[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Alberta\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":638},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,166,0,25,[9,45,71,97,124,150,174,194,220,245,266,288,315,340,362,382,415,442,464,487,510,534,563,587,612],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100652481","exploring-the-efficacy-of-the-effortful-swallow-maneuver-for-improving-swallowing-in-people-with-pd-100652481",false,"NCT07773025","Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With PD","EFFORT-PD: Exploring the Efficacy of the Effortful Swallow Maneuver for Improving Swallowing in People With Parkinson Disease","EFFORT-PD","Inclusion Criteria:\n\n* Age 18 years or older\n* Neurologist-confirmed diagnosis of Parkinson disease\n* Self-report of one or more swallowing symptoms, such as difficulty managing secretions, coughing during meals, choking on food, or respiratory infection other than COVID-19 in the past 6 months\n* Baseline videofluoroscopic swallowing assessment showing prolonged time to laryngeal vestibule closure and\u002For poor pharyngeal area at maximum constriction on regular-effort swallows with thin or mildly thick liquid stimuli, relative to healthy reference values\n\nExclusion Criteria:\n\n* History of head and neck cancer\n* History of radical neck dissection, anterior cervical spine surgery, or neck\u002Foropharyngeal surgery, except tonsillectomy or adenoidectomy\n* History of any neurological disease other than Parkinson disease\n* Cognitive or receptive communication difficulties that preclude the ability to follow English-language study instructions\n* History of brain surgery, including deep brain stimulation","ALL","18 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn whether a 4-week effortful swallow exercise program helps adults with Parkinson disease who have swallowing problems. The effortful swallow is a swallowing exercise where a person swallows with extra effort.\n\nResearchers will compare adults who start the exercise program right away with adults who start the program after a 4-week waiting period. All participants who remain eligible will have the opportunity to receive the exercise program.\n\nParticipants will have swallowing assessments, including video X-ray swallowing tests called videofluoroscopy. They will also complete questionnaires and take part in a remotely supervised swallowing exercise program with a speech-language pathologist. Participants who remain eligible and take part in the exercise program will use a tongue pressure device during practice. The main study period lasts about 10 weeks. Participants will also complete brief follow-up questionnaires at 6 months and 12 months.",[28,29],"Dysphagia","Parkinson Disease (PD)",[28,31,32],"Parkinson disease","effortful swallow","NOT_YET_RECRUITING","2026-08-14",{"date":36,"type":37},"2026-08-19","ACTUAL",{"date":39,"type":22},"2027-01-01",{"date":41,"type":22},"2030-08-31",{"name":43,"class":44},"University of Alberta","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100610751","home-monitoring-study-for-surgical-patients-100610751","NCT07231653","Home Monitoring Study for Surgical Patients","Inclusion Criteria:\n\n* Clinically stable patients requiring routine postoperative monitoring in the absence of any acute illness following surgery.\n* Able to use a smartphone or tablet for the monitoring system.\n\nExclusion Criteria:\n\n* Severe cognitive impairment or conditions that may interfere with the use of home monitoring devices.\n* Currently participation in other clinical trials involving vital sign monitoring.\n* Unable to provide informed consent.","80 Years",{"count":53,"type":22},69,"OBSERVATIONAL","This clinical trial is designed to evaluate the accuracy, usability, and patient compliance of the Wellvii VitalDetect, an FDA-cleared (510(k) K231625), Class II medical device intended for non-invasive monitoring of vital signs including blood pressure, pulse rate, and temperature. The study will focus on comparing measurements obtained in a home environment using the device to those collected in a clinical setting, with the goal of validating the device's performance for real-world, at-home use.\n\nThe Wellvii VitalDetect is a portable, battery-operated, spot-check monitor that uses finger-based technology for most parameters and an infrared sensor for forehead-based, non-contact temperature readings. It is designed for use by adults (18 years or older) in a home environment and is not intended for continuous monitoring. In addition to the cleared vital signs, the device displays other wellness parameter for general health tracking. A smartphone application supports the user experience by delivering usage instructions and data display.\n\nThe study will assess:\n\n* Measurement accuracy compared to standard clinical instruments\n* Patient ease-of-use and engagement with the device\n* Adherence to regular self-monitoring schedules\n* Overall user satisfaction and confidence I home-based monitoring\n\nThis research will contribute to the growing body of evidence supporting remote patient monitoring solutions and aims to advance the adoption of decentralized technology-enabled healthcare delivery.\n\nThe study aligns with Wellvii Inc.'s mission to transform healthcare delivery by enabling continuous, connected health monitoring from the home. The ultimate goal is to empower patients and healthcare providers with real-time, clinically actionable health at a that can lead to earlier intervention, improved outcomes, and reduced system burden.",[57,58],"Patient Monitoring","Postoperative Period",[60,61,62],"Wellvii VitalDetect","Remote patient monitoring","Postoperative monitoring","2026-08-13",{"date":65,"type":37},"2026-08-17",{"date":39,"type":22},{"date":68,"type":22},"2028-12-31",{"name":43,"class":44},1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100568590","optimizing-patients-comfort-during-scleral-indentation-100568590","NCT06683209","Optimizing Patient's Comfort During Scleral Indentation","Comparison of Scleral Indentation Instruments and Impact on Patient Comfort","Inclusion Criteria:\n\n* Symptomatic posterior vitreous detachment with or without vitreoretinal pathology\n\nExclusion Criteria:\n\n* Monocular status.\n* Media opacity which precludes view of the peripheral retina.\n* Inadequate examination (cooperation with examination, inability to achieve all directions of gaze).\n* Underlying oculodynia (recent surgery, intraocular inflammation, abnormal intraocular pressure, ocular dysesthesia syndromes (ocular, adnexal or orbital).\n* History of pain-sensitizing conditions or current analgesic use.\n* Previous scleral indented examination poorly tolerated.",true,"100 Years",{"count":81,"type":22},75,[25],"The scleral depression exam is an important routine technique for evaluating the retinal periphery for various reasons. During this examination, an instrument is used to bring the anterior part of the retina into the physician's field of view. The downside of this technique is the discomfort it may cause the patient. Different instruments can be used to depress the sclera.\n\nThe objective of this research is to compare three commonly used scleral depressors based on their performance for the ophthalmologist and the discomfort they subjectively induce in patients.\n\nPatients will be randomly allocated to one of three examination groups:\n\nGroup A: One eye examined with the Schocket scleral depressor, the other eye with the Josephberg-Besser scleral depressor.\n\nGroup B: One eye examined with the Schocket scleral depressor, the other eye with the cotton-tip applicator.\n\nGroup C: One eye examined with the cotton-tip applicator, the other eye with the Josephberg-Besser scleral depressor.",[85],"Pain",[87,88,89],"Schocket","Josephberg-Besser","Cotton tip applicator",{"date":65,"type":37},{"date":92,"type":22},"2027-07-01",{"date":94,"type":22},"2028-07-30",{"name":43,"class":44},2,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100651967","potassium-ferrate-hemostatic-sealant-assisted-early-radial-hemostasis-after-transradial-coronary-angiography-and-pci-100651967","NCT07768839","Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI","Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI. A Randomized, Single-centre, Superiority Trial at the Mazankowski Alberta Heart Institute Cardiac Catheterization Laboratory (Edmonton, Alberta, Canada)","MAHI-SEAL-60","Inclusion Criteria:\n\n* Age ≥ 18 years • Undergoing trans radial coronary angiography with or without PCI\n* Radial 6Fr Prelude sheath used for the procedure\n* Planned use of Inflation band (Sunny Medical) radial compression device for hemostasis\n* Able to provide informed consent\n* Adequate collateral circulation per institutional radial access screening (consistent with device contraindications).