[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mount Sinai Hospital, Canada\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":607},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,45,70,88,118,137,165,192,222,246,268,290,309,334,357,384,404,431,453,480,503,526,552,582],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100299553","non-operative-management-for-locally-advanced-rectal-cancer-100299553",false,"NCT03179540","Non-operative Management for Locally Advanced Rectal Cancer","Phase II Study to Assess the Safety of Non-operative Management for Low Rectal Cancer","NOM","Inclusion Criteria:\n\n* Completed chemoradiotherapy (CRT) as standard of care \\[Stage II and Stage III (T3-T4N0, AnyTN1-2)\\]; \\[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\\]\n* Planned or probable APR\n* ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT\n* 18 years or older\n* Provides written consent\n\nExclusion Criteria:\n\n* Unable to undergo MRI\n* Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)\n* Pregnancy\n* Inflammatory bowel disease\n* More than one primary colorectal cancer\n* Other malignancy within 5 years of treatment for current rectal cancer\n* Unfit for surgery","ALL","18 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a 5 year Phase II study to evaluate the safety of non-operative management (NOM) in patients with low rectal cancer (LRC) who achieve a complete clinical response (cCR) following chemoradiotherapy (CRT). The safety of NOM will be evaluated by assessing (i) rate of local re-growth and (ii) rate of macroscopically positive resection margin (R2) when surgery is required due to local re-growth. NOM will be considered safe or as effective as surgery to achieve local control if the rate of local re-growth is equal to or less than 30% and the rate of a macroscopically positive margin is 0%.",[27],"Rectal Neoplasms",[29,30,31],"Low Rectal Cancer","Complete Clinical Response","Non-operative Management","RECRUITING","2026-06-19",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2018-03-16",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"Mount Sinai Hospital, Canada","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":4},"100433980","mechanical-bowel-prep-randomized-study-100433980","NCT04931173","Mechanical Bowel Prep Randomized Study","Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* undergoing elective colon surgery for benign or malignant disease\n* over the age of 18 years\n* provides informed consent.\n\nExclusion Criteria:\n\n* known anaphylaxis to neomycin or metronidazole\n* pregnancy or lactation\n* chronic renal failure (serum creatinine \\> 220 umol\u002FL).",{"count":53,"type":21},1062,[24],"Following colon surgery, surgical site infection (SSI) is the most common complication and leads to longer recovery time for patients and increased health care costs. Currently, there is high quality evidence to show that the combination of intravenous antibiotics (IVA), mechanical bowel preparation (MBP) and oral antibiotics (OA) is the most effective bowel preparation to reduce SSI. However, there are no studies comparing IVA+MBP+OA and IVA+OA. This is an important question because if IVA+OA works the same as IVA+MBP+OA, then MBP may be safely omitted as part of the bowel preparation to reduce SSI and patients would avoid the side effects of MBP prior to their surgery. Therefore, the objective is to perform a trial to determine if IVA+OA works the same as IVA+MBP+OA to reduce SSI following colon surgery.",[57],"Colorectal Surgery",[59,60,61],"Surgical Site Infection","Mechanical Bowel Preparation","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-17",{"date":65,"type":36},"2026-06-22",{"date":67,"type":21},"2026-09",{"date":40,"type":21},{"name":42,"class":43},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":87,"locationsCount":44},"100380633","home-to-stay-mobile-app-for-colorectal-surgery-100380633","NCT04236128","Home to Stay Mobile App for Colorectal Surgery","Home To Stay: An Integrated Monitoring System Using a Mobile App to Reduce Readmissions Following Colorectal Surgery","Inclusion Criteria:\n\n* any patient who is being discharged to home after undergoing elective colorectal surgery\n* 18 years or older\n* able to speak and understand English or French\n* provides informed consent\n\nExclusion Criteria:\n\n* post-operative admission less than 3 days\n* requiring discharge to rehabilitation centre to recover prior to being able to go home",{"count":78,"type":21},670,[24],"Background: Colorectal surgery includes surgery for colorectal cancer, inflammatory bowel disease and other benign diseases such as diverticulitis. In Canada, approximately 21,000 colorectal surgeries are performed each year. Patients undergoing colorectal surgery face high rates of unplanned hospital visits including readmission to hospital and Emergency Room (ER) visits. These unplanned hospital visits lead to significant distress and anxiety for patients and increased health care costs.\n\nResearch Aims: The goal is to evaluate the use of an integrated discharge monitoring system with a mobile application (app) to support colorectal surgery patients at home following discharge from hospital.\n\nMethods: The study will include 3 hospitals across Canada. Patients will be assigned to either a control group or intervention group. Control group patients will receive standard follow up care after going home following surgery. Intervention group patients will be enrolled in an integrated discharge monitoring system using an app to monitor their progress at home following discharge after surgery. The main outcomes are to measure the number of patients with unplanned hospital visits within 30 days of discharge following surgery, the quality of patient recovery and confidence managing one's own health care. Patients are eligible if they are being discharge home after having elective colorectal surgery, are 18 years or older and speak and understand English or French. At the end of the study, the outcomes between the control group and intervention group will be compared to look for important differences.\n\nExpected Outcomes: It is expected that the results of this study will show that the integrated discharge monitoring system will lead to a significant improvement in the quality of patient recovery and self-confidence with one's own health care, as well as significantly reduce the number of unplanned hospital visits for patients undergoing colorectal surgery in Canada.",[82],"Colorectal Disorders",{"date":65,"type":36},{"date":85,"type":36},"2021-05-25",{"date":40,"type":21},{"name":42,"class":43},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":95,"minAge":18,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":22,"phases":99,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":44},"100642197","optimizing-anticoagulation-in-pregnancies-with-mechanical-heart-valves-100642197","NCT07658989","Optimizing Anticoagulation in Pregnancies With Mechanical Heart Valves","A Prospective Multicenter Cohort Pilot Study Comparing Antithrombotic Regimens in Pregnancies With Mechanical Heart Valves","Inclusion Criteria:\n\n1. Pregnant individuals with one or more MHVs\n2. Who consent to participate\n3. Are 18 years or older and\n4. Less than 12 weeks gestation\n\nExclusion Criteria:\n\n1. Have a platelet count less than 50 x 10(9)\u002FL as there is an increased risk of bleeding with thrombocytopenia, and\u002For\n2. Have active bleeding defined as bleeding resulting in a hemoglobin reduction ≥10 g\u002FL or in hemodynamic instability.