[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-diseases":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,51,79,117,151,183,216,248,295,316,340,374,399,434,458,489,508,531,559,585,604,634,668],{"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":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100531527","trans-nasal-endoscopy-for-bariatric-patients-100531527",false,"NCT06200961","Trans-nasal Endoscopy for Bariatric Patients","Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program","TNE","Inclusion Criteria:\n\n1. Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)\n2. Cared for in metabolic and bariatric clinic\n\nExclusion Criteria:\n\n1. Patient \\\u003C18 years of age\n2. Medically contraindicated to perform EGD or TNE\n3. Inability to provide informed consent","ALL","18 Years","90 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.",[28,29,30,31,32],"Obesity","Obesity, Morbid","Obese","GI Disorders","Gastrointestinal Diseases",[34,35,36,37],"Transnasal Endoscopy (TNE)","Esophagogastroduodenoscopy (EGD)","Upper Endoscopy","Endoscopy","RECRUITING","2026-06-23",{"date":41,"type":42},"2026-06-25","ACTUAL",{"date":44,"type":42},"2026-04-20",{"date":46,"type":22},"2028-06",{"name":48,"class":49},"Christopher C. Thompson, MD, MSc","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":50},"100442437","evaluation-of-patients-with-gastrointestinal-disease-100442437","NCT05041374","Evaluation of Patients With Gastrointestinal Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, aged \\>= 18 years of age\n2. Known or suspected gastrointestinal disorders or requiring clinical screening, management and\u002For treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Significant medical illnesses that the investigators feel may interfere with potential evaluations.\n2. Absence of a referring community physician who would be able to manage care outside of the NIH.\n3. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.\n4. Inability to provide informed consent.","120 Years",{"count":59,"type":22},4000,"OBSERVATIONAL","Background:\n\nOngoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future.\n\nObjective:\n\nTo collect data and samples from people being seen and\u002For treated for gastrointestinal problems at NIH, to use in future research.\n\nEligibility:\n\nAdults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines.\n\nDesign:\n\nParticipants will be screened with a physical exam. Their medical records will be reviewed.\n\nParticipants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research.\n\nParticipants may give blood, urine, and\u002For stool samples.\n\nIf participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and\u002For tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use.\n\nData will be stored at NIH. The data systems are password protected. Samples will be coded.\n\nParticipants will take part in the study for as long as they agree to be seen for their disease....",[63,32],"Lower GI Disease",[65,32,66,67,68],"Digestive System Diseases","Small Bowel Disease","Upper GI Disease","Natural History","2026-06-13",{"date":71,"type":42},"2026-06-16",{"date":73,"type":42},"2022-01-04",{"date":75,"type":22},"2035-12-31",{"name":77,"class":78},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":116},"100619934","post-market-study-of-the-signia-circular-stapler-with-tri-staple-technology-in-left-sided-colon-sigmoid-and-rectal-resections-100619934","NCT07351071","Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections","A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)","SECURE","Preoperative Inclusion Criteria:\n\n1. Subject is competent and willing to provide documented informed consent to participate in this clinical study\n2. Subject is intended to undergo an elective left sided colon\u002Fcolorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler\n3. Subject is ≥ 18 years of age at time of consent\n\nPreoperative Exclusion Criteria:\n\n1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule\n2. Subject with ASA classification ≥ IV\n3. Subject is pregnant (as determined by standard site practices)\n4. The procedure is an emergency procedure\n5. The procedure is a revision\u002Freoperation for the same indication\n6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months\n7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study\n8. Subject will undergo multiple synchronous colon resections\n9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)\n10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure\n11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)\n12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)\n13. Any subject undergoing an ileal-anal pouch anastomosis surgery\n\nIntraoperative Exclusion Criteria\n\n1. Anastomosis not attempted with the Signia™ circular stapler\n2. Any subject for which the device is intended to be used outside the instructions for use (IFU)",{"count":88,"type":22},137,[25],"The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.",[92,93,94,95,65,32,96,97,98,99,100],"Colorectal Anastomosis","Left-sided Colon Resection","Anastomotic Leak","Anastomotic Complication","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Postoperative Complications","Anastomotic Leaks",[92,93,102,94,103,104,105],"Circular stapler","Rectal cancer","Low anterior resection","Powered stapler","2026-06-11",{"date":108,"type":42},"2026-06-12",{"date":110,"type":42},"2025-12-30",{"date":112,"type":22},"2027-02-28",{"name":114,"class":115},"Medtronic - MITG","INDUSTRY",9,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":128,"conditions":129,"keywords":135,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100610070","phase-3-symbiotic-gi-03-a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-metastatic-colorectal-cancer-100610070","NCT07222800","Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer","AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER","Inclusion Criteria:\n\n* Histological or cytological confirmed colorectal adenocarcinoma.\n* Evidence of Stage IV metastatic disease.\n* No prior systemic therapy for metastatic disease.\n* Eastern Cooperative Oncology Group performance status (ECOG) 0-1\n* At least one measurable lesion according to RECIST 1.1 per Investigator assessment.\n* Adequate hepatic, liver, and renal function\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Locally confirmed BRAF V600E mutation\n* Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer\n* Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression\n* Clinically significant risk of hemorrhage or fistula\n* Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study\n* History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation\n* Any Grade ≥3 bleeding\u002Fhemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events\n* Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose\n* Participants with active autoimmune diseases requiring systemic treatment within the past 2 years\n* Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis",{"count":125,"type":22},800,[127],"PHASE3","The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have colorectal cancer that has spread to other parts of your body.