\n\nExclusion Criteria:\n\n* On a GPIIB\u002FIIIA inhibitor\n* Known hypersensitivity to device materials\n* Infection or serious skin disease at puncture site\n* Abnormal collateral circulation test \u002F insufficient dual arterial supply\n* Inability to complete study assessments before discharge\n* Conversion to femoral access or need for alternate hemostasis device\n* Prior radial artery harvest or known chronic radial artery occlusion in the study limb (per operator judgement).",{"count":106,"type":22},300,[25],"This study aims to evaluate patients undergoing coronary angiography by comparing the use of Potassium Ferrate Hemostatic Sealant (PFHS) in addition to the standard of care (SOC) pneumatic radial compression device versus SOC alone. The objective is to determine whether the addition of PFHS reduces the time to successful deflation and removal of the radial compression device.",[110,111],"Coronary Angiogram","Early Discharge Trans Radial Angiography",[113,114,115,116],"Angiogram","Angioplasty","Radial angiogram","Potassium Ferrate Hemostatic Sealant (PFHS)","2026-08-12",{"date":65,"type":37},{"date":120,"type":22},"2026-10-01",{"date":122,"type":22},"2032-06-01",{"name":43,"class":44},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100586131","phase-1-augmenting-cerebral-blood-flow-in-acute-ischemic-stroke-100586131","NCT06911385","Augmenting Cerebral Blood Flow in Acute Ischemic Stroke","Augmenting Cerebral Blood Flow Using a Novel Combined Treatment Approach in Patients With Ischemic Stroke: Protocol Development","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Both male and female participants will be included\n3. History of Stroke Symptoms\n4. Baseline modified Rankin scale score \\\u003C 2\n5. Participant or substitute decision-maker able to provide informed consent.\n\nExclusion Criteria:\n\n1. Injury to the upper arms, lower limbs (from ankles to thighs), or any other musculoskeletal disability\u002Fpain that precludes tolerating RIC and\u002For Pneumatic compression therapy.\n2. History of dermatological conditions affecting application of RIC cuff with tissue perfusion sensor and pneumatic compression boots.\n3. History of peripheral arterial disease\n4. Treatment of ongoing malignancy with expected survival \\\u003C 6 months\n5. Presence of hypertensive urgency and emergency\n6. Presence of hemodynamic instability and ongoing pulmonary edema\n7. Presence of clinical or imaging signs of raised intracranial, intrathoracic, and \u002For intra-abdominal pressure.\n8. Presence of ongoing systemic infection with antibiotic therapy\n9. Pregnant and lactating women\n10. Participant not part of other clinical intervention trial",{"count":132,"type":22},150,[134,135],"PHASE1","PHASE2","The most common type of stroke is ischemic (lack of blood flow to the brain due to a clot blocking a blood vessel). Time is brain and an average of 1.9 million brain nerve cells per minute are destroyed in patients experiencing a typical LVO. The main goal of treatment is to help restore blood flow as quickly as possible and prevent brain tissue and cell death. Acute treatments like clot-busting medication or clot removal by wire are standard of care but are available in comprehensive stroke centers in a few urban centers. Often, patients need to be transferred to these centers via ground or air ambulance, sometimes over hours, and no active treatment can be provided during these transfers.\n\nEnhancing or increasing blood flow to the brain is associated with good outcomes in stroke. This study involves an innovative approach combining two treatment interventions - Remote ischemic conditioning (arms) and Air compression therapy (legs, applied simultaneously to all four limbs, that may help improve blood flow to the brain. Remote Ischemic Conditioning is a type of treatment delivered with the help of a regular blood pressure machine. This does not involve any drug. A typical treatment involves the application of a blood pressure cuff followed by brief sessions of compressions and relaxation on the arm muscles, much akin to blood pressure measurement, but for 5 min. It leads to a transient safe state of less blood flow in arm muscles which initiates the release of molecules and signals transmitted by blood. These signals may then go on to improve blood flow in the brain. Air Compression is delivered by a commercially available device (Normatech Elite). They are inflatable sleeves resembling puffy thigh-high boots that deliver compressive pulses stimulating blood flow in the legs, in a graded manner from the ankles to the thighs. We believe this air compression device may help improve and divert blood flow to stroke-affected areas in the brain.",[138],"Stroke",[140,141,138,142,143],"Remote ischemic conditioning","Pneumatic Lower limb Compression","Cerebral blood flow","Functional near infrared spectroscopy",{"date":63,"type":37},{"date":146,"type":22},"2026-09-15",{"date":148,"type":22},"2027-05-31",{"name":43,"class":44},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":173,"locationsCount":4},"100645261","phase-1-taurine-supplementation-in-adolescents-with-post-covid-condition-100645261","NCT07682402","Taurine Supplementation in Adolescents With Post-COVID Condition","An Open-Label Study of Taurine Supplementation in Adolescents With Post-COVID Condition: Quantifying Taurine Plasma Levels and Evaluating Clinical and Biological Outcomes","TaurineLCPeds","Inclusion Criteria:\n\n1. Subjects must be between 10 and 17 years of age at the time of study enrollment\n2. Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to trial; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019, and at least 3 months prior to trial enrollment.\n3. If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks).\n4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms.\n5. Lingering symptoms from COVID-19 present at the time of trial enrollment.\n6. Individuals of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment. Highly effective methods of contraception must be discussed and approved by the overseeing Investigator.\n7. Medication(s) only available through a prescription for the purposes of treating fatigue or cognitive function have been discontinued for four weeks prior to randomization.\n8. Participants must be able to assent to their participation in the study and be both willing and able to comply with study requirements.\n9. Parents\u002Fcaregivers\u002Fguardians must be able to provide informed consent for participation.\n10. Participants must agree to avoid taking supplemental taurine (e.g. from over-the-counter preparations, energy drinks, etc.)\n\nExclusion Criteria:\n\n1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.\n2. Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.\n3. Contraindications to the study intervention.\n4. Currently already on the study intervention (Participants would be eligible if they stopped taking Taurine for a minimum of 4 weeks prior to enrollment).\n5. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).\n6. Currently pregnant or breastfeeding.\n7. The participant is currently enrolled in another research trial to treat neurocognitive symptoms in LC.","10 Years","17 Years",{"count":161,"type":22},30,[134,135],"The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19 (PASC), has emerged as a complex multisystemic condition and challenging public health issue.\n\nContrary to initial perceptions, pediatric Long COVID is a significant health concern, with studies suggesting its prevalence ranges from 10% to 25% following infection. Research in the pediatric population has largely been limited to observational studies based on self-reported symptoms or large electronic healthcare datasets. The long-term outcomes and predictors of LC in children remain poorly described, highlighting an urgent need for further mechanistic research to characterize this complex condition. While acute COVID-19 symptoms are often milder in children relative to adults, some go on to develop a range of chronic physical, immunological, psychological, and neurological symptoms persisting for weeks to years after initial infection. The most commonly reported symptoms are similar to those seen in adults and include debilitating fatigue, respiratory distress, headaches, gastrointestinal symptoms, and neurocognitive impairment. Other frequently reported symptoms include muscle pain, sleep disturbances, olfactory and gustatory disturbances, exercise intolerance, and heart palpitations\u002Fcardiovascular symptoms. These symptoms can be new, or they may persist or fluctuate from the initial illness. Additionally, many children with LC experience psychological symptoms such as anxiety, depression, and mood disturbances, which are thought to be exacerbated by experiencing prolonged illness and subsequent lifestyle disruptions.