[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":736},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,85,0,25,[9,51,79,108,145,173,202,228,252,293,316,352,374,405,433,466,489,521,548,576,604,632,664,690,718],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100642274","decision-aid-for-anticoagulation-duration-after-unprovoked-venous-thromboembolism-100642274",false,"NCT07659106","Decision Aid for Anticoagulation Duration After Unprovoked Venous Thromboembolism","Enabling and Engaging Patients to Decide Indefinite Versus Short-Term Anticoagulation for Venous Thromboembolism (DECIDE-VTE)","DECIDE-VTE","Inclusion Criteria:\n\n* Age 18 years or older\n* First episode of objectively confirmed unprovoked or weakly provoked venous thromboembolism (VTE)\n* Objectively confirmed proximal deep vein thrombosis and\u002For segmental or greater pulmonary embolism\n* Completed at least 3 months of therapeutic anticoagulation and currently receiving anticoagulation\n* Enrollment within 12 months of diagnosis of the index\u002Fqualifying VTE event\n* Able to provide written informed consent\n* Able to participate in shared decision-making in English or French\n\nExclusion Criteria:\n\n* Recurrent unprovoked or weakly provoked VTE I(i.e. multiple unprovoked\u002Fweakly provoked VTE)\n* Index\u002Fqualifying VTE is a strongly provoked VTE (e.g., associated with major surgery, major trauma, plaster cast immobilization, or prolonged bed rest)\n* Index\u002Fqualifying VTE associated with a persistent strong provoking risk factor (e.g., active cancer or ongoing immobility)\n* Women at very low recurrence risk (HERDOO2 score 0-1)\n* High bleeding risk such that anticoagulation should be discontinued\n* Requirement for long-term anticoagulation for another indication (e.g., atrial fibrillation)\n* Prior dedicated long-term anticoagulation Decision Visit regarding anticoagulation duration","ALL","18 Years",{"count":21,"type":22},850,"ESTIMATED","INTERVENTIONAL",[25],"NA","Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, is a common condition that is typically treated with blood thinners (anticoagulants). After completing at least 3 months of treatment for a first unprovoked or weakly provoked VTE, patients and clinicians must decide whether to stop anticoagulation or continue treatment for a longer period. Continuing anticoagulation reduces the risk of another blood clot but increases the risk of bleeding. Because both options involve important benefits and risks, this decision should reflect the patient's values and preferences.\n\nThe DECIDE-VTE study will evaluate whether a patient decision aid can improve decision-making for patients facing this choice. The decision aid provides evidence-based information about the risks and benefits of continuing versus stopping anticoagulation and includes a values clarification exercise to help patients identify what matters most to them.\n\nThis multicentre batched stepped-wedge cluster randomized trial will be conducted in 12 thrombosis clinics across Canada. Clinics will transition from usual care to implementation of the patient decision aid according to a randomized schedule. The primary outcome is decisional conflict immediately following the anticoagulation decision visit, measured using the Decisional Conflict Scale. Secondary outcomes include patient knowledge, treatment decisions, decisional regret, concordance with the chosen treatment strategy, recurrent venous thromboembolism, major bleeding, all-cause mortality, and implementation outcomes.",[28,29,30],"Venous Thromboembolism (VTE)","Deep Vein Thrombosis (DVT)","Pulmonary Embolism",[32,33,34,35,36,37],"Anticoagulation","Patient Decision Aid","Shared Decision Making","Extended Anticoagulation","Decisional Conflict","Stepped-Wedge Cluster Randomized Trial","NOT_YET_RECRUITING","2026-06-19",{"date":41,"type":42},"2026-06-24","ACTUAL",{"date":44,"type":22},"2026-09",{"date":46,"type":22},"2029-03",{"name":48,"class":49},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",5,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100618234","phase-3-vancomycin-taper-to-prevent-recurrent-clostridioides-difficile-100618234","NCT07328971","Vancomycin Taper to Prevent Recurrent Clostridioides Difficile","Initial Vancomycin Taper for the Prevention of Recurrent Clostridioides Difficile Infection 2: A Randomized Controlled Trial","TAPER-V2","Inclusion Criteria\n\n1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.\n2. First episode or first recurrence of CDI (i.e., second episode within 120 days) defined by a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and\u002For cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \\\u003C24 hours with a duration \\>24 hours, endoscopic\u002Fhistologic evidence of pseudomembranous colitis, or ileus. For eligibility, CDI will be considered a first recurrence if the patient experiences 2 episodes within a 120-day timeframe; those with a first ever episode, or 2 episodes separated by more than 120 days, will be categorized as a first-episode.\n\nClinical Exclusion Criteria\n\n1. Treatment with CDI-active antibiotics that will be continued throughout the trial (i.e., rifaximin for hepatic encephalopathy).\n2. Planned or current treatment of the present episode of CDI with FMT, intravenous immunoglobulins, or other microbiome therapies (i.e., VOWST or REBYOTA).\n3. Inability to take medications orally.\n4. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.\n5. Severe intolerance or allergy to oral vancomycin or fidaxomicin.\n6. The patient is being admitted to a palliative care ward or is anticipated to die within 3 months of enrollment from another illness.\n7. Fulminant CDI, defined according to the IDSA definition of CDI with the presence of hypotension, shock, ileus, and\u002For toxic megacolon.\n8. Receipt of more than 72 hours of off-study fidaxomicin or vancomycin CDI therapy for the current episode of CDI.\n9. Pregnancy or planning to become pregnant during the study period because minimal data on fidaxomicin in pregnancy are available.\n10. Active breastfeeding because minimal data on fidaxomicin in breastfeeding are available.\n11. Patients who have had ≥3 episodes of CDI in the last 1 year.\n12. Treating team declined participation.\n13. Prior enrolment in TAPER-V2.\n\nAdministrative Exclusion Criteria\n\n1. Prior enrollment in this trial.\n2. Inability to consent without a healthcare proxy.\n3. Lack of health insurance.\n4. Anticipated transfer to a site not involved in this trial, or to a palliative care ward\n5. Patient-declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.",{"count":60,"type":22},500,[62],"PHASE3","Indirect evidence from network meta-analyses of randomized controlled trials (RCTs) suggest that a pulse and taper (P-T) of vancomycin may be non-inferior to 10-days of fidaxomicin for the prevention of recurrent Clostridioides difficile infections (rCDI). The aim of this trial is:\n\n1\\) For first episodes and first recurrences of CDI, to test whether a vancomycin P-T is non-inferior to 10-days of fidaxomicin for the prevention of rCDI at 56 days",[65],"Clostridia Difficile Colitis",[67,68,69,70],"Clostridoides difficile","Recurrent Clostridioides difficile","C. difficile","Clostridium difficile","RECRUITING",{"date":41,"type":42},{"date":74,"type":42},"2026-04-24",{"date":76,"type":22},"2030-11-01",{"name":48,"class":49},1,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":78},"100591375","phase-2-secondary-prevention-of-clostridioides-difficile-using-vancomycin-100591375","NCT06979609","Secondary Prevention of Clostridioides Difficile Using Vancomycin","Secondary Prophylaxis of Recurrent Clostridioides Difficile Infections During Systemic Antibiotics With Vancomycin: A Randomized Controlled Trial","SPORES-V","Inclusion Criteria\n\n1. Inpatient or outpatient adults (≥18 years old) treated at the participating institutions.\n2. An episode of CDI within the preceding 120 days, diagnosed by both a positive C. difficile assay (including PCR toxin gene detection, toxin enzyme immunoassay, and\u002For cell cytotoxicity neutralization assay) and the presence of either ≥3 unformed stools in \\\u003C24 hours with a duration \\>24 hours, endoscopic\u002Fhistologic evidence of pseudomembranous colitis, or ileus.\n3. Treatment of the qualifying CDI episode with vancomycin or fidaxomicin for ≥10 days, and achievement of clinical cure (≤3 unformed stool per 24 hours in ≥2 days10).\n4. Receipt of ≤3 days of at least one oral or intravenous systemic antibiotic, for which therapy is planned for at least one additional consecutive day in duration.\n\nClinical Exclusion Criteria\n\n1. ≥72 hours of off-study vancomycin prophylaxis for the current episode of antibiotic re-exposure.\n2. ≤1 day elapsed since discontinuation of CDI treatment\n3. Treatment of the qualifying episode of CDI with metronidazole monotherapy or intravenous immunoglobulins.\n4. Planned treatment with or treatment of the qualifying episode of CDI with fecal microbiota transplantation (FMT), bezlotoxumab, VOWST, REBYOTA, or another microbiome agent.\n5. Inability to take medications orally.\n6. Ileostomy, colostomy, or total colectomy with ileorectal anastomosis.\n7. Severe intolerance or allergy to oral vancomycin.\n8. Lack of achievement of clinical cure during the treatment of the qualifying CDI episode\n9. The qualifying antibiotic is solely for prophylaxis (e.g., once daily trimethoprim sulfamethoxazole) or the patient is anticipated to require systemic antibiotics for \\>4 weeks (e.g., lifelong suppressive therapy or for the treatment of left-sided endocarditis or a deep-seated abscess).