[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bruyère Health Research Institute.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":286},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,49,77,106,149,177,226,255],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100640038","volunteer-facilitated-discharge-assistance-and-supports-at-home-dash-for-people-with-stroke-100640038",false,"NCT07590076","Volunteer Facilitated Discharge Assistance and Supports at Home (DASH) for People With Stroke","Volunteer Facilitated Discharge Assistance and Supports at Home (DASH) for People With Stroke: An Effectiveness-implementation Hybrid Trial.","DASH","Inclusion Criteria:\n\n* Confirmed diagnosis of stroke\n* Either undergoing or recently completed in-patient rehabilitation within the last 3 weeks\n* Lived at home pre-stroke\n* Discharged directly home (to own residence or that of a family member)\n* Live in one of the program implementation areas (i.e., Toronto, Ottawa)\n\nExclusion Criteria:\n\n* Discharged to additional hospital inpatient care, nursing home, or other long-term care\n* Inability to communicate in English\n* Inability to provide informed consent due to cognitive deficits","ALL",{"count":19,"type":20},840,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to learn if a home visit by a trained volunteer can improve stroke recovery after a stroke survivor is discharged home from the hospital. The main questions it aims to answer are:\n\n1. After 3 months of being discharged from the hospital, does this additional volunteer support at home improve coping skills for stroke survivors?\n2. Does the effects of the volunteer support last over 3 to 6 months after being discharged home?\n\nResearchers will compare between a group who will receive the volunteer support and a group who will not to see if the additional support can improve stroke recovery.\n\nParticipants will:\n\n* Either receive volunteer support over an 8-week time period OR receive no additional volunteer support\n* Continue with their usual care plan and receive educational resources from the research team during the study\n* Complete online surveys during study enrollment, at 3 months, and at 6 months after hospital discharge",[26,27,28],"Stroke","Stroke Rehabilitation","Transitional Care",[30,31,32,33,34,35],"Patient Oriented Research","Community-Based Services","Intersectoral Partnership","Volunteers","Stroke rehabilitation","Transitional care","NOT_YET_RECRUITING","2026-05-15",{"date":39,"type":40},"2026-05-18","ACTUAL",{"date":42,"type":20},"2026-06",{"date":44,"type":20},"2028-04",{"name":46,"class":47},"Bruyère Health Research Institute.","OTHER",6,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100516085","memory-support-system-feasibility-study-100516085","NCT05999929","Memory Support System Feasibility Study","Implementation of the Memory Support System: A Feasibility Study","Inclusion Criteria:\n\n* diagnosis of single or multi-domain MCI\n* Clinical Dementia Rating global (CDR) score of ≤ 0.5\n* Montreal Cognitive Assessment score of ≥18\n* available contact with a care partner ≥ 2 times weekly\n* absence or stable intake of nootropic(s) for ≥ 3 months\n\nExclusion Criteria:\n\n* visual\u002Fhearing impairment and\u002For history of reading or written inability\u002Fdisability sufficient to interfere with MSS training\n* concurrent participation in another related clinical trial","50 Years",{"count":58,"type":20},40,[23],"The purpose of this study is to determining the feasibility of providing the Memory Support System (MSS) to individuals with mild cognitive impairment (MCI) and their partners at a clinic in Ontario, Canada. This will involve a) collecting information from patients referred to the a memory clinic and geriatric day hospital about the patient's interest in and the patient's preferred method to administer the MSS; and b) a cost analysis related to implementation of the MSS. The study will also measure efficacy outcomes of the MSS regarding program adherence as well as to self-reported IADLs, self-efficacy for memory, quality of life, mood, anxiety, and caregiver burden among a sample of individuals with MCI and their care partners",[62],"Mild Cognitive Impairment",[64,65,66],"Cognition","Intervention","French","RECRUITING","2026-03-27",{"date":70,"type":40},"2026-04-01",{"date":72,"type":40},"2023-12-17",{"date":74,"type":20},"2027-03-31",{"name":46,"class":47},1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100617056","improving-care-and-mental-well-being-for-adults-with-heart-failure-100617056","NCT07313657","Improving Care and Mental Well-Being for Adults With Heart Failure","Integrating Mental Health Into Heart Failure Care: A Hybrid Type 1 Pretest-Posttest Feasibility Study of the FRAME