\n* Be in good enough health to receive study treatment.\n* Should not be pregnant before starting treatment.\n\nParticipants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.\n\nThe medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.\n\n* The study is expected to last approximately 33 months for each participant.\n* Participants will have regular visits to the study site for treatment, health checks, and tests.\n* After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects.\n* Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.",[130,131,132,133,65,32,96,97,98,134],"Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Neoplasms by Site","Colorectal Neoplasms",[136,137,138,139,140],"mCRC","metastatic disease","first-line","metastatic colorectal cancer","colon cancer","2026-06-03",{"date":143,"type":42},"2026-06-04",{"date":145,"type":42},"2025-12-11",{"date":147,"type":22},"2031-08-01",{"name":149,"class":115},"Pfizer",228,{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":160,"studyType":60,"phases":4,"briefSummary":161,"conditions":162,"keywords":166,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":50},"100639232","adding-a-gastrointestinal-subscore-to-sofa2-for-mortality-risk-assessment-in-the-icu-the-sofa2-gis-study-100639232","NCT07586254","Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in the ICU: The SOFA2-GIS Study","Development and Validation of the SOFA2-GIS Score: Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in Critically Ill Patients - A Multicenter Prospective Observational Cohort Study","SOFA2-GIS","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Admission to a participating intensive care unit\n* Expected ICU length of stay of at least 24 hours\n* Availability of clinical and laboratory data required to calculate the SOFA2 score and the AGI grade within the first 24 hours of ICU admission\n* Written informed consent obtained from the patient or, when not feasible due to the patient's clinical condition, from a legally authorized representative\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Pregnancy\n* ICU length of stay shorter than 24 hours (including patients who die or are discharged within the first 24 hours)\n* ICU readmission during the same hospital stay (only the index admission will be included)\n* Postoperative admission for routine monitoring without organ dysfunction (planned short-term observation following elective surgery)\n* Admission solely for end-of-life care or with treatment limitations (do-not-resuscitate or withdrawal of life-sustaining therapy decisions) made within the first 24 hours of admission\n* Patients with primary gastrointestinal pathology as the reason for ICU admission that would confound AGI grading (e.g., gastrointestinal surgery within the preceding 7 days, acute mesenteric ischemia as the primary diagnosis)\n* Patients with anatomical or functional conditions precluding standard AGI assessment (e.g., short bowel syndrome, permanent gastrostomy\u002Fjejunostomy with chronic feeding intolerance, chronic intestinal pseudo-obstruction)\n* Refusal of consent by the patient or legal representative\n* Participation in an interventional clinical trial that may affect outcome measures",{"count":125,"type":22},"3 Months","The goal of this observational study is to learn whether adding a gastrointestinal (GI) component to a widely used organ failure score improves the prediction of death risk in critically ill adults treated in the intensive care unit (ICU).\n\nThe Sequential Organ Failure Assessment 2 (SOFA2) score is used in ICUs to measure how severely a patient's organs are failing. The current version evaluates six organ systems but does not include the gastrointestinal system, even though gut dysfunction is common and serious in critically ill patients. Researchers in this study will add a GI subscore based on the European Society of Intensive Care Medicine (ESICM) Acute Gastrointestinal Injury (AGI) classification and create a new combined score called SOFA2-GIS.\n\nThe main questions this study aims to answer are:\n\nDoes adding a gastrointestinal subscore to the SOFA2 score improve the prediction of 28-day mortality in ICU patients? Does the new SOFA2-GIS score perform better than the standard SOFA2 score in identifying patients at higher risk of dying in the ICU or in the hospital?\n\nResearchers will compare the standard SOFA2 score with the new SOFA2-GIS score in the same patients to see which one better predicts patient outcomes.\n\nParticipants will:\n\nReceive their usual ICU care without any change, additional treatment, or extra tests Be evaluated using routinely collected clinical and laboratory information during the first 24 hours of ICU admission Be followed during their hospital stay to record outcomes such as length of stay, need for mechanical ventilation, need for dialysis, and survival\n\nThis is a multicenter, prospective, observational cohort study conducted in tertiary ICUs in Türkiye. No additional procedures, tests, or interventions will be performed for the purpose of this study.",[163,164,32,165],"Critical Illness","Multiple Organ Failure","Mortality",[167,168,169,157,170,171,172],"sofa2","sofa-2","Sequential Organ Failure Assessment","Organ dysfunction score","Prognostic score","ICU mortality","NOT_YET_RECRUITING","2026-05-20",{"date":176,"type":42},"2026-05-26",{"date":178,"type":22},"2026-07",{"date":180,"type":22},"2027-03",{"name":182,"class":49},"Ozkul Yilmaz Colak",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":194,"conditions":195,"keywords":203,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":50},"100536954","phase-4-evaluation-of-efficacy-of-skl-pro-powder-on-symptoms-of-irritable-bowel-syndrome-100536954","NCT06271538","Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome","A Randomized Double-Blind Placebo-controlled Clinical Trial on the Efficacy of Skål Pro (Lactobacillus Plantarum 299 and Galacto-oligosaccharides) in Improving Severity of Symptoms, Stool Forms, Quality of Life and Psychological Dysfunction in Patients With Irritable Bowel Syndrome (IBS)","Inclusion Criteria:\n\n* IBS diagnosed using the Rome IV criteria\n* Age above 18 years old and any gender\n* Any subtypes of IBS (diarrhea, constipation or mixed)\n\nExclusion Criteria:\n\n* Presence of red flag symptoms (weight loss, anemia, night symptoms, abdominal mass, strong family history of cancer)\n* Was prescribed antibiotic (s) within the past one month\n* Medical conditions that contraindicate probiotic use including severe sepsis and pregnancy\n* Presence of bowel malignancy\n* Diagnosis of bowel infection within the past one month\n* Previous abdominal surgeries\n* Patients with overt psychiatric illnesses including schizophrenia and manic disorders\n* A