[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Bosnia and Herzegovina\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":640},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,45,68,95,124,154,191,227,254,277,301,324,354,380,408,431,450,474,497,517,538,569,594,619],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896",false,"NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes","ALL","18 Years","75 Years",{"count":21,"type":22},645,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[28,29,30,31],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative","RECRUITING","2026-08-21",{"date":35,"type":36},"2026-08-25","ACTUAL",{"date":38,"type":36},"2025-05-27",{"date":40,"type":22},"2028-03",{"name":42,"class":43},"Spyre Therapeutics, Inc.","INDUSTRY",267,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100631683","phase-2-a-study-to-evaluate-pharmacokinetics-pk-and-safety-of-subcutaneous-sc-ublituximab-administered-at-various-injection-sites-and-relative-bioavailability-via-autoinjector-ai-versus-syringe-subcutaneously-in-participants-with-multiple-sclerosis-ms-100631683","NCT07503873","A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)","A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis","Inclusion Criteria:\n\n1. Diagnosis of relapsing multiple sclerosis (RMS) (2017 Revised McDonald criteria).\n2. Expanded Disability Status Scale (EDSS) score less than or equal to (≤) 5.5 at screening.\n3. Neurologically stable for more than (\\>) 30 days prior to screening and Day 1.\n4. Female participants of childbearing potential must consent to use an effective method of contraception from consent and for 6 months after the last dose of ublituximab.\n\nExclusion Criteria:\n\n1. Primary-progressive multiple sclerosis (PPMS) or inactive secondary progressive multiple sclerosis (SPMS).\n2. Active chronic disease of the immune system other than MS or immunodeficiency syndrome.\n3. Participants with significantly impaired bone marrow function or significant leukopenia or thrombocytopenia.\n4. Participants who received any approved therapy to treat MS within 5 half-lives of the medication prior to screening.\n5. Treatment with any investigational agent within 5 half-lives of the investigational drug prior to screening.\n6. Females who are pregnant or nursing.\n\nNote: Other protocol-specified Inclusion\u002FExclusion criteria may apply.","65 Years",{"count":54,"type":22},350,[25],"The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC administered with a prefilled pen versus syringe.",[58],"Multiple Sclerosis","2026-08-20",{"date":33,"type":36},{"date":62,"type":36},"2026-04-01",{"date":64,"type":22},"2029-05-30",{"name":66,"class":43},"TG Therapeutics, Inc.",39,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":76,"type":22},162,[25],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[80],"Chronic Inflammatory Demyelinating Polyneuropathy",[80,82,83,84,85,86],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","CIDP","Imeroprubart",{"date":33,"type":36},{"date":89,"type":36},"2025-03-18",{"date":91,"type":22},"2030-05",{"name":93,"class":43},"Immunovant Sciences GmbH",141,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":116,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":123},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","85 Years",{"count":105,"type":22},385,[25],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[29,109],"Crohn's Disease",[111,112,113,114,115,101],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":33,"type":36},{"date":118,"type":36},"2024-07-18",{"date":120,"type":22},"2030-06",{"name":122,"class":43},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":135,"conditions":136,"keywords":140,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100586795","performance-of-the-cardiac-microcurrent-c-mic-system-with-a-less-invasively-placed-left-ventricular-lead-100586795","NCT06920030","Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead","Pilot Study to Investigate the Performance of the Cardiac Microcurrent (C-MIC) System With a Less Invasively Placed Left Ventricular Lead","Inclusion Criteria Idiopathic Dilated Cardiomyopathy with HFrEF:\n\n1. Patients with idiopathic dilated cardiomyopathy who have systolic left ventricular dysfunction despite adequate therapy of heart failure (NYHA III - IV).\n2. Patients who have a baseline left ventricular ejection fraction of ≥25% and ≤35% assessed by corelab.\n\nInclusion Criteria Non-Ischaemic Cardiomyopathy with HFmrEF:\n\n1. Patients with non-ischemic cardiomyopathy with mildly reduced left ventricular ejection fraction despite adequate therapy of heart failure (NYHA III - IV).\n2. Patients who have a baseline left ventricular ejection fraction of \\>40% and \\\u003C50% assessed by corelab.\n\n   Inclusion Criteria for all Patients:\n3. Patients with symptomatic chronic heart failure for more than 1 year and less than 5 years at screening based on the date of diagnosis.\n4. Female and male patients aged ≥18 years - 75 years.\n5. Patient who understands the nature of the procedure and on-going device therapy. Patient is informed about their participation in a chronic clinical trial and about the intended treatment period of 6 months which is derived by the fact that according to current knowledge microcurrent treatment exceeding 6 months will not have additional favorable effects which means it will not further improve cardiac function. Furthermore, the patient is informed about the possibility of device explantation, informed regarding possible risks and is able to give written informed consent prior to any procedures and is considered willing and able to adhere to the study regimen and to return for all follow-up visits.\n6. Patients receiving appropriate, stable guideline directed medical therapy for heart failure at least for the 3 months prior to screening. Stable is defined as no more than a 50% increase or 50% decrease in dose. If the patient is intolerant of guideline recommended doses of heart failure medication, documented evidence must be available.\n\n   Guideline directed medical therapy includes for:\n\n   • Patients with HFrEF:\n\n   \\- Angiotensin-converting enzyme inhibitor (ACE-I) or\n\n   \\- Angiotensin receptor-neprilysin inhibitor (ARNI)\n\n   \\- Beta-blocker\n\n   \\- Mineralocorticoid receptor antagonist (MRA)\n\n   \\- Dapagliflozin\u002FEmpagliflozin inhibitor (SGLT2i)\n   * Patients with HFmrEF - Diuretics (if symptomatic)\n\n     * Dapagliflozin\u002FEmpagliflozin inhibitor (SGLT2i)\n7. Patients who can perform a non-assisted 6-minute walk test.\n8. Patients must have a body mass index within the range of 20 - 36 kg\u002Fm².\n9. Informed consent in writing obtained from patient.\n\nExclusion Criteria:\n\nPatients who are not likely to experience improvement of their chronic heart failure by the microcurrent therapy, because the causes of the disease cannot be influenced even if the patients fulfill the indication for use of the device or if the therapy with the C-MIC System is not possible or might be associated with unknown risks:\n\n1. Patients who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease.\n2. Patients with an indication for a CRT system according to current guidelines.\n3. Patients who have been hospitalized for heart failure which required the use of inotropic support within 30 days before screening.\n4. Patients with systolic blood pressure above 150 mmHg and diastolic blood pressure above 90 mmHg despite optimal antihypertensive medical treatment.\n5. Patients with hemoglobin blood level \\\u003C 12 g\u002Fdl in male and \\\u003C 10 g\u002Fdl in female patients.\n6. Patients with primary pulmonary hypertension\n7. Patients who have genetic connective tissue disease (for example Marfan syndrome).\n8. Patients with a prosthetic tricuspid valve.\n9. Patients in whom access for implantation of the leads cannot be obtained (i.e. known venous occlusion, post radiation therapy).\n10. Patient with other features (i.e. thorax deformity) that in the eyes of the investigator make the straightforward placement of the device seem unlikely.\n11. Patients with a pacemaker, an ICD system, a CRT system or with a CCM system.\n12. Current pregnancy or\n13. Breastfeeding\u002Flactating women\n14. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator) 2 months before and until 1 month after C-MIC therapy.\n\n    Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 2 months before screening.\n15. Patients whose exercise tolerance is limited by a condition other than heart failure (e.g. chronic obstructive pulmonary disease, peripheral vascular 16.