[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"St Vincent's Hospital Melbourne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":127},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,73,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100580588","effect-of-fasting-recommendations-among-patients-using-glp-1-receptor-agonists-100580588",false,"NCT06839248","Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists","Effect of Fasting Recommendations on Residual Gastric Contents Among Patients Using Glucagon-like Peptide-1 Receptor Agonists: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Age ≥18 years old at enrolment.\n* Have regularly administered any type of once-weekly GLP-1 RA medication for a period of at least one month prior to randomisation.\n* If allocated to follow standard fasting guidelines, willing to adhere to ASA and ANZCA preoperative fasting requirements. This requires participants to only consume clear liquids up to 2 hours, a light or low calorific meal up to 6 hours, and fasting from fried foods, fatty foods, or meat for at least 8 hours prior to the trial visit.\n* If allocated to follow a 24-hour clear liquid diet, willing to adhere to nothing-by-mouth (NPO) for solids and last intake of clear liquids no less than 2 hours prior to the trial visit.\n* Provide a signed and dated informed consent form for study participation in line with the requirements of the human research ethics committee (HREC) of the study site.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria, indicative of abnormal anatomy and not validated by gastric ultrasound, will be excluded from this trial:\n\n* Has a recent history of gastrointestinal bleed within the previous 1 month from enrolment.\n* Has a history of previous lower oesophageal or gastric surgery.\n* Has a known abnormal upper gastrointestinal anatomy, including hiatus hernia or gastric tumours.\n\nIn addition, participants meeting any the of following criteria will be excluded from this trial:\n\n* Participant reports having been previously diagnosed with a clinically significant gastric emptying abnormality such as gastroparesis.\n* Participant reports concomitant use of insulin.\n* Unable to assume the right lateral decubitus position required for gastric ultrasound assessment.\n* Participant has difficulty fully understanding PICF or study materials due to a primary language other than English.","ALL","18 Years",{"count":19,"type":20},154,"ESTIMATED","INTERVENTIONAL",[23],"NA","The aim of this randomised controlled trial is to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on the proportion of participants who present with increased residual gastric contents during their study visit. It also aims to determine the effect of a 24-hour clear liquid diet compared to standard fasting guidelines on:\n\n* Solid content or thick fluids\n* Patient-reported outcome measures (PROMs), including thirst, hunger, nausea, fatigue, and anxiety.\n* Compliance measures, including adherence with the intervention, time since last oral intake of solid foods, and time since last oral intake of clear liquids.\n\nWe will enrol adults who are currently using any once-weekly glucagon-like peptide-1 receptor agonist (GLP-1RA) medication. Participants will be allocated in a 1:1 ratio to follow a 24-hour clear liquid diet or standard fasting guidelines prior to attending a study visit where participants will undergo a blinded gastric ultrasound assessment.",[26,27],"Residual Gastric Contents","Pulmonary Aspiration of Gastric Contents","RECRUITING","2026-05-06",{"date":31,"type":32},"2026-05-11","ACTUAL",{"date":34,"type":32},"2025-06-20",{"date":36,"type":20},"2027-02-01",{"name":38,"class":39},"St Vincent's Hospital Melbourne","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":5},"100610275","phase-2-evaluating-safe-ketone-thresholds-to-minimise-ketosis-in-people-with-type-1-diabetes-using-dapagliflozin-100610275","NCT07225465","Evaluating Safe Ketone Thresholds To Minimise Ketosis in People With Type 1 Diabetes Using Dapagliflozin","The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in People With Type 1 Diabetes Treated With Dapagliflozin","KETO-TRACK","Inclusion Criteria:\n\n* Aged between 24 and 85 years of age inclusive (66% 24Y to 65Y; and 33% \\>65Y to 85Y)\n* Diagnosed with T1D (made on clinical criteria) for at least 1 year\n* Insulin regimen either on MDI or insulin pump with at least 40% in one mode\n* Minimum total daily insulin dose 0.4 Units per kg \u002F day (can be on insulin pump or MDI);\n* HbA1c \\\u003C10% (86mmol\u002F mol)\n* Minimum daily carbohydrate intake of 100g\n* Willing to adhere to the study protocol\n* Ability to perform high-intensity exercise (specific to the exercise sub-study)\n\nExclusion Criteria:\n\n* Pregnancy or planned pregnancy\n* eGFR \\\u003C30ml\u002Fmin\u002F1.73m2\n* History of DKA in the last 12 months\n* Use of low carbohydrate diet (\\\u003C100g\u002Fday)\n* Diabetic gastroparesis\n* Tape allergy\n* Heavy alcohol use (15 standard drinks per week or binge drinking)\n* Use of SGLT inhibitor in the last month\n* Medications increasing the risk of DKA e.g. steroids, anorectic agents (eg phentermine, naltrexone HCl\u002Fbupropion HCl, and GLP 1 agonists).\n* Major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.","24 Years","85 Years",{"count":52,"type":20},115,[54],"PHASE2","Sodium glucose cotransporter 2 (SGLT2) inhibitors are a type of medicine that help the kidneys get rid of extra sugar in the blood through urine. In people with type 2 diabetes (T2D), these medications help lower blood sugar levels, help people lose weight and improve heart and kidney health.