200,"5 Years","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare hematologic malignancy. Despite recent advances, at present there is no consensus on the optimal treatment of BPDCN. The optimal therapy of disease remains to be determined, and due to the rarity of cases, there is a need for international collaboration to collect data on BPDCN clinical presentations, diagnostics, treatment regimens and outcomes. Therefore, the objectives of this study are: (1) to build a large database of patients with BPDCN, (2) to investigate the characteristics and outcome of the disease with different treatment regimens, (3) to evaluate prognostic factors, and (4) to generate data-based prospective treatment recommendations.",[236],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",{"date":238,"type":39},"2026-06-05",{"date":240,"type":39},"2022-07-01",{"date":242,"type":22},"2032-07",{"name":223,"class":153},22,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":18,"minAge":252,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":256,"conditions":257,"keywords":262,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":182},"100643783","caya-cancer-prospective-cohort-study-100643783","NCT07632014","CAYA Cancer Prospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Prospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries.","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this study:\n\n1. Age 0 to 21 years at study enrollment.\n2. Diagnosed with cancer and receiving active treatment or undergoing follow-up at the participating sites.\n\n   a. Note: Patients seen solely for consultation or diagnostic evaluations without subsequent treatment and those who have been off treatment for more than 5 years and are seen only for survivorship follow-up are not considered as meeting this criterion.\n3. Willingness to provide informed consent\u002Fassent. For minors incapable of providing assent, or individuals unable to provide consent, consent must be obtained from a legal representative and in accordance with local requirements.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria must be excluded from this study:\n\n1\\. Any medical or psychological condition that, in the investigator's opinion, might compromise the ability of the patient to provide assent\u002Finformed consent\u002Fassent.","0 Years","21 Years",{"count":255,"type":22},6000,"Cancer is a leading cause of illness and death among children, adolescents, and young adults(CAYAs), especially in low- and middle-income countries(LMICs), where access to timely diagnosis and treatment is often limited. As a result, patients in these settings may experience higher rates of treatment complications, interruptions, and poorer outcomes compared with those in high-income countries (HICs).\n\nThis is a prospective, multicenter observational study that will follow children, adolescents, and young adults(CAYAs) with cancer who are receiving routine care at participating hospitals in low - and middle - income countries(LMICs). The study does not involve experimental treatments or changes to standard medical care. Information will be collected from medical records and from questionnaires that address access to care and social factors affecting treatment.\n\nBy describing treatment outcomes and the challenges patients and families face during cancer care, this study aims to provide data that can help inform future efforts to improve access to care and cancer outcomes in resource-limited settings.",[258,259,260,261],"Cancer","Pediatric Cancer","Lymphoblastic Lymphoma (LBL)","Acute Lymphoblastic Leukemia (ALL)",[263,264,265,266,267,268,269,270,271,272,273],"Children, Adolescents, and Young Adults (CAYA)","Low- and middle-income countries (LMIC)","Observational Study","Cancer Outcomes","Treatment-Related Toxicity","Treatment Failure","Treatment Abandonment","Diagnostic Delay","Socioeconomic Factors","High-income countries (HICs)","Central Nervous System(CNS)","2026-06-03",{"date":217,"type":39},{"date":277,"type":39},"2025-11-11",{"date":279,"type":22},"2032-11-11",{"name":281,"class":153},"Resonance, Inc.",{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":18,"minAge":289,"maxAge":111,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100432981","phase-3-efficacy-of-atenativ-in-patients-with-congenital-antithrombin-deficiency-undergoing-surgery-or-delivery-100432981","NCT04918173","Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery","A Multicenter, Prospective, Open-label, Uncontrolled Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery","Inclusion Criteria:\n\n1. Adult male or female patients ≥18 and ≤80 years of age. Solely in the US, 4 male or female patients between ≥12 and \\\u003C17 years of age will be enrolled into the PK phase, and subsequently in the treatment phase, if applicable\n2. Documented congenital antithrombin deficiency, defined by plasma activity level of antithrombin ≤60% from medical history\n3. Personal or family history of TEs or TEEs (except for PK patients)\n4. For the Treatment Phase: either a) non-pregnant surgical patients scheduled for elective surgical procedure(s) known to be associated with a high risk for occurrence of TEs or TEEs, or b) pregnant patients of at least 27 weeks gestational age who are scheduled for caesarean section or delivery\n5. For female patients of childbearing potential entering the PK Phase who are not known to be pregnant, and for female surgical patients of childbearing potential entering the Treatment Phase for any procedure other than caesarean section or delivery, a negative urine pregnancy test at screening and at baseline\n6. Patient has provided informed consent\n\nExclusion Criteria:\n\n1. Requires emergency surgery or emergency caesarean section\n2. Has undergone surgery within the last 6 weeks\n3. History or suspicion of another hereditary thrombophilic disorder other than antithrombin deficiency (e.g., activated protein C \\[APC\\] resistance\u002FFactor V Leiden, Protein S or C deficiency, prothrombin gene mutation \\[G20210A\\], or acquired \\[lupus anticoagulant\\] thrombophilic disorder)\n4. Malignancies, renal failure (patients on renal replacement therapy), or severe liver disease (aspartate aminotransferase \\[ASAT\\] \\>5 times the upper limit of normal)\n5. Body mass index \\>40 kg\u002Fm2 (for non-pregnant patients, only)\n6. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ\n7. History of anaphylactic reaction(s) to blood or blood components\n8. Refusal to receive transfusion of blood-derived products\n9. Administration of any antithrombin concentrate or antithrombin-containing blood product within 14 days of either of the two phases of the study\n10. Prior diagnosis of heparin-induced thrombocytopenia\n11. TE or TEE within the last 6 months\n12. Female patients who are nursing at the time of screening\\*\n13. Have participated in another investigational study within the last 30 days\n14. Persons dependent on the sponsor, the investigator or the centre of investigation\n15. Persons placed in an institution by administrative or judicial order\n\n    * criterion does not include female patients who plan to breastfeed after giving birth","12 Years",{"count":291,"type":22},38,[58],"The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.",[295],"Congenital Antithrombin Deficiency","2026-06-02",{"date":274,"type":39},{"date":240,"type":39},{"date":300,"type":22},"2026-12-01",{"name":76,"class":46},30,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":311,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":319,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":224},"100637673","clinical-validation-of-the-blood-pressure-measuring-device-withings-bpm-pro-2-in-pregnancy-and-pre-eclampsia-100637673","NCT07595016","Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia","Clinical Validation Of The Brachial Blood Pressure Measuring Device Withings BPM Pro 2 According To \"The Universal Protocol For The Validation Of Blood Pressure Measuring Devices By The Association For The Advancement Of Medical Instrumentation \u002F European Society Of Hypertension \u002F International Organization For Standardization (AAMI\u002FESH\u002FISO) (And Its Amendment 1 (2020) And 2 (2024))\" In Pregnancy And Pre-Eclampsia","WIHYP-PW","Inclusion Criteria:\n\n* Patient older than 18 years;\n* Known pregnancy, in second or third trimester of pregnancy ( \\> 3 months);\n* Patient normotensive, hypertensive or in preeclampsia;\n* Patient who signed the informed consent form;\n* Patient followed-up at site (in-patient or out-patient);\n* Patient with arm circumference between 22 cm and 42 cm.