\n\nPatients on immunosuppressive therapy. 17.Patie nts with present malignancy. 18. Patients with an active infection considered by the investigator to be unsafe for the patient's participation in the study.\n\n19\\. Patients with renal dysfunction (i.e., estimated glomerular filtration rate \\\u003C45 mL\u002Fmin \u002F1,73 m²). Use the \"CKD-EPI Creatinine Equation (2021)\" as found on https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fgfr\\_calculator.\n\n20\\. Patients with history or presence of relevant liver diseases or hepatic dysfunction as indicated by abnormal liver function tests at screening and baseline: ALT (SGPT), AST (SGOT), γ-GT, alkaline, phosphatase and serum bilirubin \\> 2 × upper limit of normal (ULN). Increase of these liver enzymes caused by cardiac disorders in the absence of other possible causes of liver damage are not meant by this.\n\n21\\. Patients with a history of drug or alcohol abuse within the 12 months prior to screening.\n\n22\\. Patients who, in the opinion of the Principal Investigator, are unlikely to comply with the protocol requirements, instructions and trial related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, psychological illness, and improbability of completing the trial.\n\n23\\. Participation in any study of an investigational device or drug within 90 days prior to planned study.\n\n24\\. Vulnerable Patients (e.g. patients requiring a legal representative, patients kept in detention, any service within the army, and employees of the sponsor or at an investigator site).\n\n25\\. Patients who are not able to avoid the following areas (i.e. due to work):\n\n* Areas with strong magnetic fields\n* Areas with strong external electrical influences\n* Areas with a warning notice \"Access prohibited for pacemaker patients\" or similar.\n* Areas with high temperatures",{"count":132,"type":22},22,[134],"NA","Patients with idiopathic dilated cardiomyopathy in heart failure (NYHA class III - IV) with a baseline left ventricular ejection fraction between ≥25% and ≤35%, and patients with non-ischemic cardiomyopathy in heart failure (NYHA class III-IV) with a baseline left ventricular ejection fraction \\>40% and \\\u003C50% despite guideline-directed medical therapy, will receive C-MIC treatment in addition to optimal medical management.\n\nThe device can be implanted without the need for open-heart surgery. Patients are assigned to one of two groups according to the indications under investigation. At the end of the study after 6 months, the C-MIC System will be turned off. The primary endpoint of the study is the absolute change in left ventricular ejection fraction after 6 months of treatment.",[137,138,139],"Idiopathic Cardiomyopathy","Left Ventricular (LV) Systolic Dysfunction","Non-ischemic Cardiomyopathy",[141,142,143],"dilated cardiomyopathy","heart failure","non-ischemic cardiomyopathy","2026-08-10",{"date":146,"type":36},"2026-08-11",{"date":148,"type":36},"2025-04-09",{"date":150,"type":22},"2027-04",{"name":152,"class":43},"Berlin Heals GmbH",4,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":161,"minAge":162,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"100651440","structured-periprocedural-nursing-interventions-in-men-undergoing-transrectal-prostate-biopsy-100651440","NCT07760688","Structured Periprocedural Nursing Interventions in Men Undergoing Transrectal Prostate Biopsy","Impact of Structured Periprocedural Nursing Interventions on Resilience and Anxiety in Men Undergoing Transrectal Prostate Biopsy: A Prospective Longitudinal Interventions Study With Histopathological Stratification","Inclusion Criteria:\n\n* Male participants aged 40 years or older.\n* Scheduled for transrectal ultrasound-guided prostate biopsy because of suspected prostate cancer.\n* Able to understand the study procedures and provide written informed consent.\n* Willing to complete all study assessments during the follow-up period.\n\nExclusion Criteria:\n\n* Inabillity to provide informed consent.\n* Severe cognitive impairment or psychiatric disorder preventing questionnaire completion.\n* Previous disgnosis of prostate cancer.\n* Inabillity to complete follow-up assessments.\n* Withdrawal of informed consent at any time.","MALE","40 Years",{"count":164,"type":22},120,[134],"This prospective longitudinal interventional study aims to evaluate the effect of structured peri-procedural nursing interventions on resilience and anxiety in men undergoing transrectal prostate biopsy. Participants will receive a standardized nursing intervention before and after the biopsy procedure. Resilience, anxiety, pain, lower urinary tract symptoms, and perceived nursing support will be assessed at predefined time points. Histopathological findings (benign or malignant) will be used for subgroup analyses. The study is conducted at the University Clinical Hospital Mostar, Bosnia and Herzegovina.",[168,169],"Anxiety","Biopsy",[171,172,173,174,175,176,177,178,179],"Prostate biopsy","Resilience","Nursing Intervention","Periprocedural nursing care","Prostate cancer","Patient education","Lower urinary tract symptoms","Hamilton Anxiety Rating Scale","International Prostate Symptom Score","2026-08-07",{"date":182,"type":36},"2026-08-12",{"date":184,"type":36},"2026-08-04",{"date":186,"type":22},"2027-08-04",{"name":188,"class":189},"University of Mostar","OTHER",1,{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":203,"conditions":204,"keywords":210,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100488822","phase-3-a-study-to-evaluate-efficacy-safety-and-pk-of-xembifystandard-medical-treatment-smt-compared-to-placebosmt-to-prevent-infections-in-participants-with-hgg-and-recurrent-or-severe-infections-associated-with-b-cell-chronic-lymphocytic-leukemia-multiple-myeloma-and-non-hodgkin-lymphoma-100488822","NCT05645107","A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","A Randomized, Multi-Center, Parallel, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment Compared to Placebo Plus Standard Medical Treatment to Prevent Infections in Patients With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma","EXCELL","Inclusion Criteria:\n\n* Participants ≥18 years of age at screening visit\n* Participants with documented and confirmed diagnosis of any of the below diseases:\n\n  * B-cell CLL according to International Workshop on CLL (iwCLL) criteria and RAI staging of intermediate (1 and 2) or high (3 and 4)\n  * MM according to the International Myeloma Working Group criteria (IMWG), R-ISS stage II or, III; or\n  * Histologically confirmed diagnosis of B-Cell NHL, Stage III or above (IV, Progressive\u002Frefractory, or recurrent\u002Frelapsed stage) according to the Lugano Classification.\n* Participants with HGG with IgG levels less than 5 g\u002FL. (Note: For MM subjects, the IgG level is adjusted by subtracting the M-protein \\[Mspike\\] to reflect the true polyclonal IgG concentration.)\n* Participants with documented history of at least one severe bacterial infection (bacterial or viral) or recurrent bacterial\u002Fviral infections (that is., ≥ 3 infections) within 12 months before the screening visit. Severe bacterial\u002Fviral infections ≥ Grade 3 (as defined by Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grades).\n\nExclusion Criteria:\n\n* Participants with documented history of hematopoietic stem cell transplant (allogenic transplant in the previous 24 months, and autologous transplant in the previous 3 months) before Screening visit.\n* Participants currently receiving immunoglobulin replacement therapy (IgRT) or have received IgG replacement treatment (i.e., prior immune globulin replacement therapy) within 6 months before the screening visit.\n* Participants with active infections at time of screening visit. Specific supportive anti-infective prophylactic defined in the CLL National Comprehensive Cancer Network (NCCN) or iwCLL guidelines and\u002For local\u002Finternational guidelines for the CLL, and defined in local\u002Finternational guidelines for MM and NHL are allowed, or recommended in the updated labelling of specific active target disease medicines used during the participation in the trial is also allowed.\n* Participants with active second malignancies.\n* Participants with known primary immunodeficiency (PI).\n* Participants with a life expectancy less than 1.5 years.\n* Participants with clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.\n* Participants have had a known serious adverse reaction (AR) to immunoglobulin or any anaphylactic reaction to blood or any blood-derived product.