[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Poliambulanza Istituto Ospedaliero\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100601532","comparison-between-artificial-intelligence-and-standard-reading-to-investigate-suspected-crohn-disease-the-scai-study-100601532",false,"NCT07111715","Comparison Between Artificial Intelligence and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY","Comparison Between Artificial Intelligence Assisted Capsule Endoscopy and Standard Reading to Investigate Suspected Crohn Disease: the SCAI STUDY","SCAI","Inclusion Criteria:\n\n* Age \\>= 18 and \\\u003C= 75 years\n* Clinical suspicion of Crohn's Disease (CD) with\u002Fwithout occlusive symptoms\n* Ileocolonoscopy: negative examination, aspecific inflammatory findings\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Known diagnosis of CD\n* Endoscopic diagnosis of active diverticular disease, colorectal cancer, ulcerative colitis, or infectious colitis, microscopic colitis\n* Positive stool tests for pathogenic bacteria, Yersinia enterocolitica, parasites, C. difficile infection, fecal antigen for Giardia lamblia within 6 months before VCE\n* Known intestinal obstruction or unconfirmed small bowel patency\n* Any use of NSAIDs in the 4 weeks before ileocolonoscopy and before VCE\n* Known gastrointestinal motility disorder\n* Known or suspected delayed gastric emptying\n* Swallowing disorders\n* Allergy or other contraindications or intolerance to the medications\u002Fdevices used in the study\n* Endoscopic placement of the capsule\n* Any condition that prevents adherence to the study\n* Pregnancy\n* Participation in another clinical trial involving experimental drugs or devices\n* Concomitant life-threatening condition\n* Chronic kidney disease (eGFR\\\u003C30mL\u002Fmin\u002F1.73 m2)\n* Inability to sign the informed consent","ALL","18 Years","75 Years",{"count":21,"type":22},180,"ESTIMATED","OBSERVATIONAL","The diagnosis of Crohn's Disease (CD) is based on a combination of clinical, biochemical (serological and fecal), endoscopic, radiological, and histological investigations. In the absence of obstructive symptoms or known stenosis, European guidelines recommend to investigate the small intestine using Video Capsule Endoscopy (VCE) if ileocolonoscopy is not decisive. To reduce the reading time of VCE and increase the number of identified lesions during the examination, various artificial intelligence software\u002Ftools have been developed in recent decades. This study aims to be the first prospective multicentric real-life trial to evaluate AI-assisted VCE using SmartScan in identifying typical mucosal abnormalities of the small intestine in patients with suspected CD and its ability to reduce reading time while maintaining the same diagnostic yield and diagnostic accuracy of standard reading. The objective of the study is to evaluate the role of AI-assisted VCE using the OMOM SmartScan in detecting typical small bowel inflammatory lesions (i.e. erosions and ulcers) in patients with suspected CD, and comparing AI with standard reading.",[26],"Crohn Disease (CD)",[26,28,29],"Artificial Intelligence","Video Capsule Endoscopy (VCE)","RECRUITING","2025-08-05",{"date":33,"type":34},"2025-08-08","ACTUAL",{"date":36,"type":34},"2025-07-21",{"date":38,"type":22},"2028-12-31",{"name":40,"class":41},"Fondazione Poliambulanza Istituto Ospedaliero","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":42},"100521317","the-adapta-study-adjuvant-chemotherapy-after-curative-intent-resection-of-ampullary-cancer-100521317","NCT06068023","The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer.","The ADAPTA Study: ADjuvant chemotherAPy After Curative Intent resecTion of Ampullary Cancer. A Pan-European Prospective Multicenter Double Single Arm Cohort Study.","ADAPTA","Inclusion Criteria:\n\n* Adult patients with histologically or cytologically confirmed AAC with subtyping of pancreatobiliary\u002Fmixed subtype or intestinal subtype\n* After curative resection for ampullary cancer without metastatic disease.\n* WHO performance status 0 or 1\n* Able and willing to receive adjuvant chemotherapy\n* R0\u002F R1 resection\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Prior radiotherapy, chemotherapy, or resection for AAC.\n* Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 5 years before diagnosis of AAC.\n* Pregnancy.\n* R2 resection.\n* Adjuvant chemotherapy started more than 12 weeks after surgery (aim to start within 8 weeks)\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator.\n* Known hypersensitivity or contraindications against capecitabine, 5 FU, Irinotecan, or Oxaliplatin\n* Inadequate organ functions, characterized by:\n\n  * Leucocytes (WBC) \\\u003C 3.0 X 109\u002Fl\n  * Neutrophils \\\u003C 1.500 (count per microliter of blood)\n  * Platelets \\\u003C 100 x 109 \u002Fl\n  * Hemoglobin \\\u003C 8 mmol\u002Fl\n  * Renal function: E-GFR \\\u003C 50 ml\u002Fmin (serum creatinine \\\u003C 1.5 x UNL)\n  * cholestasis with elevated levels of bilirubin and\u002For alkaline phosphatase \\> 3x UNL (can be improved by biliary drainage if necessary)\n  * elevated transaminases (ALAT\u002FASAT) ≥ 5 x UNL\n  * hypoalbuminemia \\\u003C 2.5 g\u002Fdl\n  * Inadequate coagulation status INR \\> 2 or Quick \\\u003C 50%, aPTT \\>50 sec in the absence of any drugs interfering with coagulation such as acenocoumarin, warfarin, phenprocoumon, NMH or UFH.",true,"100 Years",{"count":54,"type":22},400,"Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.",[57],"Ampullary Adenocarcinoma",[59,60,61,62,63,64],"pancreatobiliary-type","intestinal-type","mixed\u002Fhybrid-type","adjuvant chemotherapy","CAPOX","FOLFIRINOX","2023-10-03",{"date":67,"type":34},"2023-10-05",{"date":69,"type":34},"2023-07-01",{"date":71,"type":22},"2029-07-01",{"name":40,"class":41},""]