\n\nExclusion Criteria:\n\n* Patient unable to give a consent or understand properly protocol information;\n* Patient suffering from arrhythmia;\n* Patient with poor quality of Korotkov sounds;\n* Patient for whom K5 sounds are absent;\n* Patient wearing an implantable electric medical device (pacemaker,…);\n* Patient with both upper arms suffering from open wound and\u002For damaged skin.",true,{"count":313,"type":22},45,[165],"The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in pregnancy and pre-eclampsia",[317,318],"Hypertension","Pre-eclampsia",[320,321,322,323,324],"hypertension","blood pressure monitor","pregnancy","pre-eclampsia","validation","2026-06-01",{"date":274,"type":39},{"date":328,"type":39},"2026-05-11",{"date":330,"type":22},"2026-09-30",{"name":332,"class":46},"Withings",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":23,"phases":341,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":244},"100435721","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-oral-decitabine-and-cedazuridine-in-cancer-patients-with-hepatic-impairment-100435721","NCT04953910","Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Hepatic Impairment","A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Moderate and Severe Hepatic Impairment","Inclusion Criteria:\n\n* Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.\n* Participants must have a histologically or cytologically confirmed malignancy as follows:\n\n  1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.\n\n     or\n  2. AML or MDS. or\n  3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.\n* For participants with AML\u002FMDS only:\n\n  1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification; or\n  2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., \\>75 years, Eastern Cooperative Oncology Group \\[ECOG\\] performance status ≥2, severe pulmonary disorder, total bilirubin \\>1.5X ULN; and\n  3. Platelet count ≥25,000\u002Fper microliter (μ); and\n  4. Absolute neutrophil count (ANC) ≥100 cells\u002FμL.\n* For participants only with hematologic malignancies other than AML or MDS, or with solid tumors:\n\n  1. Platelet count ≥100,000\u002FμL; and\n  2. ANC ≥1000 cells\u002FμL.\n* ECOG performance status of 0 to 3.\n* Hepatic function defined per the National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) Organ Dysfunction Working Group (ODWG) as:\n\n  1. Normal hepatic function (Group A): total bilirubin ≤1× ULN; aspartate aminotransferase (AST): ≤1× ULN;\n  2. Moderate hepatic impairment (Group B): total bilirubin \\>1.5 to 3 × ULN; AST: any value;\n  3. Severe hepatic impairment (Group C): total bilirubin \\>3 × ULN; AST: any value.\n* Adequate renal function defined as creatinine clearance (CLcr, \\>50 mL\u002Fmin according to the Cockcroft-Gault equation):\n\nCLcr (mL\u002Fmin) = \\[(140-age(years)\\] × weight (in kg)\u002F 72 × serum creatinine (in mg\u002FdL)) × 0.85 \\[if female\\]\n\n* No major surgery within 30 days of first administration of oral decitabine and cedazuridine.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.\n* Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6months after completing treatment\n* Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine and for at least 3 months after completing treatment.\n\nExclusion Criteria:\n\n* Treatment with azacitidine or decitabine within 4 weeks before screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.\n* Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.\n* Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.\n* Concurrent MDS therapies, including lenalidomide, erythropoietin, cyclosporine\u002Ftacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.\n* Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.\n* High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participant at risk of not being able to complete 1 cycle of treatment.\n* Conditions which likely promote delayed ventricular repolarization (QT prolongation):\n\n  1. QTc using Fridericia's correction (QTcF) at screening or Day -1 \\>470 ms for males and \\>480 ms for females.\n\n     or\n  2. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome).\n\n     or\n  3. Concomitant medications that prolong the QT\u002FQTc interval.\n* Cardiac abnormalities or unstable cardiovascular conditions:\n\n  1. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV).\n\n     or\n  2. Uncontrolled treated\u002Funtreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥180 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C50 mmHg).\n* Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participant to high risk of noncompliance with the protocol.\n* In participants with AML\u002FMDS, rapidly progressive or highly proliferative disease or other criteria that render the participant at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.\n* Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.\n* Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.\n* Participants infected with human immunodeficiency virus (HIV).\n* Positive blood screen for hepatitis C antibody (HCV+) and positive RNA polymerase chain reaction (PCR). Participant can be included if HCV+ but negative for RNA PCR.\n* Positive blood screen for hepatitis B surface antigen (HBsAg+). Participants with positive blood screen for hepatitis B surface antibody (HBsAb+) and negative hepatitis B core antibody (HBcAb-) can be included if negative for hepatitis B surface antigen (HBsAg-).\n* Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participant (1 unit of alcohol equals 10 mL of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine, or 25 mL of spirits).\n* Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.\n* Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.",{"count":154,"type":22},[89],"This is a Phase 1b, multicenter, open-label, pharmacokinetic (PK), and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with moderate and severe hepatic impairment and cancer participants with normal hepatic function as control participants. Participants with severe hepatic impairment will be enrolled only after the safety evaluation of at least 6 participants with moderate hepatic impairment has been determined and supports the enrollment of participants with severe hepatic impairment. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration is per participant approximately up to 8 weeks.",[344,345],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","2026-05-27",{"date":348,"type":39},"2026-05-28",{"date":350,"type":39},"2022-12-23",{"date":352,"type":22},"2026-12",{"name":354,"class":46},"Taiho Oncology, Inc.",{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":372},"100435720","phase-1-study-to-evaluate-the-pharmacokinetics-and-safety-of-oral-decitabine-and-cedazuridine-in-cancer-patients-with-renal-impairment-100435720","NCT04953897","Study to Evaluate the Pharmacokinetics and Safety of Oral Decitabine and Cedazuridine in Cancer Patients With Renal Impairment","A Phase 1b, Open-label, Parallel Group, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Decitabine and Cedazuridine (ASTX727) in Cancer Patients With Severe Renal Impairment and Cancer Patients With Normal Renal Function","Inclusion Criteria:\n\n* Able to understand and comply with the study procedures, understand the risks involved in the study, and provide legally effective informed consent before the first study-specific procedure; specifically able to comply with the PK assessment schedule during the first treatment cycle.\n* Participants must have a histologically or cytologically confirmed malignancy as follows:\n\n  1. A solid tumor that is metastatic or unresectable and for which standard life-prolonging measures are not available.\n\n     or\n  2. AML or MDS. or\n  3. A hematologic malignancy other than AML or MDS for which standard life-prolonging measures are not available.\n* For participants with AML\u002FMDS only:\n\n  1. Cytologically or histologically confirmed diagnosis of AML (except M3 acute promyelocytic leukemia) or MDS according to the 2008 World Health Organization (WHO) classification or\n  2. Participants with frontline MDS or treatment naïve AML not suitable for induction therapy (e.g., age \\>75 years, Eastern Cooperative Oncology Group \\[ECOG\\] performance ≥2, severe pulmonary disorder, total bilirubin 1.5 × upper limit of normal \\[ULN\\]); or\n  3. Platelet count ≥25,000\u002Fper microliter (μL); or\n  4. Absolute neutrophil count (ANC) ≥100 cells\u002FμL.