Intervention","Inclusion Criteria:\n\nFor Patients (Surveys and Optional Interviews):\n\n* Patients at risk of heart failure (e.g., irregular heartbeat, coronary artery disease, a past heart attack, high blood pressure that is being treated, cardiomyopathy), or with a self-reported\u002Fdocumented diagnosis of heart failure OR on the following list of medications :\n\n  * Angiotensin receptor-neprilysin inhibitors (ARNI), called sacubitril-valsartan\n  * Angiotensin converting enzyme inhibitors (ACEi), called \"prils\"\n  * Angiotensin-receptor blockers (ARBs), called \"sartans\"\n  * Beta-blockers, called \"lols\"\n  * Mineralocorticoid receptor antagonists (MRAs)\n  * Sodium-glucose co-transporter-2 (SGLT2) inhibitors, called \"flozins\"\n* Receiving care at one of the participating pilot test sites or if they found their way to the tool website\n* Willing and able to provide informed consent and name, email address and phone number for follow-up contact (for survey and interview)\n\nCaregivers (Optional interviews):\n\n* Caregivers who support adult(s) with heart failure.\n\nExclusion Criteria:\n\n* Inability to provide informed consent (e.g., due to cognitive impairment or language barriers without translated support)\n* Participants who do not have access to the internet will not be able to use the web-tool.\n\nFor Healthcare Providers\n\n* Providers that are not involved in the care of heart failure patients","40 Years",{"count":86,"type":20},7300,[23],"Heart failure is a high-risk, chronic condition that impacts patients' mental health. Approximately 50% of heart failure patients experience comorbid mental health conditions, such as stress, depression and anxiety, which affect their day-to-day lives. Despite this interconnection, the integration of mental health awareness and support into cardiac care remains limited. To address this gap, the FRAME (Foundation, Recognition, Awareness, Management, Engagement) intervention was co-designed by researchers, healthcare providers, health system decisionmakers, and patient partners. This pilot study evaluates the feasibility of implementing the FRAME intervention in pilot clinical sites within two health regions in Ontario, Canada, including team-based family medicine clinics, cardiac rehabilitation\u002Fspecialist clinics, and emergency departments. Utilizing a pretest-posttest hybrid 1 model intervention design, this study evaluates process indicators and patient-focused outcomes through surveys and semi-structured qualitative interviews. Findings from this study will inform a future large scale cohort study and scalable integration of the FRAME tool into existing cardiac care pathways to enhance mental health awareness and support among heart failure patients.",[90,91,92,93,94],"Heart Failure","Mental Health","Stress","Anxiety","Depression",[96],"Heart Failure and Mental Health","2026-02-12",{"date":99,"type":40},"2026-02-17",{"date":101,"type":40},"2025-09-26",{"date":103,"type":20},"2026-11-30",{"name":46,"class":47},9,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},"100604732","evaluation-of-the-step-intervention-for-long-term-care-residents-facing-hospital-transfer-decisions-100604732","NCT07153341","Evaluation of the STEP Intervention for Long-Term Care Residents Facing Hospital Transfer Decisions","A Pre-Post Trial Evaluating the Supporting Transitions and Empowering Preferences (STEP) Decision Support Intervention for Long-Term Care Residents Facing Hospital Transfer Decisions During Acute Health Crises","STEP","Inclusion Criteria\n\nResidents-care partner dyads:\n\n* Must be residents of either Perley Health or Bruyère Health Saint-Louis LTC home.\n* Residents must be 55 years of age or older.\n* Must be able to communicate in French or English.\n\nBoth members of the dyad will be included where applicable. For dyads in which residents do not have the capacity to participate, inclusion will occur through the involvement of their substitute decision-maker (e.g., power of attorney for personal care).\n\nLTC staff:\n\n* Must be a nurse, nurse practitioner, social service worker or physician actively involved in care planning, annual conferences, or managing acute health events at Perley Health or Bruyère Health.\n* Must have been employed at the LTC home for at least 6 months to ensure familiarity with the care environment and residents.\n* Must play a role in facilitating discussions, providing clinical input (where applicable), or guiding decision-making processes related to hospital transitions or acute care management.\n* Must be able to communicate in French or English.","55 Years",{"count":116,"type":20},200,[23],"This trial will evaluate whether the Supporting Transitions and Empowering Preferences (STEP) toolkit can improve decision-making about hospital transfers in long-term care residents and their substitute decision-makers and enhance decision self-efficacy in nursing staff.