\n\nCurrently, effective treatments for LC remain elusive, leaving patients to contend with persistent symptoms that significantly impair their quality of life. For children and adolescents, these issues can profoundly impact their daily activities, academic performance, and social interactions\u002Ffriendships. Symptoms like debilitating fatigue, cognitive impairment, and mood disturbances are especially disruptive by interfering with memory, energy levels, and overall development, often leading to school absenteeism, social withdrawal, and psychological distress. Therefore, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.",[165,166,167],"Long COVID","Post COVID-19 Condition","PASC Post Acute Sequelae of COVID 19","2026-08-11",{"date":63,"type":37},{"date":171,"type":22},"2026-09-30",{"date":68,"type":22},{"name":43,"class":44},{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":70},"100626348","ketone-ester-for-treatment-of-acute-heart-failure-100626348","NCT07434466","Ketone Ester for Treatment Of Acute Heart Failure","KETO-AHF: Ketone Ester for Treatment Of Acute Heart Failure: A Vanguard Randomized Controlled Trial","KETO-AHF","Domain-Specific Inclusion Criteria:\n\n1. Primary diagnosis of AHF with dyspnea on exertion or at rest, and at least two of the following: congestion on chest radiograph, rales on chest auscultation, clinically relevant edema, or an elevated jugular venous pressure \\[21\\]\n2. Admitted to the hospital for less than 48 hours\n3. Estimated glomerular filtration rate above 15 mL\u002Fmin\u002F1.73m²\n4. NT-proBNP ≥ 1000 pg\u002Fml\n\nDomain-Specific Exclusion Criteria:\n\n1. Type 1 diabetes mellitus\n2. Patients on mechanical circulatory support\n3. Patients on more than one inotrope or on inopressors\n4. Patients on dialysis\n5. Patients with non-functioning enteral tracks",{"count":183,"type":22},60,[25],"Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects include energy provision for the failing heart and direct protective effects on other organs. Despite the strong physiological rationale, the acute effects of ketone therapy in patients with acute heart failure (AHF) is unclear. AHF is a major healthcare issue, with in-hospital mortality exceeding 10%. Therefore, we propose a vanguard randomized controlled trial to assess the effects of ketone esters in patients with AHF. Sixty patients hospitalized with AHF will be randomized to receive either 25 grams of ketone esters three times per day or a matching placebo for five days, or until death or hospital discharge. We hypothesize that ketone therapy will improve markers of systemic congestion and heart failure symptoms. Primary endpoint will be changes in NT-proBNP levels during therapy. Secondary endpoints will be KCCQ scores, and hemodynamic profile as assessed by echocardiogram. Exploratory endpoints will clinical outcomes including mortality, need for intensive care unit admission, among others.",[187],"Acute Heart Failure",{"date":63,"type":37},{"date":190,"type":22},"2026-09",{"date":192,"type":22},"2028-03",{"name":43,"class":44},{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":23,"phases":203,"briefSummary":204,"conditions":205,"keywords":208,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":70},"100616116","phase-2-subcutaneous-blinatumomab-plus-ponatinib-for-bcr-abl-b-all-100616116","NCT07301424","Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL+ B-ALL","Phase II Study of Subcutaneous Blinatumomab Plus Ponatinib for BCR-ABL Positive B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Ph positive \\[either t(9;22) and\u002For BCR-ABL1 positive\\] ALL, CD19 positive\n2. Age ≥18 years at time of informed consent\n3. No prior induction treatment for ALL. A brief corticosteroid pre-phase (\\\u003C 1 week), or hydroxyurea for cytoreduction or symptom control is permitted.\n\n3\\. Greater than or equal to 5% blasts in the BM.\n\n4\\. Performance status ≤2 (ECOG Scale, see Appendix IV)\n\n5\\. Adequate organ function: 5.1.5.1 Hepatic:\n\nAdequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\nTotal serum bilirubin less than 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome or Meulengracht disease Alanine aminotransferase (ALT) less than 3 x ULN Aspartate aminotransferase (AST) less than 3 x ULN 5.1.5.2 Pancreatic:\n\n* Serum lipase less than 2 x ULN 5.1.5.3 Renal:\n* Estimated Creatinine clearance ≥ 40 mL\u002Fmin 5.1.5.4 Cardiac:\n* Left ventricular ejection fraction \\> 40%\n\nExclusion Criteria:\n\n1. Uncontrolled infection\n2. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus\n3. Presence of cardiovascular disease of clinical relevance within the past 3 months. This includes:\n\n   5.2.3.1 Unstable angina 5.2.3.2 Myocardial infarction 5.2.3.3 Transient ischemic attack or stroke 5.2.3.4 Peripheral vascular infarction, claudication and\u002For revascularization 5.2.3.5 Symptomatic congestive heart failure 5.2.3.6 Clinically significant significant atrial\u002Fventricular tachyarrhythmias 5.2.3.7 Venous thromboembolic event requiring systemic anticoagulation\n\n   Please consult the sponsor if there are specific concerns outside of these criteria\n4. Uncontrolled hypertension\n5. History or presence of clinically relevant CNS pathology or event.\n\n   This may include, for example:\n\n   epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis.\n\n   Before excluding a potential subject, please consult the sponsor.\n6. Any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol.\n7. History of malignancy other than ALL within 3 years prior to start of protocol-specified therapy except for:\n\n   * malignancy treated with curative intent and with no known active disease present for 3 years before enrollment, and felt to be at low risk for recurrence by the treating physician\n   * adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   * adequately treated cervical carcinoma in situ without evidence of disease\n   * adequately treated breast ductal carcinoma in situ without evidence of disease\n   * prostatic intraepithelial neoplasia without evidence of prostate cancer\n8. Prior hematologic malignancy and\u002For alloSCT; this includes known CML\n9. Concurrent or prior (within 30 days) treatment with another investigational agent or study drug\n10. Female subject is pregnant or breastfeeding or planning to become pregnant breastfeed during treatment, and for an additional 4 months after the last dose of protocol-specified therapy\n11. Inability to swallow or absorb tablets\n12. Subject considered unsuitable for study for any other reason in the physician's best judgement. Before excluding a potential subject, please consult the sponsor.",{"count":202,"type":22},80,[135],"B-cell acute lymphoblastic leukemia (B-ALL) is an aggressive blood cancer; about 30% of B-ALL cases in adults have a mutation called BCR-ABL that drives the disease.\n\nBlinatumomab is an antibody drug that targets B-ALL cells and helps the immune system to kill them. It is usually given intravenously, but a newer formulation can be given under the skin. Ponatinib is a drug, taken by mouth, that targets and kills leukemia cells that have the BCR-ABL mutation.\n\nThe goal of this clinical trial is to test the effectiveness of treating patients with BCR-ABL positive B-ALL with blinatumomab given subcutaneously (under the skin) combined with ponatinib tablets. The study will also evaluate what side effects occur using this combination.\n\nParticipants will first receive ponatinib tablets for 70 days, along with prednisone for the first month. This will be followed by blinatumomab injections 3 times per week for 4 weeks, repeated for 5 treatment cycles, along with ponatinib. Participants will then continue ponatinib tablets alone for 5 years from the start of treatment.\n\nDuring treatment, participants will undergo regular blood and bone marrow tests to see how well the treatment is working, and to check for side effects. The effect of this treatments on their quality of life will also be evaluated.",[206,207],"Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)","BCR-ABL Positive Acute Lymphoblastic Leukemia",[209,210,211,212,213],"Blinatumomab","Ponatinib","BiTE antibody","Acute lymphoblastic leukemia","BCR-ABL positive acute lymphoblastic leukemia",{"date":117,"type":37},{"date":216,"type":22},"2027-01-02",{"date":218,"type":22},"2031-12",{"name":43,"class":44},{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100571568","phase-2-taurine-supplementation-in-long-covid-100571568","NCT06721949","Taurine Supplementation in Long COVID","Taurine Supplementation as a Novel Therapeutic Approach for Neurocognitive Symptoms in Long COVID","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019, and at least 3 months prior to randomization.\n3. If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks).\n4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms.\n5. Lingering symptoms from COVID-19 present at the time of randomization.\n6. Individuals of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment. Highly effective methods of contraception must be discussed and approved by the overseeing Investigator (refer to Section 5 Contraception of the Master Protocol, and Section 13.1.2 of this protocol).\n7. Must be able to provide informed consent and both willing and able to comply with study requirements.\n8. Medications prescribed for treating fatigue or cognition have been discontinued for four weeks prior to enrolment and randomization. These include sildenafil, modafinil (Provigil), or armodafinil (Nuvigil), guanfacine, N-acetyl cysteine, and stimulant medications used for attention-deficit hyperactivity disorder (ADHD).\n\nExclusion Criteria:\n\n1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.\n2. Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.\n3. Contraindications to the study intervention.\n4. Currently already on study intervention(s).\n5. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).\n6. Currently pregnant or breastfeeding.