\n* Participants have a history of blistering skin disease, bleeding disorder, diffuse rash, recurrent skin infections, or other disorders where SC therapy would be contraindicated during the study based upon the Investigator's discretion.\n* Participants have known Selective Immunoglobulin A (IgA) Deficiency (with or without antibodies to IgA) (Note: exclusion is for the specific diagnostic entity. It does not exclude other forms of humoral primary immunodeficiency which have decreased IgA in addition to decreased IgG requiring IgG replacement).\n* Participants with severe known kidney disease \\[as defined by estimated glomerular filtration rate \\[eGFR\\] less than (\\<) 30 milliliter (mL)\u002Fmin\u002F1.73 square meter (m2)\\] as determined by the Principal Investigator.\n* Participants that have liver enzyme levels (alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gammaglutamyl transferase \\[GGT\\], or lactate dehydrogenase \\[LDH\\]) greater than 3 times the upper limit of normal (ULN) at the Screening Visit as defined by the testing laboratory.\n* Participants have a history (either 1 episode within the year prior to the Screening Visit or 2 previous episodes over a lifetime) of or current diagnosis of thromboembolism (example, myocardial infarction, cerebrovascular accident, or transient ischemic attack) or deep venous thrombosis.\n* Participants currently have a known hyperviscosity syndrome or hypercoagulable states.\n* Participants have a known previous infection or clinical signs and symptoms consistent with current hepatitis B virus or hepatitis C virus infection.\n* Participants with non-controlled arterial hypertension (systolic blood pressure \\[SBP\\] greater than 140 millimeters of mercury (mmHg) and\u002For diastolic blood pressure \\[DBP\\] greater than 90 mmHg), and\u002For a heart rate (HR) greater than100 bpm.\n* Participants with known substance or prescription drug abuse within 12 months before the Screening Visit.\n* Participants have participated in another clinical trial within 30 days prior to screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).",{"count":200,"type":22},386,[202],"PHASE3","The primary purpose of the study is to evaluate whether biweekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in B-cell CLL, MM, and NHL participants with hypogammaglobulinemia (HGG) in comparison to the Placebo plus SMT group.",[205,206,207,208,209],"Hypogammaglobulinemia","Bacterial Infections","B-cell Chronic Lymphocytic Leukemia","Multiple Myleoma","Non-Hodgkin Lymphoma",[211,212,213,214,215,216],"XEMBIFY","CLL","SMT","Hypogammaglobulinemia (HGG)","MM","NHL","2026-07-28",{"date":219,"type":36},"2026-07-29",{"date":221,"type":36},"2022-12-26",{"date":223,"type":22},"2029-08",{"name":225,"class":43},"Grifols Therapeutics LLC",62,{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100643581","phase-2-a-clinical-trial-evaluating-the-safety-and-efficacy-of-ap1189-versus-placebo-as-an-add-on-to-standard-of-care-in-participants-with-respiratory-insufficiency-expected-to-be-caused-by-infection-with-respiratory-viruses-100643581","NCT07633288","A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses","A Randomized, Double-blind, Multicentre, Placebo-controlled, Proof-of-concept Clinical Trial Evaluating the Safety and Efficacy of the Biased Melanocortin Agonist AP1189 Versus Placebo as an add-on to Standard of Care (SOC) in Participants With RESPIRatory Insufficiency Expected to be Caused by Infection With Respiratory Viruses, Including Influenza, Respiratory Syncytial Virus, and Coronavirus","RESPIRE","Inclusion Criteria:\n\n* Written informed consent has been obtained prior to initiating any study-specific procedures\n* Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative PCR, or quantitative PCR (Q-PCR).\n* Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or supplementary oxygen supply via nasal catheter or facial mask (WHO Clinical Progression Scale score 5 or 6). Or in participants with hypercapnic respiratory failure (usually due to COPD) the SpO2 threshold is SpO2 ≤ 85 %.\n* Duration of disease from first symptom\\\u003C 15 days before enrolment\n* Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized\n* Females of childbearing potential with a negative pregnancy test at screening and baseline\n* As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups.\n* Screened within 24 hours of hospital admission to the hospital, or within 24 hours of receiving a patient, if the patient is transferred from another hospital or another hospital department due to respiratory distress\n\nExclusion Criteria:\n\n* In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment\n* Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical ventilation, ECMO, cardiovascular organ support (balloon pump or inotropes\u002Fvasopressors), or renal failure (Cockcroft-Gault estimated creatinine clearance \\\u003C15 ml\u002Fmin, haemofiltration or dialysis). Note: participants qualifying under inclusion criterion 8b (pre-existing renal insufficiency or dialysis) are excluded only if they meet any of the other criteria (invasive mechanical ventilation, ECMO, or cardiovascular organ support). Participants who are physically located in an ICU or HDU but do not meet the above physiological criteria are not excluded on that basis alone.\n* Participating in other drug clinical trials\n* Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures\n* Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases. Administration of steroids or other immunosuppressive medicines implemented as standard-of-care for the treatment of the respiratory viral infection is acceptable. Asthma\u002FCOPD participants are allowed to use their habitual inhalation spray containing adrenocortical hormone.\n* Pregnant women or nursing (breastfeeding) mothers",{"count":236,"type":22},96,[25],"A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.",[240],"Respiratory Viral Infection",[242,243,244],"Influenza","Respiratory Syncytial virus,","Corona virus","2026-07-27",{"date":217,"type":36},{"date":248,"type":36},"2026-05-01",{"date":250,"type":22},"2027-08-01",{"name":252,"class":43},"SynAct Pharma Aps",11,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":261,"maxAge":18,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":276},"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.","2 Years",{"count":5,"type":22},[264,25],"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.",[267],"Opioid-Induced Constipation (OIC)","2026-07-25",{"date":217,"type":36},{"date":271,"type":36},"2023-01-04",{"date":273,"type":22},"2028-06-15",{"name":275,"class":43},"Shionogi",16,{"id":278,"slug":279,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":300},"100616140","phase-2-therapeutic-equivalence-of-chf5993-pmdi-1006125-g-hfa-152a-in-subjects-with-mild-to-moderate-asthma-100616140","NCT07301736","Therapeutic Equivalence of CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-152a in Subjects With Mild to Moderate Asthma","A Phase II Multinational, Multicentre, Double-blind, Randomised, Active-controlled, 3-way Cross-over Study to Evaluate the Therapeutic Equivalence of CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-152a Versus CHF5993 pMDI 100\u002F6\u002F12.5 µg HFA-134a in Subjects With Mild to Moderate Asthma","TRECONY","Inclusion Criteria:\n\n* Male and female adults (18 ≤ age ≤ 75 years) with a diagnosis of Asthma for at least 6 months prior to screening and with diagnosis before the age of 50 years;\n* Non-smokers, ex-smokers;\n* Body mass index: within the range of 18.0 to 35.0 kg\u002Fm2 inclusive;\n* Stable asthma therapy: a stable maintenance treatment for at least 4 weeks prior to screening with:\n\n  1. low or medium doses of ICS (Inhaled Corticosteroids) alone; or\n  2. low or medium doses of ICS + LABA (Long-acting β2-agonist) (fixed or free combination).\n* Controlled or partly controlled based on an Asthma Control Questionnaire - 7 Items (ACQ-7) score \\\u003C1.5 at screening and at randomisation.\n* Pre-BD (Bronchodilator) FEV1 \\>40% and \\\u003C90% of the predicted normal value, after appropriate wash out from BDs, at the Screening Visit (V1).\n* A demonstrated increase in either FEV1 or forced vital capacity of \\>12% and \\>200 mL from baseline within 30 minutes (min) after inhalation of 400 µg salbutamol (i.e. albuterol) pMDI at the Screening Visit (V1).