[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bowel-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bowel-disease":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,88,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100527786","development-of-new-diagnostic-tools-in-capsule-endoscopy-100527786",false,"NCT06152289","Development of New Diagnostic Tools in Capsule Endoscopy","NOCE","Inclusion Criteria:\n\n\\- Any patient in whom a capsule endoscopy examination is performed as part of routine care.\n\nExclusion Criteria:\n\n\\- Opposition to the use of images and videos from daily, routine care for research purposes.","ALL",{"count":18,"type":19},10000,"ESTIMATED","OBSERVATIONAL","Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.",[23,24,25,26,27],"Bowel Disease","Crohn Disease","Celiac Disease","Chronic Diarrhea","Tumor",[29,30,31],"Small bowel","Capsule endoscopy","Artificial intelligence","RECRUITING","2026-02-27",{"date":35,"type":36},"2026-03-02","ACTUAL",{"date":38,"type":36},"2023-02-10",{"date":40,"type":19},"2028-02",{"name":42,"class":43},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":54,"conditions":55,"keywords":69,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":44},"100434493","developing-a-decision-instrument-to-guide-abdominal-pelvic-ct-imaging-of-blunt-trauma-patients-100434493","NCT04937868","Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients","NEXUS AP CT","Inclusion Criteria:\n\nBlunt trauma patients who undergo abdominal-pelvic CT imaging during their initial trauma evaluation in the emergency department.\n\nExclusion Criteria:\n\nNone",{"count":53,"type":19},12000,"Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of \"occult\" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases.\n\nExisting data suggest that a limited number of criteria can reliably identify blunt injury victims who have \"no risk\" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies.\n\nThis study seeks to determine whether \"low risk\" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner:\n\nAll blunt trauma victims undergoing computed tomography of the abdomen\u002Fpelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal\u002Fpelvic\u002Fflank pain, abdominal\u002Fpelvic\u002Fflank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study.\n\nThe criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of \"low-risk\" patients that do not have significant abdominal or pelvic injuries.",[56,57,58,59,60,61,62,63,64,65,66,23,67,68],"Abdominal Injury","Pelvic Fracture","Genital Hemorrhage","Lumbar Spine Injury","Hip Injuries","Liver Injury","Spleen Injury","Renal Injury","Diaphragm Injury","Aortic Rupture","Aortic Dissection","Vascular System Injuries","Sacral Fracture",[70,71,72,73,74,75,76,77,78],"Blunt trauma","Abdominal injury","Pelvic injury","Spine injury","Genital injury","Vascular injury","Hip injury","Computed tomography","Decision instrument","2026-01-09",{"date":81,"type":36},"2026-01-13",{"date":83,"type":36},"2018-01-15",{"date":85,"type":19},"2027-06-15",{"name":87,"class":43},"University of California, Los Angeles",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":104,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":44},"100456476","phase-4-bilateral-tap-and-rs-blocks-using-liposomal-bupivacainebupivacaine-vs-regular-bupivacaine-in-laparoscopic-colectomy-100456476","NCT05224089","Bilateral TAP and RS Blocks Using Liposomal Bupivacaine\u002FBupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy","Bilateral Mid-Abdominal Transverse Abdominis Plane and Rectus Sheath Blocks Comparing The Use of Liposomal Bupivacaine\u002FBupivacaine vs. Regular Bupivacaine in Laparoscopic Colectomy Procedures.","TAPLIP","Inclusion Criteria:\n\n* Patients scheduled for elective laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study.\n* English speaking patients\n* Patients with American Society of Anesthesiology (ASA) physical status score I- IV\n\nExclusion Criteria:\n\n1. Emergency laparoscopic colectomy surgery\n2. Patients with distant metastatic cancers (e.g. bone, lung, brain).\n3. Scheduled for multi organs resection surgery in addition to colectomy.\n4. Patients with contraindications to TAP or RS blocks including but not limited to anatomical abnormality, previous surgical intervention that limits or prevents receiving bilateral TAP blocks (e.g. surgical mesh at the site of TAP or RS block), or infection at the injection site.\n5. Current colostomies.\n6. History of allergy to local anesthetics.\n7. Coagulopathy or coagulation disorder. Also patients who are receiving antithrombotic medications as a contraindication to receiving single shot peripheral nerve blockade as per the most recent American Society of Regional Anesthesiology (ASRA) guidelines.16\n8. Weight \\\u003C 40 kg, as 40 mL of Bupivacaine 0.25%, or combination of 20 mL of bupivacaine 0.25% with 20 mL of liposomal bupivacaine is greater than the maximal dose allowed, given concern for local anesthetic toxicity.\n9. Patients who take long acting opioid medication, or on continuous opioid \\> 50 MME per day for at least 30 days within 90 days prior to surgery. Also patients who have chronic pain syndrome with a recent preoperative consultation to the chronic pain service.