[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"North Macedonia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":497},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,42,66,109,120,155,182,207,234,258,286,335,361,384,406,429,467],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951",false,"NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.","ALL","18 Years","75 Years",{"count":21,"type":22},256,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[28],"Chronic Inflammatory Demyelinating Polyneuropathy","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-02-10",{"date":37,"type":22},"2030-12-31",{"name":39,"class":40},"Dianthus Therapeutics","INDUSTRY",180,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":65},"100557429","phase-2-a-clinical-study-to-evaluate-dnth103-in-adults-with-multifocal-motor-neuropathy-100557429","NCT06537999","A Clinical Study to Evaluate DNTH103 in Adults With Multifocal Motor Neuropathy","A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)","MOMENTUM","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out\n2. Adult males and females, 18 to 75 years of age (inclusive).\n3. Weight range between 40 to 120 kilograms (kg).\n4. Confirmed diagnosis of definite or probable MMN.\n5. Evidence of:\n\n   1. Responsiveness to Ig treatment; and\n   2. Receiving a stable Ig regimen\n6. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n7. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n8. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments.\n2. Any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy).\n3. Concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. If a participant has previously used these medications, the last dose must be at least 6 months prior to randomization.\n4. Currently or previously on complement inhibitors including in a clinical trial setting.\n5. Prior history (at any time) of N. meningitidis infection.\n6. Diagnosis of an autoimmune disorder other than MMN.\n7. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.\n8. History of active malignancy within 5 years prior to Screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n9. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (Day 1).\n10. Any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes.\n11. Any other condition, including mental illness or prior therapy, that in the opinion of the Investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.",{"count":51,"type":22},36,[53],"PHASE2","The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of Claseprubart (DNTH103) in participants with multifocal motor neuropathy (MMN).",[56],"Multifocal Motor Neuropathy","2026-06-22",{"date":59,"type":33},"2026-06-23",{"date":61,"type":33},"2024-09-17",{"date":63,"type":22},"2028-03-31",{"name":39,"class":40},41,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":23,"phases":75,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100640349","niraf-guided-parathyroid-identification-during-thyroidectomy-100640349","NCT07617584","NIRAF-Guided Parathyroid Identification During Thyroidectomy","Near-Infrared Autofluorescence-Guided Parathyroid Identification During Thyroidectomy","Inclusion Criteria:\n\n* Age 18 years or older.\n* For Component A: planned thyroidectomy of any extent with an intact specimen available for ex vivo evaluation.\n* For Component B: planned total or completion thyroidectomy.\n* Ability to provide written informed consent before surgery.\n* Willingness to comply with routine postoperative laboratory testing and follow-up when feasible.\n\nExclusion Criteria:\n\n* Known pre-existing hypoparathyroidism or prior parathyroid surgery.\n* Severe chronic kidney disease or end-stage renal disease expected to substantially confound calcium and parathyroid hormone interpretation, as defined by the site investigator.\n* Pregnancy.\n* For Component B only: gross nodal disease or a surgical plan requiring extensive nodal packet dissection in the current study phase.\n* Any condition that, in the judgment of the investigator, would make participation unsafe or compromise protocol adherence.",{"count":74,"type":22},280,[76],"NA","This is a single-site, two-component prospective study evaluating whether near-infrared autofluorescence (NIRAF) imaging can improve intraoperative identification of parathyroid glands during thyroidectomy and reduce postoperative hypocalcemia.\n\nThe investigational platform is a modified wearable stereoscopic goggle system configured for label-free NIRAF imaging. Parathyroid tissue is excited with near-infrared light at approximately 780 nm and emits autofluorescence centered near 800 nm. No injected dye or external contrast agent is used. The goggles are used only during a brief mapping interval after thyroid exposure and for ex vivo interrogation of the resected thyroid specimen.\n\nComponent A is a prospective observational run-in validation cohort of 30 adults undergoing thyroidectomy of any extent. NIRAF-positive foci on the intact thyroidectomy specimen are suture-marked and correlated with targeted pathology.