history of allergy to probiotic\n* Was prescribed probiotic (s) within the past one month\n* Was previously prescribed probiotic Skal Pro™ (LP299V™)",{"count":191,"type":22},60,[193],"PHASE4","The objective of this randomized, double-blind, placebo-controlled study is to evaluate the effectiveness of Skal Pro in alleviating symptoms, enhancing stool consistency, improving quality of life, and addressing psychological distress in individuals diagnosed with irritable bowel syndrome (IBS), as compared to those who receive no intervention.",[196,32,197,198,199,200,201,202],"Irritable Bowel Syndrome","Colonic Diseases, Functional","Intestinal Disease","Digestive System Disease","Pathologic Processes","Colonic Disease","Disease",[204,205,206],"probiotic","Lactobacillus plantarum 299v","randomized controlled study","2026-05-11",{"date":209,"type":42},"2026-05-12",{"date":211,"type":42},"2024-10-17",{"date":213,"type":22},"2026-06-30",{"name":215,"class":115},"EP Plus Group Sdn Bhd",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":223,"sex":17,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":50},"100538394","phase-1-fecal-microbiota-transplantation-for-patients-with-autism-spectrum-disorder-100538394","NCT06290258","Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.","Fecal Microbiota Transplantation for Gastrointestinal, Autistic, Emotion, and Behavior Symptoms of Patients With Autism Spectrum Disorder and Gastrointestinal Problems: a Preliminary Study.","Inclusion Criteria:\n\n* Diagnosed by a child psychiatrist in line with DSM-5 Autism Spectrum Disorder\n* Combined with gastrointestinal problems, any Gastrointestinal Symptoms Rating Scale score≧3.\n* Age is between 7-30.\n* Participants who are willing to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Cases where clinical assessment cannot cooperate with fecal microbiota transplantation and examination.\n* Cases requiring antibiotics within 3 months before or after acceptance because of their physiological condition.\n* Cases requiring long-term use of proton pump inhibitors due to their physiological conditions.\n* Severe physical diseases, such as acute gastrointestinal diseases, severe malnutrition or underweight, immunodeficiency diseases, severe allergies or autoimmune diseases, brain injuries or severe organic brain diseases, will affect the evaluation of treatment results.\n* Severe mental illness, such as schizophrenia, bipolar disorder, etc.\n* Those who used probiotics one month before the case may affect the intestinal flora.\n* Pregnancy.\n* Cases that cannot understand the content of this research.\n* Participants who are unwilling to participate in the study or refuse to sign the informed consent.\n* Participants who are not suitable to include in this study, evaluate by PI or Co-PI.",true,"7 Years","30 Years",{"count":191,"type":22},[228,229],"PHASE1","PHASE2","This study aims to evaluate the efficacy of fecal microbiota transplantation on the gastrointestinal symptoms, autistic symptoms and emotional behavior symptoms of patients with autism spectrum disorder, and investigate the relations between the brain-gut axis, cytokines and autism spectrum disorder. Fecal microbiota transplantation have the potentials to improve intestinal microbiota composition, regulate immunity, and then improve gastrointestinal symptoms, autistic symptoms, emotional behavior symptoms and sleep of children with autism spectrum disorder. Early intervention at school-age may even benefit development, improve cognition and prognosis.",[232,32,233],"Autism Spectrum Disorder","Healthy",[235,232,236,237,238],"Fecal Microbiota Transplantation","gastrointestinal problems","cytokines","cognitive function","2026-03-18",{"date":241,"type":42},"2026-03-20",{"date":243,"type":42},"2024-03-06",{"date":245,"type":22},"2027-07-31",{"name":247,"class":49},"Chang Gung Memorial Hospital",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":259,"conditions":260,"keywords":276,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":50},"100625999","saudi-emergency-laparotomy-audit-100625999","NCT07429929","Saudi Emergency Laparotomy Audit","Saudi Emergency Laparotomy Audit (SELA): A National Multicenter Observational Audit of Outcomes Following Emergency Laparotomy in Saudi Arabia","SELA","Inclusion Criteria:\n\n* Age ≥14 years\n* Undergoing an emergency (E1-E4) laparotomy, laparoscopy, or laparoscopically-assisted abdominal operation\n* Procedures involving the stomach, small bowel, large bowel, or rectum for acute pathology (e.g., perforation, ischemia, abscess, bleeding, or obstruction)\n* Washout\u002Fevacuation of intra-peritoneal abscess or hematoma (excluding those secondary to appendicitis or cholecystitis)\n* Bowel resection or repair for obstructed\u002Fincarcerated hernias with acute presentation (incisional, umbilical, inguinal, femoral)\n* Adhesiolysis (open or laparoscopic)\n* Trauma-related emergency abdominal procedures\n* Inoperable pathology where a definitive operative procedure was intended (not purely diagnostic)\n* Return to theatre for major wound dehiscence (\"burst abdomen\")\n* Complications requiring general surgical intervention following interventional radiology procedures\n* Complications requiring general surgical intervention following gynecological oncology surgery\n* Complications following elective or non-elective general\u002Fupper GI surgery, where the above criteria are met\n\nExclusion Criteria:\n\n* Age \\\u003C14 years\n* Elective laparotomy or laparoscopy\n* Diagnostic-only laparotomy or laparoscopy (unless abandoned due to inoperable disease)\n* Appendicectomy or cholecystectomy (including their complications), unless incidental to a more major non-elective gastrointestinal procedure\n* Non-elective hernia repair without bowel resection or adhesiolysis\n* Minor wound dehiscence repair (unless bowel resection is required)\n* Stoma formation via trephine or laparoscopic approach (include only if midline laparotomy is the primary procedure)\n* Vascular, obstetric, gynecological (except gynecological oncology complications requiring general surgery input), transplant, hepatobiliary, urological, renal, pancreatic, or splenic procedures","14 Years",{"count":258,"type":22},10000,"The Saudi Emergency Laparotomy Audit (SELA) is a national, multicenter observational clinical audit designed to evaluate outcomes and quality of care for patients undergoing emergency laparotomy in Saudi Arabia. The audit will collect standardized data on patient characteristics, comorbidities, perioperative processes, and postoperative outcomes through a retrospective baseline phase followed by a prospective registry phase. SELA aims to establish national benchmarks, assess applicability of international risk models, support development of a Saudi-specific risk prediction tool, and drive quality improvement through systematic feedback and benchmarking across participating hospitals.",[261,262,263,264,32,265,266,267,268,269,270,271,272,273,274,275,165],"Laparotomy","Laparotomy