\n* For participants with only hematologic malignancies other than AML or MDS, or solid tumors:\n\n  1. Platelet count ≥100,000\u002FμL; and\n  2. ANC ≥1000 cells\u002FμL.\n* ECOG performance status of 0 to 3.\n* Adequate hepatic function defined as:\n\n  1. Total or direct bilirubin ≤1.5X upper limit of normal (ULN); and\n  2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5X ULN.\n* Participants must have a body surface area (BSA)-adjusted CLcr using to the Cockcroft-Gault equation:\n\n  1. Participants without renal impairment (Group B): ≥80 mL\u002Fmin\u002F1.73m\\^²;\n  2. Participants with severe renal impairment (Group A): \\\u003C30 mL\u002Fmin\u002F1.73m\\^², not requiring dialysis;\n  3. CLcr must be stable with \\\u003C30% deviation allowed from screening to Day -1 (Baseline). Participants shifting outside the prospected renal function category (normal renal function or severe renal function) on Day-1 Baseline need to be agreed by Taiho medical expert whether they are allowed to remain in the original category that was assessed at screening.\n* No major surgery within 30 days of first administration of oral decitabine and cedazuridine.\n* Life expectancy of at least 3 months.\n* Women of childbearing potential (according to recommendations of the Clinical Trial Facilitation Group) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening.\n* Women of childbearing potential must agree to practice 1 highly effective contraceptive measure of birth control with low user dependency and must agree not to become pregnant for 6 months after completing treatment.\n* Male participants with female partners of childbearing potential must agree to use a male condom and advise his partner to practice 1 highly effective contraceptive measure of birth control (user dependent or with low user dependency) and must agree not to father a child while receiving treatment with oral decitabine and cedazuridine for at least 3 months after completing treatment.\n\nExclusion Criteria:\n\n* Treatment with azacitidine or decitabine within 4 weeks before Screening. Prior cytotoxic chemotherapy for AML except for hydroxyurea to control high white blood cell (WBC) counts.\n* Hospitalization for more than 2 days for documented febrile neutropenia, pneumonia, sepsis, or systemic infection 30 days prior to first dose.\n* Treatment with any investigational medicinal product (IMP), investigational therapy, chemotherapy, immunotherapy, or targeted therapy within 2 weeks or 5 half-lives, whichever is longer, before the first dose of study treatment, or ongoing clinically significant adverse events from previous treatment.\n* Concurrent MDS therapies, including lenalidomide, cyclosporine\u002Ftacrolimus, granulocyte-colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment. Short-term use of G-CSF for febrile neutropenia is permitted at the discretion of the treating physician and should be guided by accepted practice or institutional guidelines. Hematopoietic growth factors will not be routinely used unless cleared by Taiho medical expert.\n* Administration of live (attenuated) vaccines within 4 weeks before the first administration of oral decitabine and cedazuridine until after the follow-up visit. Other vaccines, e.g., inactivated or ribonucleic acid (RNA)-based, may be administered but should not occur from 7 days before first administration of oral decitabine and cedazuridine until after the follow-up visit.\n* High medical risk because of other conditions such as uncontrolled systemic diseases, active uncontrolled infections, or comorbidities that may put the participants at risk of not being able to complete 1 cycle of treatment.\n* Conditions which likely promote delayed ventricular repolarization (QT prolongation):\n\n  1. Corrected QT interval (QTc) using Fridericia's correction (QTcF) at Screening or Day -1 \\>470 milliseconds (ms) for males and \\>480 ms for females or\n  2. History or disposition for torsades des pointes (TdP) (e.g., heart failure, hypokalemia, family history of long QT Syndrome) or\n  3. Concomitant medications that prolong the QT\u002FQTc interval\n* Cardiac abnormalities or unstable cardiovascular conditions:\n\n  1. Unstable ischemic heart disease or severe heart failure (New York Heart Association Class III or IV) or\n  2. Uncontrolled treated\u002Funtreated hypertension (defined as a mean of 3 repeated measurements for systolic blood pressure ≥ 180 millimeters of mercury (mmHg) and\u002For diastolic blood pressure ≥ 110 mmHg; current or documented history of repeated clinically significant hypotension or severe episodes of orthostatic hypotension (systolic blood pressure \\\u003C90 mmHg and\u002For diastolic blood pressure \\\u003C50 mmHg).\n* Known significant mental illness or other condition, such as active alcohol or other substance abuse or addiction, that in the opinion of the investigator predisposes the participants to high risk of noncompliance with the protocol.\n* In participants with AML\u002FMDS, rapidly progressive or highly proliferative disease or other criteria that render the participants at high risk of requiring intensive cytotoxic chemotherapy within the next 3 months.\n* Life-threatening illness or severe organ system dysfunction, such as uncontrolled congestive heart failure or chronic obstructive pulmonary disease, or other reasons including laboratory abnormalities, that in the investigator opinion, could compromise the participant safety, interfere with the absorption or metabolism of oral decitabine and cedazuridine, or compromise completion of the study or integrity of the study outcomes.\n* Untreated central nervous system (CNS) metastases. Participants with treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks before screening.\n* Participants infected with human immunodeficiency virus (HIV).\n* Participants with active hepatitis B or hepatitis C infection.\n* History of alcohol abuse or drug addiction (including soft drugs like cannabis products).\n* Average intake of more than 24 units of alcohol per week for male participants and 17 units per week for female participants (1 unit of alcohol equals 10 milliliters (mL) of pure alcohol, i.e., approximately 250 mL of beer, 75 mL of wine or 25 mL of spirits).\n* Donation or loss of more than 500 mL of blood within 60 days prior to the first study drug administration.\n* Hypersensitivity to decitabine, cedazuridine, or any of the excipients in oral decitabine and cedazuridine.",{"count":363,"type":22},18,[89],"This is a Phase 1b, multicenter, open-label, PK, and safety study of multiple oral doses of oral decitabine and cedazuridine (formerly known as ASTX727) as a fixed-dose combination of decitabine 35 milligrams (mg) and cedazuridine 100 mg in cancer participants with severe renal impairment and cancer participants with normal renal function as matched control participants. Adult participants with acute myeloid lymphoma (AML), myelodysplastic syndrome (MDS), or solid tumors who are candidates to receive oral decitabine and cedazuridine will be enrolled in this study. Study duration per participant is approximately up to 8 weeks.",[344,345],{"date":348,"type":39},{"date":369,"type":39},"2021-12-15",{"date":352,"type":22},{"name":354,"class":46},21,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":395},"100551953","phase-3-a-phase-3-study-of-efepoetin-alfa-for-treatment-of-anemia-in-patients-with-chronic-kidney-disease-on-dialysis-100551953","NCT06466785","A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","A Phase III, Randomized, Investigator-Blinded, Active-Controlled Study of Efficacy and Safety of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","Inclusion Criteria:\n\n1. Adult males and females ≥ 18 years old.\n2. Patient (or patient's legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.\n3. Patient with stage 5 CKD defined by estimated GFR (eGFR, ≤15 mL\u002Fmin\u002F1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. \\*CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.\n4. Hemodialysis patients with single-pool Kt\u002FV ≥ 1.2 or urea reduction ratio ≥ 65%.\n\n   \\*Single-pool Kt\u002FV or urea reduction ratio will be based on results measured within 4 weeks prior to screening or during the screening period.\n5. Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1.\n\n   Minimum ESA dose;\n   * Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U\u002Fweek\n   * Darbepoetin alfa: ≥20 µg\u002Fweek\n   * Mircera®: ≥30 µg\u002F2 weeks\n6. Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart, must be 9.0 g\u002FdL to 12.0 g\u002FdL, inclusive, with a difference of ≤1.5 g\u002FdL between the highest and the lowest value.\n7. Patients with serum ferritin ≥100 ng\u002FmL at screening.\n8. Patients with transferrin saturation (TSAT) ≥20% at screening.\n9. Serum folate concentrations ≥lower limit of normal (LLN) at screening.\n10. Serum total vitamin B12 concentrations ≥LLN at screening.\n\nExclusion Criteria:\n\n1. Active acute or chronic infection, or uncontrolled or symptomatic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (e.g., systemic lupus erythematosus, rheumatoid arthritis, celiac disease), or a C reactive protein level 40\\> mg\u002FL (high sensitive C-reactive protein level \\> 10 mg\u002FL).\n2. By history or current clinical evidence, patients with active acute hepatitis B virus (HBV) or hepatitis C virus (HCV) infection should be excluded. Routine screening for HBV, HCV, and human immunodeficiency virus (HIV) infection is not required in this protocol. Chronic HBV\u002FHCV infection with liver function tests (LFT) \\>3 times of normal are excluded. Known HIV positive patients are excluded.\n3. History or clinical evidence of cardiovascular, hematologic, hepatic, or any physical conditions that, in the opinion of the Investigator, would compromise participation in the study.\n4. Any of the following laboratory abnormalities at screening visit;\n\n   * Alanine transaminase (ALT) \\>3 x upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) \\>3 x ULN\n   * Total bilirubin \\>1.5 x ULN\n5. Chronic congestive heart failure (New York Heart Association class III or IV).\n6. High risk for early withdrawal or interruption of the study (due to myocardial infarction, severe or unstable coronary artery disease, stroke, or severe liver disease) within the 12 weeks before Screening or during Screening.\n7. Uncontrolled hypertension defined as a sitting systolic blood pressure ≥170 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n8. History of active malignancy except for cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, or in situ cancer at any site.\n9. Patients with a history of overt gastrointestinal bleeding or any other bleeding episode associated with a fall in Hb of ≥1 g\u002FdL within the last 8 weeks prior to Screening.\n10. Known history of myelodysplastic syndrome, multiple myeloma, hereditary hematologic disease such as thalassemia, sickle cell anemia, pure red cell aplasia, or other known causes for anemia other than CKD, hemosiderosis, hemochromatosis, known coagulation disorder, or hypercoagulable condition.\n11. Any prior functioning organ transplant or a scheduled organ transplantation, or anephric state (one or both kidneys).\n12. Planned elective surgery that could lead to significant blood loss during the study period.\n13. Hypoalbuminemia (Serum albumin \\\u003C2.5 g\u002FdL) at Screening Visit.\n14. Androgen, deferoxamine, deferiprone, or deferasirox therapy within 12 weeks prior to Day 1.\n15. Life expectancy of \\\u003C12 months.\n16. Cognitive or psychiatric condition rendering the patient unable to be cooperative with and complete study requirements.\n17. Hypersensitivity to any one of the investigational drugs or its excipients.\n18. Received a blood transfusion (including RBC transfusion) within the 12 weeks prior to Screening, or blood transfusion is anticipated during the study period (excluding temporary blood transfusion given in case of blood loss due to accident or surgery).\n19. Immunosuppressive therapy (tacrolimus\u002Fcyclosporine, and other than corticosteroids for a chronic condition) within 12 weeks prior to Day 1.\n20. History of alcohol or drug abuse within the past 2 years and inability to avoid consumption of more than \\>3 alcoholic beverages per day.\n21. Use of an investigational medication or treatment, participation in an investigational interventional study, or carryover effect of an investigational treatment expected during the study.\n22. Females of childbearing potential or males who are unable\u002Funwilling to take adequate contraceptive precautions defined by the protocol for the duration of the study and for at least 4 months for male subjects and 7 months for female patients after the end of the study. Females with a positive pregnancy test result within 24 hours prior to study entry, are otherwise known to be pregnant, plan to become pregnant in the next 12 months or are currently breastfeeding.\n23. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Sponsor or clinical research organization (CRO) employees directly involved in the conduct of the study.\n24. Patients with very limited functional capacity for which a target Hb value of 12 g\u002FdL may have a lower benefit\u002Frisk ratio.\n25. Any medical condition (patients weighing over 150 kg) that, in the opinion of the Investigator, may pose a safety risk to a patient in this study, may confound efficacy or safety assessment, or may interfere with study participation",{"count":381,"type":22},429,[58],"An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis",[385],"Anemia of Chronic Kidney Disease","2026-05-20",{"date":388,"type":39},"2026-05-22",{"date":390,"type":39},"2024-01-25",{"date":392,"type":22},"2028-03",{"name":394,"class":46},"Genexine, Inc.",58,{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":401,"acronym":4,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100568910","phase-3-a-study-to-compare-pharmacokinetics-efficacy-safety-and-immunogenicity-of-mb12-proposed-pembrolizumab-biosimilar-to-keytruda-in-non-small-cell-lung-cancer-benito-study-100568910","NCT06687369","A Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) to Keytruda® in Non-small Cell Lung Cancer (BENITO Study)","Randomized, Multicenter, Multinational, Double-Blind Study to Compare the Pharmacokinetics, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Combination With Chemotherapy for the Treatment of Patients With Advanced Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) (BENITO Study)","Inclusion Criteria:\n\n1. Adult male\u002Ffemale patients ≥18 years old at the time of signing the informed consent form (ICF).\n2. Histologic or cytologic diagnosis of advanced NSCLC, stage IV (defined by the 8th edition of the Tumor Node Metastasis \\[TNM\\] classification), with no EGFR sensitizing (activating) mutation or ALK translocation, and who have not received prior systemic treatment for metastatic NSCLC. In those patients in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n3. At least 1 radiographically measurable lesion according to response evaluation criteria in solid tumors (RECIST) 1.1.\n4. Known status of PD-L1 expression.\n5. Performance based on the Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n6. Adequate hepatic, renal, hematologic, endocrine, and coagulation function.\n\nExclusion Criteria:\n\n1. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the patient is not eligible.\n2. Known history of central nervous system metastases and\u002For carcinomatous meningitis.\n3. Prior anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated protein (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co-stimulation of T-cells or immune checkpoints).\n4. Major surgery within 3 weeks of the first dose of study treatment.\n5. Active autoimmune disease that has required systemic treatment in the last 2 years.\n6. Contraindication and\u002For intolerance to the administration of pembrolizumab or known sensitivity to any component of pembrolizumab.\n7. Has a known sensitivity to any component of cisplatin, carboplatin, or pemetrexed.",{"count":404,"type":22},726,[58],"This is a randomized, multicenter, multinational, double-blind, integrated pharmacokinetics (PK) and efficacy similarity study to compare the PK, efficacy, safety, and immunogenicity of MB12 versus Keytruda® in combination with pemetrexed-platinum chemotherapy as first-line treatment in patients with metastatic non-squamous NSCLC.",[408],"Non Squamous Non Small Cell Lung Cancer","2026-03-10",{"date":411,"type":39},"2026-03-11",{"date":413,"type":39},"2024-12-30",{"date":415,"type":22},"2027-09",{"name":417,"class":46},"mAbxience Research S.L.",151,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":426,"targetDuration":233,"studyType":142,"phases":4,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":224},"100571079","cardiac-angiosarcoma-international-registry-100571079","NCT06715579","Cardiac Angiosarcoma International Registry","CAIR","Inclusion Criteria:\n\n* Histological Confirmation: A confirmed diagnosis of cardiac angiosarcoma through histopathological examination, including subtypes such as hemangiosarcoma and epithelioid hemangiosarcoma.