\n\nComponent B is a randomized clinical study of 250 adults undergoing total or completion thyroidectomy. Participants are randomized 1:1 to standard surgery or standard surgery plus brief in vivo NIRAF mapping, ex vivo specimen interrogation, and rescue autotransplantation when indicated. The primary outcome for Component B is transient biochemical hypocalcemia on postoperative day 1, defined using albumin-corrected serum calcium.",[79,80,81,82,83,84],"Hypocalcemia","Hypoparathyroidism","Thyroid Diseases","Goiter, Nodular","Thyroid Nodule","Thyroidectomy",[86,87,88,89,84,90,91,92,93,94,95,96,97],"Near-Infrared Autofluorescence","NIRAF","Parathyroid Identification","Parathyroid Preservation","Completion Thyroidectomy","Total Thyroidectomy","Postoperative Hypocalcemia","Intact Parathyroid Hormone","iPTH","Rescue Autotransplantation","Wearable Imaging","Post-thyroidectomy hypocalcemia","NOT_YET_RECRUITING","2026-05-29",{"date":101,"type":33},"2026-06-01",{"date":101,"type":22},{"date":104,"type":22},"2029-12-01",{"name":106,"class":107},"Ss. Cyril and Methodius University of Skopje","OTHER",1,{"id":110,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":26,"conditions":113,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":117,"leadSponsor":118,"locationsCount":119},"100582074",{"count":21,"type":22},[25],[28],{"date":115,"type":33},"2026-06-02",{"date":35,"type":33},{"date":37,"type":22},{"name":39,"class":40},168,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":17,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":140,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100611437","randomized-controlled-trial-of-a-family-focused-intervention-for-caregivers-and-young-adolescents-phase-3-of-flourish-100611437","NCT07240571","Randomized Controlled Trial of a Family-focused Intervention for Caregivers and Young Adolescents (Phase 3 of FLOURISH)","Family-Focused Adolescent & Lifelong Health Promotion: Prevention of Adolescent Mental Health Problems in Eastern Europe","FLOURISH","Inclusion Criteria:\n\n* For Caregivers:\n\nMust be 18 years or older at baseline assessment\n\nMust be the primary caregiver of an adolescent aged 10-14 who has resided in the same household for at least four nights a week in the past month\n\nMust be able to speak at least one of the local languages in which the program will be offered (e.g., Macedonian, Romanian, Russian, Ukrainian or Albanian)\n\nMust agree to participate in the program and provide informed consent for both themselves and their adolescent\n\nFor Adolescents:\n\nMust be aged 10-14 at the baseline assessment\n\nMust provide assent to participate in the study\n\nMust have caregiver consent to participate.\n\nExclusion Criteria:\n\n* No formal exclusion criteria have been established for the FLOURISH project. However, during the study introduction, the research team will guide participants through a consent form that asks whether they are currently experiencing acute distress or a mental or physical health condition that could interfere with participation. The decision to participate will be made by the individual. If a potential participant indicates they are unable to take part due to acute health issues, the research team will provide appropriate referrals to other services.",true,"10 Years","14 Years",{"count":132,"type":22},1280,[76],"The aim of this study is to conduct a multi-country randomized waitlist controlled trial to evaluate the effectiveness, cost-effectiveness, and scalability of the optimized Parenting for Lifelong Health (PLH) for Parents and Teens program in Moldova and North Macedonia. In Phase 2 of the FLOURISH project, a factorial trial tested multiple intervention components and identified the optimized intervention package. In Phase 3, this trial will assess the implementation, outcomes, and economic impact of the optimized PLH program delivered to adolescents aged 10-14 and their caregivers. ALTERNATIVA will deliver the program in North Macedonia and the Health for Youth Association in the Republic of Moldova.",[136,137,138,139],"Adolescent - Emotional Problem","Parent Child Relationship","Family Functioning","Well-Being, Psychological",[141,142,143,144,145],"Multiphase Optimization Strategy (MOST)","Family-based intervention","Adolescents","Mental health","Randomized trial","2026-05-28",{"date":115,"type":33},{"date":149,"type":33},"2025-10-24",{"date":151,"type":22},"2026-11-30",{"name":153,"class":107},"University of Klagenfurt",2,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":163,"minAge":164,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100511124","phase-4-nuwiq-for-perioperative-management-of-patients-with-haemophilia-a-on-emicizumab-regular-prophylaxis-study-100511124","NCT05935358","Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study","Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)","NuPOWER","Inclusion Criteria:\n\n* Severe haemophilia A (FVIII activity \\[FVIII:C\\] \\\u003C1%) according to medical history\n* Male patients at least 12 years of age\n* Previous treatment with any FVIII product(s) for at least 150 exposure days\n* On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment\n* Freely given written informed consent of the patient, or