Surgery","Emergency Treatment","Abdominal Diseases","Intestinal Obstruction","Intestinal Obstruction and Ileus","Intestinal Perforation","Intestinal Ischemia","Peritonitis Infectious, Gastrointestinal Perforation, Surgical Infection, Postoperative Complications","Peritonitis Bacterial","Peritonitis Caused by Perforated Left-sided Colon Diverticulitis","Peritonitis Infectious","Sepsis","Postoperative Complications After Gastrointestinal Operations","Surgical Procedures, Operative",[277,278,279,280,165,281,282,283,284,285],"Emergency laparotomy","Surgical audit","Postoperative outcomes","Perioperative care","Morbidity","Quality improvement","Risk stratification","Retrospective audit","Saudi Arabia","2026-02-22",{"date":288,"type":42},"2026-02-24",{"date":290,"type":22},"2026-06-01",{"date":292,"type":22},"2028-12-31",{"name":294,"class":49},"King Faisal Specialist Hospital & Research Center",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":50},"100625579","foregut-leaks-role-of-microbiome-100625579","NCT07424469","Foregut Leaks-Role of Microbiome","The Role the Microbiome Plays in Foregut Leaks: Understanding and Utilizing This Information to Improve Patient Outcomes","Inclusion Criteria:\n\n* Patients with an esophageal or stomach leak\n* Over 18 years old\n\nExclusion Criteria:\n\n* Patients determined by physician\u002Fsurgeon as not able to tolerate biopsy\n* Under 18 years old",{"count":303,"type":22},50,[25],"Aims\n\n1. To understand the microbial composition involved with foregut leaks\n2. To define the virulence changes in the microbiota following foregut leaks\n3. To identify host response mechanisms and how they change with interventions\n4. Utilize this information to improve patient outcomes",[32],"2026-02-13",{"date":309,"type":42},"2026-02-20",{"date":311,"type":42},"2020-08-14",{"date":313,"type":22},"2028-06-01",{"name":315,"class":49},"Baylor Research Institute",{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":4,"eligibilityCriteria":322,"healthyVolunteers":223,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":50},"100536230","virtual-reality-for-non-cardiac-chest-pain-100536230","NCT06262126","Virtual Reality for Non-cardiac Chest Pain","A Feasibility Study of Virtual Reality for the Treatment of Non-cardiac Chest Pain","Inclusion Criteria:\n\n* Symptoms of non-cardiac chest pain (recurrent anginal-like or atypical chest pain)\n* Negative prior cardiac evaluation (at a minimum, including electrocardiogram)\n* Prior esophagogastroduodenoscopy and\u002For barium esophagram to rule out severe esophagitis, stricture, or motility abnormality\n\nExclusion Criteria:\n\n* Initiation of a proton pump inhibitor (PPI) within 8 weeks\n* Major concomitant illness\n* Current drug or alcohol use that that would interfere with adherence to study requirements\n* Symptoms of vertigo or dizziness that would limit tolerability of the VR headset",{"count":324,"type":22},10,[25],"The purpose of this study is to determine if virtual reality (VR) will improve symptoms in non-cardiac chest pain (NCCP).",[32,328],"Chest Pain",[330],"Virtual reality","2026-02-10",{"date":333,"type":42},"2026-02-12",{"date":335,"type":42},"2024-02-14",{"date":337,"type":22},"2026-12-31",{"name":339,"class":49},"Mayo Clinic",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":17,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":351,"conditions":352,"keywords":356,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":373},"100617493","objective-vascular-biomarkers-as-triage-for-depression-in-chronic-atrophic-gastritis-100617493","NCT07319338","Objective Vascular Biomarkers as Triage for Depression in Chronic Atrophic Gastritis","Implementing Objective Vascular Biomarkers as a Non-stigmatizing Triage Workflow for Depression in Gastroenterology Settings: a Multicenter Study Protocol for a Hybrid Effectiveness-implementation Study","Inclusion Criteria:\n\n1. Age between 20 and 60 years, regardless of sex.\n2. Diagnosed with chronic atrophic gastritis (CAG) confirmed by upper gastrointestinal endoscopy and histopathology within the past 6 months.\n3. Ability to comprehend and voluntarily complete psychological assessments and multimodal vascular examinations.\n4. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. History of major psychiatric disorders (e.g., schizophrenia, bipolar disorder) or currently experiencing an acute psychotic episode.\n2. Major cardiovascular or cerebrovascular events (e.g., acute myocardial infarction, stroke) within the past 3 months.\n3. Severe peripheral artery disease or major anatomical abnormalities in the lower extremities (e.g., Fontaine stage III-IV, diabetic foot with ulcers) that would preclude reliable dorsalis pedis artery ultrasound assessment.\n4. Severe hepatic or renal dysfunction, or malignancy with a limited life expectancy.\n5. Current use of systemic corticosteroids or potent immunosuppressants.\n6. Pregnancy or lactation.\n7. Any other condition deemed by the investigators to interfere with study participation or cooperation.","20 Years","60 Years",{"count":350,"type":22},520,"Depressive symptoms are highly prevalent in patients with chronic atrophic gastritis (CAG) but are frequently under-detected due to stigma and reliance on subjective questionnaires. This multicenter, cross-sectional observational study aims to validate a novel clinical triage workflow. It repurposes routine vascular assessments (specifically dorsalis pedis artery ultrasound and arterial stiffness metrics) as objective \"biological entry points\" to facilitate mental health referrals. The study will enroll approximately 450-520 adults with histologically confirmed CAG across four clinical centers in China. The primary objective is to determine the diagnostic accuracy of these vascular biomarkers for identifying patients with moderate-to-severe depressive symptoms (PHQ-9 score \\>= 10). Secondary objectives include evaluating the implementation feasibility (e.g., referral uptake, screening completion rate) of this integrated care model in routine gastroenterology practice.",[353,354,355,32],"Chronic Atrophic Gastritis","Depressive Symptoms","Depression",[357,358,359,360,361,362,363],"Vascular biomarkers","Dorsalis pedis artery ultrasound","Triage workflow","Implementation science","Stigma","Screening","Gut-brain axis","2025-12-21",{"date":366,"type":42},"2026-01-06",{"date":368,"type":22},"2026-02-01",{"date":370,"type":22},"2026-08-30",{"name":372,"class":49},"China Academy of Chinese Medical Sciences",4,{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":50},"100614998","enhanced-ward-rounds-and-communication-for-pre-procedural-anxiety-in-gi-endoscopy-patients-100614998","NCT07286877","Enhanced Ward Rounds and Communication for Pre-procedural Anxiety in GI Endoscopy Patients","Enhanced Ward-Round Frequency With Standardized Communication for Pre-procedural Anxiety in Hospitalized Patients Undergoing Therapeutic Gastrointestinal Endoscopy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Inpatients scheduled for therapeutic gastrointestinal endoscopy (e.g., ESD\u002FEMR, therapeutic colonoscopy).