\n7. The participant is currently enrolled in another clinical trial to treat neurocognitive symptoms in LC.",{"count":106,"type":22},[135,229],"PHASE3","The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19, has emerged as a complex multisystemic condition and challenging health issue, affecting approximately 10% of COVID-19 patients. Various symptoms characterize LC, including fatigue, sleep disturbances, cognitive impairment, and mood disturbances. Some of the symptoms are shared with Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS) - a condition marked by debilitating fatigue and a host of other symptoms without precise biomarkers or objective tests for diagnosis. Effective LC treatments remain elusive and LC patients continue to grapple with persistent symptoms that significantly impact their quality of life. Given the lack of effective treatments, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.",[165],[233,234,165,235,236],"Taurine","COVID","randomized trial","neurocognitive symptoms","RECRUITING",{"date":63,"type":37},{"date":240,"type":37},"2025-11-18",{"date":242,"type":22},"2028-12",{"name":43,"class":44},5,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":265,"locationsCount":70},"100556897","feasibility-of-prospective-surveillance-and-early-physical-therapy-for-trismus-100556897","NCT06531083","Feasibility of Prospective Surveillance and Early Physical Therapy for Trismus","Feasibility of PRospective Surveillance and Early PhysiCal Therapy for TrIsmuS in Individuals With Head and Neck CancEr: A Single-Group Feasibility Trial (PRECISE)","PRECISE","Inclusion Criteria:\n\n* Have a diagnosis of oral, oropharyngeal, or nasopharyngeal cancer\n* Be scheduled to undergo cancer treatment that includes radiation therapy\n* Be able to read and understand English\n* Be an Alberta resident.\n\nExclusion Criteria:\n\n* Previous surgery for the temporomandibular joint that is not related to the HNC diagnosis.\n* Local cancer recurrence or metastatic disease.\n* Unable to provide informed consent.",{"count":161,"type":22},[25],"Trismus, or restricted jaw movement, can occur in individuals with head and neck cancer (HNC) undergoing surgery or radiation therapy. There is a paucity of research examining interventions for trismus. We aim to assess the feasibility of prospective surveillance and early intervention to mitigate trismus in individuals undergoing HNC treatment.\n\nMethod: The investigators will conduct a pilot single group feasibility study involving 30 individuals with HNC who will be undergoing radiation therapy. Participants will be identified at the HNC new patient clinic. Participants will be seen weekly during radiation therapy and will receive early intervention including manual therapy and a device-based jaw exercise regimen if presenting with 5% or greater reduction in jaw opening compared to pre-treatment.\n\nThe investigators will assess recruitment and completion rates, intervention acceptability, and data collection procedures. Descriptive statistics will summarize feasibility metrics and participant demographics. Findings will inform the design of a larger multicentre trial.",[257,258],"Head and Neck Cancer","Trismus",[260],"Physical Therapy",{"date":117,"type":37},{"date":263,"type":37},"2025-03-01",{"date":171,"type":22},{"name":43,"class":44},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":274,"minAge":19,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":287,"locationsCount":70},"100521693","continence-sexual-function-fitness-and-the-health-of-men-after-surgery-for-prostate-cancer-100521693","NCT06072911","Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer","Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)","CONTROL4LIFE","Inclusion Criteria:\n\n* have a diagnosis of prostate cancer (stage I to IV);\n* be scheduled for a prostatectomy surgery (any surgical approach);\n* have no restriction to participate in at least mild levels of physical activity, as confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);\n* speak and understand English.\n* adult: 18 years of age or older\n* optional exercise component: willing and able to commit to the 12-week intervention\n\nExclusion Criteria:\n\n* have any medical conditions that may interfere with continence (i.e. neurological diseases);\n* have any contraindications to exercise testing or training;\n* have recent (\\>6 months) modifications to any medication aiming to reduce urinary incontinence (i.e. Myrbetric);\n* do not have regular access to the internet and a smart device or a computer at home\u002F at their community center;\n* are already receiving a pelvic floor exercise program through a pelvic floor physical therapist from their community.","MALE",{"count":276,"type":22},106,[25],"The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the recovery of continence, sexual function, and health outcomes in individuals who have undergone surgery for prostate cancer. The purpose of this study is to better understand the timelines of recovery for these outcomes after surgery for prostate cancer. As part of this study, all participants will receive resources offered by Alberta Health Services regarding pre- and post-prostatectomy care, including information on pelvic floor exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating outcomes related to physical activity, fitness and quality of life. These assessments will enable the investigators to better understand how well and how long it takes for individuals to recover after surgery for prostate cancer.",[280,281,282],"Prostate Cancer","Incontinence","Metabolic Disease",{"date":117,"type":37},{"date":285,"type":37},"2024-02-27",{"date":171,"type":22},{"name":43,"class":44},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":23,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":70},"100643685","timing-of-rehabilitation-following-cervical-spinal-surgery-in-degenerative-myelopathy-100643685","NCT07636135","Timing of Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy","Feasibility of Early Post-operative Rehabilitation Following Cervical Spinal Surgery in Degenerative Myelopathy","Inclusion Criteria:\n\n* adult (\\>18 years of age) with diagnosis of degenerative cervical myelopathy, within 2 weeks of spinal decompression surgery\n* plan to be discharged home from acute care (i.e., not admitted to another facility for post-operative rehabilitation)\n* able to stand with a maximum of one-person assist (+\u002F- use of gait aid)\n* persistent functional impairment in lower extremity strength, balance, coordination, and\u002For gait\n* ability to attend an 8-week in-person rehabilitation program in Edmonton, Alberta\n\nExclusion Criteria:\n\n* discharge from acute care facility \\> 2 weeks post-operative\n* intra-operative or early post-operative complication delaying discharge or precluding participation in early rehabilitation",{"count":296,"type":22},20,[25],"The goal of this clinical trial is to learn whether starting rehabilitation earlier after surgery can improve recovery and is feasible and acceptable for adults with degenerative cervical myelopathy (DCM) undergoing cervical spine surgery. The main question it aims to answer is:\n\nDoes starting rehabilitation earlier improve walking, balance, physical activity, quality of life, and nervous system function after surgery?\n\nResearchers will compare participants who begin rehabilitation two weeks after surgery with participants who begin rehabilitation six weeks after surgery to see if earlier rehabilitation leads to better recovery outcomes and participation.\n\nParticipants will:\n\nBe randomly assigned to begin rehabilitation either two weeks or six weeks after surgery.\n\nAttend physical therapy sessions twice per week for eight weeks focused on strength, balance, and walking.\n\nComplete assessments of walking ability, balance, physical activity, quality of life, and nervous system function over several months after surgery.\n\nProvide feedback about their experience with the rehabilitation program, including satisfaction and any side effects or challenges related to participation.",[300],"Cervical Myelopathy",[302,303,304,305,306],"physical therapy","post-operative rehabilitation","walking","degenerative cervical myelopathy","spinal cord injury","2026-08-04",{"date":309,"type":37},"2026-08-07",{"date":311,"type":37},"2026-07-01",{"date":313,"type":22},"2027-12-31",{"name":43,"class":44},{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":339,"locationsCount":70},"100614901","optimizing-graft-selection-in-glaucoma-surgery-a-comparative-study-of-sclera-pericardium-and-corneal-tissue-100614901","NCT07285616","Optimizing Graft Selection in Glaucoma Surgery: A Comparative Study of Sclera, Pericardium, and Corneal Tissue","Optimizing Graft Selection in Glaucoma Surgery","Inclusion Criteria:\n\n1. Age 18 years and older\n2. Patients selected for PreserFlo microshunt surgery and XEN stent alone or in combination with cataract surgery.\n3. Ability to comprehend the study procedures\n\nExclusion Criteria:\n\n1. Unwilling or unable to give consent\n2. Unable to come for scheduled post-operative visits\n3. Pregnant or nursing women\n4. Previous cyclodestructive procedures, scleral buckling procedures, or presence of silicone oil\n5. Conjunctival scarring precluding a glaucoma surgery superiorly\n6. Active iris neovascularization or active proliferative retinopathy\n7. Vitreous in the anterior chamber for which a vitrectomy is anticipated.\n8. Previous trabeculectomy, tube-shunt implantation, or surgeries that shunt aqueous outflow into the subconjunctival space","110 Years",{"count":324,"type":22},180,[25],"Glaucoma refers to a group of progressive optic neuropathies that lead to permanent vision loss. Glaucoma is the leading cause of irreversible blindness globally. In 2020, it was estimated to affect 76 million individuals worldwide, with projections indicating this number will rise to 111.8 million by 2040. In Canada, glaucoma affects an estimated 2.7-7.5% of individuals over the age of 50, contributing substantially to the national disease burden. This condition is linked to damage of the optic nerve due to elevated intraocular pressure (IOP; raised eye pressure), which results in the loss of retinal ganglion cells. Therefore, most of the treatments are guided towards reducing the IOP either via using laser, medications or surgery.