\n10. Patients on ongoing systemic antibiotics since the completion of treatment for the qualifying episode of CDI that have not been interrupted by at least one day.\n11. Patients admitted to a palliative care ward or who are anticipated to die within 8 weeks of enrollment from another illness.\n12. The qualifying antibiotic is non-systemic (i.e., topical) or is not considered a significant risk factor for CDI including: single-dose antibiotics, as well as macrolides, nitrofurantoin, intravenous vancomycin, metronidazole, tetracyclines, and oral fosfomycin. If two or more systemic antibiotics are given (i.e., ceftriaxone and azithromycin), as long as at least one of the systemic antibiotics does not meet exclusion criteria, then the patient will still be eligible.\n13. Concomitant receipt of rifaximin (e.g., for hepatic encephalopathy).\n14. Receipt of ≥2 courses of vancomycin prophylaxis since the qualifying episode of CDI or \\\u003C2 weeks since the last course of vancomycin prophylaxis.\n15. Treating team declined participation.\n\nAdministrative Exclusion Criteria\n\n1. Prior enrollment in this trial.\n2. Inability to consent and without a healthcare proxy.\n3. Lack of health insurance.\n4. Anticipated transfer to a site not involved in this trial or to a palliative care ward.\n5. Patient declared anticipated inability to participate in study follow-up or lack of means for contact in the outpatient setting.",{"count":88,"type":22},300,[90,62],"PHASE2","Re-exposure to systemic antibiotics (i.e., antibiotics absorbed into the bloodstream) is common after a Clostridioides difficile infection (CDI) and is the strongest risk factor for a recurrent episode. Oral vancomycin to prevent a recurrence during antibiotic re-exposure may reduce this risk but the data supporting this practice are limited. The aim of this trial is:\n\n1\\) Does oral vancomycin prophylaxis prevent CDI recurrences in patients with recent CDI (within 120 days) and who are re-exposed to systemic antibiotics?\n\nThe trial will compare oral vancomycin to placebo.\n\nParticipants will:\n\n* Take the study drug (either vancomycin or placebo) twice daily for the duration of systemic antibiotics plus once daily for 7 days after completion of systemic antibiotics.\n* Attend an in-person or over the phone follow-up at day 56\n* Respond to weekly electronic questionnaires",[93,94,95],"Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","Clostridoides Difficile Associated Disease",[97,70,98,99,69,100,101],"Clostridioides difficile","Vancomycin","Prophylaxis","Recurrence","CDI",{"date":41,"type":42},{"date":104,"type":42},"2025-11-01",{"date":106,"type":22},"2029-10-01",{"name":48,"class":49},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":78},"100642982","radio-frequency-rf-bladder-monitor-100642982","NCT07639541","Radio-frequency (RF) Bladder Monitor","Inclusion Criteria:\n\n* Age \\> 18\n* Able\u002Fwilling to sit (or stand) in place for the time it takes for bladder to fill once.\n* No implanted devices\n* Able to toilet\u002Fvoid independently\n* No pregnancy\n\nExclusion Criteria:\n\n* Age \\\u003C 18\n* Implanted devices (e.g., pacemakers)\n* Unable to toilet without assistance\n* Unable to stay relatively still for the time it takes bladder to fill once\n* Pregnancy",true,{"count":116,"type":22},40,[25],"The goal of this pilot feasibility study is to evaluate a wearable microwave (MW)-based bladder monitoring system in adult volunteers and those with spinal cord injury (SCI) who use self-catheterization for bladder management. The study aims to learn whether the device can monitor bladder filling and estimate bladder volume non-invasively.\n\nThe main questions the study aims to answer are:\n\n1. Can the MW-based monitoring system distinguish between non-full and full bladder states?\n2. How accurately do MW-based bladder volume estimates agree with ultrasound bladder scans and voided urine volumes?\n3. Is the wearable monitoring system feasible, comfortable, and usable for individuals with SCI?\n\nParticipants will:\n\n1. Complete questionnaires about bladder symptoms and quality of life\n2. Wear up to six non-invasive MW sensors on the lower pelvic region\n3. Undergo two bladder filling and voiding cycles during the study visit\n4. Have MW measurements collected approximately every five minutes during bladder filling\n5. Undergo ultrasound bladder scans and bladder volume measurements for comparison\n6. Complete a post-study usability and comfort survey",[120,121,122],"Spinal Cord Injuries (SCI)","Neurogenic Lower Urinary Tract Dysfunction","Neurogenic Bladder (NB)",[124,125,121,126,127,128,129,130,131,132,133,134,135,136],"Spinal Cord Injury","Neurogenic Bladder","Bladder Monitoring","Bladder Management","Microwave Sensing","Radio-Frequency Sensing","Wearable Medical Device","Bladder Fullness Detection","Bladder Volume Estimation","Non-Invasive Monitoring","Assistive Technology","Pilot Feasibility Study","Urology","2026-06-05",{"date":139,"type":42},"2026-06-10",{"date":141,"type":22},"2026-07-01",{"date":143,"type":22},"2027-03-31",{"name":48,"class":49},{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":162,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":78},"100642920","personalized-nutritional-intervention-in-patients-undergoing-tips-insertion-for-refractory-ascites-to-prevent-overt-hepatic-encephalopathy-100642920","NCT07634237","Personalized Nutritional Intervention in Patients Undergoing TIPS Insertion for Refractory Ascites to Prevent Overt Hepatic Encephalopathy","Personalized Nutritional Intervention to Prevent Overt Hepatic Encephalopathy in Patients With Cirrhosis and Refractory Ascites Who Undergo TIPS Insertion: A Multicenter Randomized Controlled Trial (SUPPRESS-HE Trial)","SUPPRESS-HE","Inclusion Criteria:\n\n* Diagnosis of cirrhosis\n* TIPS planned for refractory ascites\n* Being at least moderately malnourished\n\nExclusion Criteria:\n\n* TIPS insertion for other reason than refractory ascites\n* Budd Chiari Syndrome\n* Complete or cavernomatous portal vein thrombosis\n* Pre-TIPS recurrent or persistent overt hepatic encephalopathy\n* Use of lactulose or rifaximin in the last 4 weeks\n* Liver failure (MELD \\> 18 or Child Pugh score \\> 12)\n* Heart failure (NYHA ≥ III or LVEF \\\u003C 50%)\n* Kidney failure (serum creatinine \\> 250µmol\u002FL)\n* Pregnancy or breastfeeding\n* Previous Liver transplantation\n* Unable to provide informed consent","70 Years",{"count":155,"type":22},50,[25],"This study will evaluate whether a nutritional intervention is better than another to reduce the incidence of overt hepatic encephalopathy in patients undergoing TIPS insertion for refractory ascites.",[159,160,161],"Cirrhosis","Refractory Ascites","TIPS Insertion",[163,164,159,160,161],"Personalized Nutritional Intervention","Overt Hepatic Encephalopathy","2026-06-03",{"date":167,"type":42},"2026-06-08",{"date":169,"type":22},"2026-06-15",{"date":171,"type":22},"2029-12-15",{"name":48,"class":49},{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":180,"minAge":19,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":78},"100635766","phase-4-dex--mastectomy-pain-100635766","NCT07556952","Dex & Mastectomy Pain","Does the Perioperative Administration of Dexamethasone Increase the Incidence of Chronic Postmastectomy Pain? A Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\n* Female patients aged 18-75 years who can provide consent\n* undergoing unilateral or bilateral mastectomy\n* with or without lymph node dissection and\u002For immediate reconstruction,\n* ASA physical status I-III.\n\nExclusion Criteria:\n\n* Male sex;\n* pre-existing chronic pain conditions;\n* chronic opioid use;\n* pregnancy or breastfeeding;\n* breast surgery within the last three years;\n* chronic corticosteroid therapy;\n* contraindications to dexamethasone.","FEMALE","75 Years",{"count":183,"type":22},170,[185],"PHASE4","Chronic post-surgical pain is a common complication following mastectomy and represents a significant source of long-term morbidity. Pain that persists beyond the expected period of tissue healing can interfere with physical functioning, psychological well-being, and quality of life. Despite advances in surgical and anesthetic techniques, the mechanisms contributing to chronic postmastectomy pain remain incompletely understood.\n\nDexamethasone is a corticosteroid routinely administered in the perioperative setting for the prevention of postoperative nausea and vomiting. In addition to its antiemetic properties, dexamethasone has potent anti-inflammatory and immunomodulatory effects that may influence tissue healing and pain processing pathways. Given its widespread use during surgery, understanding its potential impact on long-term pain outcomes is clinically relevant.\n\nClinical observational studies examining the association between perioperative dexamethasone administration and chronic postmastectomy pain have not demonstrated a clear or consistent relationship. However, by design, observational studies cannot establish causality or definitively exclude a potential effect of perioperative dexamethasone on the development of chronic post-surgical pain.\n\nIn contrast, preclinical studies using animal models of post-surgical pain have shown that perioperative exposure to dexamethasone may be associated with increased postoperative pain sensitivity and hyperalgesia. These findings suggest a potential biological mechanism through which perioperative corticosteroid administration could influence long-term pain outcomes, although their relevance to human surgical populations remains uncertain.