\n3. Able to provide informed consent and complete required assessments.\n\nExclusion Criteria:\n\nEmergency\u002Fimmediate endoscopy required.\n\n1. Severe cognitive impairment or psychotic disorder affecting assessments. Isolation\u002Fsingle room preventing protocol implementation.\n2. Unable to complete the primary pre-procedure assessment within the 2-4 hour window.",{"count":382,"type":22},1000,[25],"This study tests a new way to help reduce anxiety in hospitalized patients waiting for therapeutic gastrointestinal (GI) endoscopy procedures, like EMR or ESD. Anxiety before these procedures is common and can make preparation harder, increase medication needs, and affect recovery.\n\nWe compare standard ward checks (twice a day) to enhanced checks (four times a day) with structured talks and simple relaxation exercises. The goal is to see if the enhanced approach lowers anxiety levels, measured by a standard scale called the Hamilton Anxiety Rating Scale (HAM-A), from baseline to 24 hours before the procedure.\n\nWho can join? Adults (18+) scheduled for inpatient GI endoscopy with at least 2 days hospital stay and mild anxiety. Exclusions include emergencies or severe mental health issues.\n\nThe study is done in hospital wards, with groups assigned by ward periods to keep it real-world. Benefits may include less anxiety and better experience; risks are low as it's just more supportive talks. Participation is voluntary with informed consent. Results could improve hospital care routines.",[386,387,388,32,389],"Anxiety","Depression Disorders","Sleep Wake Disorders","Preoperative Anxiety","2025-12-13",{"date":392,"type":42},"2025-12-16",{"date":394,"type":22},"2026-01-15",{"date":396,"type":22},"2027-02-20",{"name":398,"class":49},"LanZhou University",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":406,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":418,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100475177","pact-programme-for-parents-of-children-with-shcn-100475177","NCT05467527","PACT Programme for Parents of Children With SHCN","Effectiveness of Prosocial-orientated Acceptance and Commitment Training (PACT) Programme for Parents of Children With Special Health Care Needs in Response to Outbreaks of Novel Infectious Disease: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Cantonese-speaking Hong Kong residents\n* Living together with the child who is at preschool\u002Fschool-age (3-8 years old)\n* Caregivers who adopted the responsibility of taking care of the child,\n* has daily access to their iPhone and Android smartphones.\n\nIn addition, potential eligible parents who respond \"yes\" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https:\u002F\u002Fwww.childhealthdata.org\u002Fdocs\u002Fcshcn\u002Ftechnical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental\u002Femotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.\n\nExclusion Criteria:\n\n* Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities","21 Years",{"count":408,"type":22},196,[25],"This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.",[412,32,413,414,415,416,232,417],"Urologic Diseases","Vascular Diseases","Cleft Lip and Palate","Neurodevelopmental Disorders","Attention Deficit Hyperactivity Disorder","Developmental Delay",[419,420,421,422,423],"Acceptance and Commitment Therapy","Randomised Controlled Trial","Special health care needs","novel infectious disease","prosociality","2025-08-08",{"date":426,"type":42},"2025-08-13",{"date":428,"type":42},"2022-06-27",{"date":430,"type":22},"2025-12-31",{"name":432,"class":49},"Chinese University of Hong Kong",2,{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":17,"minAge":441,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":23,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":456,"locationsCount":50},"100461771","a-personalised-approach-utilising-the-frailty-index-to-empower-consumers-100461771","NCT05292989","A Personalised Approach Utilising the Frailty Index to Empower Consumers","A Personalised Approach Utilising the Frailty Index to Empower Consumers to Make Informed Decisions About Having a Colonoscopy to Avoid Low Value Care. A Prospective Randomized Controlled Trial.","Inclusion Criteria:\n\n* Patients aged over 65 years of age\n* Ability to understand the study instructions and answering questionnaires\n\nExclusion Criteria:\n\n* Inability to consent or participate in the assessments (e.g. frailty assessment) that are required as part of this project.\n* Lack of informed consent","65 Years","100 Years",{"count":444,"type":22},200,[25],"Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.",[32],[449],"colonoscopy surveillance","2025-07-29",{"date":452,"type":42},"2025-08-01",{"date":454,"type":42},"2023-08-14",{"date":368,"type":22},{"name":457,"class":49},"Princess Alexandra Hospital, Brisbane, Australia",{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":223,"sex":17,"minAge":465,"maxAge":466,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":476,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":433},"100455362","immune-responses-to-gluten-100455362","NCT05209568","Immune Responses to Gluten","Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten","Inclusion Criteria:\n\n1. On a gluten-free diet for ≥ 4 weeks\n2. Willing to consume gluten for research\n3. For the celiac disease arm, diagnosis confirmed by serology and\u002For histology\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Wheat allergy\n3. Type 1 diabetes\n4. BMI z-score \\\u003C -2\n5. History of more than minimal symptoms following gluten exposure on a gluten-free diet\n6. Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results","2 Years","101 Years",{"count":468,"type":22},400,[25],"This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.",[472,473,199,198,32,474,475],"Celiac Disease","Malabsorption Syndromes","Gluten Sensitivity","Celiac Disease in Children",[477,478,479],"gluten","cytokine","T cell immune response","2025-04-18",{"date":482,"type":42},"2025-04-23",{"date":484,"type":42},"2023-01-15",{"date":486,"type":22},"2029-09-30",{"name":488,"class":49},"Boston Children's Hospital",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":4,"eligibilityCriteria":495,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":497,"conditions":498,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":50},"100557693","analytical-validation-of-stream-platform-100557693","NCT06541431","Analytical Validation of Stream™ Platform","Analytical Validation of Stream™ Platform - Sample Collection Protocol","Inclusion Criteria:\n\n* Age ≥ 18 years - male or female\n* Subject understands and has voluntarily signed and dated Informed Consent Form (ICF)\n* Subjects must be willing to comply with trial requirements\n* Subject has performed an open or laparoscopic