parent\u002Flegal representative where applicable, obtained in accordance with local regulations\n\nExclusion Criteria:\n\n* Coagulation disorder other than haemophilia A\n* Present or past FVIII inhibitor (≥0.6 Bethesda units \\[BU\\]\u002FmL) according to medical history\n* Severe liver or kidney disease (alanine aminotransferase \\[ALT\\] and\u002For aspartate aminotransferase \\[AST\\] levels \\>5 times the upper limit of normal; or creatinine \\>120 μmol\u002FL)\n* Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)\n* Already had surgery in this study\n* Current participation in another interventional clinical trial\n* Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit","MALE","12 Years",{"count":166,"type":22},28,[168],"PHASE4","Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis",[171],"Severe Hemophilia A","2026-05-08",{"date":174,"type":33},"2026-05-12",{"date":176,"type":33},"2023-11-28",{"date":178,"type":22},"2026-09",{"name":180,"class":40},"Octapharma",18,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":189,"maxAge":18,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":206},"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":191,"type":22},24,[193,53],"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.",[196],"Opioid-Induced Constipation (OIC)","2026-04-23",{"date":199,"type":33},"2026-04-29",{"date":201,"type":33},"2023-01-04",{"date":203,"type":22},"2026-06-15",{"name":205,"class":40},"Shionogi",16,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":215,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100372032","comparison-of-the-outcomes-of-single-vs-multiple-arterial-grafts-in-women-100372032","NCT04124120","Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women","Randomized Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women (ROMA:Women) Trial","ROMA:Women","Inclusion Criteria:\n\n1. Women patients ≥18 years old.\n2. Isolated coronary artery bypass grafting.\n3. Primary (first time) cardiac surgery procedure.\n4. Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.\n\nExclusion Criteria:\n\n* Male gender\n* Single graft\n* Emergency operation\n* Myocardial infarction within 72 hours of surgery\n* Left ventricular ejection fraction \\\u003C 35%\n* Any concomitant cardiac or non-cardiac procedure\n* Previous cardiac surgery\n* Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduces life expectancy to less than 5 years.\n* Inability to use the saphenous vein or to use both radial and right internal thoracic arteries\n* Anticipated need for coronary thrombo-endarterectomy\n* Planned hybrid revascularization","FEMALE",{"count":217,"type":22},2300,[76],"The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG).\n\nThe specific aims of ROMA:Women are:\n\nAim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,300 women randomized 1:1 to MAG or SAG. Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time.\n\nHypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events.\n\nHypothesis 1.1. The improvement with MAG will be consistent across key subgroups.\n\nAim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated.\n\nHypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG.\n\nHypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG.\n\nHypothesis 2.2. The improvement with MAG will be consistent across key subgroups.",[221,222,223],"Heart Diseases","Coronary Artery Disease","Coronary Artery Bypass Grafting","2026-03-31",{"date":226,"type":33},"2026-04-01",{"date":228,"type":33},"2023-04-17",{"date":230,"type":22},"2030-03",{"name":232,"class":107},"Weill Medical College of Cornell University",146,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":23,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":257},"100488135","phase-3-a-research-study-to-look-at-how-ziltivekimab-works-compared-to-placebo-in-people-with-heart-failure-and-inflammation-100488135","NCT05636176","A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation","Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation","HERMES","Inclusion Criteria:\n\n* Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg\u002FL) at screening (visit 1) Disease specific - cardiovascular\n* At least one of the following:\n\n  1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg\u002FmL) at screening (Visit 1) for patients without ongoing atrial fibrillation\u002Fflutter. If ongoing atrial fibrillation\u002Fflutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg\u002FmL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.\n  2. Hospitalisation or urgent\u002Funplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg\u002FmL at screening (Visit 1) for patients without ongoing atrial fibrillation\u002Fflutter. If ongoing atrial fibrillation\u002Fflutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg\u002FmL.\n* Diagnosis of heart failure (New York Heart Association \\[classification\\] \\[NYHA\\] Class II-IV).\n* Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g., myocardial infarction \\[MI\\] or heart failure \\[HF\\] hospitalisation).\n* Structural heart disease and\u002For functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following:\n* Left atrial (LA) volume index greater than 34 milliliter per meter square (mL\u002Fm\\^2).