\n3. Have new valve thrombosis identified immediately prior to pregnancy","FEMALE","45 Years",{"count":98,"type":21},100,[24],"The purpose of this pilot study is to collect data on pregnancies with mechanical heart valves to see if using a blood thinner called low molecular weight heparin (LMWH) and low dose aspirin (LDA) is comparable to warfarin\u002Fvitamin K antagonist (VKA) to reduce the chance of clotting around the mechanical valve and improve survival. The study is a pilot study as the study investigators need to ensure that the blood levels needed for adequate amounts of LMWH and warfarin can be maintained during pregnancy to be able to compare LMWH and aspirin to warfarin. If this study shows that we can collect the tests that are needed for a larger study, the individuals' information who participated in this pilot study will be moved to the larger study. The larger study will compare survival, clot development and cardiac function as well as safety of these two common blood thinners.",[102,103,104],"Pregnancy","Prosthetic Heart Valve","Anticoagulant Therapy",[102,106,107,108,109,110],"Prosthetic heart valve","Anticoagulant therapy","Low molecular weight heparin","warfarin","vitamin K antagonist","2026-06-15",{"date":65,"type":36},{"date":114,"type":36},"2026-05-26",{"date":116,"type":21},"2030-12",{"name":42,"class":43},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":44},"100539548","effectiveness-of-two-different-body-positions-during-facemask-ventilation-in-obese-patients-100539548","NCT06305273","Effectiveness of Two Different Body Positions During Facemask Ventilation in Obese Patients","Effectiveness of Two Different Body Positions During Facemask Ventilation in Class 3 Obesity Patients: a Randomized Crossover Trial","Inclusion Criteria:\n\n* BMI \\> 40 kg\u002Fm2\n* age \\> 18 years\n* scheduled for elective surgery under general anesthesia\n* have the ability to comprehend the rationale for the study and provide consent\n\nExclusion Criteria:\n\n* pregnancy,\n* risk of aspiration of gastric content\n* patients using glucagon-like peptide(GLP)-1 agonists\n* emergency cases\n* upper airway disease or airway anatomical abnormalities\n* presence of major cardiovascular, respiratory, or cerebral vascular disease\n* if the provider anesthesiologist indicates an awake technique to secure the airway",{"count":126,"type":21},50,[24],"It is important to provide enough oxygen to the patients who are asleep during surgery. One way to do this is by using a mask placed over the face to help them breathe. When it becomes difficult getting enough oxygen into the patient's body using the mask, it's called difficult mask ventilation. There can be different reasons for this, and having a higher BMI is one of them. Body physique is assessed by Body Mass Index (BMI). This calculation gives an indication of a person's weight relative to their height.\n\nThere is some evidence in the research literature to suggest that when the patient is positioned in a way that helps their airway, like using a device to lift their head and torso 25 degrees , it might help the process of getting enough oxygen work better. The study aims to determine if patients with high BMI can breathe better using a face mask while they are in a head elevated position compared to lying flat on their back.",[130],"Obesity",{"date":63,"type":36},{"date":133,"type":36},"2024-03-25",{"date":135,"type":21},"2026-12-01",{"name":42,"class":43},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":144,"sex":95,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":44},"100512539","phase-2-presacral-nerve-block-versus-sham-block-on-post-operative-pain-for-total-laparoscopic-hysterectomy-100512539","NCT05953766","Presacral Nerve Block Versus Sham Block on Post-operative Pain for Total Laparoscopic Hysterectomy","A Randomized Controlled Trial (RCT) Comparing Presacral Nerve Block Versus Sham Block on Post-operative Pain in Women Undergoing Total Laparoscopic Hysterectomy.","Inclusion Criteria:\n\n* 18 years of age or older\n* Undergoing total laparoscopic hysterectomy\n\nExclusion Criteria:\n\n* Previous presacral neurectomy\n* Concurrent surgical procedure other than salpingectomy and\u002For oophorectomy\n* Gynecological cancer beyond stage 1 disease\n* BMI \\> 50\n* Chronic opioid consumption\n* Fibromyalgia\n* Language barrier\n* Inability to communicate and provide consent",true,{"count":146,"type":21},60,[148],"PHASE2","The study is a single-center parallel group randomized controlled trial comparing the administration of a presacral nerve block using 20mL of local ropivacaine 5.0mg\u002Fml versus 20mL of normal saline (sham block) on post-operative pain following total laparoscopic hysterectomy.",[151],"Post-operative Pain",[153,154,155,156],"Hysterectomy","Presacral nerve block","Laparoscopy","Anesthesia","2026-03-31",{"date":159,"type":36},"2026-04-06",{"date":161,"type":36},"2025-09-24",{"date":163,"type":21},"2026-07",{"name":42,"class":43},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":191},"100465427","phase-2-co-administration-of-acetaminophen-with-ibuprofen-to-improve-duct-related-outcomes-in-extremely-premature-infants-100465427","NCT05340582","Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants","Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial","Inclusion Criteria:\n\n* Preterm infants born \\\u003C27+0 weeks gestational age\n* Permission given by the attending clinician to approach and then consent obtained from parents\n* Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt\n* Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.\n\nExclusion Criteria:\n\n* Chromosomal anomaly\n* Pre-treatment renal dysfunction defined as urine output \\\u003C 1ml\u002Fkg\u002Fhour for the previous 24 hours or serum creatinine \\> 100 micromol\u002FL\n* Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \\> 100 units\u002FL94\n* Platelet count \\\u003C50,000 per microliter\n* Permission denied by the attending clinician to approach parents\n* Parental consent not available\n* Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).","27 Weeks",{"count":174,"type":21},310,[148],"Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \\\u003C 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \\>60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action.\n\nThe objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).