\n* Diagnosis Timing: Eligible patients must have been diagnosed between January 2015 and January 2035.\n* Geographical Representation: Participants should be from diverse geographical locations to ensure a comprehensive understanding of the disease across different populations.\n* Treatment Status: Patients who have received any treatment (surgery, chemotherapy, immunotherapy or radiation) for cardiac angiosarcoma may be included to evaluate treatment outcomes.\n* Informed Consent: For prospective patients, informed consent must be obtained before they are included in the registry.\n* Clinical Data Availability: Relevant clinical data, including demographics, tumor characteristics (size, location), treatment regimens, and outcomes, must be available for analysis.\n* Follow-Up Willingness: Participants should be willing to undergo follow-up assessments as part of the registry's data collection efforts.\n\nExclusion Criteria:\n\n* Patients who decline to provide informed consent.\n* Cases where cardiac involvement is secondary to another primary malignancy",{"count":427,"type":22},500,"Primary cardiac angiosarcomas (PCA) are highly aggressive malignant heart tumors arising from the endothelial cells (ECs) lining the blood vessels of the heart and account for approximately 25%-30% of all primary cardiac malignancies. It is considered to be the most fatal and aggressive primary cardiac malignancy. This international registry aims to establish a large multicenter database of patients with cardiac angiosarcoma. Our objectives are:\n\n1. Collect clinical data, including demographics, medical history, treatments, and outcomes, to build a comprehensive database.\n2. Analyze data to evaluate and identify genetic, environmental, or lifestyle risk factors for cardiac angiosarcoma.\n3. Evaluate the effectiveness of various treatments (surgery, chemotherapy, immunotherapy, radiation) to inform best practices.\n4. Develop evidence-based guidelines and recommendations for prevention, diagnosis, treatment, and management based on registry data.",[430],"Cardiac Angiosarcoma",[430,432,433,434,435],"Angiosarcoma","Hemangiosarcoma","Epithelioid Hemangiosarcoma","Primary Cardiac Sarcoma","2026-02-15",{"date":438,"type":39},"2026-02-18",{"date":440,"type":39},"2025-05-01",{"date":442,"type":22},"2035-05",{"name":223,"class":153},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":461,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":472,"locationsCount":182},"100617936","phase-1-pvek-corneal-implant-for-treatment-of-corneal-edema-100617936","NCT07325097","PVEK Corneal Implant For Treatment of Corneal Edema","A Prospective, Single Arm Study to Assess the Safety and Tolerability of PVEK Corneal Implant for the Treatment of Corneal Edema","CIFRE","Inclusion Criteria:\n\nage 18\u002F50 years or older\n\nCorneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and\u002For pseudophakic bullous keratopathy\n\nPseudophakic study eye\n\nBest corrected visual acuity (BCVA) in the study eye between 6\u002F379 (1.8 logMAR) and 6\u002F12 (0.3 logMAR)\n\nCentral corneal thickness greater than 0.6 mm by OCT\n\nExclusion Criteria:\n\nPhakic study eye\n\nStudy eye is a \"single sight eye\" (per protocol definition) \u002F fellow eye does not meet protocol vision requirement\n\nMalpositioned intraocular lens (dislocation\u002Fsubluxation) in the study eye\n\nPrior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL\n\nAxial length below 21 mm or above 26 mm\n\nOther significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring\u002Fopacities not expected to improve with treatment\n\nActive ocular or eyelid infection\u002Finflammation; active\u002Fprior herpetic ocular infection; uveitis\n\nGlaucoma \u002F history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye)\n\nSynechiae; abnormal anterior segment (e.g., aphakia, aniridia)\n\nCorneal endothelial cell density above 1000 cells\u002Fmm² at screening (or not reliably measurable)\n\nUncontrolled systemic conditions",{"count":453,"type":22},15,[89],"The goal of this clinical trial is to learn if PVEK, a corneal implant , is safe and well tolerated for people with corneal swelling caused by Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty.\n\nThe main questions it aims to answer are:\n\nWhat side effects may happen after the PVEK implant?\n\nHow many participants can complete the first 6 months after surgery without needing another treatment because the implant did not help enough or was not tolerable?\n\nThis is a Phase 1 (first-in-human) study with one study group, meaning all participants receive the PVEK implant (there is no placebo or comparison group). About 15 participants will take part and will be followed for up to 12 months after surgery.\n\nParticipants will:\n\nComplete screening tests (including eye exams and routine health checks)\n\nHave the PVEK implantation surgery\n\nUse prescribed eye drops after surgery\n\nReturn for follow-up visits over the next 12 months for eye exams and tests (such as vision testing, eye pressure checks, and eye scans)",[457,458,459,460],"Corneal Edema","Fuchs' Endothelial Dystrophy","Pseudophakic Bullous Keratopathy","Corneal Endothelial Dysfunction",[462,463,464,465],"Endothelial keratoplasty","Tissue-engineered corneal implant","Corneal endothelial cells","Collagen scaffold","2026-01-08",{"date":468,"type":39},"2026-01-12",{"date":470,"type":39},"2025-09-16",{"date":415,"type":22},{"name":473,"class":46},"Precise Bio",{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":18,"minAge":252,"maxAge":253,"enrollmentInfo":481,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":483,"conditions":484,"keywords":490,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":509},"100611871","caya-cancer-retrospective-cohort-study-100611871","NCT07246213","CAYA Cancer Retrospective Cohort Study","Improving Cancer Outcomes for Children, Adolescents, and Young Adults: A Multicenter Retrospective Cohort Study on Treatment Failure and Toxicity in Low- and Middle-Income Countries","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this registry:\n\n1. Participants must be willing and able to provide informed consent prior to enrollment in the registry.\n\n   1. For minors or individuals unable to provide informed consent, assent must be obtained along with consent from a legal guardian.\n   2. Note: Exemption applies to this criterion when waiver of informed consent\u002Fassent is granted by Institutional Review Board(IRB)\u002FIndependent Ethics Committee(IEC)\u002FCompetent Authorities(CAs).\n2. A confirmed diagnosis of any type of cancer within the 15 years prior to the site's activation date.\n3. Age 0 to 21 years at the time of diagnosis.\n4. Received substantial anti-cancer treatment at the participating center, including but not limited to:\n\n   1. Chemotherapy\n   2. Surgery\n   3. Radiation therapy\n   4. Immunotherapy\n5. Medical records are available and accessible for review\n\nExclusion Criteria:\n\n* Subjects meeting any of the following criteria will be excluded from this registry:\n\n  1. Patients who only visited the participating center for:\n\n     1. Consultation without subsequent primary anti-cancer treatment at the participating center\n     2. Pathology, radiology, or other diagnostic evaluations without treatment",{"count":482,"type":22},18000,"Despite advances in cancer treatment, significant disparities in outcomes persist between high-income countries (HICs) and low-and middle-income countries (LMICs). Around 80% of children with cancer live in LMICs, where they face challenges such as delayed diagnosis, misdiagnosis, comorbidities, distance to treatment, financial barriers, and limited access to risk-adapted therapies.\n\nAcute lymphoblastic leukemia(ALL)\u002Flymphoblastic lymphoma(LBL), for example, is one of the greatest success stories in pediatric oncology, however, such improvements are not evenly distributed worldwide, and the outcomes for leukemia patients are poorer in LMICs compared to HICs, primarily due to reduced access to quality healthcare.