\n* LA diameter greater than equal to 3.8 centimeter (cm).\n* LA length greater than equal to 5.0 cm.\n* LA area greater than equal to 20 cm square.\n* LA volume greater than equal to 55 milliters (mL).\n* Intraventricular septal thickness greater than equal to 1.1 cm.\n* Posterior wall thickness greater than equal to 1.1 cm.\n* Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m\\^2 ) in men or greater than equal to 95 g⁄m\\^2 in women.\n* E\u002Fe' (mean septal and lateral) greater than equal to 10.\n* e' (mean septal and lateral) less than 9 centimeter per second (cm\u002Fs).\n* No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).\n\nExclusion Criteria:\n\nMedical conditions - cardiovascular\n\n* Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).\n* Systolic blood pressure greater than equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).\n* Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).\n* Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).\n* Planned cardiac device or atrial flutter\u002Fatrial fibrillation ablation procedure known during the screening period (visit 1).\n* Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2).\n* Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease.\n* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.\n* Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).\n\nMedical conditions - infections\u002Fimmunosuppression\n\n\\- Clinical evidence of, or suspicion of, active infection at the discretion of the investigator.",{"count":243,"type":22},5600,[25],"This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.",[247],"Heart Failure","2026-03-10",{"date":250,"type":33},"2026-03-11",{"date":252,"type":33},"2023-05-08",{"date":254,"type":22},"2027-07-02",{"name":256,"class":40},"Novo Nordisk A\u002FS",1117,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":17,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":23,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":108},"100626215","one-versus-two-doses-of-tranexamic-acid-in-surgically-treated-extracapsular-hip-fractures-100626215","NCT07432737","One Versus Two Doses of Tranexamic Acid in Surgically Treated Extracapsular Hip Fractures","Prophylactic Administration of One Versus Two Doses of Tranexamic Acid in Surgically Treated Patients With Pertrochanteric and Subtrochanteric Femoral Fractures","Inclusion Criteria:\n\n* Written informed consent obtained\n* Patients aged 65 years or older\n* Patients with pertrochanteric femoral fracture (AO\u002FOTA classification: 31A1.2, 31A1.3, 31A2, 31A3) or subtrochanteric femoral fracture (AO\u002FOTA classification: 32; fractures from the level of the lesser trochanter to 5 cm distally)\n* Surgical treatment performed within 48 hours of hospital admission\n\nExclusion Criteria:\n\n* Age younger than 65 years\n* Known allergy or hypersensitivity to tranexamic acid\n* Active thromboembolic event (deep vein thrombosis, arterial thrombosis, pulmonary embolism) or history of vascular event within the past year (myocardial infarction, coronary or peripheral vascular stenting, thromboembolism, stroke)\n* Impaired renal function defined as serum creatinine \\>120 µmol\u002FL in the last preoperative laboratory test\n* History of malignant disease\n* History of seizure disorder or chronic anticonvulsant therapy\n* Polytrauma or multiple trauma\n* More than one fracture\n* Previous fracture of the same hip\n* Preoperative hemoglobin level \\\u003C8 g\u002FdL (last laboratory test before surgery)\n* Thrombocytopenia or other coagulation disorders\n* Treatment with vitamin K antagonists with INR \\>1.5\n* Treatment with low-molecular-weight heparins without appropriate preoperative discontinuation according to clinical protocol (usually ≥24 hours for prophylactic doses and ≥24-36 hours for therapeutic doses)\n* Treatment with direct oral anticoagulants without appropriate preoperative discontinuation (usually 24-48 hours, depending on renal function and bleeding risk)\n* Treatment with P2Y12 inhibitors (e.g., ticagrelor, clopidogrel, prasugrel) when, according to anesthesiologist assessment, surgery cannot be safely performed within 48 hours","65 Years",{"count":267,"type":22},120,[76],"The goal of this clinical trial is to learn whether giving one dose or two doses of tranexamic acid can safely lower blood loss in older adults having surgery for certain hip fractures. The study includes adults aged 65 years or older who need surgery for pertrochanteric or subtrochanteric hip fractures.\n\nThe main questions the study aims to answer are:\n\n* Does giving two doses of tranexamic acid lower the need for blood transfusions compared to one dose?\n* Does tranexamic acid help keep hemoglobin levels higher after surgery?\n* Is tranexamic acid safe in this group of participants? Researchers will compare participants who receive one dose of tranexamic acid with those who receive two doses to see which approach works better and is safe.