\n\nThe study will also evaluate the effects of combination regime vs. ibuprofen alone on neurodevelopmental outcomes at 18-30 months corrected age.",[178],"Patent Ductus Arteriosus After Premature Birth",[180,181,182,183,184],"Preterm Neonates","Patent Ductus Arteriosus","Echocardiography","Acetaminophen","Ibuprofen",{"date":159,"type":36},{"date":187,"type":36},"2022-12-12",{"date":189,"type":21},"2027-04",{"name":42,"class":43},9,{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":205,"conditions":206,"keywords":211,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":44},"100615618","phase-3-impact-of-semaglutide-withdrawal-on-cardiometabolic-profile-and-physiology-of-energy-balance-recovery-effects-after-semaglutide-termination-100615618","NCT07294950","Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: Recovery Effects After Semaglutide Termination","Impact of Semaglutide Withdrawal on Cardiometabolic Profile and Physiology of Energy Balance: a Randomized Controlled Trial Comparing Gradual Dose Reduction With Immediate Treatment Cessation.","REST","Inclusion Criteria:\n\n* Men and women with previously diagnosed BMI ≥ 30 kg\u002Fm2 or BMI ≥ 27 kg\u002Fm2 and adiposity-related complications (such as osteoarthritis, nonalcoholic liver disease, sleep apnea, and hypertension) without preexisting cardiovascular disease or type 2 diabetes.\n* Age 18 - 75 years inclusive\n* Ongoing weight-loss treatment consisting of weekly subcutaneous semaglutide at minimum dose of 1 mg\u002Fweekly with documented weight reduction of at least 10% of pre-treatment body weight\n* Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Previously diagnosed cardiovascular disease defined as previous myocardial infarction, previous stroke, or symptomatic peripheral arterial disease.\n* Currently pregnant or lactating\n* Previously diagnosed type 2 diabetes\n* Use of any other pharmacological treatment for weight-loss\n* Previous surgical treatment for weight loss such as gastric bypass or gastric band\n* Any history of eating disorder\n* Renal dysfunction as evidenced by estimated glomerular filtration rate \\\u003C 25 ml\u002Fmin by CKD-EPI Creatinine Equation\n* New York Heart Association class II-IV heart failure\n* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \\>2.5X the upper limit of normal\n* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)\n* Personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2\n* Any other factor likely to limit adherence to the study, in the opinion of the investigators","75 Years",{"count":202,"type":21},98,[204],"PHASE3","Semaglutide is a medication from the class of drugs called glucagon-like peptide-1 agonists that promote weight loss. There is little clinical data on the best strategy to achieve weight maintenance following weight reduction induced by semaglutide. For people who need to discontinue treatment, it is unknown whether the weight regain, its accompanied health benefits could be ameliorated with a gradual reduction in semaglutide. The investigators will study if a gradual reduction of semaglutide is associated with different heart risk profile and hormones involved in energy regulation as compared to immediate treatment cessation.",[207,208,209,210],"Obesity (Disorder)","Weight Change","Blood Pressure Monitoring","Appetite Regulation",[212,213],"Randomized controlled trial","Interventional","2026-02-09",{"date":216,"type":36},"2026-02-11",{"date":218,"type":36},"2026-02-01",{"date":220,"type":21},"2029-05",{"name":42,"class":43},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":243,"leadSponsor":245,"locationsCount":44},"100613889","time-restricted-eating-for-type-2-diabetes-and-metabolic-health-the-tea-time-trial-100613889","NCT07272460","Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial","Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes","TEA-TIME","Inclusion Criteria:\n\n* Individuals with previously diagnosed BMI ≥ 25 kg\u002Fm2 and type 2 diabetes within preceding 10 years.\n* Age 18 - 75 years inclusive\n* Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)\n* Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.\n* Ability to read and understand English\n\nExclusion Criteria:\n\n* Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and\u002For sulfonylureas.\n* Use of any other pharmacological treatment for weight-loss\n* Previous surgical treatment for weight loss such as gastric bypass or gastric band\n* Any history of eating disorder\n* Currently pregnant or lactating\n* Renal dysfunction as evidenced by estimated glomerular filtration rate \\\u003C 25 ml\u002Fmin by CKD-EPI Creatinine Equation\n* New York Heart Association class II-IV heart failure\n* Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases \\>2.5X the upper limit of normal\n* Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)\n* Any other factor likely to limit adherence to the study, in the opinion of the investigators\n* Concurrent participation in another research study relevant to diabetes and metabolic health",{"count":231,"type":21},112,[24],"Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.",[235,236],"Type 2 Diabetes","Overweight (BMI > 25)",[212,238,239,240],"Time-restricted eating","Intermittent fasting","Type 2 diabetes",{"date":216,"type":36},{"date":218,"type":36},{"date":244,"type":21},"2029-07-31",{"name":42,"class":43},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":144,"sex":17,"minAge":253,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":44},"100384553","digital-bridge-using-technology-to-support-patient-centered-care-transitions-from-hospital-to-home-100384553","NCT04287192","Digital Bridge: Using Technology to Support Patient-centered Care Transitions From Hospital to Home","DB","Inclusion Criteria:\n\n* Patients with anticipated discharge home will be recruited at the time of admission to one of the services (i.e medicine or rehab) in the study. Patients aged 60 and over, with CCN defined as presenting with 3 or more chronic conditions from the 16 most prominent in the population, which is an established method to identifying patients with CCN. As the technology is only currently available in English, patients (or a caregiver) must be able to speak and read English. Patients with mild cognitive impairment will not be excluded if able to provide informed consent, and engage with the intervention (independently or with caregiver aid).