\n\nThis study aims to assess cancer treatment outcomes in LMICs, focusing on acute lymphoblastic leukemia\u002Flymphoblastic lymphoma. The findings will inform future studies to implement evidence-based interventions that improve care quality and reduce treatment failures through targeted strategies.",[485,486,487,488,489,261,260],"Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Young Adult Cancer","Adolescent Cancer","Childhood Cancers",[491,492,493,494,495,496,497,498,499,500],"Cancer outcomes","Low- and Middle-Income Countries (LMICs)","Childhood cancer","Adolescent and young adult cancer (CAYA)","Treatment failure","Therapy-related toxicities","Retrospective cohort","Leukemia outcomes","Oncology disparities","High-Income Countries (HICs)","2025-12-12",{"date":503,"type":39},"2025-12-19",{"date":505,"type":39},"2025-06-04",{"date":507,"type":22},"2028-12-04",{"name":281,"class":153},5,{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":515,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":111,"enrollmentInfo":517,"targetDuration":4,"studyType":23,"phases":518,"briefSummary":519,"conditions":520,"keywords":522,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":529,"leadSponsor":531,"locationsCount":533},"100593085","endovascular-therapy-for-late-window-ischemic-stroke-patients-selected-by-automatic-plain-computerized-tomography-100593085","NCT07001852","EnDOvascular Therapy for Late WiNdow IschEmic Stroke Patients Selected bY AutoMatic Plain ComputErized Tomography","DONE SYMPLE","Inclusion Criteria:\n\n1. 18 to 80 years of age:\n\n   1. Pre-stroke score (mRS) of 0-1 in participants aged 18 to 70 years.\n   2. Pre-stroke Modified Rankin Scale (mRS) score of 0 in participants older than 70 years.\n2. Presenting with signs and symptoms consistent with an acute ischemic stroke within 24-72 hours from last known well. \\*\n3. Baseline NIHSS ≥8.\n4. NCCT imaging indicating the existence of an anterior circulation LVO by an automated software, or CTA (when available).\n5. Core volume ≤ 70 cc determined by a deep learning algorithm in automated software and\u002For ASPECTS scoring ≥ 6. \\*\\*\n6. Arterial puncture within 72 hours (after the first symptoms or LKW).\n7. Arterial puncture within 90 minutes from initial CT.\n8. Ability to randomize within 72 hours after stroke onset (last seen well).\n9. Ability to obtain signed informed consent or subject's Legally Authorized representative (LAR) has signed Consent form \\*\\*\\*\n\n   * Patients in the 6-24-hour after Last Known Well (LKW) may be enrolled only in centers where thrombectomy is not offered as standard of care due to the absence of advanced imaging capabilities.\n\n     * In cases of discrepancy between the automated tool LVO detection and volume, and ASPECT Score or CTA judgment or Computed Tomography Angiography CTA findings, ASPECTS and CTA will take precedence.\n\n       * If approved by local ethics committee and country regulations, the investigator is allowed to enroll a patient utilizing emergency informed consent procedures if neither the patient nor the representative or person of trust is available to sign the informed consent form. However, as soon as possible, the patient is informed, and his\u002Fher consent is requested for the possible continuation of this research.\n\nExclusion Criteria:\n\n1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test.\n2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications.\n3. Refractory hypertension (defined as persistent systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg) despite medication.\n4. CT evidence of the following conditions:\n\n   * Midline shift or herniation.\n   * Evidence of intracranial hemorrhage.\n   * Mass effect with effacement of the ventricles.\n5. Bilateral strokes.\n6. Clot retrieval previously attempted \\\u003C6 hours.\n7. Treated with thrombolytics \\>4.5 hours after last seen well.\n8. Intracranial tumors.\n9. Life expectancy less than 90 days prior to stroke onset.\n10. Participation in another randomized clinical trial that could confound the evaluation of the study.\n11. Presumed septic embolus, or suspicion of bacterial endocarditis.\n12. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).\n13. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed.",{"count":427,"type":22},[165],"The DONE SYMPLE Investigator-initiated phase III prospective, randomized, open-label, blinded endpoint-controlled clinical trial.\n\nThis clinical trial is a global clinical study testing whether a procedure called endovascular therapy, which removes blood clots from blocked brain arteries, can safely benefit more stroke patients when used up to 72 hours after symptoms begin. Endovacular Therapy is already proven to improve recovery in patients treated within 6 hours, but only when advanced imaging like Computed Tomography (CT) perfusion or Magnetic Resonance Imaging (MRI) is available to guide treatment. Unfortunately, many hospitals, specially in underserved areas, do not have access to this type of imaging.\n\nThis trial will investigate whether a basic brain scan called non-contrast CT, which is widely available in hospitals around the world, can be used instead. Special software will automatically analyze the CT scan to help doctors decide if a patient has enough brain tissue left to save with Endovascular Therapy. If this simpler approach works, it could expand access to lifesaving stroke care for more people globally.\n\nThe study will enroll 500 adult stroke patients, ages 18 to 80, with a large vessel blockage in the brain's anterior circulation, moderate to severe stroke symptoms, and who are between 6 and 72 hours from when they were last known to be well. All participants will undergo CT imaging analyzed by the automated software. If the scan shows a small core of already damaged brain tissue and a larger area of threatened but still viable brain, the patient will qualify.\n\nParticipants will be randomly assigned to receive either standard medical therapy alone or medical therapy plus Endovasculat Therapy which involves inserting a catheter through a blood vessel to reach the brain and using a device to remove the clot. This procedure is performed by trained stroke or neurointerventional specialists. The study is \"open-label,\" meaning patients and doctors know which treatment is given, but the assessment of patient recovery will be done by independent reviewers who do not know the group assignments.\n\nThe primary goal is to determine if patients who receive Endovascular Therapy have better recovery at 90 days, measured by a scale called the modified Rankin Scale, which assesses how much disability a patient has after a stroke. The trial will also look at safety (especially brain bleeding after treatment), size and growth of brain injury on follow-up scans, recovery of strength and language, and overall quality of life and survival. Imaging will be reviewed centrally by a specialized team, and results will be analyzed to see how well Endovascular Therapy performs using this new patient selection method.\n\nThe DONE SYMPLE Trial is sponsored by Foundacio Ictus in Barcelona Spain and the University of Iowa is the Central Coordinating Center for the Study. It will take place at up to 20 hospitals worldwide. All patients will be followed closely with exams and imaging at specific time points up to 90 days after treatment.\n\nIf successful, this trial could change stroke care around the world by proving that Endovascular Therapy can be used safely and effectively even without advanced imaging, using tools available in most hospitals. This could help more stroke patients, especially in rural or resource-limited areas, access treatments that may improve their chances of recovery and reduce long-term disability.",[521],"Stroke Acute",[523,524],"large vessel occlusion","Acute Ischemic Stroke","2025-10-14",{"date":527,"type":39},"2025-10-16",{"date":525,"type":39},{"date":530,"type":22},"2029-07-01",{"name":532,"class":153},"Santiago Ortega Gutierrez",2,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":311,"sex":541,"minAge":85,"maxAge":542,"enrollmentInfo":543,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":224},"100605007","phase-1-a-comparative-bioavailability-study-of-tamsulosin-04-mg-prolonged-release-tablets-versus-the-reference-drug-omnic-ocas-tamsulosin-hydrochloride-04-mg-prolonged-release-film-coated-tablets-in-healthy-adult-male-subjects-under-fasting-conditions-100605007","NCT07156916","A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions","A Prospective, Randomised, Open Label, Single Dose, Two-treatment, Two-period, Two-sequence, Crossover Bioequivalence Study of Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Tablets (Synthon Hispania SL, Spain) Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets (Astellas Pharma Europe B.V., the Netherlands), in Healthy Adult Male Subjects, Under Fasting Conditions","Inclusion Criteria:\n\n1. Capable of understanding the informed consent form (ICF) and giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n2. Healthy male subjects aged 18 to 45 years inclusive, at the time of signing the ICF, able to tolerate venipuncture.