\n\nGlaucoma surgery is typically reserved for cases where IOP remains uncontrolled while on maximum tolerated medical therapy and\u002For where glaucoma progression warrants surgery. The goal of many glaucoma surgeries is to divert aqueous humor from the anterior chamber to the subconjunctival space, therefore reducing intraocular pressure. The device used for this purpose are the PRESERFLO™ MicroShunt (Glaukos Corporation, Laguna Hills, CA, USA) (the documents will interchangeably use terms \"stent\" and \"shunt\" to refer to these devices in the text below). The device is implanted using the ab externo approach to channel fluid from the anterior chamber to the subconjunctival\u002Fsubtenon space. To reduce postoperative fibrosis and inhibit fibroblast activity that could obstruct flow and lead to device failure, 5-fluorouracil (5-FU) or mitomycin C (MMC) are administered. Additionally, a double-layered closure of conjunctiva and Tenon's is performed to minimize Tenon's migration and blockage of tenon the stents. Despite these measures, stent encapsulation and failure are still too common requiring revisions and bleb needling in 2-20% of cases within the first 12 months of follow-up.\n\nThis project will involve a series of studies evaluating graft selection in PreserFlo MicroShunt implantation, focusing on donor sclera, cornea, and pericardium as patch graft materials. First, the investigators will conduct a prospective, randomized study comparing clinical outcomes between these graft types. Outcomes of interest will include surgical success rates, post-operative hypotony, tube erosion, conjunctival complications, infection, and overall device longevity. Donor sclera has long been used as a patch graft in glaucoma drainage device surgery and is associated with low erosion rates and reliable long-term results. Corneal tissue is increasingly used due to its transparency and availability through eye banks, with demonstrated safety in ocular surface reconstruction and tube coverage. Pericardium is another durable, biocompatible option, historically applied in both cardiovascular and ocular surgery, and has shown effectiveness as a patch graft in glaucoma drainage implants. This comparison will extend to both primary implantation and revision surgeries, recognizing the high clinical relevance of graft performance in complex cases.\n\nBuilding on these results, the investigators will then perform a cost-effectiveness analysis of graft strategies, incorporating surgical time, post-operative management, complication rates, and need for re-operation. An economic model will be developed to evaluate costs and resource utilization associated with each material, providing valuable data for policy and surgical decision-making. Finally, the investigators will conduct a patient-reported outcome (PRO) study to assess patient comfort and satisfaction with different grafts. Surveys will evaluate domains such as foreign body sensation, cosmesis, and overall satisfaction at key time points (immediate post-operative period, 1 week, 3 weeks, and 3 months). These results will highlight the patient perspective, an often underrepresented but critical factor in surgical innovation.\n\nTogether, these studies will comprehensively assess graft selection from surgical, economic, and patient-centered perspectives, informing evidence-based practice in glaucoma care.",[328],"Glaucoma",[330,331,332],"PRESERFLO","surgery","MicroShunt","2026-07-23",{"date":335,"type":37},"2026-07-24",{"date":146,"type":22},{"date":338,"type":22},"2027-12-30",{"name":43,"class":44},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":347,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":23,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":96},"100472513","impact-of-metabolic-health-patterns-and-breast-cancer-over-time-in-women-100472513","NCT05432856","Impact of Metabolic Health Patterns And Breast Cancer Over Time in Women","IMPACT-Women","Inclusion Criteria:\n\n* Female biological sex at birth\n* \\>18 years\n* Diagnosis of stage I, II, or III breast cancer\n* starting neoadjuvant or adjuvant intravenous chemotherapy\n* ECOG \\\u003C3;\n* Oncologist approval to participate;\n* English speaking (all study materials and study staff will be in English)\n* Willing and able to adhere to study intervention\n\nExclusion Criteria:\n\n* Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone).\n* Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \\>10%\n* Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy)\n* Uncontrolled thyroid disorder\n* Self-reported eating disorder history\n* Body mass index \\\u003C18.5 kg\u002Fm2 or clinical signs of cachexia (discretion of treating oncologist)\n* ≥5% body weight loss within last 6 months\n* Those who are currently working night\u002Frotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals\u002Fday in the past 3 months.\n* patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.","FEMALE",{"count":349,"type":22},65,[25],"Background \\& Rationale:\n\nBreast cancer (BC) is the most commonly diagnosed malignancy in women worldwide (2.1 million diagnoses in 2018, 25% of new cancer cases). In Canada, early stage BC mortality rates have decreased by 48% over the past 30 years as a result of advances in prevention, detection, and treatment. However, competing risks for mortality from non-cancer causes have emerged, where cardiovascular disease (CVD) is now a leading cause of death for BC survivors. The direct toxic effects of BC treatment on the heart (cardiotoxicity) are well characterized by the investigators and many others, as a contributor to elevated cardiovascular risk. However, BC treatment and the associated lifestyle changes (i.e. physical inactivity, poor diet quality, stress) are increasingly recognized to also strongly affect metabolism negatively manifesting as insulin resistance, dyslipidemia and adipose tissue (fat) accumulation. These adverse metabolic changes are strongly linked to CVD risk and represent a currently underappreciated contributor to the elevated CVD risk among BC survivors. Preliminary data and recent publications demonstrate that regional fat accumulation occurs during BC treatment and that the fat burden in key locations is associated with poor cardiorespiratory health. A trigger of these adverse metabolic and inflammatory effects is excess fat specifically within ectopic fat (viscera, intermuscular, or hepatic) regions. In 2019, a member of the study team found that the volume of visceral and intermuscular but not subcutaneous fat at BC diagnosis were linearly associated with CVD events within 6 years, even among those with normal BMI and after adjustment for pre-existing CVD risk factors and for BC treatment type. Using MRI, investigators found that \\~1 year after chemotherapy, BC survivors had significantly larger depots of visceral fat (49% larger) and thigh intermuscular fat (41% larger) compared to age and sex-matched controls, despite similar BMI and subcutaneous fat volumes in the two groups. Investigators also showed that the fat fraction within the thigh muscle and visceral fat volumes independently explained \\~50% of the variation in cardiorespiratory fitness (measured by peak VO2). In particular, peak VO2 is one of the most powerful predictors of all-cause and CVD mortality and health care costs, and is the most consistently reported negative sequelae after treatment for BC. Unfortunately, there are no known therapies to recover long-term myocardial damage (i.e. cell death, fibrosis) from cancer therapies. There are several reasons to target fat as a therapeutic target in BC patients: 1) The study team have compelling preliminary data showing accelerated formation of ectopic fat during BC treatment. 2) Investigator's recent data showed that high fat content in key fat pools was associated with reduced peak VO2. 3) The burden of fat and the associated metabolic abnormalities are dynamic and malleable, and thus highly treatable.\n\nResearch Question \\& Objectives:\n\nThe primary purpose of this study is to evaluate the effect of a behavioural intervention involving supported time-restricted eating (TRE), diet quality improvements, and reduced sedentary time versus usual cancer and nutrition care in BC patients receiving chemotherapy treatment on ectopic fat, cardiometabolic profile, and chemotherapy outcomes. The investigators hypothesize that the intervention will attenuate the growth of ectopic fat during chemotherapy and reduce chemotherapy symptoms.",[353,354,282],"Cardiovascular Diseases","Cardiovascular Morbidity","2026-07-16",{"date":357,"type":37},"2026-07-20",{"date":359,"type":37},"2024-03-13",{"date":242,"type":22},{"name":43,"class":44},{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":347,"minAge":19,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":23,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":70},"100453705","exercise-and-the-menstrual-cycle-in-type-1-diabetes-100453705","NCT05188014","Exercise and the Menstrual Cycle in Type 1 Diabetes","Effects of the Menstrual Cycle on Blood Glucose Changes During Exercise in Women With Type 1 Diabetes Using Oral Contraceptives","Inclusion Criteria:\n\n* type 1 diabetes diagnosed for at least 1 year\n* regular menses\n* using monophasic oral contraceptives\n* residing in Edmonton, Alberta and able to visit the lab at the University of Alberta\n\nExclusion Criteria:\n\n* HbA1c \\> 9.9%\n* frequent and unpredictable hypoglycemia\n* change in insulin management strategy within