\n\nExclusion Criteria:\n\n* Previously participated in the study (in case of re-admission); discharge destination is another acute care facility, palliative care unit, complex continuing care, or long term care; died in hospital, cannot be contacted by telephone after discharge; unable to respond to survey question for any reason and lack of availability of family members and\u002For other caregivers willing and able to provide assistance.","60 Years",{"count":255,"type":21},640,[24],"Older adults who live with multiple chronic conditions are more likely to experience frequent admissions and discharges from hospital. These transitions are often challenging and leave people at risk of readmission. Appropriate, timely and person-centred communication across all health care providers involved in transitions (in and out of hospital) as well as with patients and their families is critical to ensure a smooth and effective transition process. Digital health technologies can play an important role in improving person-centred communication across clinical settings and clinicians. This project will develop and test a Digital Bridge by connecting communication technologies already in use in hospital and primary care\u002Fcommunity settings to improve communication between providers in hospital and in primary care, patients and family caregivers from admission to 6 months post-discharge. The investigators will engage with all the technology users to co-design the Digital Bridge, ensuring that how the investigators connect the existing technologies and adopt them into practice will meet the needs of providers, patients and their caregivers. Next hospital partners will adopt the technology into general medicine and rehabilitation services in hospital systems in Toronto (Sinai Health System) and Mississauga (Trillium Health Partners). The investigators will evaluate the Digital Bridge through a pre-post pragmatic trial, assessing impact on patient experience (quality of transition), patient outcomes (quality of life), transition processes (provider communication and teamwork), and system costs (economic evaluation). This project adopts an implementation science lens, allowing the investigators to collect qualitative data on enablers and barriers to adopting the Digital Bridge to help inform development of a scale and spread strategy.",[259],"Older Adults With Complex Care Needs","2025-09-29",{"date":262,"type":36},"2025-10-03",{"date":264,"type":36},"2023-04-15",{"date":266,"type":21},"2026-03-30",{"name":42,"class":43},{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":4,"eligibilityCriteria":274,"healthyVolunteers":144,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":22,"phases":276,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":44},"100578013","evaluating-the-use-of-educational-videos-in-newly-diagnosed-patients-in-a-medical-oncology-sarcoma-clinic-100578013","NCT06805773","Evaluating the Use of Educational Videos in Newly Diagnosed Patients in a Medical Oncology Sarcoma Clinic","Evaluating the Use of Educational Videos in a Medical Oncology Sarcoma Clinic to Improve Patient Knowledge and Satisfaction.","Inclusion Criteria:\n\n1. Signed written and voluntary informed consent.\n2. Have histologically documented advanced metastatic sarcoma, or is a caregiver of a patient with histologically documented advanced metastatic sarcoma.\n3. Age ≥ 18 years.\n4. Have not received any previous systemic treatment for sarcoma, or is a caregiver of a sarcoma patient who has not received any previous systemic treatment for sarcoma.\n5. Willing\u002Fable to complete questionnaires.\n6. Able to read and write in English.\n\nExclusion Criteria:\n\n1. Inability to provide informed consent.\n2. Previously seen by a medical oncologist for their sarcoma.",{"count":98,"type":21},[24],"This study aims to evaluate how sarcoma-specific educational videos improve patients' knowledge of their disease and treatment options before their first clinic appointment.\n\nParticipants will watch four educational videos before their first appointment with a medical oncologist. Participants will be asked to complete surveys to assess their understanding of sarcoma and its treatment options before and after their first medical oncology clinic appointment.",[279],"Sarcoma",[281,279],"Education","2025-09-23",{"date":284,"type":36},"2025-09-25",{"date":286,"type":36},"2025-05-05",{"date":288,"type":21},"2026-04",{"name":42,"class":43},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":44},"100371855","diet-intervention-treatment-for-active-ulcerative-colitis-100371855","NCT04121806","Diet Intervention Treatment for Active Ulcerative Colitis","Diet Intervention as a Prebiotic Treatment for Active Ulcerative Colitis","Inclusion Criteria:\n\n* • Females and Males between the ages of 18 - 75 years of age at the time of enrolment\n\n  * Must have established diagnosis of UC by standard endoscopic, radiographic, or histological criteria\n  * Must have active UC defined by having a Mayo score equal to or greater than 2 within two months prior to enrollment\n  * Must have had \\> 10cm involvement at some point in their disease history\n  * FCP\\>250 or active endo within 6 months\n  * If a smoker, must not change smoking habits (frequency) during the course of the study\n  * If receiving medical therapy, no baseline therapy change within 4 weeks of study initiation and no change during the course of the study\n\nExclusion Criteria:\n\n* • Uncontrolled inflammation which will likely require surgery or escalation of therapy within 4 weeks of enrollment\n\n  * Pregnant or lactating females\n  * Allergy or intolerance to key or a great number food components of the study diet\n  * Current NSAID use\n  * Diagnosed with PSC\n  * Using topical therapies or suppositories\n  * Antibiotic use within 4 weeks of the study enrollment or during the study\n  * Confirmed C. difficile infection within 3 months of recruitment;\n  * Diagnosis of primary PSC;\n  * Currently using topical therapies or suppositories\n  * History of dysplasia or colorectal neoplasia.",{"count":298,"type":21},20,[24],"The purpose of this study is to determine if a sustainable non-elemental diet can be used as a probiotic tool to alter the dysbiotic microbiome found in individuals with ulcerative colitis and thereby decrease disease activity.",[302],"Colitis, Ulcerative",{"date":260,"type":36},{"date":305,"type":36},"2021-03-01",{"date":307,"type":21},"2026-09-30",{"name":42,"class":43},{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":144,"sex":95,"minAge":18,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":324,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":44},"100596523","methoxyflurane-for-iud-insertion-and-endometrial-biopsy-100596523","NCT07046572","Methoxyflurane for IUD Insertion and Endometrial Biopsy","A Double-blind Placebo-controlled Randomized Controlled Trial (RCT) of 3ml Methoxyflurane for Intrauterine Device (IUD) Insertion and Endometrial Biopsy","Inclusion Criteria\n\n* Any participant ≥18 years and ≤ 65 years presenting for an IUD insertion or endometrial biopsy\n* For IUD insertion, only nulliparous patients\n* English speaking participants only\n* Availability of a ride home from the appointment\n\nExclusion Criteria\n\n* Use of pain medication that is not an NSAID or acetaminophen (e.g. opioids, benzodiazepines) within past 24 hours\n* Misoprostol administration within 24 hours\n* Breastfeeding\n* Any diagnosed chronic pain syndromes (e.g. fibromyalgia, vaginismus)\n* Allergy to methoxyflurane\n* Renal or liver disease\n* Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives\n* Baseline vital signs of systolic blood pressure \\\u003C100, diastolic blood pressure \\\u003C60 and\u002For pulse \\\u003C60.\n* Previous unsuccessful office attempt of IUD insertion or endometrial biopsy by the same practitioner (note of clarification: previous unsuccessful IUD insertion or biopsy attempt by a different practitioner will still be eligible)\n* Clinically evident respiratory impairment","65 Years",{"count":318,"type":21},174,[24],"The aim of this study is to determine if 3ml of inhaled Methoxyflurane, in the form of a Penthrox inhaler, reduces pain during IUD insertion and\u002For endometrial biopsy. The proposed study is a double-blind, placebo-controlled RCT.