[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"upper-gastrointestinal-bleeding-ugib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:upper-gastrointestinal-bleeding-ugib":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,46,69,100,122,156,175],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100631224","fenox-trial-comparative-effectiveness-of-fexuprazan-co-therapy-in-patients-receiving-non-vitamin-k-antagonist-oral-anticoagulants-100631224",false,"NCT07497893","FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX Study (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX","Inclusion Criteria:\n\n* Age ≥18 years\n* Documented non-valvular atrial fibrillation\n* Receiving or initiating therapy with a non-vitamin K antagonist oral anticoagulant (NOAC) at guideline-recommended dosing\n* At least one high-risk factor for upper gastrointestinal bleeding, including:\n\n  * Age ≥75 years\n  * Chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²)\n  * Concomitant antiplatelet therapy\n  * Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids\n  * Prior peptic ulcer disease or upper gastrointestinal bleeding\n  * HAS-BLED score ≥3\n\nExclusion Criteria:\n\n* Active gastrointestinal bleeding at the time of screening\n* Requirement for mandatory long-term proton pump inhibitor (PPI) therapy that cannot be discontinued\n* Severe hepatic dysfunction\n* Life expectancy \\\u003C1 year\n* Known hypersensitivity or contraindication to fexuprazan\n* Participation in another interventional clinical trial that may interfere with study outcomes","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended for stroke prevention in non-valvular atrial fibrillation (AF). Although NOACs substantially reduce intracranial hemorrhage, upper gastrointestinal bleeding (UGIB) remains a frequent and clinically consequential complication. Proton pump inhibitors (PPIs) may reduce UGIB risk; however, concerns regarding long-term safety and pharmacodynamic variability persist. Fexuprazan, a potassium-competitive acid blocker (P-CAB), provides rapid and sustained acid suppression independent of acid activation and CYP2C19 metabolism. No randomized trial has evaluated P-CAB therapy for prevention of UGIB in anticoagulated patients.\n\nMethods FENOX is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) superiority trial. Approximately 1,000 high-risk patients with non-valvular AF initiating NOAC therapy will be randomized 1:1 to receive fexuprazan plus NOAC therapy or NOAC therapy alone. High-risk enrichment includes advanced age, renal impairment, concomitant antiplatelet therapy, prior ulcer disease, or elevated HAS-BLED score. The primary endpoint is clinically relevant upper gastrointestinal bleeding (CR-UGIB) at 12 months, defined according to ISTH criteria. All events will be adjudicated by an independent blinded Clinical Events Committee. Primary analyses will follow the intention-to-treat principle using time-to-event methods.\n\nResults The planned sample size provides 80% power to detect a 50% relative risk reduction in CR-UGIB, assuming a 12-month incidence of 10% in the control group. Interim safety monitoring will be conducted under independent oversight.\n\nConclusion FENOX is the first randomized trial designed to evaluate a P-CAB-based gastroprotective strategy for prevention of clinically relevant UGIB in high-risk patients receiving NOAC therapy. By integrating high-risk enrichment, pragmatic design, and blinded endpoint adjudication, the study aims to provide rigorous evidence to inform gastroprotective strategies in anticoagulated populations.",[27,28,29,30],"Atrial Fibrillation (AF)","Upper Gastrointestinal Bleeding (UGIB)","Gastrointestinal Hemorrhage (Clinically Important, Upper)","Drug-Related Side Effects and Adverse Reactions",[32],"Non-vitamin K antagonist oral anticoagulants (NOACs), potassium-competitive acid blocker (P-CAB), Upper gastrointestinal bleeding (UGIB)","NOT_YET_RECRUITING","2026-03-23",{"date":36,"type":37},"2026-03-27","ACTUAL",{"date":39,"type":21},"2026-12-01",{"date":41,"type":21},"2032-11-30",{"name":43,"class":44},"Ewha Womans University Mokdong Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100618827","phase-4-effect-of-ondansetron-on-patient-tolerance-efficacy-and-endoscopist-workload-in-unsedated-endoscopy-for-upper-gastrointestinal-bleeding-100618827","NCT07336680","Effect of Ondansetron on Patient Tolerance, Efficacy and Endoscopist Workload in Unsedated Endoscopy for Upper Gastrointestinal Bleeding","Inclusion Criteria:\n\n* Presence of suspected or confirmed upper gastrointestinal bleeding with an indication for emergent endoscopic intervention.