two months of the study\n* use of an automated insulin delivery system\n* blood pressure \\> 140\u002F95\n* history of cardiovascular disease\n* severe peripheral neuropathy\n* active proliferative retinopathy\n* use of medications (other than insulin) that would affect blood glucose levels\n* any musculoskeletal condition that would contraindicate exercise (e.g. sprain, strain, joint injury, etc.)","50 Years",{"count":371,"type":22},15,[25],"Female participants with type 1 diabetes using oral contraceptives will be asked to wear a continuous glucose monitor for at least three days on two separate occasions (once during the last week of active pills and once during the no pill\u002Fplacebo pill phase of the menstrual cycle). An exercise session (45 minutes of aerobic exercise at 60% VO2peak on a cycle ergometer) will take place at 5 pm on the second day of glucose monitoring.",[375],"Type 1 Diabetes",{"date":357,"type":37},{"date":378,"type":37},"2022-03-15",{"date":380,"type":22},"2027-08-30",{"name":43,"class":44},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":51,"enrollmentInfo":390,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":392,"conditions":393,"keywords":399,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":70},"100613918","impact-of-semaglutide-ozempicwegovy-on-heart-and-muscle-mass-100613918","NCT07272837","Impact of Semaglutide (Ozempic\u002FWegovy®) on Heart and Muscle Mass","GLP-1 Receptor Agonist-Induced Muscle Mass Evaluation and Retention","GLIMMER","Inclusion Criteria:\n\n* Adults 18-80 years of age\n* Starting semaglutide for type 2 diabetes or weight loss\n* Able to safely undergo an MRI scan (including meeting the physical requirements for MRI equipment)\n\nExclusion Criteria:\n\n* Current use of semaglutide for more than 2 weeks\n* Major recent heart issues or other severe health conditions\n* Concerns related to MRI use (including magnetic implants, pacemaker, severe claustrophobia)\n* Dependence on a mobility aid (unable to participate in exercise MRI)",{"count":391,"type":22},50,"The aim of this study is to use advanced MRI scans to track changes in both muscle and fat in the body and heart over a 12-month period in individuals starting semaglutide. By doing so, we hope to gain a clearer understanding of how semaglutide affects muscle health and function. Our goal is to ensure the medication supports long-term well-being, particularly for people who may be at higher risk of muscle loss.\n\nThis study involves (3) in-person study visits. At each visit, participants will be asked to:\n\n* Undergo magnetic resonance imaging (MRI) while resting and during exercise to take pictures of their heart, abdomen, and legs.\n* Complete tests to assess balance, sit-to-stand, walking speed, and handgrip strength.\n* Complete questionnaires related to demographics, health information, physical activity, and nutrition.\n* Have a blood sample collected from a vein in your arm.\n* Have your blood levels assessed through three finger pricks.\n* Complete three days of food records.",[394,395,396,397,398],"Type 2 Diabetes","Obesity","Semaglutide","GLP-1","Diabetes",[396,394,398,395,400,401,402,403,404,397,405,406],"Body Composition","Muscle Mass","Skeletal Muscle Mass","Cardiac Muscle Mass","GLP-1 Receptor Agonist","MRI","Magnetic Resonance Imaging","2026-07-15",{"date":409,"type":37},"2026-07-17",{"date":411,"type":37},"2026-05-15",{"date":413,"type":22},"2028-04-30",{"name":43,"class":44},{"id":416,"slug":417,"hasResults":12,"nctId":418,"briefTitle":419,"officialTitle":420,"acronym":421,"eligibilityCriteria":422,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":23,"phases":426,"briefSummary":428,"conditions":429,"keywords":431,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":436,"startDateStruct":437,"completionDateStruct":439,"leadSponsor":441,"locationsCount":96},"100570324","phase-4-tezepelumab-in-the-treatment-of-emergency-room-asthma-in-adults-teraa-100570324","NCT06705764","Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)","Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension","TERAA","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female and\u002For male aged 18 to 55 years\n3. History of physician-diagnosed asthma\n4. All subjects will have been prescribed high dose inhaled corticosteroid (\\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment.\n5. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months\n6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.\n7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug\u002Fmatching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.\n8. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.\n9. Subject willing and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site)\n2. Previous enrolment in the present study\n3. Participation in another clinical study with an investigational product during the last 6 months\n4. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.\n5. Patients who are admitted to hospital at screening.\n6. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.\n7. Known to have tested positive for human immunodeficiency virus\n8. Current smokers with a smoking history of \\> 10 pack-years. Current smokers with a smoking history of \\\u003C 10 pack-years are permitted . Ex-smokers should not have a smoking history \\> 10 pack-years at screening. Participants who use e-cigarettes will also be excluded from the study.\n9. Known history of drug or alcohol abuse within 1 year of screening\n10. Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).\n11. History of QT prolongation associated with other medications that required discontinuation of that medication.\n12. Congenital long QT syndrome.\n13. Creatinine clearance \\\u003C50 ml\u002Fmin (calculated by Cockcroft-Gault formula, reference Appendix G).\n14. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n15. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.","55 Years",{"count":425,"type":22},100,[427],"PHASE4","Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.\n\nA new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.",[430],"Severe Asthma",[432,430,433,434,435],"Asthma","Asthma Exacerbation","Tezepelumab","Emergency deparment visits for asthma",{"date":409,"type":37},{"date":438,"type":37},"2026-05-11",{"date":440,"type":22},"2026-11",{"name":43,"class":44},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":78,"sex":347,"minAge":19,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":452,"conditions":453,"keywords":456,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":70},"100509066","sleep-disordered-breathing-endothelial-function-and-adverse-events-in-pregnancy-100509066","NCT05908591","Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy","SLEEP: Sleep Disordered Breathing, Endothelial Function, and Adverse Events in Pregnancy","SLEEP","Inclusion Criteria:\n\n* over 18 years of age\n* pregnant (20-24 weeks gestation at enrollment)\n\nExclusion Criteria:\n\n* worked shift work past 11pm in the previous month\n* previously diagnosed with a sleep disorder by a physician",{"count":451,"type":22},109,"This is a prospective longitudinal cohort study whereby pregnant individuals are asked to complete an 8-day testing protocol to measure their sleep and cardiovascular health at two timepoints during pregnancy.",[454,455],"Pregnancy Related","Sleep-Disordered Breathing",[457],"Cardiovascular Health",{"date":409,"type":37},{"date":460,"type":37},"2023-01-01",{"date":462,"type":22},"2027-04-18",{"name":43,"class":44},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":471,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":473,"conditions":474,"keywords":476,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":486},"100503623","trifecta-lung-cfdna-mmdx-study-100503623","NCT05837663","Trifecta-Lung cfDNA-MMDx Study","Trifecta-Lung cfDNA-MMDx Study: Comparing the Dd-cfDNA Test to MMDx Microarray Test and Central HLA Antibody Test","Inclusion Criteria:\n\nAdult, Older adult\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they decline participation Are unable to give informed consent. Recipients of multiple organs, cancer patients and pregnant women",{"count":472,"type":22},600,"Demonstrate the relationship between dd-cfDNA levels and HLA antibodies in blood transplant recipient and Demonstrate the Molecular Microscope® (MMDx) Diagnostic System results in indication and protocol biopsies from lung transplants.",[475],"Lung Transplantation",[477,478,479,480],"Donor derived cfDNA","Gene expression","Lung transplant biopsy","Blood",{"date":409,"type":37},{"date":483,"type":37},"2023-11-01",{"date":242,"type":22},{"name":43,"class":44},19,{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":491,"acronym":492,"eligibilityCriteria":493,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":70},"100491618","metabolic-and-inflammatory-outcomes-of-the-ketogenic-diet-comparing-saturated-and-unsaturated-fat-sources-100491618","NCT05681468","Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources","KETO-IM","Inclusion Criteria:\n\n* Having overweight or obesity and HbA1C ≥ 5.7% at screening\n\nExclusion Criteria:\n\n* Individuals with specific nutritional habits preventing them from adhering to nutritional recommendations\n* Pregnant women\n* People on dialysis or recommended to follow a low-protein diet (base on glomerular filtration rate)\n* Familial hypercholesterolemia or hypertriglyceridemia\n* Transitioning trans-gender\n* For safety purposes, other individuals would be excluded if are under unstable health conditions.","70 Years",{"count":496,"type":22},175,[25],"The goal of this clinical trial is to compare a healthy KETO diet supplemented with canola oil (KETO-Can) compared to a traditional KETO diet high in saturated fat (KETO-Sat) and low-fat diet (LFD) in adults at high risk of or diagnosed with type 2 diabetes. The main question\\[s\\] it aims to answer are:\n\n* Effects on CVD risk factors (plasma cholesterol, TG, ApoB100, glucose, insulin and HbA1C).