\n\nEach participant will be randomly assigned to one of two arms:\n\n1. Intervention (3ml of Methoxyflurane via a Penthrox inhaler)\n2. Placebo (3ml of normal saline via an identical placebo Penthrox inhaler)\n\nThe primary outcome is global pain score, which will be patient-reported by the 100 mm Visual Analogue Scale (VAS) 5-minutes following the procedure (endometrial biopsy or IUD insertion).",[322,323],"Endometrial Biopsy","Intrauterine Devices",[325],"methoxyflurane","2025-07-28",{"date":328,"type":36},"2025-07-30",{"date":330,"type":36},"2025-07-24",{"date":332,"type":21},"2026-03-01",{"name":42,"class":43},{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":144,"sex":95,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":22,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":44},"100554837","low-versus-standard-pressure-pneumoperitoneum-on-shoulder-tip-pain-100554837","NCT06504277","Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain","A Randomized Controlled Trial (RCT) Comparing the Effect of Low Versus Standard Pressure Pneumoperitoneum on Post-operative Shoulder Tip Pain in Patients Undergoing Laparoscopic Gynecologic Surgery for Benign Indications","Inclusion Criteria: The participant must meet all of the inclusion criteria to eligible for this clinical trial:\n\n1. All ages \\> or = to 18 years old;\n2. Must be deemed to have capacity to provide informed consent;\n3. Must sign and date the informed consent form;\n4. Stated willingness to comply with all study procedures;\n5. Must be undergoing unilateral or bilateral salpingo-oopherectomy or salpingectomy or ovarian cystectomy;\n\nExclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this clinical trial:\n\n1. Previous midline laparotomy;\n2. Gynecological cancer beyond stage 1 disease;\n3. Chronic pain;\n4. Known diagnosis of endometriosis or evidence of endometriosis intra-operatively;\n5. Fibromyalgia;\n6. BMI \\>50;\n7. Language barrier;\n8. Inability to communicate or provide informed consent;",{"count":342,"type":21},82,[24],"This proposed study is a single-center, double blind, parallel group RCT comparing the use of low (10 mm Hg) versus standard pressure (15 mm Hg) pneumoperitoneum at the time of benign gynecologic laparoscopic surgery. Patients will be randomized to the control group (standard pressure) or the intervention group (low pressure) and surgeons will be blinded to the study pressure. Data on post-operative recovery and pain scores will be recorded for each patient.",[346,347,155,348,151,349],"Surgery","Laparoscopic","Penumoperitoneum","Post-operative Recovery",{"date":351,"type":36},"2025-07-31",{"date":353,"type":36},"2025-07-02",{"date":355,"type":21},"2026-09-15",{"name":42,"class":43},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":364,"maxAge":365,"enrollmentInfo":366,"targetDuration":368,"studyType":369,"phases":4,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100465939","dopamine-vs-norepinephrine-for-hypotension-in-very-preterm-infants-with-late-onset-sepsis-100465939","NCT05347238","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis","Dopamine vs. Norepinephrine for Hypotension in Very Preterm Infants With Late-onset Sepsis: An International Comparative Effectiveness Research Project","Inclusion Criteria:\n\n* ≤32 weeks gestational age and \\> 48 hours of life\n* Receiving primary vasopressor therapy with Dopamine or Norepinephrine in the context of suspected late-onset sepsis or necrotizing enterocolitis with systemic hypotension (defined as: culture positive or negative bloodstream infection)\n\nExclusion Criteria:\n\n* Known chromosomal or genetic anomalies\n* Receiving primary therapy with agents other than Dopamine or Norepinephrine","21 Weeks","32 Weeks",{"count":367,"type":21},550,"36 Weeks","OBSERVATIONAL","Fluid-unresponsive hypotension needing cardiotropic drug treatment is a serious complication in very preterm neonates with suspected late-onset sepsis (LOS; defined as culture positive or negative bloodstream infection or necrotizing enterocolitis occurring \\>48 hours of age). In Canada, \\~250 very preterm neonates receive cardiotropic drugs for LOS related fluid-unresponsive hypotension every year; of these \\~35-40% die. Unlike for adult patients, there is little evidence to inform practice. While several medications are used by clinicians, the most frequently used medications are Dopamine (DA) and Norepinephrine (NE). However, their relative impact on patient outcomes and safety is not known resulting in significant uncertainty and inter- and intra-unit variability in practice. Conducting large randomized trials in this subpopulation can be operationally challenging and expensive. Comparative effectiveness research (CER), is a feasible alternative which can generate high-quality real-world evidence using real-world data, by comparing the impact of different clinical practices.\n\nAim: To conduct an international CER study, using a pragmatic clinical trial design, in conjunction with the existing infrastructure of the Canadian Neonatal Network to identify the optimal management of hypotension in very preterm neonates with suspected LOS.\n\nObjective: To compare the relative effectiveness and safety of pharmacologically equivalent dosages of DA versus NE for primary pharmacotherapy for fluid-unresponsive hypotension in preterm infants born ≤ 32 weeks gestational age with suspected LOS.\n\nHypothesis: Primary treatment with NE will be associated with a lower mortality\n\nMethods: This CER project will compare management approach at the unit-level allowing inclusion of all eligible patients admitted during the study period. 16 centers in Canada, 2 centers in Ireland, 1 center in each of Israel, Spain and the UK, and 6 centers in the United States have agreed to standardize their practice. All eligible patients deemed circulatory insufficient will receive fluid therapy (minimum 10-20 cc\u002Fkg). If hypotension remains unresolved:\n\nDopamine Units: start at 5mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 5 mics\u002Fkg\u002Fmin to a maximum dose of 15 mics\u002Fkg\u002Fmin or adequate response\n\nNorepinephrine Units: start at 0.05 mics\u002Fkg\u002Fmin, increase every 16-30 minutes by 0.05 mics\u002Fkg\u002Fmin to maximum dose of 0.15\u002Fmics\u002Fkg\u002Fmin or adequate response",[372,373,374],"Late-Onset Neonatal Sepsis","Extreme Prematurity","Neonatal Hypotension","2025-07-03",{"date":377,"type":36},"2025-07-08",{"date":379,"type":36},"2023-02-06",{"date":381,"type":21},"2027-03-31",{"name":42,"class":43},23,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":144,"sex":95,"minAge":390,"maxAge":253,"enrollmentInfo":391,"targetDuration":4,"studyType":369,"phases":4,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":44},"100253832","toronto-gestational-glucose-tolerance-cohort-100253832","NCT02583061","Toronto