surgery with abdominal\u002F pelvic drainage\n\nExclusion Criteria:\n\n* Subject is expected to be discharged less than 8 hours post-surgery\n* Subject carries has a known infectious disease such as Hepatitis B or C, HIV, TB, infections caused by multi-drug resistant organisms, or known parasitic infections affecting the gastrointestinal tract\n* Involvement in the planning and conduct of the clinical investigation",{"count":303,"type":22},"The accurate monitoring of physiological parameters in postoperative patients is essential for early detection and management of potential complications. One such critical parameter is the pH of abdominal drainage fluid, which can provide valuable insights into the patient's recovery and the presence of any postoperative infections or complications after gastrointestinal surgery. The Stream™ Platform, consisting of the Origin™ inline biosensor system and supporting materials, represents a significant advancement in this area. Origin™ is designed to be integrated inline with a standard surgical drain, enabling real-time monitoring of drainage effluent characteristics, specifically pH, which represents the acidity of the fluid.\n\nThis protocol details the analytical validation of the Stream™ Platform, focusing on the pH measurements conducted by the Origin™ device. The study aims to establish the precision, linearity, and analytical specificity of the Origin™ system. Additionally, method comparison studies will be conducted to evaluate the performance of the Origin™ device against standard bench-top comparators.\n\nThe multi-center study will be conducted using commercially available calibration fluids and abdominal drainage samples collected from patients undergoing abdominal surgeries. These samples, which include those from colorectal, hepatobiliary, and trauma and acute care patients, will be utilized to validate the Origin™ device's capability to deliver accurate and reliable pH measurements.",[32],"2025-03-10",{"date":501,"type":42},"2025-03-12",{"date":503,"type":42},"2024-11-19",{"date":505,"type":22},"2025-07",{"name":507,"class":115},"FluidAI Medical",{"id":509,"slug":510,"hasResults":11,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":223,"sex":17,"minAge":515,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":518,"conditions":519,"keywords":520,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":50},"100582866","anonymous-data-sharing-for-small-bowel-100582866","NCT06868875","Anonymous Data Sharing for Small Bowel","Data Sharing With Collaborative Partners to Develop Computer Aided Detection for the Assessment of the Small Bowel Using MRI","Inclusion Criteria:\n\n* Had a small bowel MRI at UCLH between 2005 and Sept 2010 as part of routine clinical practice who:\n* Have a clinical standard of reference within 6 weeks of the MRI scan\n* Patients with normal small bowel MRI studies and no clinical evidence of bowel pathology on any additional diagnostic investigations\n\nExclusion Criteria:\n\n* Patients \\\u003C16 or not fulfilling either inclusion criteria","16 Years",{"count":517,"type":22},1500,"Crohn's disease is characterised by an abnormal immunological response within the bowel wall leading to abnormal wall thickening, stricturing (narrowing), fistulation (abnormal connections) to adjacent organs and strictures (narrowing), abnormal motility, and local sepsis (infection). Radiological imaging of the small bowel defines diagnosis, disease extent, biological activity and complications and is vital for timely and efficacious clinical management. Small bowel magnetic resonance imaging (MRI) does not impart ionising radiation and is proving to be a safe, well tolerated and robust method of assessing the small bowel and is widely implemented in the NHS and Europe. MRI evaluates multiple disease related features such as bowel wall thickness and motility which are proving increasing reliable for disease identification, staging, therapeutic guidance and assessment of treatment response.\n\nCurrently however radiologists must manually make these measurements which are time consuming and difficult.\n\nThere are no computer tools that can quickly and accurate make relevant measurements on MRI to guide patient management. Radiologists at University College Hospital have formed collaborations with groups within University College London (UCL) and around Europe. The investigators have received grant funding to develop computer software to accurately assess the small bowel using MRI over 3 years. To develop this software, it is necessary to use anonymised datasets from patients with and without Crohn's disease undergoing small bowel MRI. Part of this project will require prospective collection of MRI data which has been granted ethical approval as a major amendment to a currently running project (09\u002FH0714\u002F62). The department of Radiology at UCLH has been running a clinical small bowel MRI service since 2005 and have several hundred datasets on its PACS. This current ethics application seeks permission to datashare with the collaborative partners fully anonymised MRI datasets and relevant clinical data from patients previously undergoing small bowel MRI for clinical indications at UCLH.",[66,32],[521],"Observational","2025-03-04",{"date":524,"type":42},"2025-03-11",{"date":526,"type":42},"2011-04-24",{"date":528,"type":22},"2027-08-31",{"name":530,"class":49},"University College, London",{"id":532,"slug":533,"hasResults":11,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":537,"eligibilityCriteria":538,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":539,"enrollmentInfo":540,"targetDuration":4,"studyType":23,"phases":542,"briefSummary":543,"conditions":544,"keywords":548,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":558},"100499342","sci-pex-study---safety-and-performance-of-pexyeazy-a-device-for-treatment-of-hemorrhoids-100499342","NCT05782010","SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids","SCI-Pex, a Multi-center, Prospective, Non-controlled Investigation to Evaluate the Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids","SCI-Pex","Inclusion Criteria:\n\n* Adult\n* Hemorrhoidal disease grade II and III\n* American Society of Anesthesiologists (ASA) classification I-III.\n\nExclusion Criteria:\n\n* Previous surgical treatment for hemorrhoids by all methods except rubber band ligation or sclerosing injection therapy within the last 3 years.\n* Previous surgical treatment with rubber band ligation or injection therapy within the last 2 months.\n* More than three surgical treatments with rubber band ligation or sclerosing injection therapy within the last 3 years.\n* Under medication with immunosuppressive drugs and\u002For anticoagulant drugs (not including 75mg acetylsalicylic acid) and not able to interrupt the anticoagulant drug medication or replace it with low molecular weight heparin for 5 days.\n* Have ulcerative colitis, Crohn's disease or other intestinal inflammatory disease or presence of inflamed or thickened mucosa of the rectum.