\n\nTo date, no randomized controlled trials have directly evaluated whether perioperative dexamethasone administration affects the incidence of chronic postmastectomy pain in humans. Given the routine use of dexamethasone in perioperative care, the absence of definitive clinical evidence, and the presence of preclinical signals suggesting a possible effect on pain sensitization, a randomized, double-blind, placebo-controlled trial is warranted.\n\nThis study focuses on adult patients undergoing mastectomy, a population with a well-established risk of chronic post-surgical pain. Chronic pain will be assessed three months after surgery, a commonly accepted time point for distinguishing chronic post-surgical pain from normal postoperative recovery. The proposed study design aims to minimize bias and generate high-quality evidence to inform perioperative medication practices.",[188],"Post-Mastectomy Chronic Pain Syndrome",[190,191,192,193],"dexamethasone","mastectomy","chronic pain","post-operative","2026-06-02",{"date":196,"type":42},"2026-06-04",{"date":198,"type":42},"2026-04-13",{"date":200,"type":22},"2028-06-30",{"name":48,"class":49},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":153,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":78},"100640773","people-with-osteoporosis-can-walk-best-to-reduce-fall-and-fracture-risk-100640773","NCT07621679","People With Osteoporosis Can Walk-BEST to Reduce Fall and Fracture Risk","Walk-BEST","Inclusion Criteria:\n\n* men and women 70 years and older\n* able to walk independently with or without a walking aid\n* experienced a prior fracture after the age of 40, OR two falls in the past 12 months, OR who have a bone mineral density test (done as part of routine clinical evaluation) with a T-score \\\u003C -2.5, OR on a Health Canada-approved anti-osteoporosis medication (oral or intravenous bisphosphonate, denosumab, teriparatide, or romozosumab) to reduce fracture risk or on a bisphosphonate drug holiday (planned treatment interruption)\n\nExclusion Criteria:\n\n* fracture sustained in the past 12 months\n* unable to walk unsupervised because of active medical or neurocognitive reasons\n* unable to provide informed consent, or cannot communicate in English or French",{"count":210,"type":22},28,[25],"The aim of the Walk BEST study is to provide evidence that it is feasible to implement the technology assisted gait- focused walking program Walk-BEST™ in older adults with osteoporosis, and that this program is acceptable to this population.",[214],"Osteoporosis",[216,217,218,219,220],"Gait","Wearable","Walking","Falls","Fracture Risk","2026-05-29",{"date":194,"type":42},{"date":224,"type":42},"2026-05-07",{"date":226,"type":22},"2027-05",{"name":48,"class":49},{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":23,"phases":238,"briefSummary":239,"conditions":240,"keywords":242,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":78},"100638269","phase-2-restage-repurposing-statins-to-improve-outcomes-in-gastroesophageal-cancer-trial-100638269","NCT07625930","RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial","RESTAGE (REpurposing STAtins to Improve Outcomes in GastroEsophageal Cancer) Trial: A Phase II Randomized Open-Label Trial of Perioperative Simvastatin Plus Standard-of-Care Systemic Therapy in Gastroesophageal Adenocarcinoma","RESTAGE","Inclusion Criteria:\n\n1. Signed, informed consent.\n2. Age, 18 years or older.\n3. Histological diagnosis of adenocarcinoma or poorly differentiated carcinoma of the esophagus or EGJ.\n4. The tumour must be deemed potentially resectable by the surgical team. This assessment is based on complete staging imaging studies (detailed below) - clinical staging of the tumor and ruling out metastatic disease.\n5. Locally advanced disease as defined per AJCC\u002FUICC 8th edition37: stage IIA, IIB, III, IVA (T1-4a N2-3).\n6. Eligibility for standard-of-care perioperative systemic therapy with FLOT+\u002F-D.\n7. Life expectancy greater than 3 months.\n8. ECOG performance status \\\u003C 2.\n\nExclusion Criteria:\n\n1. Prior esophageal or gastric malignancy.\n2. History of allergic reactions to simvastatin or atorvastatin or similar chemical or biological compounds.\n3. Ongoing cholesterol-lowering therapy (statins, fibrates, ezetimibe, PCSK9 inhibitors), in which case the patient is offered enrollment in the observational arm.\n4. Hepatic dysfunction (alanine aminotransferase level more than three times the upper limit of the normal range) or renal dysfunction (creatinine level more than three times the upper limit of the normal range).\n5. Predisposing factors for rhabdomyolysis: hypothyroidism, reduced renal function, muscle disease, or excessive alcohol consumption AND creatine kinase up to less than five times the upper limit (measured in the presence of predisposing factors).\n6. Concurrent medication with potent CYP3A4-inhibitors, e.g. ketokonazole, erythromycin, gemfibrozil, cyclosporine, or danazol.\n7. Pre-existing medical conditions precluding treatment, including any contraindication systemic chemotherapy or major surgery.\n8. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, discussed before registration in the trial.\n9. Pregnant and breastfeeding women.\n10. Unwillingness to undergo per-protocol investigations or treatments.",{"count":237,"type":22},184,[90],"Esophageal and gastroesophageal junction cancers are serious diseases with limited cure rates, even when patients receive chemotherapy and surgery. New ways to improve treatment are urgently needed.\n\nThis study will test whether adding a commonly used cholesterol-lowering medication, simvastatin, to standard cancer treatment can improve outcomes. Simvastatin is widely used, safe, and inexpensive. Research suggests that it may also slow cancer growth by blocking pathways that cancer cells rely on for survival.\n\nIn this trial, patients will receive standard chemotherapy (with or without immunotherapy) before surgery. Half of the patients will also take simvastatin daily for up to two years. Researchers will compare how well tumors respond to treatment and whether patients remain cancer-free longer.\n\nIf successful, this approach could offer a simple and accessible way to improve survival for patients with these cancers without adding significant side effects or cost.",[241],"Gastroesophageal Adenocarcinoma",[243,244,245,241],"Esophageal cancer","Gastroesophageal junction cancer","Statin",{"date":196,"type":42},{"date":248,"type":22},"2027-01",{"date":250,"type":22},"2031-04",{"name":48,"class":49},{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":23,"phases":262,"briefSummary":263,"conditions":264,"keywords":270,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":292},"100614816","phase-2-a-clinical-trial-using-tirzepatide-to-help-adults-with-type-1-diabetes-automatically-control-their-blood-sugar-100614816","NCT07284511","A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar","Fully Closed-Loop Glucose Control in Adults With Type 1 Diabetes Using Tirzepatide: a Randomized, Multi-center, Open-label, Non-inferiority, Parallel Trial","TZP","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of type 1 diabetes for ≥ 1 year, per investigator judgment (confirmatory C-peptide and autoantibodies not required).\n* A BMI ≥ 27 kg\u002Fm2.\n* HbA1c \\> 6.5%, and \\\u003C 12%.\n* Current therapy: multiple daily injections or insulin pump.\n* Willingness to use Tandem Control IQ insulin pump system with the use of rapid or ultra rapid-acting insulins compatible with Tandem Control-IQ pump (e.g. Fiasp is not compatible)\n* Active carbohydrate counting for prandial insulin dosing.\n* Individuals of childbearing potential must be using or agree to use an effective birth-control method. Childbearing potential refers to participants of the female sex post-menarche who have not reached menopause and who do not have a medical condition causing sterility (e.g., hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n\nExclusion Criteria:\n\n* Use of GLP1-RAs within the last four weeks.\n* Use of antihyperglycemic agents other than insulin or metformin within the last 2 weeks.\n* Planned or ongoing pregnancy.\n* Breastfeeding.\n* Severe hypoglycemia requiring hospitalization in the past 2 months. Severe hypoglycemia is defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions.\n* Diabetic ketoacidosis within the last 2 months.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe renal impairment with eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (CKD-EPI), measured within the last four months.\n* Clinically significant proliferative diabetic retinopathy or gastroparesis, as per the judgment of the investigator.\n* Current or ≤ 1 month use of supraphysiological doses of oral or intravenous glucocorticoids.\n* History of bariatric surgery within the last 6 months.\n* Medical or psychiatric illness likely to interfere with participation (e.g. cirrhosis, active cancer, decompensated schizophrenia), per investigator judgment.\n* Inability or unwillingness to comply with safe diabetes management practices, in the view of the investigator.\n* Any safety concern that, in the investigator's judgment, precludes participation.",{"count":261,"type":22},105,[90,62],"This research study is testing whether a weekly medication called tirzepatide can help adults with type 1 diabetes use their insulin pump more easily, specifically by reducing or eliminating the need to count carbohydrates at meals.