\n\nParticipants will:\n\n* Receive either one dose of tranexamic acid before surgery or two doses, one before and one after surgery\n* Have standard surgery to fix their hip fracture within 48 hours of hospital admission\n* Be monitored during their hospital stay for blood loss, transfusions, and medical problems\n* Be followed for up to 90 days after surgery to check for safety A total of 120 participants will take part in this study, which is being conducted at the University Clinic \"St. Naum Ohridski\" in Skopje, North Macedonia.",[271],"Hip Fractures",[273,274,275,276],"tranexamic acid","blood loss","blood transfusion","safety","2026-02-24",{"date":279,"type":33},"2026-02-27",{"date":281,"type":33},"2026-02-17",{"date":283,"type":22},"2027-09",{"name":285,"class":107},"University Hospital for Surgical Diseases St. Naum Ohridsk i- Skopje",{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":296,"studyType":297,"phases":4,"briefSummary":298,"conditions":299,"keywords":308,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":334},"100587722","adult-congenital-heart-disease-international-evaluation-of-the-effectiveness-of-sglt2i-registry-100587722","NCT06932081","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry","Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i (ACHIEVE-SGLT2i) Registry","ACHIEVE-SGLT2i","Inclusion Criteria:\n\n* Congenital heart defect.\n* Age ≥ 18 years.\n* Initiated on treatment with an SGLT2i.\n\nExclusion Criteria:\n\n\\- No consent for data collection.",{"count":295,"type":22},400,"1 Year","OBSERVATIONAL","This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.",[300,301,302,303,304,305,306,307],"Adult Congenital Heart Disease","Congenital Heart Disease","Systemic Right Ventricle","Transposition of the Great Arteries","Congenitally Corrected Transposition of the Great Arteries","Fontan","Single Ventricle","Tetralogy of Fallot (TOF)",[309,310,311,312,313,314,315,316,317,318,319,320,321,305,322,323,324],"adult congenital heart disease","ACHD","congenital heart disease","CHD","sodium-glucose cotransporter 2 inhibitors","SGLT2i","SGLT2","heart failure","HF","transposition of the great arteries","TGA","systemic right ventricle","sRV","single ventricle","tetralogy of fallot","ToF","2026-02-11",{"date":327,"type":33},"2026-02-13",{"date":329,"type":33},"2023-01-01",{"date":331,"type":22},"2027-12-31",{"name":333,"class":107},"Leiden University Medical Center",11,{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":343,"enrollmentInfo":344,"targetDuration":4,"studyType":23,"phases":346,"briefSummary":347,"conditions":348,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100572670","phase-4-post-authorization-efficacy-and-safety-study-paes-to-confirm-and-collect-more-clinical-data-of-buccalin-tablets-in-the-prophylaxis-of-recurrent-lower-respiratory-tract-infections-rlrtis-100572670","NCT06736288","Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).","Randomized, Double Blind, Placebo Controlled, Two-Arms, Multicenter, Post Authorization Efficacy and Safety Study (PAES) to Confirm and Collect More Clinical Data of Buccalin® Tablets In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIs).","BUC-01-23","Inclusion Criteria:\n\n1. Patients willing and able to provide voluntary informed consent and to follow protocol requirements.\n2. Male or females from 18 to 99 years old, (Adult, Older Adult).\n3. Patients with Recurrent LRTIs including tracheitis, tracheobronchitis, acute bronchitis and exacerbations of chronic lung disease (asthma and\u002For COPD and\u002For bronchiectasis), who present with both of the following:\n\n   a) ≥2 episodes within 12 months prior to the run-in period based on patient reported medical history (to access the run-in period) b) ≥2 episodes during the run-in period documented by appropriate microbiological diagnostic test (to access the treatment period)\n4. Patients:\n\n   1. not vaccinated or\n   2. vaccinated against the most common pathogens for respiratory infectioan (within 12 months prior to the run-in period or during the run-in period, but not during the treatment period)\\*:\n\n      \\- Anti-pertussis vaccination\n\n      \\- Covid-19 vaccination\n\n      \\- Respiratory Syncytial Virus vaccination\n\n      \\- Influenza vaccination\n\n      \\- Pneumococcal vaccination\n\n      \\* Patients vaccinated with other types of vaccines that have no effect on the lower respiratory tract (e.g. hepatitis b vaccination, shingles\u002Fherpes zoster vaccination, papilloma virus vaccine), in addition to the ones listed above, may also be included.\n\nExclusion Criteria:\n\nRUN-IN period\n\n1. Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).\n2. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.\n3. Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.\n4. Pneumonia (based on the EMA Referral Procedure EMEA\u002FH\u002FA-31\u002F1465).\n5. Known history of tuberculosis and\u002For cystic fibrosis.\n6. Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).\n7. Severe heart failure (NYHA class III and IV).\n8. Haematologic diseases including severe anaemia (defined according to the National Cancer Institute as Hemoglobin \\\u003C 8.0 g\u002FdL).\n9. Renal failure (eGFR \\\u003C 30 mL\u002Fmin).