\n* Capability to provide informed consent.\n\nExclusion Criteria:\n\n* Presence of any contraindication to upper gastrointestinal endoscopy.\n* Concurrent severe primary diseases of the respiratory, cardio-cerebrovascular, renal, central nervous, or hematologic systems.\n* Pregnancy.\n* Presence of neuropsychiatric disorders, including severe depression or severe anxiety.\n* Presence of a known history of cardiac arrhythmia.\n* Allergic to dyclonine hydrochloride or ondansetron.","65 Years",{"count":54,"type":21},80,[56],"PHASE4","The goal of this clinical trial is to evaluate whether intravenous ondansetron can improve patient tolerance and reduce discomfort during unsedated emergency esophagogastroduodenoscopy (EGD). The main questions it aims to answer are:\n\n* Does pre-procedural administration of ondansetron improve patient cooperation during emergency EGD?\n* Does it improve endoscopic field visibility and improve the success rate of initial endoscopic hemostasis？\n* Does it reduce the operator's perceived workload or stress?\n\nResearchers will compare patients who received intravenous ondansetron with patients who received placebo to see if ondansetron can reduce patient discomfort and improve patient cooperation, therefore improve the quality of the procedure.\n\nParticipants will receive either intravenous ondansetron and dyclonine hydrochloride mucilage or intravenous saline and dyclonine hydrochloride mucilage prior to the endoscopic procedure.",[59,28],"Esophagogastroduodenoscopy","2026-01-02",{"date":62,"type":37},"2026-01-13",{"date":64,"type":21},"2026-01-01",{"date":66,"type":21},"2026-06",{"name":68,"class":44},"Peking Union Medical College Hospital",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":45},"100602862","phase-3-optimization-strategies-for-blood-transfusion-protocols-in-the-emergency-treatment-of-hemorrhagic-shock-100602862","NCT07129031","Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock","Inclusion Criteria:\n\n* Patients with hemorrhagic shock due to trauma or upper gastrointestinal bleeding who meet emergency transfusion criteria (hemoglobin \\\u003C 7 g\u002FdL or active bleeding).\n\nAge 10-90 years. Time from onset to hospital admission \\\u003C 24 hours.\n\nExclusion Criteria:\n\n* Severe underlying diseases (end-stage organ failure or active malignancy). Known coagulopathy or history of severe transfusion reactions. Refusal to participate or inability to complete follow-up.","10 Years","90 Years",{"count":78,"type":21},180,[80],"PHASE3","This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A\u002FB IgM titer \\\u003C 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.",[83,84,28],"Hemorrhage","Hemorrhagic Shock",[86,87,88,89,90],"Hemorrhagic shock","transfusion","low-titer O-group whole blood","group of 1:1:1 component","group of ABO- and Rh-compatible whole blood","2025-08-18",{"date":93,"type":37},"2025-08-19",{"date":95,"type":21},"2025-09-01",{"date":97,"type":21},"2027-12-31",{"name":99,"class":44},"Xijing Hospital",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":45},"100599806","external-validation-of-the-glasgow-blatchford-bleeding-score-in-a-tunisian-population-100599806","NCT07089277","External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population","Inclusion Criteria:\n\n* Adult patients (≥18 years) presenting with non-traumatic upper gastrointestinal bleeding\n\nExclusion Criteria:\n\n* patients under 18 years of age.\n\nDiagnosis of external hemorrhoids with mucosal lesions.