\n\nPeople with type 1 diabetes must take insulin for life, and even with advanced insulin pumps and continuous glucose monitors, many still struggle to keep blood sugar within the target range. One of the biggest challenges is carbohydrate counting, which requires estimating the amount of carbohydrates in every meal to give the correct insulin dose.\n\nTirzepatide is a medication currently approved for type 2 diabetes and weight management. Early research suggests it may also help people with type 1 diabetes by lowering appetite, slowing digestion, reducing insulin needs, and smoothing after-meal blood sugar rises.\n\nThis study will include 105 adults with type 1 diabetes at centers in Canada and Switzerland. Everyone will use the Tandem Control-IQ insulin pump with a Dexcom G7 continuous glucose monitor. Participants are randomly assigned to one of two groups:\n\nTirzepatide group:\n\nParticipants receive weekly tirzepatide injections. After the dose is gradually increased over 12 weeks, they will eventually try using their insulin pump without entering carbohydrate amounts at meals.\n\nControl group:\n\nParticipants continue their usual therapy and keep counting carbohydrates for their mealtime insulin doses.\n\nThe main goal of the study is to learn whether people taking tirzepatide can safely maintain good blood sugar control without counting carbs, compared with standard care. All participants will attend several clinic visits and share their glucose, insulin, and health data throughout the 32-week trial. Some centers will also conduct heart\u002Ffitness, or body-composition tests.\n\nAs with any medication, tirzepatide may cause side effects such as nausea, vomiting, diarrhea, or decreased appetite. Rare but serious risks like gallbladder disease or pancreatitis are also monitored. Pregnancy must be avoided during the trial.\n\nOverall, this study aims to understand whether adding tirzepatide to automated insulin delivery can simplify diabetes management, reduce burden, and maintain safe and effective glucose control for adults living with type 1 diabetes.",[265,266,267,268,269],"Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus",[265,271,272,273,274,275,276,277,278,279,280,281,282,283],"Overweight or obesity in type 1 diabetes","Automated insulin delivery","Insulin pump","Continuous glucose monitoring","Tirzepatide","Mounjaro","GIP\u002FGLP-1 receptor agonist","Dual incretin therapy","Adjunctive tirzepatide therapy","Tandem Control-IQ","Hybrid closed-loop system","Closed-loop insulin delivery","Dexcom G7","2026-05-22",{"date":286,"type":42},"2026-05-27",{"date":288,"type":42},"2026-05-19",{"date":290,"type":22},"2029-01",{"name":48,"class":49},4,{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":114,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":23,"phases":300,"briefSummary":301,"conditions":302,"keywords":308,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":4},"100639129","the-women-veterans-health-mission-100639129","NCT07608952","The Women Veteran's Health Mission","Inclusion Criteria: Must be:\n\n* Canadian Woman Veteran or\n* Family Member of a Canadian Women Veteran or\n* Friend of a Canadian Women Veteran\n\nExclusion Criteria:\n\n\\-",{"count":60,"type":22},[25],"The purpose of this study is to evaluate the impact of a customized web-based e-health program to provide online health promotion (Missions), peer support, and social connectivity to women Veterans and their families.\n\nPrimary Objective\n\n• To assess participant engagement in the program including:\n\ncompletion rates (%) for each 6-12 week health program (Mission) defined as completing the assessments following the intervention number of login days among those who register and drop-out rates (%) defined as those who start but do not complete the program.\n\nSecondary Objectives • To assess the impact of a web-based wellness program on health metrics including: change in body weight (lbs) sleep, and chronic pain (PROMIS 29 Questionnaire) stress (PROMIS Perceived Stress) social isolation (PROMIS Social Isolation Short Form 4a).\n\n• To determine whether there is a dose-response between the number of login days into the program and changes in health metrics.",[303,304,305,306,307],"Chronic Pain","Poor Sleep Quality","Social Isolation or Loneliness","Sedentary Behaviors","Anxiety Chronic",[309],"web-based health promotion",{"date":286,"type":42},{"date":312,"type":22},"2026-10-01",{"date":314,"type":22},"2029-05-01",{"name":48,"class":49},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":114,"sex":18,"minAge":324,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":335,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":78},"100625207","this-study-investigates--hydroxy--methylbutyrate-hmb-and-2-hydroxybenzylamine-2-hoba-when-administered-either-individually-or-in-combination-contributes-to-an-increased-quality-of-health-specifically-improving-muscular-strength-and-cognitive-functioning-in-adults-over-the-age-of-65-100625207","NCT07419633","This Study Investigates β-hydroxy-β-methylbutyrate (HMB) and 2-hydroxybenzylamine (2-HOBA), When Administered Either Individually or in Combination Contributes to an Increased Quality of Health, Specifically Improving Muscular Strength and Cognitive Functioning in Adults Over the Age of 65.","The Effects of Beta-Hydroxy-Beta-methylbutyrate (HMB) and\u002For 2-hydroxybenzylamine (2-HOBA) on Markers of Health Span in Older Adults. A Randomized Control Trial.","H2AGE","Inclusion Criteria:\n\n•. 65 years of age\n\n* English or French speaking\n* Females not of childbearing potential\n* Willing to maintain current lifestyle and dietary habits, including level of physical activity, allowed medication\u002Fsupplements habits for the duration of the study\n\nExclusion Criteria:\n\n* Known cardiac diseases, known arterial fibrillation, hepatic diseases, immune diseases (e.g. Individuals with an acute infectious disease, autoimmune disease or are immune compromised), ulcers, asthma, gout, severe anemia, hay fever, nasal polyps.\n\n  * Chronic kidney disease \\[estimated glomerular filtration rate (GFR) \\\u003C 35 mL\u002Fmin\\].\n  * Neurological injury\u002Fdisorder with significant persistent neurological or functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, myopathy, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy).\n  * Neuropsychological condition and\u002For cognitive impairment that, in the QI's opinion, could interfere with study participation\n  * History of confirmed chronic obstructive pulmonary disease with a severity grade \\> 2 on the Medical Research Council Dyspnea Scale.\n  * Uncontrolled hypothyroidism or hyperthyroidism. Hypothyroid patients who have changed their dose of hormone replacement therapy in the 6 weeks before screening are not eligible.\n  * Underlying muscle diseases, including a history of or currently active myopathy (e.g., dermatomyositis, polymyositis, etc.) or muscular dystrophies.\n  * Confirmed rheumatoid arthritis, acquired immunodeficiency syndrome (AIDS), type 1 or type 2 diabetes mellitus.\n  * History of cancer in the last 6 months.\n  * Not on any medications including NHPs\u002Fliving with medical conditions that would compromise the study outcome or the safety of the research participant.\n  * Known allergy to study medication or its components (non-medicinal ingredients).\n  * Allergy to aspirin\u002Fsalicylate or if using other drugs containing acetylsalicylic acid or other salicylates and a history of ASA-sensitive asthma\u002Fbronchospasm\n\nThe following list of medications\u002FNHPs will be excluded (and weaned as seen necessary by the study physician) prior to and during the study:\n\n* Participants on newly initiated cholesterol-lowering medication will be excluded. Those on stable regimens for ≥3 months will be included and will be monitored for potential interactions as per the HMB monograph.\n* Medications associated with muscle weakness or immune effects (i.e., oral glucocorticoids).\n* Medications or supplements affecting skeletal muscle metabolism or weight including: Use of MAO-I's (monoamine oxidase inhibitors), additional consumption of 2-HOBA, Vitamin D or HMB, anabolic steroids, selective androgen receptor modulators (SARMs), corticosteroids, GLP-1s, or other weight loss medications).\n* Excessive protein supplementation (i.e., \\>2.0 g\u002Fkg\u002Fday).\n* All participants must be on a stable dose of allowed supplements\u002Fmedications for at least 3 months prior to enrollment. All concomitant therapies will be documented.\n\nNon-pharmacological interventions that could influence study outcomes (e.g., pulmonary rehabilitation, structured exercise programs) will not be permitted.