Gestational Glucose Tolerance Cohort","Inclusion Criteria:\n\n* Pregnant women\n\nExclusion Criteria:\n\n* Pre-existing diabetes before the index pregnancy","20 Years",{"count":392,"type":21},350,"In this prospective observational cohort study, women representing the full spectrum of gestational glucose tolerance status are undergoing longitudinal cardiometabolic characterization at regular intervals in the years after the index pregnancy.",[395],"Type 2 Diabetes, Gestational Diabetes, Pre-diabetes","2025-05-06",{"date":398,"type":36},"2025-05-09",{"date":400,"type":4},"2003-09",{"date":402,"type":21},"2029-10",{"name":42,"class":43},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":95,"minAge":18,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100585850","fetoscopic-robotic-open-spina-bifida-treatment-100585850","NCT06907732","Fetoscopic Robotic Open Spina Bifida Treatment","Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study","FROST","Inclusion Criteria:\n\n* Isolated open fetal spina bifida\n* Healthy pregnant patient without risk factors for preterm delivery\n* Candidate for open fetal spina bifida surgery.\n* Maternal age 18 years or more and able to consent\n* Provision of written informed consent to participate in this study\n* Gestational age allowing for fetal surgery prior to 26 weeks gestation.\n\nExclusion Criteria:\n\n* Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI \\>40 kg\u002Fm2)\n* History of preterm birth, short cervical length, cervical cerclage\n* Placenta or vasa previa, invasive placentation\n* Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition\n* Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap\n* Neural tube defects other than open spina bifida\n* Absence of Chiari II malformation on ultrasound or MRI\n* Severe fetal kyphosis (\\>30 degrees)\n* Upper lesion level lower than sacral vertebra S1.\n* Multiple gestation\n* Fetal bleeding disorder (eg. Fetal\u002Fneonatal allo-immune thrombocytopenia)\n* Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)",{"count":413,"type":21},15,[24],"Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero. Fetal surgery between 22-26 weeks gestation has been shown to stop the gradual fetal deterioration observed in this disease and improve infant outcomes. Children with spina bifida who have undergone fetal surgery have a lower need for hydrocephalus treatment (80%-\\>40%) and twice the chance to walk independently by the age of 3 years (20%-\\>40%). These benefits are also sustained in the longer term.\n\nThe traditional 'open' fetal surgical approach, however, as currently offered clinically at the Ontario Fetal Centre, comes with significant risks: it increases the risk of preterm birth, carries significant maternal morbidity and results in important uterine scarring. The latter comes with a risk of uterine rupture and fetal death both in the index pregnancy and future pregnancies.\n\nTo overcome these down sides of open fetal surgery, different centers have attempted a fetoscopic approach to the surgery. Fetoscopy indeed avoids uterine scarring and is likely protective against uterine rupture but is technically complex. This results in long surgical learning curves, poor dissemination of the surgery amongst centers worldwide, longer procedures and suboptimal surgical results which translate in decreased infant benefits - particularly with regards to motor function.\n\nThe investigators have developed a fetoscopic robotic approach where they leverage the dexterity of robotic instruments to perform these complex surgeries. The team expects that this will result in easier and faster procedures with better surgical outcomes and therefore fetal benefits comparable to open fetal surgery, while at the same time avoiding the need for hysterotomy.\n\nIn this prospective exploratory phase 1 study, the investigators propose to assess the feasibility of such a robotic approach, as developed and trained on a high-fidelity phantom, in 15 patients. The research team will collect maternal and fetal safety and efficacity data to inform later studies.",[417,418,419,420,421,422],"Fetal Congenital Abnormalities","Fetoscopy","Fetal Surgery","Robotic Surgical Procedure","Neural Tube Defect","Open Spina Bifida","2025-05-04",{"date":425,"type":36},"2025-05-07",{"date":427,"type":21},"2025-07",{"date":429,"type":21},"2027-12",{"name":42,"class":43},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":4,"eligibilityCriteria":436,"healthyVolunteers":144,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":369,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":44},"100519349","genome-analysis-across-populations-in-inflammatory-bowel-disease-100519349","NCT06042387","Genome Analysis Across Populations in Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Subjects: diagnosed with Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis, IBD-undetermined)\n* Available medical records to confirm IBD diagnosis (Crohn's disease, Ulcerative colitis, IBD undetermined (IBD-U))\n* Healthy controls: no personal history of IBD, no family history of IBD, no history of unexplained chronic diarrhea\u002Fblood in stool\u002Fanemia\u002Fabdominal pain\u002Fweight loss\n* Any age\n\nExclusion Criteria:\n\n\\- Subjects with other gastrointestinal conditions not meeting the above IBD or Healthy Control criteria",{"count":438,"type":21},150,"Objective:\n\nTo use clinical, genetic and genome analysis to better understand and define the genetic and environmental factors that contribute to IBD within affected populations.",[441,442,443,444],"Ulcerative Colitis","Healthy","Crohn Disease","Inflammatory Bowel Diseases","2025-03-20",{"date":447,"type":36},"2025-03-25",{"date":449,"type":36},"2022-05-01",{"date":451,"type":21},"2027-09",{"name":42,"class":43},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":458,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":369,"phases":4,"briefSummary":462,"conditions":463,"keywords":467,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":479},"100493665","prediction-of-intraventricular-hemorrhage-using-echocardiography-and-near-infrared-spectroscopy-100493665","NCT05708105","Prediction of Intraventricular Hemorrhage Using Echocardiography and Near Infrared Spectroscopy","PIONIRS","Inclusion Criteria:\n\n* Preterm infants born \\\u003C=27+6 weeks gestational age\n\nExclusion Criteria:\n\n* Known genetic or congenital anomalies that are likely to affect cardiac or cerebral oxygenation measures\n* Palliative care plan prior to or immediately following delivery",{"count":461,"type":21},380,"Moderate-severe intraventricular hemorrhage (msIVH, Grades II-IV) is a significant neurological complication among extremely low gestational age neonates (ELGANs, \\\u003C=27+6 weeks) and is associated with long-term neuro-disabilities. In Canada, msIVH affects \\~25-30% of the 1300 ELGANs born annually, with little change in incidence over last decade. Typically, it occurs between days 2-7 of age, providing a finite window of opportunity. Instituting therapies at the population level, however, exposes many