\n* Effects on systemic inflammation and immune function.\n* Adherence to interventions.\n\nParticipants will be randomized into 1 of the dietary treatments during which they will follow a Keto or a low-fat diet.\n\nComparisons among groups at 3 and 6 months of intervention will be conducted.",[500,501,502],"PreDiabetes","Diabetes Mellitus, Type 2","Overweight and Obesity","2026-07-14",{"date":355,"type":37},{"date":506,"type":37},"2023-09-18",{"date":508,"type":22},"2027-01-31",{"name":43,"class":44},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":517,"maxAge":518,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100369906","evaluation-of-effectiveness-of-child-oriented-goal-setting-in-paediatric-rehabilitation-the-engage-approach-100369906","NCT04096430","Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach)","Evaluation of Effectiveness of Child-oriented Goal-setting in Paediatric Rehabilitation (the ENGAGE Approach): A Pragmatic Cluster Randomized Controlled Trial and Economic Analysis","Inclusion criteria are children with a diagnosed disability who:\n\n1. are between the ages of 5-12 years\n2. are able to engage in the goal-setting process (determined by therapists)\n3. are referred to PT and\u002For OT for a period of direct treatment\n4. speak English.\n\nChildren will be excluded from the trial if:\n\n1. the parent or guardian who attends therapy does not speak English\n2. the child has a diagnosis that suggests developmental regression\n3. the child has uncontrolled seizures (i.e., seizure within the past 2 months).","5 Years","12 Years",{"count":520,"type":22},96,[25],"Children with disabilities often access rehabilitation services to improve their abilities to participate in everyday activities. Goal-directed therapy is considered an important therapeutic strategy to achieve outcomes that are meaningful to families. Not a lot is known about the effects of goal setting on rehabilitation outcomes. Strategies to help children participate in the goal-setting process are rarely used in clinical practice. The aim of this project is to test the effects of a child-focussed goal setting approach, Enhancing Child Engagement in Goal Setting (ENGAGE), on therapy outcomes. Service use and the cost vs. benefits of the ENGAGE approach compared to usual practice will also be examined. Children with neurodevelopmental disabilities aged 5-12 years old (n=96) who access paediatric rehabilitation services at six rehabilitation sites will participate. Therapists (n=24) at participating sites in Alberta, Canada will be randomized into 1) the ENGAGE intervention group or 2) the usual therapy practice control group. Children will participate in the ENGAGE approach to goal setting or usual practice based on the allocation of their therapist. This study will determine if the ENGAGE approach to goal setting affects child goal performance, satisfaction with goal performance, functional abilities, participation, and parent and child quality of life. The investigators will also evaluate differences in parent and child quality of life in relation to parent costs (e.g., absenteeism, presenteeism, travel costs) and compare amount of therapy time between the two groups to see which approach is more cost-effective and efficient. After the study, children, parents and therapists will be asked to discuss aspects that influenced effective implementation of the ENGAGE approach. This study could provide evidence to improve meaningful child and family outcomes in paediatric rehabilitation and improve efficiency of paediatric rehabilitation services.",[524,525,526],"Autism Spectrum Disorder","Neurodevelopmental Disorders","Cerebral Palsy",{"date":407,"type":37},{"date":529,"type":37},"2022-03-01",{"date":531,"type":22},"2026-08-31",{"name":43,"class":44},6,{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":540,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":544,"briefSummary":545,"conditions":546,"keywords":548,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":560,"leadSponsor":562,"locationsCount":70},"100645749","withdrawal-of-prostacyclin-pathway-therapy-in-patients-with-pulmonary-arterial-hypertension-receiving-sotatercept-waterloo-100645749","NCT07700303","Withdrawal of Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept (WATERLOO)","Withdrawal of Background Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept: an Open Label Non-inferiority Trial","WATERLOO","Inclusion Criteria: In order to be eligible for this study, a participant must meet all of the following criteria:\n\n1. Adults ≥ 18 years old diagnosed with PAH.\n2. Treatment with sotatercept for ≥6 months.\n3. Background therapy with ≥2 PAH vasodilator therapies, one of which is a parenteral prostacyclin or selexipag.\n4. At low or intermediate-low risk, defined using the 2022 ESC\u002FERS guidelines 4-strata risk assessment tool (Table 1).\n5. RHC at screening or historical within 8 weeks of screening, and after at least 6 months of sotatercept treatment, demonstrating a mPAP ≤40 mmHg and PVR ≤5 WU\n6. The ability to adhere to the study visit schedule and to comprehend and comply with all protocol requirements.\n7. Ability to provide informed consent.\n\nExclusion Criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known intolerance to sotatercept\n2. A RHC at screening or historical within 8 weeks of screening and after ≥6 months of sotatercept treatment demonstrating mPAP \\> 40 mmHg or PVR \\> 5 WU.\n3. Hospitalization for worsening PAH or right heart failure within the 3 months prior to screening.\n4. Active listing for lung or heart\u002Flung transplantation.\n5. Metastatic cancer or any other condition with a life expectancy \\\u003C 6 months,\n6. Female patients who are pregnant or who are of childbearing age and are unwilling to use contraception during the study.\n7. History of ≥ 3 interruptions or missed doses of sotatercept for any reason within the previous 6 months prior to screening.\n8. Patients who received any investigational medication within 1 month prior to screening (unless known to be placebo) or who are scheduled to receive another investigational drug during the course of this study.",{"count":543,"type":22},78,[25],"Pulmonary arterial hypertension (PAH) is a rare lung disease that leads to elevated blood pressure in the lungs and strain on the right side of the heart. For many years, treatments for PAH have included drugs that target the prostacyclin pathway using intravenous, subcutaneous, oral, and inhaled drugs. These drugs help widen the blood vessels in the lungs so the heart does not have to work as hard. However, these medicines can cause side effects such as jaw pain, flushing, diarrhea, and nausea, and the pump therapy can be very hard to manage day-to-day.\n\nA newer medicine called sotatercept works in a different way. It helps fix some of the root causes of PAH. Early reports suggest that some people do very well on sotatercept and may not need to keep taking their prostacyclin therapy. However, investigators do not yet know if it is safe to stop prostacyclin therapies or how to do so. This study, called WATERLOO, is designed to find out whether slowly stopping prostacyclin therapy while the participant is doing well on sotatercept is safe. Investigators will compare people who stop their prostacyclin therapy to people who keep taking it. This study is being done at PAH expert centres in Canada and Europe.",[547],"Pulmonary Arterial Hypertension",[549,550,551,552,553,554,555,556],"Prostacyclin","sotatercept","open label","non-inferiority","Weatherald","Canadian VIGOUR Centre","CVC","pulmonary arterial hypertension","2026-07-13",{"date":407,"type":37},{"date":171,"type":22},{"date":561,"type":22},"2030-03-30",{"name":43,"class":44},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":18,"minAge":369,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":575,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":533},"100645561","behavioral-intervention-and-guided-stepping-training-early-post-stroke-100645561","NCT07702643","Behavioral Intervention and Guided Stepping Training Early Post-Stroke","Behavioral Intervention and Guided Stepping Training Early Post-Stroke (BIG STEPS): A Randomized Controlled Trial Investigating the Effect of a 3-month Behavioral Intervention and Guided Stepping Training in Early Post-stroke Patients.","BIG STEPS","Inclusion Criteria:\n\n* Aged 50 - or older\n* Had an ischemic or hemorrhagic stroke within the last 3 months\n* Have recently returned or are returning home from hospital\n* Able to walk 5 meters with or without a gait aid\n\nExclusion Criteria:\n\n* Previously diagnosed with a mobility limiting musculoskeletal condition\n* Previously diagnosed with a mobility limiting neurological condition\n* Have cardiac conditions (e.g. blood pressure ≥180\u002F100 mmHg)\n* Are without access to an internet-enabled computer or mobile device\n* Are enrolled in another interventional trial such as exercise or neuroprotection trials\n* Have aphasia or are unable to provide consent in English.",{"count":132,"type":22},[25],"Low daily steps and prolonged sedentary behavior are associated with reduced functional outcomes and quality of life in patients with stroke. The goal of this research project is to test the effect of increasing daily step counts and reducing sedentary time early after stroke, on functional mobility and global disability outcomes.