\n\nExclusion Criteria:\n\n* History of near fatal asthma or hospitalisation for asthma in intensive care unit, inpatient setting or emergency room access for asthma in the previous 6 months prior to screening, which in the judgement of the Investigator may place the subjects at undue risk;\n* Recent asthma exacerbation requiring systemic corticosteroids (SCSs), or emergency room admission or hospitalisation within 3 months prior to screening and\u002For during the run-in period ;\n* Non-persistent asthma: exercise-induced, seasonal asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine;\n* Asthma subjects currently treated with any of the following :\n\n  1. High dose ICS;\n  2. Long-acting muscarinic antagonist (LAMA);\n  3. Systemic, depot or slow-release corticosteroids within 12 weeks prior to screening;\n  4. Any other asthma treatments (e.g. cromolyn sodium, nedocromil sodium, leukotriene modifiers) within 4 weeks prior to screening;\n  5. Any biologic therapy (e.g. omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) within 6 months prior to screening;\n* Respiratory disorders other than asthma\n* Lung resection;\n* Lower respiratory tract infection;\n* Lung cancer and history of lung cancer;\n* Subjects with active cancer or a history of cancer (other than lungs) ;\n* Patients who have clinically significant cardiovascular condition;\n* Run-in compliance: e-Diary completion \\\u003C75% and run-in treatment compliance \\\u003C75% at randomisation;",{"count":286,"type":22},780,[25],"This study will compare an asthma inhaler that uses a new climate friendly alternative propellant to an asthma inhaler with an existing propellant. We want to make sure both versions of the inhaler work the same way for people with mild to moderate asthma.",[290],"Asthma","2026-06-24",{"date":293,"type":36},"2026-06-25",{"date":295,"type":36},"2025-12-17",{"date":297,"type":22},"2027-06-03",{"name":299,"class":43},"Chiesi Farmaceutici S.p.A.",167,{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100565814","phase-1-a-study-to-evaluate-the-safety-and-activity-of-sar448501dr-0201-in-patients-with-autoimmune-rheumatic-diseases-100565814","NCT06647069","A Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Autoimmune Rheumatic Diseases","A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of SAR448501\u002FDR-0201 in Patients With Select Autoimmune Rheumatic Diseases","Inclusion Criteria:\n\n* Diagnosis of SLE and\u002For RA. American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria should be used.\n* Contraception during the study intervention period and for at least 140 days after the last administration of study intervention: Male participants must agree to refrain from donating or cryopreserving sperm, and either be abstinent or use contraception\u002Fbarrier. Female participants must use of a highly effective contraceptive measure for all females of childbearing potential. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose.\n* Specific to Systemic Lupus Erythematosus (SLE):\n\n  * Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening.\n  * At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening\n  * Positive ANA (titer ≥1:80) as documented in the participant's medical history\n  * Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies\n  * Inadequate response to systemic glucocorticoids and to at least 1 therapy other than antimalarials for at least 12 weeks including: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.\n* Specific to Rheumatoid Arthritis (RA):\n\n  \\-- Moderate-to-severe disease activity as defined by a 28-joint disease activity score using C reactive protein (DAS28-CRP) \\>3.2 at screening.\n* Inadequate response or intolerance to at least 2 disease-modifying antirheumatic drugs (DMARDs, at least 1 biologic \\[bDMARD\\] or targeted synthetic \\[tsDMARD\\]) after a minimum of 12 weeks treatment duration.\n* At least 6 tender joints at screening.\n* At least 6 swollen joints at screening.\n* Methotrexate (MTX) for at least 12 consecutive weeks, and at a stable dose of ≤25 mg\u002Fweek oral or SC since at least 4 weeks prior to randomization, OR - in case of MTX intolerance - conventional DMARDs at a stable dose for at least 28 days.\n* If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.\n\nExclusion Criteria:\n\n* Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.\n* Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.\n* Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.\n* Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \\>20 mg\u002Fday, abatacept.\n* Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.\n* Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.\n* Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.\n* Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.\n* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.\n* History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.\n* Active infection or a history of serious infections as defined in the protocol.\n* Surgery within 28 days prior to Day 1.\n* 12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.\n* Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).\n* Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.\n* High dose of antimalarial or a change in dose within 28 days prior to Day 1.\n* Receipt of systemic corticosteroids \\>20 mg\u002Fday (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.\n* Documented liver disease including documented diagnosis of cirrhosis.\n* Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.\n* Specific to SLE:\n\n  * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.\n  * Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein\u002F24h; or urine protein\u002Fcreatinine ratio \\>0.5g\u002Fg) at screening.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":226,"type":22},[264],"This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501\u002FDR-0201.\n\nThe study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.",[312,313],"Systemic Lupus Erythematosus (SLE)","Rheumatoid Arthritis (RA)","2026-05-21",{"date":316,"type":36},"2026-05-22",{"date":318,"type":36},"2025-03-27",{"date":320,"type":22},"2029-06-25",{"name":322,"class":43},"Sanofi",7,{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":331,"sex":332,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":336,"phases":4,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":190},"100600692","vitamin-b12-folic-acid-and-vitamin-d-status-in-women-of-reproductive-age-100600692","NCT07100795","Vitamin B12, Folic Acid and Vitamin D Status in Women of Reproductive Age","Assessment of Serum Concentrations of Vitamin B12, Folic Acid, and Vitamin D in Women of Reproductive Age to Determine Recommended Supplementation Doses in the Preconception Period and During Pregnancy","Inclusion Criteria:\n\n* Women of reproductive age (18-49 years)\n* Informed consent obtained\n\nExclusion Criteria:\n\n* diabetes (Type I or II)\n* epilepsy\n* oncological diseases, inflammatory bowel disease\n* supplementation with vitamin B12, folic acid, or vitamin D within the last 3 months",true,"FEMALE","49 Years",{"count":335,"type":22},360,"OBSERVATIONAL","This cross-sectional observational study aims to assess serum concentrations of vitamin B12, folic acid, and vitamin D in women of reproductive age in Herzegovina. The study is led by Professor Vajdana Tomić, MD, PhD, who serves as the Principal Investigator, at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina. The goal is to determine whether current international supplementation guidelines reflect the actual micronutrient status of this population. A total of 360 women aged 18-49 will be enrolled between December 2024 and December 2025 after providing informed consent. The findings will inform population-specific recommendations for micronutrient supplementation during the preconception period and pregnancy.\n\nThe study will be conducted at the Faculty of Health Studies, University of Mostar, Bosnia and Herzegovina.",[339,340,341],"Vitamin D, Vitamin B 12 and Folic Acid Concentrations","Micronutrient Status in Women of Reproductive Age","Vitamin Status Assessment",[343,344,345],"Vitamin B12","Vitamin D","Folic acid","2026-04-29",{"date":348,"type":36},"2026-05-06",{"date":350,"type":36},"2024-12-23",{"date":352,"type":22},"2026-12-01",{"name":188,"class":189},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":332,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":5},"100402145","phase-1-a-study-of-azenosertib-zn-c3-in-patients-with-ovarian-cancer-100402145","NCT04516447","A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer","A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer","MUIR","INCLUSION CRITERIA:\n\nFor Part 1:\n\n* Histologically or cytologically confirmed FIGO Stage III\u002FIV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.