\n\nParticipants undergoing such therapies will be excluded. Any new interventions started during the study must be reported and if judged inappropriate, will result in withdrawal from the trial.","65 Years",{"count":326,"type":22},120,[25],"In this study, participants will be assigned to receive HMB, 2-HOBA, a combination of both, or a comparison supplement for a set period of time. During the study, participants will attend scheduled visits where researchers will assess muscle strength, physical function, and overall health. Blood samples may be collected to measure markers related to metabolism, inflammation, and oxidative stress. Study staff will also monitor safety and any side effects throughout the study.",[330,331,332,333,334],"Muscle","Cognitive Functioning","Geriatric","Ageing and Geriatric Health","Ageing",[336,330,337,338,339,340,341,342,343],"Health","Cognitive","Memory","natural product","ageing","natural","supplement","preservation","2026-05-11",{"date":346,"type":42},"2026-05-14",{"date":348,"type":42},"2026-03-06",{"date":350,"type":22},"2027-02-05",{"name":48,"class":49},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":18,"minAge":360,"maxAge":19,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":78},"100636980","impact-of-a-paced-breathing-exercise-intervention-on-autonomic-nervous-system-function-after-pediatric-concussion-acute-phase-100636980","NCT07572734","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function After Pediatric Concussion (Acute Phase)","Impact of a Paced Breathing Exercise Intervention on Autonomic Nervous System Function and Symptom Severity in Youth Post-concussion: a Pilot Feasibility Study","Breathe - PED","Inclusion Criteria:\n\n* Aged 9-18 years old\n* 0-72 hours post-concussion\n* present to the ED with at least one post-concussion symptom in the Post-concussion Symptom Inventory (PSCI) that is relevant to ANS dysfunction (e.g. dizziness, nausea, fatigue, confusion, anxiety or sleep disturbances)\n\nExclusion Criteria:\n\n* known heart disease,\n* previous neurological problems other than concussion","9 Years",{"count":362,"type":22},20,[25],"The goal of this pilot clinical trial is to assess the feasibility of administering a paced breathing exercise intervention program to children and adolescents in the acute period after concussion. Secondary objectives include documenting symptom severity (ANS related symptoms, post-concussion symptoms, anxiety, sleep) before and after administration of the intervention and examine whether early paced-breathing exercise can accelerate recovery and symptom improvement.\n\nParticipants will be instructed to perform a daily 10-minutes daily paced breathing home-exercise program and to document the daily exercises performed within a performance log, or receive usual care from the Pediatric Emergency Department. A weekly phone meeting will be performed with all participants to assess recovery progress. Participants randomized to the intervention group will also be asked about their exercises, will be provided specific instructions and adjustments as necessary. All participants (intervention and control group) will undergo a second assessment after four weeks following completion of the intervention program. During the second assessment, information regarding the intervention feasibility, time to return to school, return to sport, and clear from medication will be collected as well.",[366],"Concussion, Mild Traumatic Brain Injury",{"date":368,"type":42},"2026-05-12",{"date":370,"type":42},"2026-05-01",{"date":372,"type":22},"2027-05-30",{"name":48,"class":49},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":380,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":382,"enrollmentInfo":383,"targetDuration":384,"studyType":385,"phases":4,"briefSummary":386,"conditions":387,"keywords":392,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":78},"100635387","detection-of-respiratory-events-using-acoustic-monitoring-in-extremely-preterm-infants-100635387","NCT07552025","Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants","Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants (DREAM 2)","DREAM 2","Inclusion Criteria:\n\n* Infants with gestational age \\\u003C 29+0 weeks.\n* Off respiratory support at the time of study recording.\n\nExclusion Criteria:\n\n* Infants with known major congenital anomalies.\n* Infants deemed clinically unstable for the study by the attending physician.","29 Weeks",{"count":155,"type":22},"9 Weeks","OBSERVATIONAL","Extremely preterm infants, born before 29 weeks of pregnancy, often face breathing difficulties, also known as respiratory events, due to their undeveloped lungs and respiratory systems. These respiratory events include pauses in breathing, shallows breaths, and irregular breathing patterns. These problems are most common right after birth but can continue for weeks, leading to extended hospital stays, higher medical costs, and potential long-term health concerns affecting the eyes, lungs, and brain.\n\nCurrently, neonatal intensive care units (NICUs) use methods like measuring oxygen levels, heart rate, and electrical resistance in the chest to monitor for respiratory events. However, these methods have limitations. For instance, they cannot accurately measure airflow and do not distinguish between different types of respiratory events. As a results, some breathing problems might go unnoticed or be managed improperly.\n\nTo address this, the investigators have developed a wireless acoustic sensor that uses advanced microphones and motion sensors to record airflow and chest movements. In initial tests with healthy preterm infants, this sensor proved reliable in detecting breathing patterns and airway obstruction, suggesting it could offer a more precise and non-invasive monitoring method.\n\nThis study aims to assess how well this new sensor performs compared to existing methods in detecting and distinguishing different types of respiratory events in a high-risk group of extremely preterm infants. The investigators will track respiratory patterns in preterm infants at various stages between 32 and 44 weeks of age. By comparing the new sensor's performance with currents standards and gold-standard methods, the investigators hope to improve the management of these respiratory events and reduce the related health risks.",[388,389,390,391],"Apnea of Prematurity","Preterm Infant","Periodic Breathing","Hypopnea",[393,394,395,396,397,398],"Apnea of prematurity","Preterm infants","Diagnostic accuracy study","Respiratory acoustics","Respiratory events","Neonatal Intensive Unit Care",{"date":368,"type":42},{"date":401,"type":22},"2026-05",{"date":403,"type":22},"2028-09",{"name":48,"class":49},{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":411,"eligibilityCriteria":412,"healthyVolunteers":12,"sex":18,"minAge":413,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":23,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},"100554386","phase-2-shorter-and-safer-treatment-regimens-for-latent-tb-100554386","NCT06498414","Shorter and Safer Treatment Regimens for Latent TB","SSTARLET: Shorter and Safer Treatment Regimens for Latent TB","SSTARLET","Inclusion Criteria:\n\n* Adults, and children aged ≥5 years with weight of \\> 15Kg.\n* Positive test for TB infection: either Tuberculin test (\\>5mm, or \\>10mm, based on epidemiologic and clinical factors and interpreted following local guidelines) or interferon gamma release assay based on Manufacturer's criteria; and,\n* Recommended for Tuberculosis Preventive Treatment (TPT), following Canadian guidelines (for Canadian sites), and World Health Organization (WHO) guidelines (for international sites).\n\nExclusion Criteria:\n\n* Current tuberculosis (TB) disease - detected pre-enrolment with symptom screen, chest x-ray, and confirmatory microbiological (culture or genotypic) testing as needed; Prior to referral to research staff (research clinic) for consideration as potential participants, all persons must undergo symptoms screen and a chest Xray. If chest Xray is not available, then a negative results from a GeneXpert MTb RIF Ultra of spontaneous (expectorated) sputum will be considered sufficient to exclude TB disease pre-referral. If Chest Xray is abnormal or symptoms consistent with TB disease are present then at least two AFB smears and mycobacterial cultures must be done, and must be negative, or one GeneXpert MTb Rif Ultra must be negative before enrolment\n* Children aged 0-4 years;\n* Persons weighing \\\u003C15 kg.\n* Women who are pregnant or breast-feeding;\n* Women of child-bearing potential and not willing to take an effective form of contraception (non-hormonal) during the treatment phase;\n* Documented prior treatment for tuberculosis (TB) infection or disease;\n* Pre-enrolment - alanine transaminase (ALT), White Blood Cells, platelets or hemoglobin that correspond to a Grade 3 adverse event (AE);\n* Rifampin or rifapentine contra-indicated - due to allergy\u002Fhypersensitivity to any rifamycin (rifampin, rifabutin or rifapentine), or, drug interactions too difficult to manage;\n* Have a prolonged QT interval on routine ECG pre-enrolment or take any medications that may prolong the QT interval and that are not recommended to take with a fluroquinolone. (See APPENDIX 5 in supplement for list of medications contra-indicated to take with Levofloxacin);\n* Household contacts (HHC) of index TB patients with phenotypic or genotypic resistance to Rifampin or Levofloxacin. HHC may be enrolled, then excluded post-randomization, if resistance is identified later. Note that all sites routinely test Rifampin resistance in all people newly diagnosed to have TB disease, but do not test routinely for susceptibility to Levofloxacin unless Rifampin resistance is detected. Hence HHCs may be enrolled if their Index TB patient is Rifampin susceptible, even if Drug Susceptibility Testing to Levofloxacin is not done and\u002For not available.","5 Years",{"count":415,"type":22},1800,[90,62],"Our study rationale is based on:\n\n1. Tuberculosis Preventive Treatment (TPT) is given to healthy people and needs to be safe;\n2. Tuberculosis Preventive Treatment (TPT) with shorter regimens are superior with respect to acceptance, completion, and costs;\n3. 4 months of Rifampin 10mg\u002Fkg (4R10) is the safest regimen, but is completed by \\\u003C80% of patients;\n4. The safety of 2 months of Rifampin 20mg\u002Fkg (2R20) is similar to that of 4 months of Rifampin 10mg\u002Fkg (4R10), but completion is a concern;\n5. 