\n10. Patients with current substance abuse, or history of substance abuse within 3 months, this includes any illicit drugs or excessive alcohol consumption as defined 4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men.15\n11. Pregnant, nursing, or planning to become pregnant during the study or within 1 month postoperatively\n12. Refusal or lack of providing the study consent","18 Years",{"count":98,"type":19},114,"INTERVENTIONAL",[101],"PHASE4","This study will be a single center, prospective triple blinded randomized controlled study, comparing the use of liposomal bupivacaine (Exparel) to regular bupivacaine with adjuncts in bilateral mid-abdominal transverse abdominis plane (TAP) blocks for patients undergoing laparoscopic colectomy procedures.",[23],[105,106,107,108,109,110,111],"Liposomal Bupivacaine","Exparel","Bupivacaine","Laparoscopic Colectomy","Transverse Abdominis Plane Blocks (TAP)","Regional anesthesia","Rectus Sheath Block","2025-03-28",{"date":114,"type":36},"2025-04-02",{"date":116,"type":36},"2022-04-27",{"date":118,"type":19},"2026-02",{"name":120,"class":43},"Hartford Hospital",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":16,"minAge":96,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":99,"phases":132,"briefSummary":134,"conditions":135,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":44},"100520701","phase-3-induction-treatment-with-subcutaneous-infliximab-for-crohns-disease-100520701","NCT06059989","InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease","A Multicenter Randomized, Open-label Study to Compare the Efficacy of Subcutaneous Infliximab Monotherapy with Subcutaneous Infliximab and Concomitant Immunosuppression in the Treatment of Moderate to Severe Crohn's Disease","DIRECTCD","Inclusion Criteria:\n\n1. Patients 18 years or older diagnosed with Crohn's disease\n2. Patients with moderate to severely active Crohn's disease with a Crohn's Disease Activity Index (CDAI) of 250 to 450 and presence of endoscopic ulceration in the terminal ileum, colon or both. Minimal SES-CD is ≥ 6 or ≥ 4 for isolated ileal disease.\n3. Patients who had no response or loss of response to or have had intolerable side effects to one or more to the following: glucocorticoids, thiopurines (azathioprine\u002F6-mercaptopurine\u002F6-thioguanin), methotrexate , adalimumab, vedolizumab or ustekinumab OR patients in need of immediate top-down treatment with IFX at the discretion of the treating physician.\n4. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.\n5. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedure.\n6. Male or non-pregnant, non-lactating females. No wish to become pregnant in the coming 26 weeks.\n\nExclusion Criteria:\n\n1. Patients at imminent need of surgery as judged by the treating clinician\n2. Patients with the short bowel syndrome, an ostomy or a symptomatic non-inflammatory stricture\n3. Patients previously exposed to IFX (intravenous or subcutaneous)\n4. Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate)\n5. Treatment with adalimumab or vedolizumab or ustekinumab within 30 days\n6. Patients who have had a primary non-response to adalimumab or had intolerable class-related side effects (as evaluated at the discretion of the treating physician)\n7. Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening\n8. Ongoing participation in another interventional trial\n9. Patients with Ulcerative Colitis or Inflammatory bowel disease unclassified (IBD-U)\n10. Patients with ongoing abdominal or undrained perianal abscess\n11. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed\n12. Active or latent tuberculosis (screening according to national guidelines). Except when the latter has been treated appropriately according to national guidelines.\n13. Cardiac failure in the New York heart Association (NYHA) stage III-IV\n14. History of demyelinating disease\n15. Recent live vaccination (≤ 4 weeks)\n16. Patients with ongoing acute\u002Fchronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical human papillomavirus (HPV)\n17. History of cancer in the last 5 years with the exception of non-melanoma skin cancer\n18. Male patients with Epstein-Barr virus (EBV) negative serology\n19. A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures\n20. Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures\n21. Patients unable to attend all study visits\n22. Patients with a history of non-compliance with clinical study protocols\n23. Contraindication for endoscopy\n24. Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer\n25. Pregnancy or lactation or wish to become pregnant in the coming 26 weeks","80 Years",{"count":131,"type":19},158,[133],"PHASE3","Study Design:\n\nA Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease.\n\nPrimary endpoint:\n\nThe proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\\\u003C150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26.\n\nAccrual and feasibility:\n\nThis study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient\u002Fcentre\u002Fmonth leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021.\n\nTreatment, dosage and administration:\n\nEligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.",[136,137,23],"Inflammatory Disease","Disease Crohn",[139,140,141],"Crohn's disease","Biological","Subcutaneous","2024-12-05",{"date":144,"type":36},"2024-12-10",{"date":146,"type":36},"2021-11-25",{"date":148,"type":19},"2025-12",{"name":150,"class":43},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)"]