\n\nThe trial will answer the questions:\n\n* Does the STEP tool reduce decisional conflict in residents and care partners at the time of transfer decisions?\n* Does it improve nurse self-efficacy related to hospital transfer decisions?\n\nParticipants will:\n\n* Use the STEP tool during key moments of care planning (admission, care conferences, and acute events)\n* Complete a short survey measuring their decisional conflict\n* Be supported by trained nurses who use STEP to guide hospital transfer discussions\n\nResearchers will compare data collected before and after the STEP tool is implemented at two long-term care homes to see if it improves shared decision-making related to hospital transfers by reducing decisional conflict.",[120],"LTC-to-hospital Transfer Decision-making",[122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139],"long-term care","hospital transfers","acute health events","decision-making in older adults","resident-centred care","substitute decision-makers","frailty","cognitive impairment","shared decision-making","avoidable hospitalizations","transitional care","decision aid","health decision support","decision coaching","pre-post intervention study","healthcare quality improvement","decisional conflict","decisional regret","2026-02-04",{"date":142,"type":40},"2026-02-06",{"date":144,"type":40},"2025-10-01",{"date":146,"type":20},"2027-09-01",{"name":46,"class":47},2,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100597851","phase-3-psilocybin-microdose-for-psychological-and-existential-distress-in-palliative-care-psyched-pal-rct-100597851","NCT07063862","Psilocybin Microdose for Psychological and Existential Distress in Palliative Care (PSYCHED-PAL-RCT)","PSilocybin Microdose for psYCHological and Existential Distress in PALliative Care (PSYCHED-PAL): A Multi-site Phase 3 Double-blind, Placebo-controlled, Parallel-arm Clinical Trial","Inclusion Criteria:\n\n1. Patients \\>\u002F=18 years of age with advanced illness under palliative care management, defined as having an estimated 2 to 12 months life expectancy (in the judgment of the palliative care provider)\n2. Experiencing psychological distress, defined as a score of 7 or greater on the Depression, Anxiety, or Well-being item of the Edmonton Symptom Assessment System-revised (ESAS-r)\n3. Living situation falls under one of two categories:\n\n   1. Living in the community (i.e., receiving palliative care as an outpatient or through community home visits)\n   2. Living in a chronic care inpatient facility (i.e., receiving long-term supportive care because care is unable to be provided in a community home - e.g., ALS) and have a family member who can administer the psilocybin\u002Fplacebo medication to the patient\n4. Ability to understand and communicate in English or French\n5. For patients in community settings, patients must be able to have another individual present with them during and for 2 hours after they take their psilocybin\u002Fplacebo dose for the first week of the intervention period\n\nExclusion Criteria:\n\n1. Current or previously diagnosed, or first-degree relative with, psychotic or bipolar disorder\n2. Previously deemed eligible for MAiD with intention to proceed with MAiD regardless of study intervention effectiveness (this criteria is meant to exclude patients who would be unlikely to complete follow-up - those considering or being assessed for MAiD will still be eligible)\n3. Documented or suspected delirium in the past 3 months without a clearly defined reversible cause (e.g. opioid toxicity, infection) and resolution\n4. Documented moderate or severe dementia diagnosis\n5. Inability to provide first-person informed consent\n6. Inability to complete assessments via telephone or video-conferencing platform\n7. Severe or unstable physical symptoms based on the judgment of the palliative care provider\n8. Palliative Performance Scale (PPS) \\\u003C50%\\*\n9. Cancer with known central nervous system (CNS) involvement or other CNS disease\n10. Use of high-dose psychedelic substances in the past year\n11. Taking lithium at any dose\n12. Taking tramadol at any dose\n13. Taking tapentadol at any dose\n14. Taking any monoamine oxidase inhibitor at any dose \\[American Hospital Formulary Service (AFHS) group 28:16.04.12 or 28:36.32, including, but not limited to, moclobemide, tranylcypromine, phenelzine, selegiline, rasagiline\\]\n15. Taking any atypical antipsychotic (aripiprazole, asenapine, brexpiprazole, clozapine, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)\n\n    a. Note: patients can be included if their atypical antipsychotic is stopped or, if appropriate, substituted with haloperidol 48 hours prior to the start and for the duration of the intervention period and follow-up.