\n\nSGLT2 inhibitors are mainly used in T2D, however some studies show they might also help people with type 1 diabetes (T1D). The same health benefits observed in people with T2D the investigators anticipate may help those with T1D. Currently, there is a safety concern that people with T1D using these medicines can raise the risk of diabetic ketoacidosis (DKA). DKA occurs when the body doesn't have enough insulin (a hormone made in the pancreas that helps your body use sugar (glucose) for energy), it starts to break down fats as a source of energy. This breakdown of fats produces ketones. Very high levels of ketones in the blood can make the blood acidic (toxic) and lead to DKA. If not treated in time, this can make the person living with T1D very ill and can be life-threatening. Because of this risk, health agencies like the FDA in the U.S., and the TGA in Australia have not approved use of SGLT2 inhibitors for people with T1D.\n\nStill, some experts believe SGLT2 inhibitors may safely be used alongside insulin in T1D if DKA risk is carefully managed. This might be possible with early detection and treatment of rising ketone levels. One approach is using continuous ketone monitors, which track ketone levels in real time and can alert users early. People would also need proper education on what to do if ketone levels start rising.\n\nTo date, there's no official agreement on the exact ketone level that should trigger action. Some suggest action when ketone levels reach 1.0 or 1.5 mmol\u002FL. A lower limit like 1.0 mmol\u002FL may be safer, but it could also lead to too many alarms and extra stress, or unnecessary eating to bring ketones down.\n\nTherefore, the aim of this study is to assess if initiating responses to elevated ketone levels at a threshold of 1.0 mmol\u002FL, compared to a threshold of 1.5 mmol\u002FL, will reduce the risk of DKA in people with T1D using Dapagliflozin.\n\nThe investigators will recruit 115 adults with T1D and provide Dapagliflozin (SGLT2 inhibitor) and continuous glucose and ketone monitoring (DGK) devices. Participants will be randomly assigned to two groups. Group 1 will wear a DGK with alarms set at ketone level of 1.0 mmol\u002FL and receive education about taking action when ketone levels are ≥1.0 mmol\u002FL. Group 2 will wear a DGK with alarms set at ketone level of 1.5 mmol\u002FL and receive education about taking action when ketone levels are ≥1.5 mmol\u002FL. Participants will be assessed for time spent with critically high ketone levels, incidence of DKA, glucose and person reported outcomes.\n\nFindings from this study will provide real life data and clinical evidence to help guide safe use of SGLT2 inhibitors in people with T1D by informing protocols for monitoring and managing associated DKA risks.",[57],"Type 1 Diabetes Mellitus",[59,60,61,62,63],"Ketosis","Dapagliflozin","Type 1 Diabetes","Dual Glucose and Ketone Monitor","SGLT2 inhibitor","NOT_YET_RECRUITING","2025-11-04",{"date":67,"type":32},"2025-11-06",{"date":69,"type":20},"2026-02",{"date":71,"type":20},"2028-02",{"name":38,"class":39},{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100436990","phase-1-microbial-restoration-in-inflammatory-bowel-diseases-100436990","NCT04970446","Microbial Restoration in Inflammatory Bowel Diseases","The MIRO II Study: Microbial Restoration in Inflammatory Bowel Diseases","MIRO II","Inclusion Criteria:\n\nActive Crohn's disease\n\n* Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND\n* CDAI score of 220-450 AND\n* One of the following:\n\n  * CRP ≥5mg\u002FL\n  * faecal calprotectin ≥100μg\u002Fg\n  * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)\n* Willing and able to attend the study sites for regular endoscopic procedures.\n\nExclusion Criteria:\n\nActive perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109\u002FL; Albumin less than 20g\u002FL; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis\u002Fsevere allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \\>20mg or budesonide dose \\>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.","70 Years",{"count":83,"type":20},120,[85,54],"PHASE1","This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.",[88,89,90,91],"Fecal Microbiota Transplantation","Crohn Disease","Inflammatory Bowel Diseases","Microbiome","2025-02-23",{"date":94,"type":32},"2025-02-26",{"date":96,"type":32},"2022-05-01",{"date":98,"type":20},"2026-04-01",{"name":38,"class":39},1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":111,"studyType":112,"phases":4,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":100},"100448305","intraductal-papillary-mucinous-neoplasm-ipmn-database---a-tool-to-predict-pancreatic-cancer-100448305","NCT05117723","Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer","MAPS","Inclusion Criteria:\n\n* Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging\n\nExclusion Criteria:\n\n* Patients who formally decline enrolment into the study","90 Years",{"count":110,"type":20},1000,"6 Months","OBSERVATIONAL","Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.",[115,116],"IPMN, Pancreatic","IPMN",[118],"pancreatic cyst","2024-04-16",{"date":121,"type":32},"2024-04-18",{"date":123,"type":32},"2021-08-26",{"date":125,"type":20},"2031-07",{"name":38,"class":39},""]