\n\nPatients who do not consent, are lost to follow-up, or have incomplete data.",{"count":107,"type":21},250,"OBSERVATIONAL","This study aims to externally validate the Glasgow-Blatchford Score (GBS) in a Tunisian population presenting with non-traumatic upper gastrointestinal bleeding. Despite advances in endoscopic management, early risk stratification remains essential to guide clinical decision-making. In Tunisia, the routine hospitalization of all patients for observation presents a challenge, highlighting the need for reliable prognostic tools.\n\nThe study is designed as a multicenter, descriptive, and analytical investigation across several emergency departments. Adult patients (≥16 years) will be included, with follow-up conducted at 30 days to assess for adverse outcomes including rebleeding, the need for hemostasis, complications, and mortality.\n\nClinical and epidemiological data will be collected using a standardized form. Statistical analysis will evaluate the predictive performance of the GBS, focusing on sensitivity, specificity, and predictive values for 30-day outcomes.\n\nThe results are expected to determine whether GBS is a valid and useful tool for risk assessment in the Tunisian context, potentially aiding in more efficient and targeted patient management.",[28,111],"Glasgow-Blatchford Score","RECRUITING","2025-07-21",{"date":115,"type":37},"2025-07-28",{"date":117,"type":37},"2024-01-01",{"date":119,"type":21},"2025-12-30",{"name":121,"class":44},"Hôpital Universitaire Sahloul",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":140,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100581291","capsule-gastric-endoscopy-for-gastric-disease-screening-in-simulated-home-scenarios-100581291","NCT06848400","Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios","A Multicenter, Prospective Study of Capsule Gastric Endoscopy for Gastric Disease Screening in Simulated Home Scenarios","Inclusion criteria\n\n1. Aged 18 years or older.\n2. Individuals meeting the following criteria:\n\n   i. Healthy volunteers; ii. Suspected presence of gastrointestinal diseases, with one or more of the following clinical symptoms: abdominal pain, nausea, vomiting, hematemesis, black or bloody stools, loss of appetite, bloating, or indigestion; iii. Follow-up of gastric lesions post-endoscopic resection.\n3. Willing to participate voluntarily in the clinical trial and provide written informed consent.\n4. Capable of communicating with researchers and complying with trial requirements.\n\nExclusion criteria\n\n1. Pregnant individuals.\n2. Individuals at high risk of gastrointestinal obstruction, including those identified as being at risk of gastrointestinal stenosis based on the Gastrointestinal Stenosis Assessment Form, those in whom gastrointestinal obstruction cannot be clinically excluded, or individuals with a history of gastrointestinal surgery, severe motor dysfunction, or pseudobulbar palsy.\n3. Individuals with swallowing dysfunction.\n4. Individuals deemed unfit for surgery or unwilling to undergo any surgical procedures.\n5. Participants who are unable to comprehend and\u002For comply with physician instructions during the examination.\n6. Individuals with other medical risks that contraindicate the use of a capsule gastric endoscopy system, or those deemed unsuitable for participation in this study at the discretion of the investigator.",true,{"count":131,"type":21},482,[24],"The goal of this clinical trial is to evaluate the diagnostic accuracy of the AI-integrated Capsule Gastroscopy (ACG) system in simulated home-use conditions for detecting upper gastrointestinal (UGI) abnormalities. It will also compare the diagnostic accuracy and time efficiency of AI-assisted interpretation versus manual reading of ACG data. The main questions it aims to answer are:\n\nWhat is the diagnostic accuracy of the ACG system, using conventional esophagogastroduodenoscopy (EGD) as a standard of reference?\n\nDoes AI-assisted ACG reading improve diagnostic accuracy or reduce reading time compared to manual ACG video reading?\n\nResearchers will compare ACG results to conventional EGD findings (standard of reference) to determine if ACG can serve as a reliable method for UGI disease detection in home scenarios.