\n16. No enteral route of drug administration available\n17. Pregnancy or lactation\n\n    * Does not apply to the open-label access or open-label extension phases (since participants are expected to decline in overall health and function from baseline due to natural disease progression towards the end of life).\n\nIndividuals with dementia (assessed at baseline by the treating team - no formal screening of dementia will be done during the intervention or follow-up period) or delirium are excluded. While the safety and effects of psilocybin have not previously been studied in these populations, it can be reasonably assumed that hallucinogenic substances could exacerbate or lead to worsening of delirium or dementia symptoms common among people at the end of life (e.g., confusion, agitation).\n\nThe use of selective serotonin reuptake inhibitors (SSRIs) and antipsychotic medications (other than atypical antipsychotics) is a relative contraindication. For participants taking either an SSRI or an antipsychotic medication, there are several conditions for participation: (1) the palliative care provider must approve their participation in the study; (2) the SSRI\u002Fantipsychotic medication dose cannot change for the duration of the intervention trial and follow-up, and; (3) the patient must not be taking more than the maximum allowable trial dose for each SSRI.\n\nThe decision to not include SSRI and antipsychotic medications as an absolute contraindication was three-fold. Firstly, there is no empirical evidence from psilocybin microdosing literature that supports these medications as absolute contraindications. Risks related to serotonin syndrome are theoretical in nature for microdosing protocols, with no actual cases being observed. Secondly, the physician investigator team has estimated the risk to participants of rebound syndrome and associated symptoms from being taken off SSRIs and\u002For antipsychotics to be similar to or greater than that of serotonin syndrome. Lastly, to safely have participants stop taking SSRIs and\u002For antipsychotic medications, this would require a relatively long period of time (weeks to months) to taper the medication, which is not feasible for palliative care and end-of-life populations.\n\nAll trial participants must agree to not take any other psychedelic substance for the duration of the clinical trial and follow-up, and to notify the investigative team of any medication changes during intervention or follow-up. Participants must also notify the investigative team if any cannabis products are consumed during the treatment days. Participants must also agree not to take their benzodiazepine or antipsychotic medication, if applicable, within 12 hours (6 hours pre and 6 hours post) of taking their study dose. Participants must also agree not to drive or operate any heavy machinery on any treatment day after taking the drug (psilocybin or placebo) for the duration of the 2-week intervention. Lastly, for patients in the community setting, participants must agree not to take the study dose alone for the first week of the intervention; at least one individual must stay with the participant at the time they take their dose and for at least 2 hours following dose administration. This is to ensure participants are not alone in the event of a serious adverse drug reaction.","18 Years",{"count":158,"type":20},120,[160],"PHASE3","About 30-50% of patients with advanced illness experience depression, anxiety, or decreased sense of purpose and autonomy. Together, these are called psychological distress. Treatment options such as medication and therapy are available; however, they do not always work and can be time-consuming and expensive. We need treatments that work well, quickly, and can be available to all patients with advanced illness who have psychological distress.\n\nPsilocybin, a psychedelic medication (commonly called 'magic mushrooms') works well for improving psychological distress in people with cancer or chronic illness when given in high doses with specific forms of therapy. However, psilocybin has not been well-studied among people with advanced illness, and there are concerns about safety and side effects in people approaching the end of life.\n\nHowever, reports on psilocybin microdosing, which involves taking small doses that do not cause hallucinations and do not require therapy, suggest that this may be effective, safer, and more acceptable for people with advanced illness. We recently completed a small study of psilocybin microdosing. Our results showed psilocybin microdose improved psychological distress in most participants with advanced illness, without serious side effects. Our next step is to do a randomized clinical trial where some patients receive psilocybin microdose and some receive placebo (a drug that contains no medicinal ingredients). By comparing these two groups, we can remove the possibility that improvements in symptoms are only because patients thought they were getting treatment.