1-month regimens have promising efficacy;\n6. Safety and tolerability must be carefully assessed with comparisons to 4 months of Rifampin 10mg\u002Fkg (4R10), and head-to-head with each other.\n\nOBJECTIVES: The investigator will use a Bayesian adaptive Phase 2 randomized open-label trial design to test at least three experimental Tuberculosis Preventive Treatment (TPT) regimens to identify at least one regimen of ≤2 months duration that has non-inferior safety, completion, and tolerability in adults and children relative to the reference Tuberculosis Preventive Treatment (TPT) regimen. The shortest, safest, and best tolerated regimen identified in this Phase 2 trial will be tested for effectiveness and efficacy in a Phase 3 trial.\n\nSpecific Tuberculosis Preventive Treatment (TPT) regimens (All are daily and self-administered) Reference: Rifampin at a dose of 10 mg\u002Fkg\u002Fday for 4 months (4R10); Experimental: 1) Rifampin at 20 mg\u002Fkg\u002Fday for 2 months (2R20); (2) one month Levofloxacin and Rifapentine (1LP). At a later stage a 3rd experimental regimen will be selected and added: one another novel 1-2-month regimen identified from pre-clinical and clinical studies. When selected, this will be explained fully including preliminary data on safety and efficacy in an amended protocol and consent - which will be submitted for ethics and regulatory approval at that time).",[419],"Tuberculosis Infection, Latent",[421,422,423,424],"Tuberculosis infection","Rifampin","Short treatment for latent tuberculosis","High dose rifampin","2026-05-06",{"date":344,"type":42},{"date":428,"type":42},"2025-06-10",{"date":430,"type":22},"2029-06-01",{"name":48,"class":49},14,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":441,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":23,"phases":444,"briefSummary":445,"conditions":446,"keywords":448,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":465},"100603899","helping-couples-communicate-better-does-this-help-persons-with-type-2-diabetes-respond-better-to-a-step-count-prescription-100603899","NCT07142512","Helping Couples Communicate Better: Does This Help Persons With Type 2 Diabetes Respond Better to a Step Count Prescription?","A Dyadic Coping Strategy to Enhance Step Prescription Effects in Type 2 Diabetes: a Bayesian Adaptive Basket Randomized Controlled Trial","PartnerStepT2D","Inclusion Criteria:\n\n* (i) Index participant has T2D;\n* (ii) Index participant 45 years of age or older;\n* (iii) Index participant and partner: Co-habiting with a partner (same or different sex) for two or more years;\n* (iv) Index participant and partner: Absence of gait difficulties or other co-morbid conditions that impede walking in the index participant;\n* (v) Willingness to complete an audiovisual recording of a conversation between the couple members to capture couple communication styles\n* (vi) Index participant and partner Smartphone and Internet access.","45 Years",{"count":443,"type":22},200,[25],"Being active is one way to reach better blood sugar control and heart health in type 2 diabetes. The investigators developed a strategy to help people with type 2 diabetes walk more. They track their steps with a step counter and set targets with their doctor through a kind of 'step prescription.' While this strategy helps people increase their physical activity, it can be useful to have support besides the clinic visits. Their partner might be a good person to help.\n\nPartners often have similar activity levels. Partners of people with type 2 diabetes are also more likely to develop type 2 diabetes. There are good reasons to work together! However, not all partners communicate in a way that helps them work together effectively. The investigators are going to give a step counter and step prescriptions to a large group of people with type 2 diabetes. The partners will also receive counters and step prescriptions. Half of the couples will be randomized (assigned to a group based on something equivalent to a coin toss) to participate in online or in-person sessions with a counselor. They will work together to figure out how to communicate more kindly and effectively. The investigators will see if the people with these sessions wind up having higher steps and better sugar control than the people who do not. To figure out in which types of couples the strategy works, The investigators will also divide the couples into groups based on the type of marriage that they have (figured out through a questionnaire) and body size. The investigators will see if the counseling strategy helps in both 'high' and 'low' quality relationships and if couples where both partners have extra weight respond differently to the strategy than other couples. During the trial, if The investigators see that the strategy is not working well in one particular group of people, The investigators may recruit fewer in this group and more in the others. The investigators will do this in consultation with specialized statisticians who will look at the data at specific points in time. This is a way of making sure that the investigators are testing the right strategy in the right group, increasing the 'efficiency' and relevance of the study.",[447],"Type 2 Diabetes",[449,450,451,452,453,454,455,456,457,458],"Type 2 diabetes","Partner","Spouse","Wife","Husband","Step counts","Step targets","Hemoglobin A1C","Couple counseling","Dyadic coping",{"date":224,"type":42},{"date":461,"type":42},"2025-10-01",{"date":463,"type":22},"2027-12",{"name":48,"class":49},3,{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":473,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":23,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":78},"100535770","investigating-modified-protocols-of-oral-immunotherapy-to-validate-efficacy-and-safety-100535770","NCT06256146","Investigating Modified Protocols of Oral Immunotherapy to Validate Efficacy and Safety","IMPROVES","Inclusion Criteria:\n\n* A history suggestive of immediate allergy to the food. A convincing clinical history of an IgE mediated reaction to a specific food will be defined as a minimum of 2 mild signs\u002Fsymptoms or 1 moderate or 1 severe sign\u002Fsymptom that was likely IgE mediated and occurred within 120 minutes after ingestion or contact\n* The presence of at least one of the following confirmatory tests:\n\n  * Positive SPT to the culprit food allergen (weal diameter 3 mm larger than that of the normal saline control). The allergens used will be commercial extracts of the foods (Omega Labs, Toronto, Ontario).\n  * Detection of serum specific IgE (\\>0.35 kU\u002FL) to the culprit food or any of its proteins, measured by fluorescence enzyme immunoassay (Phadia, CAP System, Uppsala, Sweden).\n\nExclusion Criteria:\n\n* Patients who have uncontrolled respiratory disease (asthma, cystic fibrosis, etc.)\n* Patients who present with intercurrent disease active at the time of starting desensitization.\n* Non IgE mediated or non-immunological adverse reactions to milk or peanuts.\n* Malignant or immunopathological diseases and\u002For severe primary or secondary immune deficiencies.\n* Patients receiving oral immunosuppressor therapy.\n* Patients receiving β-blockers (including topical formulations), or who receive daily doses of NSAIDs, aspirin or ACE inhibitors for cardiac issues.\n* Associated diseases contraindicating the use of epinephrine: cardiovascular disease, severe hypertension or hypotension.\n* Patients diagnosed with eosinophilic gastrointestinal disorders, including patients with a history of antacid use for reflux related to food impaction or with a history of esophageal spasm.\n* Patients already tolerating processed\u002Fcooked forms of the food (e.g.,baked goods with milk).","2 Years","40 Years",{"count":476,"type":22},360,[25],"Protocols for Oral Immunotherapy (OIT) for the main food allergens have been recently incorporated in clinical practice for food allergies and their clinical benefits have been acknowledged in European and Canadian official guidelines. There has been some reluctance in both clinicians and patients to implement these therapies, primarily because of the risk of allergic reactions during the desensitization process. This study will investigate if protocols using low doses of a food allergen or processed versions of the allergen can be both effective in conferring desensitization while inducing fewer allergic symptoms during the desensitization process.",[480,481,482],"Peanut Allergy","Milk Allergy, Cow's","Egg Allergy",{"date":224,"type":42},{"date":485,"type":42},"2022-03-01",{"date":487,"type":22},"2030-02-28",{"name":48,"class":49},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":497,"enrollmentInfo":498,"targetDuration":4,"studyType":23,"phases":500,"briefSummary":501,"conditions":502,"keywords":509,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":518,"leadSponsor":520,"locationsCount":78},"100636071","temporomandibular-disorder-tmd-diagnostic-concordance-between-physiotherapist-and-surgeon-100636071","NCT07560917","Temporomandibular Disorder (TMD) Diagnostic Concordance Between Physiotherapist and Surgeon","Improving Access and Care Quality for Temporomandibular Disorder Patients - a Prospective Study to Examine Diagnostic Concordance Between Advanced-practice Physical Therapist and Oral and Maxillofacial Surgeon","TMD","Inclusion Criteria:\n\n* Referred for new consultation at the MUHC TMJ clinic for temporomandibular joint (TMJ) pain or dysfunction\n* Residents of the province of Quebec and benefiaries of provincial universal health insurance coverage (Régie de l'Assurance Maladie du Québec - RAMQ)\n* Be able to understand and communicate in either French of English\n* Be