\n* Subjects must have received 1 or 2 prior therapeutic regimens\u002Flines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.\n* The disease must be platinum resistant (ie, the PFI must have been \\\u003C 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.\n\nFor Part 2 Dose Escalation:\n\nPrior therapy:\n\n• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy\n\nResponse to prior platinum therapy:\n\n1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.\n2. In the 2L setting:\n\n   1. Progressive Disease \\>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,\n   2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.\n\n      * Adequate hematologic, and organ function\n\nFor Part 2 Dose Expansion:\n\n* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease\n* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply\n\nEXCLUSION CRITERIA:\n\n* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.\n* Subjects with carcinosarcomas (even if there is a serous component)\n* A serious illness or medical condition(s)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.\n\nAdditional protocol-defined exclusion criteria may apply",{"count":363,"type":22},172,[264],"This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.",[367,368,369,370],"Solid Tumor","Epithelial Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer",[367],{"date":373,"type":36},"2026-04-07",{"date":375,"type":36},"2020-10-26",{"date":377,"type":22},"2028-06-30",{"name":379,"class":43},"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc",{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":386,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":407},"100573434","drug-eluting-balloon-or-drug-eluting-stent-in-acute-myocardial-infarction-a-randomized-controlled-trial-100573434","NCT06746233","Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial","A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.","BOOST-AMI","Inclusion Criteria:\n\n* Age \\>18 years with a life expectancy of \\>1 year;\n* Patients fulfilling criteria for STEMI (\\>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)\n* Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.\n\nExclusion Criteria:\n\n* Killip class\\>II on admission\n* Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb\u002FIIIa inhibitor\n* Previous myocardial infarction\n* Previous PCI in the territory of the infarct-related artery (IRA)\n* Previous CABG\n* 3-vessel disease requiring revascularization\n* Left-main disease\n* Extremely angulated or severely calcified vessels\n* History of ischemic stroke within the past 6 months or hemorrhagic stroke\n* Planned CABG for a non-culprit vessel\n* Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study",{"count":389,"type":22},598,[134],"The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).\n\nRandomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.",[393],"ST Elevation Myocardial Infarction (STEMI)",[395,396,397],"STEMI","DES","DCB","2026-03-25",{"date":400,"type":36},"2026-03-30",{"date":402,"type":36},"2024-12-25",{"date":404,"type":22},"2028-12",{"name":406,"class":189},"Institute of Cardiovascular Diseases, Vojvodina",5,{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":415,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":430},"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":416,"type":22},726,[202],"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.",[420],"Non Squamous Non Small Cell Lung Cancer","2026-03-10",{"date":423,"type":36},"2026-03-11",{"date":425,"type":36},"2024-12-30",{"date":427,"type":22},"2027-09",{"name":429,"class":43},"mAbxience Research S.L.",151,{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":336,"phases":4,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":190},"100628173","apixaban-safety-and-therapy-adherence-in-patients-with-atrial-fibrillation-100628173","NCT07458191","Apixaban Safety and Therapy Adherence in Patients With Atrial Fibrillation","Monitoring Safety and Therapeutic Adherence During Anticoagulant Prophylaxis With Apixa® in Patients With Nonvalvular Atrial Fibrillation (Praćenje Sigurnosti i Terapijske Adherence u Toku Antikoagulantne Profilakse Lijekom Apixa® Kod Pacijenata sa Nevalvularnom Atrijalnom Fibrilacijom)","Inclusion Criteria:\n\n* Patients over 18 years of age.\n* Hemodynamically stable patients.\n* Patients with non-valvular atrial fibrillation.\n* Patients in whom the investigator, based on clinical assessment makes a decision to introduce apixaban therapy.\n* Patients who are on apixaban therapy for the first time\n\nExclusion Criteria:\n\n* Positive history of angioneurotic edema.\n* Active, clinically significant bleeding.\n* Congenital or acquired bleeding disorder.\n* The presence of a malignant tumor.\n* Current or recent presence of gastrointestinal ulcer.\n* The presence of established or suspected esophageal varices.\n* Positive history of arteriovenous malformations, vascular aneurysms or intraspinal and intracerebral vascular anomalies.\n* Patients with artificial heart valves.\n* Liver cirrhosis and active liver disease associated with coagulopathy and clinically significant risk of bleeding.\n* Dialysis patients (GFR \\\u003C15 ml\u002Fmin).\n* Simultaneous use of other anticoagulants.\n* Pregnancy and breastfeeding.\n* Patients who previously used apixaban in therapy.\n\nWithdrawal Criteria:\n\n* Deterioration of the clinical picture of the underlying disease that requires discontinuation of investigational therapy.\n* Development of serious adverse events that require discontinuation of therapy.\n* Occurrence of pregnancy.\n* Development of another disease that affects the course of research.",{"count":439,"type":22},800,"The aim of this observational study is to evaluate safety and therapeutic adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation. The main questions it aims to answer are:\n\n* What is the incidence of major bleeding and clinically relevant non-major bleeding during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation?\n* What is therapy adherence during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation?\n* What is frequency and types of other adverse reactions, excluding bleeding, during anticoagulant prophylaxis with apixaban in patients with nonvalvular atrial fibrillation? Participants will be followed for six months through four measurements. The first and fourth measurements will be performed in person, while the remaining measurements can also be recorded by telephone, if the patient's condition allows. Any bleeding or serious adverse reactions to the medication being administered will be recorded immediately, through unscheduled measurements. Adverse reactions will be recorded at each measurement. Adherence to the medication being administered will be evaluated using the BARS scale.",[442],"Nonvalvular Atrial Fibrillation","2026-03-09",{"date":423,"type":36},{"date":446,"type":36},"2025-10-09",{"date":150,"type":22},{"name":449,"class":43},"Bosnalijek D.D",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":473},"100495553","algorithm-based-tailoring-of-dual-antiplatelet-therapy-to-improve-outcomes-following-percutaneous-coronary-interventions-100495553","NCT05732701","Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions","TAILOR-DAPT","Inclusion Criteria:\n\n1. PCI with drug eluting stent (DES) implantation\n2. Age ≥18 years\n3. Ability to sign informed consent before any study-specific procedure\n\nExclusion Criteria:\n\n1. Planned staged PCI (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop an indication for percutaneous valve intervention can undergo treatment 30 days after full coronary revascularization)\n2. Indication for oral anticoagulation\n3. Peri-procedural complication which affects DAPT regimen based on the operator's opinion (e.g. untreated flow-limiting angiographic complication, intraprocedural stent thrombosis, persistent vessel occlusion\u002Fno-reflow at the end of the procedure, major side-branch occlusion, puncture-site related or other relevant bleeding)\n4. Treatment for stent thrombosis at qualifying PCI or within 1 year prior to qualifying PCI\n5. Active bleeding requiring medical attention at qualifying PCI\n6. The presence of hemodynamic instability (persistent systolic blood pressure below 90mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and\u002For use of percutaneous left ventricular assist devices)\n7. Life expectancy less than 1 year\n8. Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)\n9. Planned surgery within the next 3 months\n10. Contraindication or known allergy against aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, and prasugrel)\n11. Participation in a drug trial",{"count":458,"type":22},2788,[134],"The use of aspirin combined with a P2Y12 inhibitor (dual antiplatelet therapy, DAPT) represents the standard of care for patients undergoing percutaneous coronary intervention (PCI) with stent implantation. The TAILOR-DAPT trial aims to investigate the benefits of a score-based decision-making algorithm to guide DAPT duration compared to a standard-of-care DAPT duration without the use of risk scores in patients undergoing PCI.",[462,463,464],"Percutaneous Coronary Intervention","Platelet Aggregation Inhibitors","Coronary Artery Disease","2025-09-15",{"date":467,"type":36},"2025-09-16",{"date":469,"type":36},"2023-06-27",{"date":404,"type":22},{"name":472,"class":189},"Insel Gruppe AG, University Hospital Bern",3,{"id":475,"slug":476,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100603007","phase-1-a-study-of-aumolertinib-in-european-participants-with-non-small-cell-lung-cancer-100603007","NCT07130916","A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer","A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Aumolertinib in European Participants With Locally Advanced or Metastatic, EGFR-mutated Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Male or female European participants (inhabitant of a European country and of European descent) must be ≥ 18 years of age, at the time of signing the informed consent.\n2. Histological or cytological confirmation diagnosis of newly diagnosed locally advanced (clinical stage IIIB or IIIC) or metastatic (clinical stage IVA or IVB) NSCLC or recurrent NSCLC (per The Eighth Edition of The American Joint Committee on Cancer \\[AJCC\\] Cancer Staging Manual in Lung Cancer), not amenable to curative surgery or definitive radiotherapy with or without chemotherapy.\n\n   NOTE: if small cell elements are present, the participant is ineligible.\n3. Prior anti-tumor systemic therapy. Participant must fulfill one of below:\n\n   1. Participants who have not received any prior anti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).\n   2. Participants who have received prior neoadjuvant, adjuvant therapies with curative intent for nonmetastatic disease must have completed treatment for at least 12 months prior to the development of recurrent or metastatic disease, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).\n   3. Participant who only received one line of first- or second-generation EGFR-TKI in the locally advanced or metastatic setting and have documented radiological progression prior to enrolling in the study, and the tumor must harbor EGFR T790M mutation.\n4. Confirmation that the tumor harbors at least one of the EGFR mutations (ex19del, L858R, or T790M) using a clinically validated assay in a licensed laboratory with applicable local accreditation based on tumor tissue and\u002For circulating tumor deoxyribonucleic acid (ctDNA) in blood.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 and no deterioration in the previous two weeks with a minimum life expectancy of 12 weeks.\n6. Participants must have evaluable disease. At least one measurable (not previously irradiated) and\u002For non-measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Appendix 6) that can be accurately assessed at baseline and suitable for repeated assessments by computed tomography (CT) or magnetic resonance imaging (MRI) scans. If only one measurable lesion exists, it is acceptable to be used (as a target lesion \\[TL\\]) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.\n7. Adequate bone marrow reserve or organ function without blood transfusion or growth factor support ≤ 14 days before sample collection at screening as demonstrated by any of the following laboratory values:\n\n   1. Absolute neutrophil count ≥ 1.5 × 109\u002FL;\n   2. Platelet count ≥ 80 × 109\u002FL;\n   3. Hemoglobin ≥ 90 g\u002FL;\n   4. ALT ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;\n   5. AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;\n   6. Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases;\n   7. Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL\u002Fmin (measured or calculated by Cockcroft and Gault equation);\n   8. The confirmation of creatinine clearance is only required when creatinine is ≤ 1.5 × ULN;\n   9. International normalized ratio (INR) ≤ 1.5;\n   10. Activated partial thromboplastin time ≤ 1.5 ULN;\n8. Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   NOTE: The reliability of sexual abstinence for male and\u002For female enrollment eligibility needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception.\n\n   Male Participants:\n\n   • A male participant must agree to use a highly effective contraception as detailed in Appendix 4 of this protocol from screening to three months after the last dose of study intervention.\n\n   Female Participants:\n\n   • A female participant is eligible to participate if she has a negative pregnancy test no later than 72 hours prior to start of dosing if of childbearing potential, not breastfeeding from screening to three months after the last dose of the study intervention, and at least one of the following conditions applies:\n   * Not a woman of childbearing potential (WOCBP) as defined in Appendix 4. OR\n   * A WOCBP who agrees to follow the contraceptive guidance in Appendix 4 from screening to three months after the last dose of study intervention and should not be breastfeeding from screening to three months after the last dose of the study intervention.\n9. Participant is capable of giving signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n1. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention with the exception of alopecia and Grade 2 neurotoxicity related to prior platinum-therapy.\n2. History of another primary malignancy except for the malignancy treated with curative intent with no known active disease ≤ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include, but are not limited to, adequately resected non melanoma skin cancer, and curatively treated in situ disease.\n3. Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks prior to start of study intervention.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding within two weeks prior to the first dose of study intervention, active infection (e.g., active HBV infection, HCV infection), or HIV infection, which in the Investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardise compliance with the protocol.\n5. Any of the following cardiac criteria: mean resting corrected QT (QT; the time from the start of the Q wave to the end of the T wave in an ECG) interval corrected for heart rate using Fridericia's correction factor (QTcF) \\> 470 ms obtained from three ECGs; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 ms; any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under age of 40 or any concomitant medication known to prolong the QT interval; Left ventricular ejection fraction (LVEF) ≤ 40%.\n6. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n7. Refractory nausea, vomiting, or chronic GI disorders; Participants unable to swallow oral medication or participants with GI disorders or significant GI resection likely to interfere with the absorption of study intervention.\n8. Participant has any disease or condition that, in the judgment of the physician, may increase the risk to the safety or interfering with study assessments.\n9. Participant with a known hypersensitivity to study intervention, structural analog, or any of the excipients of the products.\n10. Received any of the following treatments:\n\n    1. Treatment with a first- or second-generation EGFR-TKI (e.g., erlotinib or gefitinib) within 8 days of the first dose of study intervention or 5 half-lives, whichever is the longer.\n    2. Treatment with prior third-generation EGFR-TKI (e.g., osimertinib).\n    3. Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study taken within 14 days of the first dose of study intervention or 5 half lives, whichever is longer.\n    4. Treatment with medications known to be potent strong inhibitors or inducers of CYP3A4 or narrow therapeutic index drugs for CYP3A4 sensitive substrates (see Appendix 7) within 7 days of the first dose of study intervention or 5 half-lives, whichever is the longer.\n    5. Major surgery (excluding placement of vascular access) within four weeks of the first dose of study intervention.