\n\nThe investigators aim to recruit 150 participants, aged 50 years and over, within three months of stroke onset, whom have recently returned or are returning home from hospital and are able to walk 5 meters with or without a gait aid. At baseline, demographic and stroke characteristics will be determined and documented. A battery of impairment, psychosocial, and functional measures will be completed. Step counts (primary outcome) and sedentary time will be determined from activPAL accelerometry.\n\nFollowing randomization, a sedentary behaviour change and guided stepping intervention (BIG STEPS) will be extended to the experimental arm (early BIG STEPS), the intervention will span 3 months, with final follow-up assessments every 90 days, until the final assessment at 12 months. The waitlist control group (delayed BIG STEPS) will receive the BIG STEPS intervention after a 6 month wait period.\n\nThe primary outcome of this study is change in step counts from baseline to 3 months, measured with an activPAL accelerometer. Secondary outcomes include sedentary time, functional mobility, and walking endurance measured every 90 days for 12 months. Patient-reported mood, fatigue, and quality of life outcomes will also be assessed.\n\nThe BIG STEPS program will allow individuals with stroke to take an active role in their recovery, encouraging engagement, autonomy and sustained health outcomes. The implementation of a waitlist RCT design allows for the evaluation the critical period for intervention delivery. The results of this trial will help inform future changes in best practice, reducing disability after stroke and improving patient quality of life.",[138],[576,577,578,579],"stroke","daily steps","sedentary time","self efficacy","2026-07-08",{"date":503,"type":37},{"date":583,"type":22},"2026-08-03",{"date":585,"type":22},"2031-06-30",{"name":43,"class":44},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":23,"phases":596,"briefSummary":597,"conditions":598,"keywords":600,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":70},"100603743","phase-4-sotatercept-in-pulmonary-arterial-hypertension-100603743","NCT07140484","Sotatercept in Pulmonary Arterial Hypertension","A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)","Eligible participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Age ≥ 18 years.\n2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:\n\n   * Idiopathic PAH\n   * Heritable PAH\n   * Drug\u002Ftoxin-induced PAH\n   * PAH associated with CTD\n   * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair.\n3. Symptomatic PAH classified as WHO FC II or III.\n4. On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).\n5. Females of childbearing potential must:\n\n   * Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.\n   * If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.\n   * Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment.\n6. Male participants must:\n\n   * Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.\n   * Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment\n7. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.\n8. Ability to understand and provide written informed consent.\n\nExclusion Criteria\n\n1. 1\\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5\n2. Musculoskeletal limitation that precludes participation in cycle ergometry\n3. Resting oxygen saturation \\\u003C 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).\n4. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.\n5. Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.\n6. Baseline platelet count \\\u003C 50,000\u002Fmm3 (\\\u003C 50.0 × 109\u002FL) in the enrollment period.\n7. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\> 160 mmHg or sitting diastolic blood pressure \\> 100 mmHg during a screening visit after a period of rest.\n8. Baseline systolic blood pressure \\\u003C 90 mmHg at screening.\n9. Pregnant or breastfeeding women.\n10. Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002Fm2 (as defined by the Modification of Diet in Renal Disease \\[MDRD\\] equation)\n    * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \\> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).\n11. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.\n12. History of full pneumonectomy.\n13. Pulmonary function test (PFT) values of forced vital capacity (FVC) \\\u003C 60% predicted and\u002For FEV1\u002FFVC \\\u003C lower limit of normal at the screening visit or within 6 months prior to the screening visit.\n14. Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.\n15. Body mass index ≥ 40 kg\u002Fm2.\n16. Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).\n17. Known history of portal hypertension or chronic liver disease, including hepatitis B and\u002For hepatitis C (with evidence of recent infection and\u002For active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).\n18. History of restrictive, constrictive, or congestive cardiomyopathy.\n19. History of atrial septostomy within 180 days prior to the screening visit.\n20. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \\> 500 ms during the Screening Period\n21. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.\n22. Left ventricular ejection fraction \\\u003C 45% on historical echocardiogram within 6 months prior to the screening visit.\n23. Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.\n24. Cerebrovascular accident within 3 months prior to the Screening Visit.\n25. Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).\n26. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.\n27. Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.",{"count":595,"type":22},27,[427],"The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.\n\nParticipants will be asked to:\n\n* Take Sotatercept every 21 days (±3 days)\n* Each participant will be enrolled in the study for 29 Weeks\n* Visit the clinic 18 times\n* Have a physical exam\n* Perform assessments of lung function and exercise tests\n* Have an ultrasound of their heart\n* Have blood draws done at regular intervals\n\nThe main objectives of the study are:\n\nPrimary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.\n\nSecondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.",[599],"Pulmonary Artery Hypertension",[601,602,603],"diffusing capacity","membrane diffusing capacity","pulmonary capillary blood volume","2026-07-07",{"date":606,"type":37},"2026-07-09",{"date":608,"type":37},"2025-10-06",{"date":610,"type":22},"2030-01-01",{"name":43,"class":44},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":626,"overallStatus":237,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":631,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":637},"100550412","low-dose-intensity-vs-standard-dose-intensity-continuous-renal-replacement-therapy-in-critically-ill-patients-wisdom-100550412","NCT06446739","LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM)","LoW Dose-Intensity vs. Standard Dose-Intensity COntinuous Renal ReplaceMent Therapy in Critically Ill Patients (WISDOM): A Pilot Randomized Trial","WISDOM","Inclusion Criteria:\n\n* age ≥ 18 years\n* weight ≥ 55 kg\n* plan to initiate CRRT or within 24 hours of having started CRRT for AKI\n* expected to survive and receive CRRT for a duration of ≥ 48 hours\n* able to provide informed consent or have an authorized representative provide consent after being informed on the details and risks of the trial unless a deferred consent process is approved by local Research Ethics Board (REB).\n\nExclusion Criteria:\n\n* indication for sustained higher dose-intensity CRRT as designated by the attending clinicians\n* end-stage kidney disease receiving maintenance dialysis\n* receipt of any RRT for AKI during the current hospitalization\n* inability to comply with the requirements of the study protocol.",{"count":425,"type":22},[25],"An estimated 10-15% of critically ill patients with acute kidney failure in the intensive care unit receive acute dialysis therapy. The majority of these patients initially receive a continuous form of dialysis therapy call continuous renal replacement therapy (CRRT). Prior studies have suggested that higher CRRT dose-intensity improved health outcomes for these patients; however, this was not found in high-quality clinical trials. These more recent trials suggested a lower range of dose-intensity compared with the higher range as the new standard of care. This was incorporated into guidelines. To date, no clinical trials have evaluated this lower range and specifically, it is plausible that an even lower dose-intensity of CRRT may be well tolerated, safe, associated with similar outcomes and be more cost-effective. This is the objective of the WISDOM trial, to compare the guideline standard with lower dose-intensity among patients who are started on CRRT in the intensive care unit.",[624,625],"Acute Kidney Injury","Dialysis; Complications",[627,628,629,235,630],"acute kidney injury","continuous renal replacement therapy","dose-intensity","pilot feasibility",{"date":606,"type":37},{"date":633,"type":37},"2024-11-14",{"date":635,"type":22},"2027-06",{"name":43,"class":44},10,""]