legally capable of providing informed consent\n\nExclusion Criteria:\n\n* Presenting for a follow-up visit (i.e., not a new consultation)\n* Have undergone TMJ surgery within the past six months\n* Referred directly from a recognized orofacial pain dentist or oral medicine specialist\n* Referred for acute TMJ trauma requiring urgent management (e.g., fractures, dislocations)\n* Present with complex or multi-system pathology that could confound the diagnostic process and are not related to TMD","85 Years",{"count":499,"type":22},70,[25],"Jaw disorders is the leading cause in facial pain, affecting many people in the world. Despite many patients finding relief from conservative treatment, many get referred to the surgeon for an evaluation. In order to improve access to care and reduce wait times, a new advanced practice physiotherapist-led triage model is being studied.",[503,504,505,506,507,508],"Temporo-mandibular Dysfunction","Temporomandibular Disorder (TMD)","Temporomandibular Dysfunction (TMD)","Temporomandibular Disorders (TMDs)","Temporomandibular Joint and Muscle Disorder","Temporomandibular Joint",[495,510,511,512,513,514,508],"Physiotherapy","Physical Therapy","Oral and Maxillofacial Surgery","Diagnostic","TMJ","2026-04-28",{"date":370,"type":42},{"date":44,"type":22},{"date":519,"type":22},"2027-06",{"name":48,"class":49},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":385,"phases":4,"briefSummary":530,"conditions":531,"keywords":538,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":78},"100614362","the-rheumsafer-study-improving-medication-appropriateness-in-people-with-rheumatic-conditions-100614362","NCT07278609","The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions","Inclusion Criteria:\n\n* Aged ≥60\n* Followed by a rheumatologist at MUHC for an inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, spondyloarthritis), a systemic autoimmune rheumatic disease (such as systemic lupus erythematosus, inflammatory myositis, systemic sclerosis, antiphospholipid antibody syndrome, Sjogren syndrome, systemic vasculitis), or another chronic musculoskeletal or rheumatic condition (such as crystal arthritis and osteoarthritis)\n* Currently taking ≥5 regular medications and ≥1 PIM\n* Anticipated ongoing clinical follow-up in rheumatology at an interval of every 3-9 months\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Acute life-threatening illness or life expectancy \\\u003C12 months","60 Years",{"count":529,"type":22},100,"The goal of this prospective observational quality improvement study is to determine if a physician tool, MedSafer, combined with educational brochures for patients, can help to reduce the use of 'potentially inappropriate medications' (PIMs) in adults aged 60 and over with rheumatic conditions and polypharmacy (taking 5 or more regular medications).\n\nResearchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following interventions:\n\n* MedSafer reports provided to treating physicians\n* EMPOWER consumer brochures provided to participants\n\nParticipants will complete 4 study visits over 18-20 months during which researchers will collect information on medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life.",[532,533,534,535,536,537],"Rheumatic Diseases","Inflammatory Arthritis","Systemic Lupus Erthematosus (SLE)","Vasculitis","Muskuloskeletal Diseases","Systemic Autoimmune Diseases",[539,540,532,541],"Deprescribing","Potentially inappropriate medications","Polypharmacy","2026-04-27",{"date":370,"type":42},{"date":545,"type":42},"2025-10-29",{"date":200,"type":22},{"name":48,"class":49},{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":18,"minAge":556,"maxAge":557,"enrollmentInfo":558,"targetDuration":4,"studyType":385,"phases":4,"briefSummary":560,"conditions":561,"keywords":562,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":78},"100597618","acoustics-as-a-metric-of-airway-pressure-in-premature-infants-using-bubble-continuous-positive-airway-pressure-100597618","NCT07060833","Acoustics as a Metric of Airway Pressure in Premature Infants Using Bubble Continuous Positive Airway Pressure","The Use of Bubble Continuous Positive Airway Pressure in Premature Infants: Acoustics as a Metric of Effective Pressure Delivery","Bubble CPAP","Inclusion Criteria:\n\n* Infants on bCPAP with gestational age \\\u003C 32+0 weeks\n* Postmenstrual age between 28+0 and 36+6 weeks at the time of the study\n* Postnatal age greater than 168 hours (7 days) at the time of the study\n* On the bubble CPAP device with binasal prongs at the time of the study\n* Receiving bubble CPAP levels of 5 to 7 cm H2O with gas flows between 6L\u002Fmin and 10L\u002Fmin at the time of the study\n\nExclusion Criteria:\n\n* Infants with known major congenital anomalies\n* Infants with known congenital heart disorders\n* Infants with known neuromuscular disease\n* Infants receiving ventilator-derived CPAP at the time of the study\n* Infants receiving CPAP via a nasal mask interface at the time of the study\n* Infants receiving inotropes, narcotics or sedative agents at the time of the study\n* Infants deemed clinically unstable for the study by the attending neonatologist","28 Weeks","32 Weeks",{"count":559,"type":22},30,"This is an observational, proof-of-concept, feasibility study where 30 preterm infants on bubble CPAP with gestational age \\\u003C 32+0 weeks will be recruited from the neonatal intensive care unit (NICU) at the Montreal Children's Hospital.\n\nThe study's main goals are:\n\n1. To determine the relationship between ambient bubbling sounds and delivered pressures in preterm infants on bCPAP.\n2. To determine the relationship between transmitted bubbling sounds and airway pressures transmitted to the lungs of preterm infants on bCPAP.\n3. To develop models to predict delivered and transmitted bCPAP pressures from the acoustic properties of bubbling sounds.",[389],[554,563,564,396,565,566,567],"Airflow","Neonatal Intensive Care","Acoustic monitoring","Airway pressure monitoring","Bubbling sounds","2026-03-24",{"date":570,"type":42},"2026-03-30",{"date":572,"type":42},"2025-04-03",{"date":574,"type":22},"2026-12",{"name":48,"class":49},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":582,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":556,"enrollmentInfo":584,"targetDuration":4,"studyType":385,"phases":4,"briefSummary":585,"conditions":586,"keywords":588,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":603},"100518941","post-extubation-assessment-of-clinical-stability-in-elbw-infants-100518941","NCT06037083","Post-Extubation Assessment of Clinical Stability in ELBW Infants","Post-Extubation Assessment of Clinical Stability in Extremely Preterm Infants: The PEACE Feasibility Study","PEACE","Inclusion Criteria:\n\n* Birth weight \\\u003C 1000g and gestational age \\\u003C 28+0 weeks,\n* Received mechanical ventilation within the first 72h of life,\n* Undergoing their first planned extubation within the first 6 weeks of life.\n\nExclusion Criteria:\n\n\\- Congenital anomalies and congenital heart disorders.",{"count":362,"type":22},"This is an observational, proof-of-concept, feasibility study that aims to evaluate the feasibility of a monitoring system that integrates clinical data, high-resolution waveforms from the bedside monitor, regional oxygenation (via cerebral and splanchnic near-infrared spectroscopy), and regional ventilation (via electrical impedance tomography) from 20 extremely low birth weight infants at high-risk of reintubation.",[587],"Extremely Low Birth Weight Infants",[589,590,591,592,593,594,595,596],"Reintubation","Extubation","Extremely low birth weight infants","Electrical impedance tomography","Cerebral and splanchnic oxygenation","Near infrared spectroscopy","apnea","intermittent hypoxia",{"date":570,"type":42},{"date":599,"type":42},"2024-10-29",{"date":601,"type":22},"2027-04",{"name":48,"class":49},2,{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":385,"phases":4,"briefSummary":612,"conditions":613,"keywords":618,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":631,"locationsCount":78},"100626411","analysis-of-inflammatory-biomarker-changes-in-dry-blood-spot-versus-venous-blood-samples-100626411","NCT07435285","Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples","DBS-VB","Inclusion Criteria:\n\n* Men or women aged ≥18 years, who are planning to receive a seasonal vaccine OR have a scheduled acute stressor\\*.\n\nExclusion Criteria:\n\n* Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days\n* Any self-reported active\u002Frecent use of cocaine, injection drugs, or amphetamines\n* Acute worsening of a known chronic health condition within the previous 30 days (e.g., of IBD, COPD, asthma, rheumatologic disease)\n* Known severe allergy or intolerance to the planned vaccine\n* Contraindication to the vaccine received, if applicable\n\n  \\*List of possible scheduled acute stressors include:\n* Hard exercise (incl. 10km run or longer, high-intensity interval training, or comparable endurance activity)\n* Social event with moderate alcohol consumption\n* Planned change in medication dose and\u002For frequency of use\n* Onset of menstruation (day 1)\n* Other pre-planned stressors expected to elicit an inflammatory response",{"count":155,"type":22},"The purpose of this study is to see whether dried blood spot (DBS) samples can measure inflammatory biomarkers as accurately as venous blood samples.\n\nInvestigators will be measuring inflammatory biomarkers changes obtained in DBS compared with paired venous blood samples following a controlled physiological stressor (i.e. after a vaccine or other planned event that can cause a temporary rise in inflammation).