\n    6. Radiotherapy with a limited field of radiation for palliation within one week prior to the first dose of study intervention or receiving radiation with more than 30% of the bone marrow or with a wide field of radiation within four weeks prior to the first dose of study intervention.\n11. Participants participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, before Screening Visit.\n\n    Other Exclusion Criteria\n12. Participant who, in the judgment of the Investigator, may have poor compliance with the procedures, limitations, and requirements of the study and are not suitable for enrollment.",{"count":482,"type":22},20,[264],"This is a Phase 1, open-label, multicenter, multiple-dose study to evaluate aumolertinib in European participants with a confirmed diagnosis of activating EGFR mutation positive (EGFRm+) locally advanced or metastatic NSCLC.",[486],"Non-Small Cell Lung Cancer","2025-08-18",{"date":489,"type":36},"2025-08-19",{"date":491,"type":36},"2024-12-05",{"date":493,"type":22},"2027-12-31",{"name":495,"class":43},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",6,{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":332,"minAge":18,"maxAge":333,"enrollmentInfo":502,"targetDuration":4,"studyType":336,"phases":4,"briefSummary":337,"conditions":503,"keywords":505,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":190},"100600599","vitamin-b12-folic-acid-and-vitamin-d-status-in-women-of-reproductive-age-100600599","NCT07099586","Vitamin B12, Folic Acid, and Vitamin D Status in Women of Reproductive Age",{"count":335,"type":22},[504,340,341],"Vitamin d, Vitamin B 12 and Folic Acid Concentrations",[506,507,508],"vitamin B12","vitamin D","folic acid","2025-07-25",{"date":511,"type":36},"2025-08-01",{"date":513,"type":36},"2024-12-20",{"date":515,"type":22},"2025-12-01",{"name":188,"class":189},{"id":518,"slug":519,"hasResults":11,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":522,"eligibilityCriteria":523,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":496},"100453847","the-c-mic-ii-follow-up-study-100453847","NCT05189860","The C-MIC-II Follow-Up Study","C-MIC-II-FU","Inclusion Criteria:\n\n* Patients who have received a C-MIC System during the C-MIC-II Study.\n* Informed consent in writing from the patient.\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to participate in the study visits.\n* Vulnerable Patients.",{"count":525,"type":22},31,[134],"The C-MIC System is a medical device used to treat heart failure per the intended purpose which is to treat heart failure by applying an electrical micro-current to the heart.\n\nTarget patients for this study are patients who have received the device in a prior study.",[529],"Systolic Left Ventricular Dysfunction","2025-06-05",{"date":532,"type":36},"2025-06-08",{"date":534,"type":36},"2022-03-03",{"date":536,"type":22},"2026-11-15",{"name":152,"class":43},{"id":539,"slug":540,"hasResults":11,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":546,"targetDuration":4,"studyType":23,"phases":548,"briefSummary":549,"conditions":550,"keywords":553,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":568},"100454735","phase-3-namodenoson-in-the-treatment-of-advanced-hepatocellular-carcinoma-in-patients-with-child-pugh-class-b7-cirrhosis-100454735","NCT05201404","Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Advanced Hepatocellular Carcinoma in Patients With Child-Pugh Class B7 Cirrhosis","LIVERATION","Inclusion Criteria:\n\n1. Males and females at least 18 years of age.\n2. Diagnosis of HCC:\n\n   * For patients without cirrhosis at the time of diagnosis, histologic confirmation is required (archival tissue is acceptable).\n   * For patients with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Marrero 2018).\n3. HCC is advanced (i.e., treatment-refractory or metastatic) and no standard therapies are expected to be curative.\n4. HCC has progressed on at least 1, but no more than 2, prior systemic treatment regimens; prior locoregional therapy is allowed.\n5. Barcelona Clinic Liver Cancer (BCLC) Stage B or C (Llovet 1999).\n6. Prior HCC treatment was discontinued for at least 2 weeks prior to the Baseline Visit.\n7. Measurable disease by RECIST v1.1 (Eisenhauer 2009).\n8. ECOG PS of ≤ 1.\n9. Cirrhosis classified as CPB7; if ascites is used as a scoring criterion, it must be classified as Grade ≥2 by the Clinical Practice Guidelines of the European Association for the Study of the Liver (EASL 2010).\n10. The following laboratory values must be documented within ten days prior to the first dose of study drug:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL\n    * Platelet count at least 75 × 10\\^9\u002FL\n    * Creatinine clearance at least 50 mg\u002FdL (estimated glomerular filtration rate by the Cockcroft-Gault or the Modification of Diet in Renal Disease methods)\n    * AST and ALT ≤ 5 × the upper limit of normal (ULN)\n    * Total bilirubin ≤ 3.0 mg\u002FdL\n    * Serum albumin ≥ 2.8 g\u002FdL.\n11. Life expectancy of ≥ 6 weeks.\n12. For women of childbearing potential, negative serum pregnancy test result.\n13. Provide written informed consent to participate.\n14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other trial-related procedures.\n\nExclusion Criteria:\n\n1. Receipt of \\>2 prior systemic drug therapies for HCC.\n2. Receipt of systemic cancer therapy, immunomodulatory drug therapy, immunosuppressive therapy, or corticosteroids \\> 20 mg\u002Fday prednisone or equivalent within 14 days prior to the Baseline Visit or concurrently during the trial.\n3. Locoregional treatment within 4 weeks prior to the Baseline Visit.\n4. Major surgery or radiation therapy within 4 weeks prior to the Baseline Visit.\n5. Use of any investigational agent within 4 weeks prior to the Baseline Visit.\n6. Concomitant use of P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) inhibitors and\u002For substrates with a narrow therapeutic index unless the medication can be taken at least 3 hours before or after taking the investigational product (see Section 12.2).\n7. Child-Pugh Class A, B8\u002F9, or C cirrhosis.\n8. Hepatic encephalopathy.\n9. Occurrence of esophageal or other gastrointestinal hemorrhage requiring transfusion within 4 weeks prior to the Baseline Visit.\n10. Uncontrolled or clinically unstable thyroid disease, per judgment of the Principal Investigator.\n11. Active bacterial, viral, or fungal infection requiring systemic therapy or operative or radiological intervention.\n12. Known human immunodeficiency virus- or acquired immunodeficiency syndrome-related illness.\n13. Liver transplant.\n14. Active malignancy other than HCC.\n15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4).\n16. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to initiation of study drug.\n17. History of, or ongoing, cardiac dysrhythmias requiring treatment, atrial fibrillation of any grade, or persistent prolongation of the QTc (Fridericia) interval to \\> 470 msec (patients with bundle branch block will not be excluded for QTc reasons).\n18. Pregnant or lactating female.\n19. Women of childbearing potential, unless they agree to use dual contraceptive methods which, in the opinion of the Investigator, are effective and adequate for the patient's circumstances while on study drug.\n20. Men who partner with a woman of childbearing potential, unless they agree to use effective, dual contraceptive methods (i.e., a condom, with female partner using oral, injectable, or barrier method) while on study drug and for 3 months afterward.