\n* Presence of anal fissure, anal stenosis, stricture, fistulas or ulcers in the rectal area.\n* The rectum has not been prepared prior to the investigation with rectal enema and is contaminated with feces that cannot easily be removed.\n* Have schizophrenia, untreated depression or other mental illness or conditions that may affect judgment, sensation of pain or inability to complete the follow-up.\n* Under medication of morphine or other strong painkillers, not including paracetamol.\n* Fecal incontinence (not including soiling due to hemorrhoidal disease), or conditions with impaired sensation in the rectal area or impaired function of the anal sphincter.\n* Previous rectal radiation.\n* Rectal cancer or previous surgery due to rectal cancer.\n* Pregnancy\n* Hypercoagulability disorders or diseases that result in increased risk of bleeding.\n* Impaired immune system or condition that increases the risk of infection.","84 Years",{"count":541,"type":22},35,[25],"The SCI-Pex study is a multicenter, prospective, non-controlled investigation on PexyEazy®, a new device for treatment of hemorrhoids based on the mucopexy method. Mucopexy is a well established method where sutures are applied above the hemorrhoids. When knots are tied, the hemorrhoids are lifted inwards to their normal position, which makes them swell down and symptoms disappears. PexyEazy® perform a mukopexy in a semiautomatic, faster and easier way on awake patient in less than 10 minutes. The SCI-Pex study will evaluate the safety and performance of PexyEazy on 35 patients with hemorrhoids grade II and III with a follow-up after 1 week, 3 months and 1 years. Adverse events, pain and other complications will be recorded, quality of life and hemorrhoid symptom questionnaires and clinical examination after 3 months and 1 year will be monitored to evaluate the result after a PexyEazy® procedure.",[545,546,547,98,32],"Hemorrhoids","Hemorrhoids, Internal","Suture; Complications, Infection or Inflammation",[549],"PexyEazy",{"date":551,"type":42},"2025-03-07",{"date":553,"type":42},"2023-06-15",{"date":555,"type":22},"2026-05-30",{"name":557,"class":115},"Developeration AB",3,{"id":560,"slug":561,"hasResults":11,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":4,"eligibilityCriteria":565,"healthyVolunteers":223,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":568,"conditions":569,"keywords":570,"overallStatus":173,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":433},"100537475","correlation-of-toxins-with-gastrointestinal-gi-and-overall-health-100537475","NCT06278311","Correlation of Toxins With Gastrointestinal (GI) and Overall Health","Association of Presenting Symptoms and Diagnosis, With Urinary Mycotoxins, Metals, Polyfluorinated Alkyl Substance (PFAS) and Environmental Toxins - A Prospective Study in an Urban Gastroenterology Practice","Inclusion Criteria:\n\n* Patients suffering from gastrointestinal and\u002For other symptoms\n* Patients willing to provide urine samples\n* Patients willing to provide consent\n\nExclusion Criteria:\n\n* Use of antibiotics 2 weeks prior to the study\n* Patients unwilling to consent",{"count":567,"type":22},250,"The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health.",[32],[571,572,573,574,575,576],"Gastrointestinal symptoms","Toxins","Environmental Toxins","Heavy metals","PFAS","Mycotoxins","2024-11-14",{"date":503,"type":42},{"date":580,"type":22},"2025-02",{"date":582,"type":22},"2026-01",{"name":584,"class":115},"Vibrant America Clinical Lab",{"id":586,"slug":587,"hasResults":11,"nctId":588,"briefTitle":589,"officialTitle":590,"acronym":4,"eligibilityCriteria":591,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":602,"locationsCount":50},"100460379","a-practice-change-for-patients-with-severe-chronic-clinically-unexplained-gastrointestinal-symptoms-100460379","NCT05274854","A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms","A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness","Inclusion Criteria:\n\n* Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study.\n* Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score \\> 35\n* Patients aged 18 years or older to 90 years old\n\nExclusion Criteria:\n\n* Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study\n* Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated.\n* Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways.\n* Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded",{"count":444,"type":22},[25],"This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.",[32,196],"2024-11-10",{"date":598,"type":42},"2024-11-12",{"date":600,"type":42},"2023-05-01",{"date":430,"type":22},{"name":603,"class":49},"The University of Queensland",{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":223,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":633},"100533565","a-clinical-study-to-map-the-hla-genomic-region-in-the-greek-population-100533565","NCT06227468","A Clinical Study to Map the HLA Genomic Region in the Greek Population","A Clinical Study to Map the HLA GENomic Region and Its potEntial aSsocIation With Selected diSeases in the Greek Population","GENESIS","Inclusion Criteria:\n\nThe study will include adult subjects (age ≥ 18) that:\n\n* possess a Greek social security number and are visiting hospitals\u002Fclinics, and\u002For other private laboratory institutions (incl. clinics and health care groups) as part of standard clinical practice in Greece,\n* are willing and able to provide written informed consent to participate in the study according to the study protocol.\n\nExclusion Criteria:\n\n* Subjects not able to provide written informed consent (e.g. ICU patients, mental illness patients, lack of legal capacity).\n* Subjects who have had an allogeneic (non-self-donor):\n\n  * bone marrow transplant\n  * stem cell transplant\n  * blood transfusion less than two weeks prior to buccal swab sample collection\n  * liver transplant\n* Subjects who participated in an interventional clinical trial in the past that according to the subject's physician opinion might have had an impact on their HLA genome.",{"count":613,"type":22},12000,"The aim of GENESIS clinical study is to map the HLA genomic region in the Greek population and evaluate possible correlations with selected underlying diseases.",[233,616,617,618,619,620,621,32,622,623],"Respiratory Disease","Chronic Renal Failure","Cardiovascular Diseases","Metabolic Disease","Psychiatric Disorder","Neurologic Disorder","Haematologic Disease","Rheumatologic Disease","2024-01-25",{"date":626,"type":42},"2024-01-26",{"date":628,"type":42},"2023-12-12",{"date":630,"type":22},"2026-08-31",{"name":632,"class":49},"Athens LifeTech Park",8,{"id":635,"slug":636,"hasResults":11,"nctId":637,"briefTitle":638,"officialTitle":639,"acronym":640,"eligibilityCriteria":641,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":23,"phases":645,"briefSummary":646,"conditions":647,"keywords":652,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":50},"100477215","phase-2-xelox-combined-with-anlotinib-and-penpulimab-vs-xelox-as-adjuvant-therapy-in-ctdna-positive-gastric-and-esophagogastric-junction-adenocarcinoma-100477215","NCT05494060","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma","XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial","EXPLORING","Inclusion Criteria:\n\n* Subjects aged ≥18 and ≤75 years old, male or female.