\n\nThese findings will help understand whether DBS can be a reliable alternative to traditional blood draws in future research and healthcare.",[614,615,616,617],"Inflammation","Inflammation Biomarkers","Blood Sampling","Dried Blood Spot",[619,620,621,622,623,624],"inflammation","blood sampling","biomarkers","inflammatory biomarkers","dried blood spot","paired sampling","2026-03-23",{"date":627,"type":42},"2026-03-27",{"date":629,"type":42},"2026-01-15",{"date":574,"type":22},{"name":48,"class":49},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":637,"eligibilityCriteria":638,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":649,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":661,"leadSponsor":663,"locationsCount":78},"100566078","phase-4-dabigatran-vs-oral-anti-xa-inhibitors-in-s-aureus-bacteremia-100566078","NCT06650501","Dabigatran vs. Oral Anti-Xa Inhibitors in S. Aureus Bacteremia","DABI-SNAP","The participant must meet all inclusion and exclusion criteria for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:\n\nInclusion Criteria:\n\n* Patient is taking (or will imminently start taking) an oral Xa inhibitor (e.g., apixaban, edoxaban, rivaroxaban) for: stroke prevention in atrial fibrillation, treatment or secondary prevention of deep venous thrombosis or pulmonary embolism, prevention of VTE in patients who have undergone elective total hip or total knee replacement surgery provided there are 30 or more days of planned treatment remaining at the time of enrolment.\n\nExclusion Criteria:\n\n* Active bleeding as determine by the site investigator after discussion with the treating team (patient may remain eligible for up to 120 hours from platform entry if condition is resolved and antithrombotic therapy is resumed)\n* Anticipated major cardiac surgery, neurosurgery, or spine surgery within the next 3 days\n* Known pregnancy (with testing available for women with childbearing potential)\n* Known use of dabigatran within last month\n* Allergy to dabigatran\n* Concomitant use of amiodarone, ketoconazole, rifampin, verapamil, clopidogrel, prasugrel, or ticagrelor\n* eGFR \\\u003C 30mL\u002Fminute calculated by Cockcroft-Gault equation using adjusted weight \\[patient may remain eligible for up to 120 hours from platform entry if acute kidney injury is resolved such that antithrombotic therapy can be safely resumed\u002Fprescribed\\]\n* Off label use (e.g., metallic mechanical heart valve, left ventricular thrombus, antiphospholipid antibody syndrome)",{"count":88,"type":22},[185],"This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.\n\nDabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigatran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.\n\nThis study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).\n\nIf positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.",[643,644,645,646,647,648],"Staphylococcus Aureus Endocarditis","Staphylococcus Aureus Septicemia","Staphylococcus Aureus Bacteremia","Staphylococcus Aureus Bloodstream Infection","S. Aureus Bacteremia","S. Aureus Bloodstream Infection",[650,651,652,653,654,655,656],"S. aureus bacteremia","S. aureus bloodstream infection","S. aureus endocarditis","Dabigatran","Edoxaban","Rivaroxaban","Apixaban","2026-03-17",{"date":659,"type":42},"2026-03-20",{"date":629,"type":42},{"date":662,"type":22},"2030-01",{"name":48,"class":49},{"id":665,"slug":666,"hasResults":12,"nctId":667,"briefTitle":668,"officialTitle":669,"acronym":670,"eligibilityCriteria":671,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":672,"targetDuration":4,"studyType":23,"phases":674,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":292},"100629984","biomarker-signature-supported-antibiotic-treatment-decisions-in-icu-100629984","NCT07481773","Biomarker Signature-Supported Antibiotic Treatment Decisions in ICU","Biomarker Signature-Supported Antibiotic Treatment Decisions in Intensive Care Units","BAST-ICU","Inclusion Criteria:\n\n* Admitted to the Intensive Care Unit (ICU)\n* Started on antibiotics for any suspected or confirmed infection in the preceding 72 hours (about 3 days)\n* Treating doctor(s) willing to consider BV test result in antibiotic treatment decision making\n\nExclusion Criteria:\n\n* Severe immunocompromise\u002Fimmunosuppression\n\n  1. Congenital immunodeficiency\n  2. HIV with CD4 \\\u003C 20\n  3. Active chemotherapy and profound neutropenia (ANC \\\u003C 100) expected to last \\> 7 days;\n  4. solid organ or stem cell transplant within preceding 6 months AND active GVHD\n  5. Receiving high dose steroids (Pred \\> 20mg\u002Fday for \\> or = 2 weeks)\n* Advanced metastatic cancer irrespective of treatment\n* Palliative intent, death imminent and inevitable within 4 weeks\n* Antibiotic to be discontinued within 24h (ex. Prophylaxis)\n* Active infection diagnosed and treated with antibiotics within preceding 2 weeks\n* Previously included during the same hospitalization",{"count":673,"type":22},1200,[25],"The goal of this randomized clinical trial is to determine whether a biomarker-signature (BV) supported antibiotic treatment decision matrix can have a beneficial impact on antibiotic use and patient outcomes in an ICU population.",[677],"Intensive Care Unit (ICU) Admission",[679,680,681],"ICU, Antibiotic Assesment, Diagnostic, Intervention, Medical Device","Antimicrobial Stewardship","Antimicrobial Resistance","2026-03-14",{"date":684,"type":42},"2026-03-19",{"date":686,"type":42},"2025-05-13",{"date":688,"type":22},"2028-08",{"name":48,"class":49},{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":23,"phases":699,"briefSummary":700,"conditions":701,"keywords":704,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":710,"lastUpdatePostDateStruct":711,"startDateStruct":713,"completionDateStruct":715,"leadSponsor":717,"locationsCount":78},"100586305","phase-2-effect-of-canagliflozin-on-ultrafiltration--fibrosis-in-patients-on-peritoneal-dialysis-100586305","NCT06913647","Effect of Canagliflozin on Ultrafiltration & Fibrosis in Patients on Peritoneal Dialysis","Effect of Canagliflozin on Ultrafiltration and Fibrosis in Peritoneal Dialysis: a a Proof-of-concept Randomized Phase II Crossover Clinical Trial","CAN-PD","Inclusion Criteria:\n\n* Adult patients with kidney failure on PD (both incident and prevalent) who are on a stable prescription of dextrose-based solutions for at least 3 months.\n* Only high or high-average transporters, as classified by PET, will be included.\n\nExclusion Criteria:\n\n* History of euglycemic ketoacidosis\n* Known hypersensitivity to canagliflozin\n* Active peritonitis or tunnel infection\n* Kidney transplant scheduled in the next 6 months\n* Severe liver cirrhosis (Child-Pugh class C stage)\n* Recurrent severe genital or urine infections\n* Patients receiving digoxin, phenobarbital, phenytoin, rifampin, or ritonavir if these agents cannot be safely discontinued\n* Pregnancy or breastfeeding",{"count":559,"type":22},[90],"This is a phase II, proof-of-concept, placebo-controlled, double-blind, cross-over randomized clinical trial, assessing the effect of canagliflozin on peritoneal membrane function in patients on PD.\n\nThe primary aim of this trial is to determine the short-term effects of canagliflozin, an SGLT-2 inhibitor, on glucose absorption by the peritoneal membrane and on ultrafiltration, as assessed by a standardized peritoneal equilibrium test. The secondary aims are to determine the effect of canagliflozin on solute clearance and on effluent biomarkers of inflammation, angiogenesis, and fibrosis at 26 weeks. We hypothesize that canagliflozin will prevent glucose absorption by the peritoneal membrane, as compared with placebo, and will attenuate the development of inflammation, angiogenesis, and fibrosis of the peritoneal membrane, as assessed by relevant biomarkers in the dialysate.",[702,703],"ESRD","CKD (Chronic Kidney Disease) Stage 5D",[705,706,707,708,709],"SGLT-2 inhibitors","Canagliflozin","Ultrafiltration failure","Peritoneal fibrosis","Peritoneal dialysis","2026-03-12",{"date":712,"type":42},"2026-03-16",{"date":714,"type":42},"2026-02-01",{"date":716,"type":22},"2028-12-31",{"name":48,"class":49},{"id":719,"slug":720,"hasResults":12,"nctId":721,"briefTitle":722,"officialTitle":723,"acronym":4,"eligibilityCriteria":724,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":725,"targetDuration":4,"studyType":385,"phases":4,"briefSummary":726,"conditions":727,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":729,"lastUpdatePostDateStruct":730,"startDateStruct":731,"completionDateStruct":733,"leadSponsor":735,"locationsCount":78},"100530025","lsm-and-ssm-for-the-diagnosis-of-csph-a-prospective-cohort-study-100530025","NCT06181409","LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study","Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study","Inclusion Criteria:\n\n* Age above 18years old\n* Advanced chronic liver disease (defined as LSM ≥ 10kPa)\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Transjugular intrahepatic portosystemic shunt\n* previous liver transplantation\n* Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)\n* Hematological malignancy",{"count":443,"type":22},"The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are:\n\n\\- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease?\n\nParticipants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.",[728],"Advanced Chronic Liver Disease","2026-03-10",{"date":710,"type":42},{"date":732,"type":42},"2024-01-10",{"date":734,"type":22},"2028-12",{"name":48,"class":49},""]