low-risk infants to side effects, adversely affecting risk-benefit profile and requiring large sample sizes in trials. A targeted preventative approach, though ideal, is currently challenged by our inability to reliably identify at-risk ELGANs early after birth. Near-infrared spectroscopy (NIRS) has emerged as a promising non-invasive bedside neuromonitoring tool. Pilot studies using NIRS, including ours, found lower cerebral saturations (CrSO2) and greater periods of altered cerebral autoregulation in infants who later developed msIVH. However, a systematic planned investigation is needed to establish the predictive characteristics of NIRS-derived markers, using clinically translatable methods (cumulative burden over time-period vs. single time-point values) and identify their relative performance at different time-points during transition. Further, incorporating echocardiographic (ECHO) hemodynamic markers, known to be associated with msIVH, may allow for the establishment of robust multi-model prediction models and the gain of mechanistic hemodynamic insights to inform future management. Hence, our objective is to investigate the utility of multi-modal assessment using NIRS and ECHO for early identification of ELGANs at risk of msIVH, and generate clinically applicable predictive model(s).",[464,465,466],"Intraventricular Hemorrhage of Newborn Grade 2","Intraventricular Hemorrhage of Newborn Grade 3","Intraventricular Haemorrhage Grade IV",[468,182,469,470],"Near-infrared spectroscopy","Head ultrasound","Preterm neonates","2025-03-19",{"date":473,"type":36},"2025-03-24",{"date":475,"type":36},"2024-04-22",{"date":477,"type":21},"2027-11-01",{"name":42,"class":43},4,{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":487,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":369,"phases":4,"briefSummary":489,"conditions":490,"keywords":493,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":44},"100484575","respiratory-support-and-brain-health-in-preterm-infants-100484575","NCT05589831","Respiratory Support and Brain Health in Preterm Infants","Respiratory Support and Brain Health in Preterm Infants: a Prospective Crossover Study","Inclusion Criteria:\n\n* Preterm infants born between 22+0 and 31+6 weeks' GA\n* Weight \\> 500 g at the time of approach for consent\n* A minimum of 3 days of age\n* Clinically stable for \\> 24 hours while receiving NIPPV or NIV-NAVA\n\nClinical stability will be defined as meeting all the following criteria for a 24 hour period prior to recruitment:\n\n1. differences in maximum and minimum fractions of inspired oxygen (FiO2) of \\\u003C20%\n2. differences in maximum and minimum MAP \\\u003C4 cm H2O\n3. no active infection\n4. no hypotension\n5. no use of cardioactive medications or medical therapy for patent ductus arteriosus.\n\nExclusion Criteria:\n\n* Infants with IVH of grade 3 or 4\n* Birth weight \\\u003C 3rd percentile\n* Genetic or congenital abnormalities","3 Days",{"count":126,"type":21},"Premature babies often require breathing support during their neonatal intensive care unit stay. This is because their lungs are not fully developed to perform the work of breathing on their own. Although breathing support can be provided via a breathing tube, it is preferable to provide breathing support non-invasively from a breathing machine which is then connected to a mask or prongs placed on the baby's nose. In premature babies born under 32 weeks gestation, a commonly used mode of non-invasive breathing support is called Non-Invasive Positive Pressure Ventilation (NIPPV). In this mode, the breathing machine provides 2 levels of support: one is the constant distending pressure to keep the lungs open and the other provides additional 'breaths' on top of that distending pressure. This is to mimic regular breathing. These breaths are set at a fixed rate and pressure. Although NIPPV protects the lungs from injury caused by a breathing tube, the breaths are not in sync with the baby's own breathing effort. Another mode of non-invasive breathing support recently being used in premature infants called Neurally Adjusted Ventilatory Assist (NAVA). When NAVA is provided non-invasively using a mask or prongs similar to NIPPV, it is called Non-invasive NAVA (NIV-NAVA). During NIV-NAVA a special feeding tube is used that detects the baby's own breathing movement from the electrical signal of the baby's diaphragm and feeds back to the machine which then provides a 'top-up' to the baby's own breath. This top-up breath also provides only as much pressure as the baby needs on top on their own breathing effort. Therefore, this is thought to be in sync with the baby's own breathing effort. However, it is not known if this mode of ventilation leads to improved sleep, improved brain oxygen levels, reduced discomfort and improved functioning of the diaphragm. The investigators aim to examine these indices in this research project.",[491,492],"Sleep","Cerebral Oxygenation",[494,495,180,496],"Neurally Adjusted Ventilatory Assist","Non-Invasive Positive Pressure Ventilation","Amplitude integrated electroencephalography",{"date":473,"type":36},{"date":499,"type":36},"2023-07-04",{"date":501,"type":21},"2026-01",{"name":42,"class":43},{"id":504,"slug":505,"hasResults":11,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":509,"eligibilityCriteria":510,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":22,"phases":513,"briefSummary":514,"conditions":515,"keywords":516,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":44},"100578005","this-is-a-randomized-study-of-early-involvement-of-palliative-care-along-side-standard-treatment-versus-standard-treatment-alone-in-newly-diagnosed-patients-with-advanced-or-metastatic-soft-tissue-sarcoma-sarquality-100578005","NCT06805669","This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)","Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study","SARQUALITY","Inclusion Criteria:\n\n* Signed written and voluntary informed consent.\n* Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.\n* Age ≥ 18 years.\n* Have not received any previous systemic treatment with palliative intent for advanced sarcoma.\n* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.\n* Life expectancy \\> 6 months.\n* Willing\u002Fable to complete questionnaires.\n\nExclusion Criteria:\n\n* Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.\n* Patient in need of urgent home support services or symptom management through a palliative care team.\n* Patient is being actively followed by a palliative care physician.\n* Active psychiatric disorder or drug abuse.\n* Insufficient English literacy to complete questionnaires.",{"count":512,"type":21},136,[24],"The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.