\n21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with trial participation or study drug administration; may interfere with the informed consent process and\u002For with compliance with the requirements of the trial; or may interfere with the interpretation of trial results and, in the Investigator's opinion, would make the patient inappropriate for entry into this trial.",{"count":547,"type":22},471,[202],"This is a clinical trial in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh Class B7 (CPB7) cirrhosis whose disease has progressed on at least 1st-line therapy. The trial will evaluate the efficacy and safety of namodenoson as compared to placebo.",[551,552],"Hepatocellular Carcinoma","Cirrhosis",[554,555,556,557,558],"Hepatocellular carcinoma","HCC","Liver cancer","Child-Pugh Class B7 cirrhosis","CPB7","2025-04-28",{"date":561,"type":36},"2025-04-29",{"date":563,"type":36},"2023-03-15",{"date":565,"type":22},"2026-10",{"name":567,"class":43},"Can-Fite BioPharma",32,{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":579,"studyType":336,"phases":4,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":593},"100562292","scad--a-registry-of-spontaneous-coronary-artery-dissection-100562292","NCT06601270","SCAD : a Registry of Spontaneous Coronary Artery Dissection","A Registry of Spontaneous Coronary Artery Dissection","SCAD","Inclusion Criteria:\n\n* Patient having signed an Informed Consent\n* Patient aged 18 years and over\n* SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery\n\nExclusion Criteria:\n\n* Patient unwilling or unable to consent\n* Patients with iatrogenic or atherosclerotic coronary dissection",{"count":578,"type":22},1500,"5 Years","Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.",[582],"Spontaneous Coronary Artery Dissection","2024-10-28",{"date":585,"type":36},"2024-10-29",{"date":587,"type":36},"2021-01-30",{"date":589,"type":22},"2027-10",{"name":591,"class":592},"European Society of Cardiology","NETWORK",73,{"id":595,"slug":596,"hasResults":11,"nctId":597,"briefTitle":598,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":11,"sex":17,"minAge":600,"maxAge":4,"enrollmentInfo":601,"targetDuration":603,"studyType":336,"phases":4,"briefSummary":604,"conditions":605,"keywords":607,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":190},"100565675","first-degree-ankle-sprains-100565675","NCT06645262","First-degree Ankle Sprains","Inclusion Criteria:\n\n* Individuals diagnosed with Grade I acute ankle sprain confirmed by a specialist physician in radiology,\n* Age of participants ≥ 18 years,\n* Individuals of both sexes\n\nExclusion Criteria:\n\n* Recurrent ankle injury,\n* Acute ankle sprains of Grade II and III,\n* Presence of other physical and\u002For mental health issues.","18 Weeks",{"count":602,"type":22},100,"3 Weeks","Grade I ankle sprains are common, especially among athletes, women, teenagers, and physically active individuals. While over a million cases are reported annually, this represents only half of the total occurrences. These injuries can lead to complications like chronic ankle instability or osteoarthritis. Treatment often involves conservative methods, including the PRICEMMS protocol (protection, rest, ice, compression, elevation, modalities, medication, and support), while surgery is reserved for severe cases. Therapeutic exercises and rehabilitation play a key role in recovery. The Bowen technique, effective for other musculoskeletal issues, has not yet been extensively studied for Grade I ankle sprains.",[606],"Ankle Sprain 1St Degree",[608,609],"ankle sprain","Bowen technique","2024-10-14",{"date":612,"type":36},"2024-10-16",{"date":614,"type":36},"2024-06-12",{"date":616,"type":22},"2024-12-01",{"name":618,"class":189},"Rehabilitation Centre Zivot",{"id":620,"slug":621,"hasResults":11,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":23,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":5},"100416065","phase-2-namodenoson-in-the-treatment-of-non-alcoholic-steatohepatitis-nash-100416065","NCT04697810","Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n1. At least 18 years of age.\n2. AST at Screening of ≥20 IU\u002FL.\n3. FibroScan LSM ≥8.5 kPa\n4. Diagnosis of NASH by biopsy at Screening showing NAS ≥4 by central read, with a score of at least 1 point in each of the 3 histologic categories of steatosis, inflammation, and hepatocellular ballooning (Kleiner 2005). If the subject has had a qualifying liver biopsy within 6 months prior to Baseline and the slides are available for central read prior to randomization, this biopsy can be waived.\n5. Concomitant biopsy-proven Stage 1-3 hepatic fibrosis by NASH CRN criteria by central read (Kleiner 2005).\n6. At least 2 of the following criteria for the metabolic syndrome:\n\n   * Obesity, defined waist circumference \\>88 cm for women or \\>102 cm for men\n   * Hypertriglyceridemia, defined as \\>150 mg\u002FdL (\\>1.7 mmol\u002FL) or on drug treatment for hypertriglyceridemia\n   * Reduced high-density lipoprotein (HDL) cholesterol, defined as \\\u003C40 mg\u002FdL (\\\u003C1.03 mmol\u002FL) in men or \\\u003C50 mg\u002FdL (\\\u003C1.3 mmol\u002FL) in women\n   * History of hypertension, currently controlled in the judgment of the Investigator\n   * Elevated fasting glucose, defined as ≥100 mg\u002FdL (≥5.6 mmol\u002FL).\n7. Acceptable hepatic metabolic and synthetic function, as indicated at Screening by:\n\n   * Serum albumin ≥3.5 gm\u002FdL\n   * International normalized ratio ≤1.3\n   * Serum total bilirubin ≤2.0 mg\u002FdL (unless subject has known Gilbert's Syndrome).\n8. The following laboratory values must be documented at Screening:\n\n   * Absolute neutrophil count at least 1.0 x 109\u002FL\n   * Platelet count at least 150 x 109\u002FL\n   * Estimated glomerular filtration rate (eGFR) ≥50 mL\u002Fmin\u002F1.73m2\n9. Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or are post-menopausal, defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range.\n10. Male subjects must refrain from sperm donation during treatment and until at least 90 days after the end of study drug dosing. Male subjects with fertile or pregnant partners must agree to use condoms throughout the course of the trial and for 3 months after.\n11. Patients taking herbal supplements, homeopathic medications, or other alternative treatments, must be on a stable regimen for at least 3 months prior to randomization.\n12. Understand and provide written informed consent to participate.\n13. Willing to undergo 2 liver biopsies.\n14. Willing to comply with scheduled visits, treatment plans, laboratory assessments, and other study-related procedures.\n\nExclusion Criteria:\n\n1. Ascites, hepatic encephalopathy, or other clinical evidence of cirrhosis.\n2. Other active acute or chronic liver disease, such as autoimmune hepatitis, hepatitis B, hepatitis C, alcoholic liver disease, or hepatocellular carcinoma.\n3. Seropositivity for markers of viral hepatitis or human immunodeficiency virus (HIV) at Screening.\n4. Weight loss of \\>5% within 3 months prior to Baseline.\n5. History of bariatric surgery within 5 years of Screening.\n6. Diabetes mellitus other than Type II.\n7. Hemoglobin A1c \\>9.0% (subjects with diabetes).\n8. Any contraindication to percutaneous liver biopsy.\n9. Daily alcohol intake \\>20 g (2 units)\u002Fday for women and 30 g (3 units)\u002Fday for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire.\n10. Treatment with therapeutic doses of Vitamin E (≥800-1000 IU daily), or any of the following anti-diabetic medications: GLP-1 receptor agonists (such as Januvia \\[sitagliptin\\], Byetta \\[incretin\\], etc.), pioglitazone, or SGLT2 inhibitors (\"gliflozin\" drugs); unless the dose and regimen has been stable for at least 3 months.\n11. Active rheumatoid arthritis treated with small-molecule (including methotrexate) or biologic disease-modifying anti-rheumatic agent concurrently or within 1 year.\n12. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids \\>10 mg prednisone-equivalent concurrently or within 1 year.\n13. More than 7 days of treatment with valproic acid, tamoxifen, amiodarone, or anti-cholinergic agents within 3 months.\n14. Uncontrolled or clinically unstable thyroid disease.\n15. Uncontrolled arterial hypertension or congestive heart failure (New York Heart Association Classification 3 or 4), or other heart disease which is, in the Investigator's judgment, clinically unstable.\n16. Angina, myocardial infarction, cerebrovascular accident, coronary\u002Fperipheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism within 3 months.\n17. QTcF interval on Screening Visit ECG or an average of triplicate Baseline Visit ECGs \\> 450 milliseconds (msec) for males or \\> 470 msec for females.\n18. A condition which increases proarrhythmic risk, including hypokalemia, hypomagnesemia, or congenital Long QT Syndrome.\n19. Ongoing or planned use of a concomitant medication that is on the CredibleMedsTM list of drugs known to cause Torsades des Pointes.\n20. Active gastrointestinal disease which could interfere with the absorption of oral medication.\n21. Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that would make the patient inappropriate for entry into this study.",{"count":627,"type":22},114,[25],"Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks. Subjects will be evaluated regularly for safety, and efficacy biomarkers will be measured at Baseline and Weeks 6, 12, 24, and 36. At Week 36, all subjects will undergo liver biopsy.",[631],"NASH - Nonalcoholic Steatohepatitis","2024-07-30",{"date":634,"type":36},"2024-07-31",{"date":636,"type":36},"2021-12-10",{"date":638,"type":22},"2025-10-15",{"name":567,"class":43},""]