\n10. History of known liver damages defined by the METAVIR classification (F1-F4)\\*.\n11. Malignancies with a remission period of \\\u003C 5 years.\n12. Wheezing documented to be caused by gastroesophageal reflux\\*\\*.\n13. Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.\n14. Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.\n15. History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.\n\n    * This criterion only applies to patients with known liver disease who can produce valid fibroscan and\u002For biopsy results and bring them for demonstration.\n\n      * The criterion can only be applied if the patient presents clinically reliable documentation that the wheezing is not due to a lung disease (i.e. gastroscopy).\n\nTREATMENT period\n\n1. Female patient: pregnant, lactating or planning pregnancy (Female of child-bearing potential will undergo urine pregnancy test).\n2. Female of potential child-bearing that does not use at least one effective contraceptive method for the entire study.\n3. Contraindication or known hypersensitivity to the active ingredients of bacterial lysates or any excipients listed in the ingredients.\n4. Pneumonia (based on the EMA Referral Procedure EMEA\u002FH\u002FA-31\u002F1465).\n5. Known history of tuberculosis and\u002For cystic fibrosis.\n6. Known history of immunodeficiency diseases (e.g., HIV infection, AIDS, or any type of congenital or iatrogenic immune deficiency, including IgA deficiency).\n7. Severe heart failure (NYHA class III and IV).\n8. Haematologic diseases including severe anaemia (defined according to the National Cancer Institute Hemoglobin \\\u003C 8.0 g\u002FdL).\n9. Renal failure (eGFR \\\u003C 30 mL\u002Fmin).\n10. History of known liver damages defined by the METAVIR classification (F1-F4)\\*.\n11. Malignancies with a remission period of \\\u003C 5 years.\n12. Injection or oral administration of steroids within 4 weeks prior to randomization\\*\\*.\n13. Use of immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to randomization.\n14. Previous use within 6 months prior to randomization or ongoing use of bacterial lysates.\n15. Any major surgery within the last 3 months prior to randomization.\n16. Wheezing documented to be caused by gastroesophageal reflux\\*\\*\\*.\n17. Patient legally or mentally incapacitated unable to give informed consent for the participation in this study.\n18. Patient who is unable or unwilling to comply with the appointments or with all the requirements of the Protocol.\n19. History of autoimmune diseases and acute intestinal infections, as reported in Buccalin® SmPC.\n\n    * This criterion only applies to patients with known liver disease who can produce valid fibroscan and\u002For biopsy results and bring them for demonstration.\n\n      * In these instances, patients may undergo a washout period of 4 weeks to qualify for the treatment period.\n\n        * The criterion can only be applied if the patient presents clinically reliable documentation that the wheezing is not due to a lung disease (i.e. gastroscopy).","99 Years",{"count":345,"type":22},240,[168],"The goal of this clinical trial is to assess if BUCCALIN® works In the Prophylaxis of Recurrent Lower Respiratory Tract Infections (RLRTIS). It will also evaluate the safety of BUCCALIN®.\n\nThe primary aim is to reduce the number of infection episodes in the treatment period (12 months) in the BUCCALIN® group versus the Placebo group.\n\nPatients diagnosed with RLRTIS will be screened for enrolment. Patients will be requested to provide informed consent before the start of the study related assessments.\n\nEligible patients who meet the study inclusion and exclusion criteria will be randomized with a 1:1 ratio allocation to the 2 treatment groups.\n\nResearchers will compare BUCCALIN® (gastro-resistant tablets) to a placebo (gastro-resistant tablets containing only excipients) to treat RLRTIS.\n\nPatients who participate in the study will perform several study visits divided as reported below:\n\n* Run-in phase (12 months): patients will not receive any treatment. This phase is designed to increase adherence to the study and reduce loss to follow-up in the clinical trial. During this phase, patients should experience ≥ 2 episodes of RTIs to be eligible for the Treatment period.\n* Treatment period (12 months): patients will receive BUCCALIN® or Placebo treatment for 12 consecutive months (3 days per month, posology as per authorized SmPC).\n* Follow-up period (12 months): patients will not receive any treatment. This phase is designed to observe how patients respond to treatments.",[349,350],"Respiratory Infection","Lower Respiratory Tract Infection (LRTI)","2025-12-03",{"date":353,"type":33},"2025-12-10",{"date":355,"type":33},"2025-10-21",{"date":357,"type":22},"2029-04",{"name":359,"class":40},"Laboratorio Farmaceutico SIT srl",10,{"id":362,"slug":363,"hasResults":11,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":368,"targetDuration":370,"studyType":297,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":383},"100272903","computerized-registry-of-patients-with-venous-thromboembolism-riete-100272903","NCT02832245","Computerized Registry of Patients With Venous Thromboembolism (RIETE)","RIETE","Inclusion Criteria:\n\n* Confirmed VTE (acute deep-vein thrombosis, pulmonary embolism and\u002For superficial venous thrombosis) by objective tests.