\n* ECOG performance status score 0-1.\n* Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.\n* Pathological stage:III (8th AJCC TNM).\n* Estimated lifetime is greater than 6 months.\n* The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:\n\n  1. Routine blood test:\n\n     1. Hemoglobin (HB) ≥90 g\u002FL.\n     2. Neutrophil count (ANC) ≥1.5×109\u002FL.\n     3. Platelet count (PLT) ≥100×109\u002FL.\n  2. Biochemical test:\n\n     1. Total bilirubin≤1.5×ULN (upper limit of normal).\n     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.\n     3. Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL\u002Fmin.\n* No obvious clinical symptoms of heart disease.\n* Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT chest and CT or MRI of abdomen and pelvis) per investigator assessment within 28 days prior to enrollment.\n* Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study, and ≥ 120 days after the last dose of penpulimab and 180 days after the last dose of chemotherapy.\n* Volunteer to participate in this study and sign an informed consent form.\n* Considering that NGS analysis may take up to 10 working days, patients could receive 1 cycle of XELOX chemotherapy after ctDNA sampling.\n\nExclusion Criteria:\n\n* Participation in other drug clinical trials within four weeks.\n* Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.\n* History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.\n* Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.\n* Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.\n* Long-term unhealed wound or unhealed fracture.\n* Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage as judged by the investigator.\n* Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically significant abnormality); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) ≤ 1.5 are allowed to take low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes.\n* Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism.\n* Urine routine showed urine protein and 24 h urine protein was confirmed to be \\> 1.0g.\n* Previous use of immune targeted therapy drugs.\n* History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.\n* Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids.\n* History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic diarrheal diseases; history of sarcoidosis or tuberculosis; history of active hepatitis B, C and HIV infection; well-controlled non-serious immune diseases, such as dermatitis, arthritis, psoriasis, etc. Hepatitis B virus \\\u003C 1000 copies\u002Fml can be detected.\n* Patients with hypersensitivity to human or murine monoclonal antibodies.\n* Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders.\n* Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention.\n* Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the efficacy judgment or safety judgment.\n* Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.","75 Years",{"count":644,"type":22},80,[229],"This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks\u002Fcycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.",[648,32,649,650,65,651,131],"Carcinoma","Stomach Cancer","Gastroesophageal-junction Cancer","Gastric Cancer",[653,654,655,656,657,658],"Penpulimab","Anlotinib","Capecitabine","Oxaliplatin","ctDNA","adjuvant therapy","2023-11-03",{"date":661,"type":42},"2023-11-07",{"date":663,"type":42},"2022-03-16",{"date":665,"type":22},"2027-02",{"name":667,"class":49},"The First Affiliated Hospital with Nanjing Medical University",{"id":669,"slug":670,"hasResults":11,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":676,"targetDuration":4,"studyType":23,"phases":678,"briefSummary":679,"conditions":680,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":50},"100458627","phase-2-anlotinib-hydrochloride-capsules-combined-with-tqb2450-injection-in-esophageal-squamous-cell-carcinoma-patients-100458627","NCT05252078","Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients","An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy","ALTER-E005","Inclusion Criteria:\n\n* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.\n* ≥ 18 years old.\n* ECOG performance status of 0-1\n* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.\n* Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.\n* Laboratory tests must be met:\n* Neutrophils count =\u002F\\> 1.5 x 109\u002FL, platelets count =\u002F\\> 75 x 109\u002FL, Hb =\u002F\\> 90 g\u002FL, WBC =\u002F\\> 3 x 109\u002FL.\n* total bilirubin =\u002F\\\u003C 1.5 x ULN, ALT and AST =\u002F\\\u003C 2.5 x ULN.\n* Creatinine =\u002F\\\u003C 1.5 x ULN.\n* APTT, INR, PT =\u002F\\\u003C 1.5 x ULN.\n* TSH =\u002F\\\u003C ULN.\n* Myocardial enzymes in the normal range.\n* LVEF =\u002F\\> 50%.\n\nExclusion Criteria:\n\n* Patients received other antitumor adjuvant therapy after surgical resection.\n* Concurrent malignancy (except cured basal cell carcinoma of the skin).\n* Patients was diagnosed cervical esophageal carcinoma.\n* Patients who have received prior targeted therapy (anti-VEGF\u002FVEGFR) or immunity therapy (anti-PD-1\u002FPD-L1\u002FCTLA-4).\n* Patients who are allergic to other monoclonal antibodies.\n* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.\n* Immunosuppressant, systemic, or absorbable local hormone therapy (\\> 10mg\u002F day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.\n* Patients with multiple factors affecting oral administration.\n* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.\n* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.\n* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.\n* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg).\n* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \\> 450 ms, female\\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.\n* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).\n* HIV test positive.\n* Proteinuria =\u002F\\>2+ and confirmed 24-hour urinary protein quantification \\> 1.0 g.\n* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.\n* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.",{"count":677,"type":22},30,[229],"This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).",[681,682,683,131,32,132,65,133,684,685,686],"Esophageal Squamous Cell Carcinoma","Esophageal Neoplasms","Esophageal Diseases","Neoplasms by Histologic Type","Neoplasms, Squamous Cell","Carcinoma, Squamous Cell","2022-12-14",{"date":689,"type":42},"2022-12-16",{"date":691,"type":42},"2022-06-02",{"date":693,"type":22},"2026-11",{"name":695,"class":49},"Jiangxi Provincial Cancer Hospital"]