\n3. Verified diagnosis of being \"healthy\" according to results of standard clinical, laboratory and instrumental methods of examination.\n4. Body weight ≥50 kg and ≤ 120 kg, Body Mass Index between ≥18.5 and ≤30.0 kg\u002Fm2.\n5. Non-smokers (for at least 3 months).\n6. Subjects should be willing to remain abstinent (refrain from heterosexual intercourse) or use double barrier contraception during participation in the study and for 30 days thereafter. Double-barrier contraceptive method: condom used together with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository.\n\nExclusion Criteria:\n\n1. History or presence of allergies.\n2. Known hypersensitivity or intolerance to tamsulosin and\u002For other alpha 1 adreno-receptor antagonists and\u002For any other excipient of the study drugs.\n3. History of drug-induced angioedema.\n4. History, presence or necessity of glaucoma or cataract surgery.\n5. History or presence of acute or chronic diseases of cardiovascular (including arterial hypotension), bronchopulmonary, nervous, endocrine, reproductive systems (including ejaculation disorders), and also diseases of the gastrointestinal tract, liver (including hepatic insufficiency), urinary tract and kidneys (including renal insufficiency), blood, mental diseases; history of convulsive attacks.\n6. Acute infectious diseases (e.g. influenza, acute respiratory viral infections incl. COVID-19) less than 4 weeks before the first IMP administration.\n7. The presence of any other condition which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results, or the subject's ability to participate in the study.\n8. Surgery on the gastrointestinal tract (except appendectomy).\n9. Deviations from the normal parameters in clinical blood count analysis, biochemical blood analysis, urinalysis.\n10. History or presence of orthostatic hypotension or syncope.\n11. Systolic blood pressure measured in a sitting position, less than 100 mmHg or above 130 mmHg and\u002For diastolic blood pressure below 60 mmHg or above 89 mmHg.\n12. Heart rate less than 60 or more than 80 beats per minute.\n13. Deviation on the ECG intervals and heart rate or ECG morphology.\n14. Positive test results for HIV or hepatitis B or C or syphilis at screening.\n15. Positive test result for cotinine in the urine at screening or before randomisation.\n16. Positive screen for drugs or alcohol at screening or before randomisation.\n17. Known or suspected drug or alcohol abuse as judged by the Investigator.\n18. Alcohol consumption more than 10 units of alcohol a week (1 unit equivalent to 200 ml of dry wine or 50 ml of strong alcoholic drinks or 500 ml of beer) during the six months prior to the first administration of the IMP.\n19. Intake of xanthine containing substances (e.g., coffee, tea, chocolate, energy drinks, cola) as well as citrus fruits (grapefruit, grapefruit juice etc.) and cranberry (including juices, fruit drinks, etc.) within the last 72 hours before the IMP administration.\n20. Administration of medicines that have a significant effect on circulatory dynamics, liver function, etc. (barbiturates, omeprazol, cimetidin, NSAIDs, ACE inhibitors, angiotensin II receptor antagonists, diuretics, etc.) less than 2 months or 5 half-lives (whatever is longer) before screening.\n21. The use of depot-forms of any drugs for 3 months or 5 half-lives (whatever is longer) before screening.\n22. Use of any prescribed or non-prescribed medication, herbal remedies, vitamins and minerals during the two weeks prior to the first administration of the IMP or longer (at least 5 elimination half-lives) if the medication has a long half-life.\n23. Mental, physical and other reasons that do not allow the subjects according to investigator's opinion to assess their behavior adequately, to follow correctly the requirements of the clinical study protocol and to assess the expected risks and possible discomfort.\n24. Dehydration (e.g. due to diarrhea, vomiting, or other causes) within the last 48 hours before the IMP administration.\n25. Subjects who have been on a special diet (for whatever reason, e.g. vegetarians or hypocaloric diet \\[less than 1000 cal\u002Fday\\]) during the 28 days prior to the first IMP administration and intention to maintain the diet during the study.\n26. Intention to perform excessive physical activities during the trial.\n27. Plasma donation within one month from screening or blood donation\u002Fblood loss \\>500 ml within 3 months before screening.\n28. Unwillingness or inability to follow the procedures and restrictions outlined in the protocol and the ICF.\n29. Participation in another clinical study within 3 months before the first IMP administration.\n30. Difficulty swallowing tablets or fasting or consuming standard meals.\n31. Any reason in the opinion of the Investigator, would prevent the subject from participating in the study.\n32. Scheduled to have vaccination during the study.","MALE","45 Years",{"count":544,"type":22},46,[89],"The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg, prolonged-release film-coated tablets (Astellas Pharma Europe B.V., the Netherlands), after single dose administration in healthy adult male subjects under fasting conditions.",[548],"Healthy Volunteer Male Subjects",[550,551],"Bioequivalence","Tamsulosin","2025-10-02",{"date":554,"type":39},"2025-10-03",{"date":556,"type":39},"2025-09-08",{"date":558,"type":22},"2026-05-01",{"name":560,"class":46},"Berlin-Chemie AG Menarini Group",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":311,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":570,"conditions":571,"keywords":575,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":596,"locationsCount":598},"100546453","low-dead-space-injecting-equipment-distribution-program-for-people-who-inject-drugs-in-low--and-middle-income-countries-100546453","NCT06395129","Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries","Implementing a Low Dead-space Injecting Equipment Distribution Program for People Who Inject Drugs in Low- and Middle-income Countries: a Process and Outcome Evaluation","Inclusion Criteria:\n\n* Aged ≥18 years (note that country-specific protocols may include participants aged ≥16 where appropriate and relevant);\n* Reporting a history of recent (past month) injection drug use;\n* Accessing the NSP to receive injecting equipment at either a facility, mobile service or through outreach and have an accompanying assigned program unique ID;\n* Able to understand and communicate in the local language(s);\n* If self-reporting HCV\u002FHIV negative status, interested in and agreeing to undergo HCV and HIV testing; and\n* Willing and able to provide informed consent to take part in the study.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":569,"type":22},2400,"Implementation and evaluation of a distribution program for low dead-space syringes\u002Fneedles (LDSS\u002FN) in Armenia, Georgia, and Tanzania, Egypt, Nigeria, Vietnam, India, Ukraine, and South Africa. This study aims to generate evidence on best practice LDSS\u002FN distribution programs which will enhance acceptability and sustain high levels of LDSS\u002FN uptake.\n\nPeople who inject drugs and access needle and syringe programs will be invited to attend up to three focus group discussion rounds (with 25 participants in each focus group round) to inform and provide feedback on a concurrent distribution program of LDSS\u002FN.\n\nThroughout distribution, a cohort study will be run alongside distribution with 240 participants enrolled per country (with the exception of Nigeria, where 480 participants will be recruited) who will undergo HIV and HCV testing and answer surveys on their sociodemographic and behavioral status. Key informant interviews will also be held with participating staff and stakeholders to evaluate the feasibility and acceptability of this program.