\n\nParticipants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.",[279],[279,517],"Palliative Care","2025-01-28",{"date":520,"type":36},"2025-02-03",{"date":522,"type":36},"2024-03-20",{"date":524,"type":21},"2027-10",{"name":42,"class":43},{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":479},"100576970","phase-4-antiviral-strategies-in-the-prevention-of-long-term-cardiovascular-outcomes-following-covid-19-the-paxlovidremdesivir-effectiveness-for-the-prevention-of-long-covid-clinical-trial-100576970","NCT06792214","Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD\u002FRemdesivir Effectiveness For the prEvention of loNg coviD Clinical Trial","Antiviral Strategies in the Prevention of Long-term Cardiovascular Outcomes Following COVID-19: The paxloviD\u002FRemdesivir Effectiveness For the prEvention of loNg coviD (DEFEND) Clinical Trial","DEFEND","Inclusion Criteria:\n\n* ≥18 years old\n* Positive PCR test for SARS-CoV-2 within 5 days of admission to hospital\n* Normoxic (not receiving supplemental oxygen)\n* Able to provide informed written consent (or, if patient is unable, have substitute decision maker available)\n\nExclusion Criteria:\n\n* Absolute contraindications to Paxlovid or Veklury (any of the following): Severe allergy to Paxlovid or Veklury (e.g. anaphylaxis), co-administration with drugs highly dependent on CYP3A for clearance, co-administration with potent CYP3A inducers\n* Exposure to Paxlovid or Veklury within previous 14 days;\n* Receiving supplemental oxygen;\n* Known positive SARS-CoV-2 PCR or rapid antigen test 5-90 days prior to admission;\n* Limited life expectancy estimated to be ≤3 months;\n* Pregnant and breastfeeding women",{"count":535,"type":21},118,[537],"PHASE4","The DEFEND trial will be the world's first clinical trial to study the effectiveness of Paxlovid or Veklury in the prevention of cardiovascular post-acute sequelae of SARS-CoV-2 among hospitalized adults. Additionally, this pilot study will inform the design and conduct of a future full-scale multi-centre trial by testing the feasibility and accuracy of this study design.",[540],"SARS CoV-2 Post-Acute Sequelae",[542,543],"SARS CoV-2","long covid","2025-01-23",{"date":546,"type":36},"2025-01-24",{"date":548,"type":36},"2025-01-03",{"date":550,"type":21},"2027-01",{"name":42,"class":43},{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":95,"minAge":18,"maxAge":559,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":561,"briefSummary":562,"conditions":563,"keywords":570,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":4},"100572471","the-use-of-virtual-reality-technology-during-oocyte-retrieval-for-in-vitro-fertilization-100572471","NCT06733701","The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization","The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization: a Randomized Controlled Pilot Study","Inclusion Criteria:\n\n\\- All adults undergoing their first oocyte retrieval\n\nExclusion Criteria:\n\n* severe visual impairment\n* contraindications to using VR technology according to manufacturer specifications including:\n* severe motion sickness\n* epilepsy\u002Fprevious seizure\n* claustrophobia\n* current migraine\n* heart disease\n* use of medical devices such as cardiac pacemaker or hearing aids","43 Years",{"count":126,"type":21},[24],"Ultrasound-guided oocyte retrieval (OR) is a short, but oftentimes painful procedure, during which the follicles are punctured trans-vaginally to obtain oocytes for in vitro fertilization (IVF). Conscious sedation is the most commonly used method of pain relief, yet several studies have shown that more than half of women report moderate to high levels of pain and up to 7% of women report extreme or unacceptable levels of pain during OR. Adjuvant virtual reality (VR) therapy has been explored to reduce psychological stress during dental procedures, burn wound care, colonoscopy, as well as other minor procedures. Hence, the purpose of this study is to evaluate the use of VR technology during IVF treatment, particularly with respect to tolerability, patient satisfaction, and pain reduction during oocyte retrieval.",[564,565,566,567,568,569],"Oocyte Retrieval","Adverse Events","Procedural Anxiety","Pain Intensity","Satisfaction","Medication Administration",[571,564,572,573],"Virtual Reality","In Vitro Fertilization","Randomized Control Trial","2024-12-13",{"date":576,"type":36},"2024-12-18",{"date":578,"type":21},"2025-01-15",{"date":580,"type":21},"2025-12-31",{"name":42,"class":43},{"id":583,"slug":584,"hasResults":11,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":11,"sex":17,"minAge":253,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":22,"phases":590,"briefSummary":591,"conditions":592,"keywords":594,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":605,"locationsCount":606},"100516455","antibiotics-for-delirium-in-older-adults-with-no-clear-urinary-tract-infection-100516455","NCT06004739","Antibiotics for Delirium in Older Adults With No Clear Urinary Tract Infection","A-DONUT","Inclusion criteria\n\n* Age ≥ 60 and admitted to a hospital ward (including rehabilitation hospital);\n* Active delirium (defined by CAM: \\[1\\] inattention AND \\[2\\] acute and fluctuating level of consciousness, and either \\[3\\] disorganized thinking OR \\[4\\] altered mental status; OR physician's diagnosis)\n* Less than 24 hours of antibiotics (prior to trial assessment)\n* Either pyuria (defined as white blood cells detected on urinalysis or dipstick) or bacteriuria (defined as bacteria growing on urine culture)\n\nExclusion criteria\n\n* Fever (temperature \\> 37.9C or \\> 100.2F) in the past 48 hours;\n* Signs of lower urinary tract infection symptoms (such as new dysuria) or upper urinary symptoms (such as costovertebral tenderness)\n* In the opinion of the treating physician, there is a reason apart from delirium and urine test results to treat with antibiotics (e.g., pneumonia)\n* Indwelling urinary catheter for \\> 72 hours\n* Receipt of an antibiotic where a single dose suffices for the treatment of a UTI (such as Fosfomycin)",{"count":367,"type":21},[24],"Delirium is an acute confusional state that is experienced by many older adults who are admitted to hospital. To treat delirium the underlying cause needs to be identified promptly, but this is challenging. One of the potential causes of delirium is infection. Urine tests show that most patients experiencing delirium have bacteria in their urine, however, bacteria in the urine is common among older adults, and does not automatically indicate an infection is present. As a result it is difficult to know whether a lower urinary tract infection is present as individuals with delirium are frequently unable to report clinical signs of infection - symptoms of pain or discomfort with urination, having to urinate more frequently or pelvic discomfort. Very often, individuals with delirium are treated with antibiotics despite the fact that it is unknown whether antibiotics help to improve delirium in cases where bacteria in the urine is present. This proposed study is a randomized controlled trial that will examine if adults (age 60 or older) with delirium and suspected infection benefit from taking antibiotics.",[593],"Infectious Disease",[595,596,597,598],"Delirium","Antibiotics","Older adults","Urinary Tract Infection","2024-09-09",{"date":601,"type":36},"2024-09-19",{"date":603,"type":36},"2024-05-18",{"date":451,"type":21},{"name":42,"class":43},7,""]