\n* Informed consent to the participation in the study, according to the requirements of the ethics committee within each hospital.\n\nExclusion Criteria:\n\n* Participation in a therapeutic clinical trial with an unknown drug.\n* Inability to the 3 month follow-up",{"count":369,"type":22},120000,"3 Years","The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism.\n\nThe main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.\n\nAs an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.\n\nThe primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.",[373],"Venous Thromboembolism","2025-09-23",{"date":376,"type":33},"2025-09-24",{"date":378,"type":4},"2001-03",{"date":380,"type":22},"2027-12",{"name":382,"class":107},"Manuel Monreal",257,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":370,"studyType":297,"phases":4,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":405},"100522708","detection-and-prevention-of-cancer-related-cardiovascular-toxicity-registry-100522708","NCT06086132","Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry","Detection and Prevention of Cancer-Related Cardiovascular Toxicity Registry (ISACS CARDIONCO-PREDICT)","Inclusion Criteria:\n\n* Age 18 years old or older\n* Capable of giving informed consent\n* Diagnosis of cancer scheduled for treatment according to treating physician's discretion\n* Life expectancy \\>1 year\n* For the prospective validation of HFA-ICOS risk score validation: Newly diagnosed breast cancer undergoing treatment with anthracyclines analogues with or without radiotherapy, with or without trastuzumab, or other anticancer drugs\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* Not able to give informed consent\n* Life expectancy \\\u003C1 year\n* Advanced-stage cancer not eligible for treatment (subjects with an indication of palliative care) according to treating physician's",{"count":392,"type":22},10000,"This study is being done in order to assess the cardiovascular events known as cardiovascular toxicity of chemotherapy agents and radiotherapy protocols in cancer subjects to identify risk prediction, prevention and treatment of cancer therapy-related cardiovascular toxicity and cancer therapy-related cardiac dysfunction",[395],"Cancer Related Cardiovascular Toxicity","2025-06-16",{"date":398,"type":33},"2025-06-19",{"date":400,"type":33},"2025-05-01",{"date":402,"type":22},"2026-12-31",{"name":404,"class":107},"University of Bologna",5,{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":413,"targetDuration":4,"studyType":23,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":428},"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":414,"type":22},31,[76],"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.",[418],"Systolic Left Ventricular Dysfunction","2025-06-05",{"date":421,"type":33},"2025-06-08",{"date":423,"type":33},"2022-03-03",{"date":425,"type":22},"2026-11-15",{"name":427,"class":40},"Berlin Heals GmbH",6,{"id":430,"slug":431,"hasResults":11,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":439,"studyType":297,"phases":4,"briefSummary":440,"conditions":441,"keywords":447,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":466},"100579374","advancing-knowledge-in-ischemic-stroke-patients-on-oral-anticoagulants-100579374","NCT06823466","Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants","Advancing Knowledge in Ischemic Stroke Patients on Oral Anticoagulants - The ASPERA International Registry","ASPERA","Inclusion Criteria:\n\n* Age ≥18 years at the time of the index ischemic stroke.\n* Confirmed diagnosis of ischemic stroke according to the World Health Organization (WHO) definition.\n* Availability of at least one neuroimaging exam (either a non-contrast computed tomography \\[NCCT\\] or magnetic resonance imaging \\[MRI\\] of the brain) demonstrating one or more ischemic lesions consistent with patient symptoms.\n* Ongoing oral anticoagulation at the time of the index ischemic stroke, defined as the last intake within 48 hours prior to stroke symptom onset for patients on direct oral anticoagulants (DOACs), or an international normalized ratio (INR) of ≥1.5 in patients on vitamin K antagonists (VKAs), regardless of the time elapsed between the last intake and stroke symptom onset.\n* Prior diagnosis of AF or other cardioembolic arrhythmias.\n\nExclusion Criteria:\n\n* Symptoms not indicative of acute stroke (i.e., syncope, tonic or clonic activity, dizziness alone, confusion and amnesia alone, chronic or subacute development of focal neurological deficit).