\n\nParticipants will:\n\nUndergo an ACG examination in a simulated home environment. Complete an EGD procedure within 24 hours post-ACG ingestion.",[135,136,28,137,138,139],"Gastric Lesion","Gastritis","Gastric Dysplasia","Gastric Ulcer","Gastric Neoplasms",[141,142,143,144,145],"upper gastrointestinal diseases","Capsule Endoscopy","Prospective Study","Diagnostic accuracy","Upper Gastrointestinal abnormalities","2025-07-03",{"date":148,"type":37},"2025-07-09",{"date":150,"type":37},"2025-03-03",{"date":152,"type":21},"2026-12-31",{"name":154,"class":44},"Nanfang Hospital, Southern Medical University",12,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":129,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":4},"100588740","study-of-patients-with-drug-induced-non-variceal-upper-gastrointestinal-bleeding-100588740","NCT06945328","Study of Patients With Drug-induced Non-variceal Upper Gastrointestinal Bleeding","Inclusion Criteria:\n\n* Adult patients (aged 18 years and above) presented with signs and symptoms of UGIB (hematemesis and\u002For melena)\n\nExclusion Criteria:\n\n* Variceal bleeding\n* Age below 18 years\n* Pregnant women\n* Consent refusal",{"count":163,"type":21},100,"* To study the association between non-variceal UGIB and the use of NSAIDs, VKAs, DOACs and antiplatelet therapy.\n* To compare the severity of bleeding related to specified drugs.\n* To determine risk factors associated with non-variceal UGIB.",[28],"2025-04-24",{"date":168,"type":37},"2025-04-27",{"date":170,"type":21},"2025-05",{"date":172,"type":21},"2026-02",{"name":174,"class":44},"Assiut University",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":189,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":199,"locationsCount":45},"100583845","phase-4-tranxemic-acid-and-vitamin-k-injection-to-control-upper-gastrointestinal-bleeding-in-cirrhotic-patients-100583845","NCT06881628","Tranxemic Acid and Vitamin K Injection to Control Upper Gastrointestinal Bleeding in Cirrhotic Patients","Efficacy of Tranexamic Acid and Vitamin k Injection in Control of Upper Gastrointestinal Bleeding in Egyptian Cirrhotic Patients: A Randomized Controlled Study","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver cirrhosis\n* Upper gastrointestinal bleeding\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years\n* Allergy to tranexamic acid\n* Allergy to vitamin K injection\n* DIC.\n* Thromboembolic event.\n* Pregnancy or lactation.\n* End-stage renal disease.\n* Unwilling to participate in our study.",{"count":183,"type":21},194,[56],"The goal of this randomized controlled clinical trial is to evaluate the efficacy of Tranexamic acid and vitamin K injection versus placebo in control of upper gastrointestinal bleeding (UGIB) in Egyptian cirrhotic patients.\n\nResearchers will compare the bleeding and mortality rates (at 5 days and 6 weeks post endoscopic intervention for UGIB) between patients receiving tranxemic acid and vitamin K injection and patients receiving placebo.\n\nParticipants presenting with variceal bleeding will be randomly assigned to receive tranexamic acid (1 g loading dose followed by 3 g maintenance dose over 24- 48 hours) and intravenous injection of 10 mg daily of vitamin K for 24-48 h or matching placebo group receiving IV saline. Intervention will be carried out besides the recommended initial management of airway management, hemodynamic stabilization, octreotide analogue, PPI, antibiotics, and endoscopy.\n\nFollow-up All patients will be kept at the hospital for at least 5 days from the index bleed and will be discharged if no other reason was observed to keep them at the hospital.\n\nThe rate of rebleeding, need for blood transfusion, hospital stay, adverse effects, and mortality rate were evaluated and compared across the groups.\n\nAt discharge, all patients will be started on nonselective beta-blockers if there was no contraindication. They will be given instructions to attend to hospital if they noticed any melena or hematemesis.\n\nSecond follow-up after 6 weeks for the rebleeding rate and mortality related to bleeding rate.",[28,187,188],"Variceal Bleeding","Cirrhosis",[190,191,192],"Variceal bleeding","Tranexamic acid and vitamin K","Liver cirrhosis","2025-03-11",{"date":195,"type":37},"2025-03-18",{"date":197,"type":37},"2024-12-02",{"date":119,"type":21},{"name":200,"class":44},"Tanta University"]