\n\nPrimary outcomes assessed through this study include 1) community values and preferences for LDSS\u002FN, 2) barriers and facilitators to accessing LDSS\u002FN, 3) feasibility and effectiveness of the distribution program on increasing LDSS\u002FN uptake, 4) model the potential public health impact and cost effectiveness of LDSS\u002FN distribution in this setting.",[572,573,574],"Drug Use","Hepatitis","Hiv",[576,577,578,579,580,581,582,583,584,585,586,587,588,589],"Low dead-space needles and syringes","Qualitative interviews","LDSS\u002FN","High dead space needles\u002Fsyringes (HDSS\u002FN)","Rapid diagnostic test (RDT)","Feasibility","Acceptability","Cost effectiveness","Modelling","Focus group discussions","Harm Reduction","Values and preferences","Needle and syringe exchange program","Blood borne virus","2025-09-25",{"date":592,"type":39},"2025-10-01",{"date":594,"type":39},"2024-09-13",{"date":352,"type":22},{"name":597,"class":153},"Médecins du Monde",9,{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":23,"phases":609,"briefSummary":611,"conditions":612,"keywords":615,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":224},"100528341","early-phase-1-simplifying-hepatitis-c-pathways-for-people-who-inject-drugs-in-armenia-georgia-and-tanzania-100528341","NCT06159504","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania","Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (CUTTS HepC): a Non-randomised, Quasiexperimental, Prospective Comparative Trial","CUTTS HepC","Inclusion Criteria:\n\n* 18 years or older\n* Able and willing to provide informed consent in local language\n* Not currently on or previously had treatment for hepatitis C\n* Attending site for needle \u002F syringe program, OR self-reports ever injecting drugs\n\nExclusion Criteria:\n\n* Self-reported history of decompensate cirrhosis of the liver\n* Women who are pregnant or breast-feeding\n* Self-report other significant co-morbidities such as uncontrolled HIV infection, history of renal dysfunction, tuberculosis infection, or chronic hepatitis B infection\n* Unable \u002F unwilling to stop any contraindicated medications \u002F supplements",{"count":608,"type":22},3040,[610],"EARLY_PHASE1","The goal of this non-randomised, quasi-experimental, prospective comparative trial is to trial simplified care pathways for hepatitis C testing and treatment for people who inject drugs in Armenia, Georgia, and Tanzania.\n\nThe main questions it aims to answer are:\n\n1. What is the feasibility of implementing a hepatitis C simplified care and same-day treatment care model in community and harm reduction settings in the three study countries?\n2. Does a same-day treatment initiation model involving only POC antibody tests (with a shortened read-time) increase hepatitis C treatment uptake and SVR12 outcome (cure) among people who inject drugs compared with a simplified care model involving POC antibody followed by a confirmatory RNA test?\n3. What is the comparative cost-effectiveness between a same-day antibody only hepatitis C testing and treatment model and the simplified care model (POC antibody\u002Fconfirmatory RNA test) model?\n\nParticipants will:\n\n* be enrolled in a new simplified model of care in each country (Arm 1). After the enrolment target is met for Arm 1 (approx. 3-9 months into implementation) new participants will be enrolled into a same-day treatment trial, using presumptive treatment after a reactive POC test result at shortened read-time (5minutes) (Arm 2)\n* if in Arm 1, participants will commence SOF-VEL DAA treatment after receiving an RNA test to confirm current hepatitis C infection. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n* if in Arm 2, participants will begin SOF-VEL DAA treatment on the same day as the 5 minute RDT testing. They will then continue along the treatment pathway, returning for RNA testing 4-16 weeks after SVR12 to determine cure.\n\nResearchers will compare cure and participant retention rates between the two groups.",[613,614],"Hepatitis C","RDT",[616,617,577,581,582,618,584],"Point of care (PoC)","Nucleic acid testing","Cost-effectiveness","2025-07-15",{"date":621,"type":39},"2025-07-18",{"date":623,"type":39},"2024-10-03",{"date":352,"type":22},{"name":597,"class":153},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":4,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":18,"minAge":632,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":646},"100493963","rare-embryonal-tumors-of-the-central-nervous-system-international-registry-100493963","NCT05711992","Rare Embryonal Tumors of the Central Nervous System: International Registry","Inclusion Criteria:\n\n* Patients diagnosed with rare embryonal tumors of CNS since 01.01.2010:\n\n  * ETMR (including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma (EBL) and medulloepithelioma (MEPL) which were previously classified as CNS-PNETs)\n  * FOXR2-activated CNS neuroblastoma\n  * cribriform neuroepithelial tumor\n  * CNS tumor with BCOR internal tandem duplication\n  * all patients diagnosed with neuroblastoma and ganglioneuroblastoma with no molecular genetic tests available\n* Patients ≤ 25 years of age\n* Signed informed consent form for prospective patients ≥ 18 years of age\n* Signed parental permission and child assent forms for prospective patients \\\u003C 18 years of age\n\nExclusion Criteria:\n\n• CNS metastases of extracranial embryonal tumors","1 Day","25 Years",{"count":190,"type":22},"Central nervous system (CNS) tumors are the most common solid malignancies among children. Although some types of CNS tumors like medulloblastomas and low-grade gliomas are widespread and well-studied, there is a huge number of rare diseases that need further research. This international registry aims to establish a large multicenter database of pediatric and young adult patients with rare embryonal tumors of the central nervous system and describe the clinical presentations, diagnostics, treatment regimens, and outcomes. Embryonal tumors with multilayered rosettes (ETMR), FOXR2-activated CNS neuroblastoma, cribriform neuroepithelial tumor, and CNS tumor with BCOR internal tandem duplication are extremely rare embryonal tumors some of which were first described in the last edition of the World Health Organization (WHO) Classification of Tumors of the Central Nervous System. Objectives of the registry are 1) to evaluate prognostic factors, 2) to identify diagnostic and treatment gaps, 3) to investigate the characteristics and outcome of the disease with different treatment regimens, and 4) to generate data-based prospective diagnostic and treatment recommendations.",[637],"Embryonal Tumor","2025-05-07",{"date":640,"type":39},"2025-05-08",{"date":642,"type":39},"2023-02-01",{"date":644,"type":22},"2033-02",{"name":223,"class":153},11,{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":653,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":142,"phases":4,"briefSummary":657,"conditions":658,"keywords":668,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":681,"completionDateStruct":683,"leadSponsor":685,"locationsCount":687},"100508736","armenian-nationwide-registry-of-systemic-autoimmune-and-autoinflammatory-diseases-100508736","NCT05904301","Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases","Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases","NAREG","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of at least one of following autoimmune systemic diseases:\n\n   Behcet disease, ANCA -positive vasculitis, Takayasu arteritis, Giant cell arteritis, Systemic sclerosis, Sjogren syndrome, Rheumatoid arthritis, Spondylarthritis (psoriatic, ankylosing, crohn's related), Angioedema hereditary and acquired, Pediatric dermatology, Autoinflammatory diseases (hereditary and acquired), Unexplained infertility, Immune thrombocytopenic purpura\u002F Autoimmune hemolytic anemia (ITP, AHA), Primary anti-phospholipid syndrome (APS), Celiac disease.\n2. Age: major and minor\n3. Patients who have been informed and provided with written informed consent to participate Or consent from legal representative\n\nExclusion Criteria:\n\n1. Patients refusing to participate in the registry\n2. Non-consent from legal representative\n3. Breastfeeding or pregnant patients",{"count":656,"type":22},800,"Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.",[659,660,661,662,663,664,665,666,667],"Behcet Disease","Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis","Takayasu Arteritis","Giant Cell Arteritis","Sjogren's Syndrome","Rheumatoid Arthritis","Hereditary and Acquired Angioedema","Primary Antiphospholipid Syndrome","Celiac Disease",[669,670,671,672,673,674,675,676,677],"arthritis","autoimmune","systemic","autoinflammatory","Behcet","Takayasu","Giant Cell","Angioedema","APS","2025-04-04",{"date":680,"type":39},"2025-04-08",{"date":682,"type":39},"2023-06-21",{"date":684,"type":22},"2028-06-30",{"name":686,"class":153},"Santé Arménie French-Armenian Research Center",6,""]