\n* Ongoing parenteral (intravenous or subcutaneous) anticoagulation at the time of the index event, including bridging with heparin in patients initiating VKA.",{"count":438,"type":22},200,"5 Years","The Advancing knowledge in ischemic Stroke PatiEnts on oRal Anticoagulants (ASPERA) study aims to investigate characteristics of ischemic stroke cases occurring in patients on oral anticoagulation for atrial fibrillation (AF) or other cardioembolic arrhythmias and to characterize short and long-term outcomes associated with different secondary prevention strategies to prevent stroke recurrences. The ASPERA study is a multicenter, observational, both retrospective and prospective real-world study involving acute ischemic stroke patients occurring on oral anticoagulation. The study will encompass a retrospective (ASPERA-R) and prospective (ASPERA-P) data collection. Patient will be recruited consecutively at different emergency services and stroke units worldwide. University of L'Aquila (UnivAQ) will be in charge of study coordination, data analysis and management. The duration of ASPERA-R will be of 5-year from the study initiation of the study. Participating centers will be given a 6-month timeframe to enter retrospective data, commencing from the date of study approval.\n\nASPERA-P duration will be of 2 years of enrollment from the study approval and follow-up of 5 years. (study conclusion after 7 years of approval). Inclusion criteria will be: 1.Confirmed diagnosis of ischemic stroke. 2. Availability of at least one neuroimaging exam positive for ischemic lesion(s) consistent with patient symptoms. 3. Ongoing oral anticoagulation at the time of the index ischemic stroke. 4. Prior diagnosis of atrial fibrillation or other cardioembolic arrhythmias. 5. Written informed consent provided by the patient himself or by proxy. Patients with Symptoms not indicative of acute stroke, ongoing intravenous or subcutaneous anticoagulation at the time of stroke will be excluded. ASPERA-R: characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. The primary outcome will be: ASPERA-R : characterization of demographic, clinical and neuroimaging features of ischemic stroke cases occurring on oral anticoagulants. ASPERA-P: risk of ischemic stroke recurrence of ischemic stroke cases occurring on oral anticoagulants across different secondary preventive strategies (i.e., maintaining the same type of oral anticoagulation versus switching to a different secondary prevention strategy) at 90 days, 1 and 5 years after the index stroke. Additionally, the study will aim to investigate the risk of safety events (hemorrhagic transformation, intracranial hemorrhage, other major bleeding events, any bleeding events, death due to any cause), risk of other major ischemic events (transient ischemic attack, myocardial infarction, death due to vascular causes) at each follow-up and to identify demographic, clinical and neuroimaging features of ischemic stroke recurrences.",[442,443,444,445,446],"Ischemic Stroke","Oral Anticoagulation","Atrial Fibrillation (AF)","Outcome Assessment","Clinical Presentations",[448,449,450,451,452,453,454,455,456],"Ischemic stroke","Oral anticoagulation","Atrial fibrillation","Direct oral anticoagulants","Vitamin k antagonists","Outcomes","Prognosis","Clinical characteristics","Secondary prevention","2025-02-17",{"date":459,"type":33},"2025-02-20",{"date":461,"type":33},"2025-02-12",{"date":463,"type":22},"2031-02-12",{"name":465,"class":107},"University of L'Aquila",47,{"id":468,"slug":469,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":163,"minAge":474,"maxAge":475,"enrollmentInfo":476,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":484,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100548135","caudal-anesthesia-versus-local-anesthesia-in-hypospadias-100548135","NCT06417060","Caudal Anesthesia Versus Local Anesthesia in Hypospadias","THE IMPACT OF CAUDAL BLOCK ANESTHESIA ON POSTOPERATIVE COMPLICATIONS IN DISTAL HYPOSPADIAS SURGERY: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL","Inclusion Criteria:\n\n* Aged between 6 and 48 months\n* Distal hypospadias\n* Acceptance of participation\n\nExclusion Criteria:\n\n* Midpenil hypospadias\n* Proximal hypospadias\n* Prior surgery\n* Comorbidity (diabetes, hypertention, cardiac pathology)","6 Months","48 Months",{"count":438,"type":22},[76],"Hypospadias is among the most common congenital genital malformations in boys and is typically treated through surgical intervention. During pediatric urological surgery, caudal anesthesia, also known as a caudal block, is frequently employed as a regional anesthetic technique. It has proven to be a safe and effective anesthetic approach in children, with a low rate of anesthesia-related complications. However, despite the low incidence of complications directly associated with the caudal block, there is limited and inconclusive evidence regarding its impact on surgical complications. Therefore, this randomized controlled superiority trial aims to evaluate whether the use of caudal anesthesia, compared to the dorsal penile block, is associated with an increased incidence of urethrocutaneous fistulas and glans dehiscence following hypospadias repair.",[480,481,482,483],"Hypospadias","Hypospadias, Coronal","Caudal Anesthesia","Children",[480,485,486],"Caudal anesthesia","Urethrocutanous fistula","2024-08-19",{"date":489,"type":33},"2024-08-20",{"date":491,"type":33},"2023-05-25",{"date":493,"type":22},"2024-08-30",{"name":495,"class":107},"Necmi Kadıoğlu Hospital",3,""]