\n\nWe will enroll 120 patients from inpatient, outpatient, and community care settings across seven sites. Participants in the microdose psilocybin group will receive 2 or 3 mg of psilocybin daily, 4 days per week, for two consecutive weeks. The placebo group will receive placebo with the same treatment schedule. All participants will be offered microdose psilocybin after 2-week follow-up. If this study is successful, we have the potential to change how psychological distress is managed in patients with advanced illness.",[163],"Psychological Distress",[165,166,167],"Psychological distress","psilocybin","microdosing","2026-01-26",{"date":170,"type":40},"2026-01-27",{"date":172,"type":20},"2026-01",{"date":174,"type":20},"2027-09",{"name":46,"class":47},7,{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":185,"sex":186,"minAge":187,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":191,"phases":4,"briefSummary":192,"conditions":193,"keywords":203,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":76},"100612012","smartphone-vs-manual-interpretation-of-biomarkers-for-ovulation-and-luteal-phase-detection-smom-study-100612012","NCT07248046","Smartphone vs Manual Interpretation of Biomarkers for Ovulation and Luteal Phase Detection (SMOM Study)","Comparing Cervical Mucus, PDG, LH, and Basal Body Temperature Combinations for Ovulation and Luteal Phase Identification Using the Premom Smartphone App Versus User-Read Test Results: A Prospective Observational Study","SMOM","Inclusion Criteria:\n\n* Female, aged 16 to 45\n* Natural menstrual cycles equal or less than 35 days\n* Off hormonal contraception for more than 3 months\n* Current user of the Premom App\n* Willing to track cervical mucus, LH, PDG, and BBT for 3 full cycles\n* Lives within 50 km of study site in the Ottawa region\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Current hormonal therapy or contraception\n* Known anovulatory disorders, e.g., Polycystic Ovary Syndrome, hypothalamic amenorrhea.\n* Very irregular or absent cycles\n* Not using the Premom App\n* Unable or unwilling to complete tracking or provide consent",true,"FEMALE","16 Years","45 Years",{"count":190,"type":20},30,"OBSERVATIONAL","This study will compare different combinations of fertility signs (cervical mucus (CM), luteinizing hormone \\[LH\\], pregnanediol glucuronide \\[PDG\\], and basal body temperature \\[BBT\\]) to determine which are most reliable for identifying ovulation and luteal phase length. Thirty existing Premom App users will track daily observations for three menstrual cycles. Participants will record mucus, perform urine tests, upload test strip photos to the Premom App, and measure BBT. Both participant readings and AI-assisted app readings will be analyzed. The main goal is to find which marker pairings give the most accurate picture of ovulation timing and luteal phase length. Secondary goals include understanding ease of use, the number of tests required, and whether the app improves accuracy.",[194,195,196,197,198,199,200,201,202],"Fertility","Mobile Applications","Artifical Intelligence","Cervical Mucus","Body Temperature","Luteinizing Hormone (LH)","Ovulation","Menstrual Cycle","Progesterone",[200,204,201,194,197,205,206,202,207,208,209,195,210,211,212,213,214,215,216,217],"Luteal Phase","Luteinizing Hormone","Pregnanediol Glucuronide","Basal Body Temperature","Female Reproductive Physiology","Fertility Awareness-Based Methods","Smartphone App","Artificial Intelligence","Self-Testing","Home Diagnostic Tests","Observational Study","Prospective Studies","Digital Health","Women's Health","2026-01-10",{"date":220,"type":40},"2026-01-13",{"date":222,"type":20},"2026-01-15",{"date":224,"type":20},"2026-11-15",{"name":46,"class":47},{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":76},"100589375","transcranial-magnetic-stimulation-to-treat-prolonged-grief-disorder-100589375","NCT06953596","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder","Transcranial Magnetic Stimulation to Treat Prolonged Grief Disorder: A Single-centre, Single-arm, Open-label Phase I\u002FII Proof-of-concept and Feasibility Clinical Trial","Inclusion Criteria:\n\n1. Bereaved individuals \\>\u002F= 18 years of age\n2. Score \\>25 on the Inventory of Complicated Grief\n3. Must have a primary care physician\n4. Ability to understand and communicate in English\n5. Ability to provide first-person informed consent\n\nExclusion Criteria:\n\n1. Current or previously diagnosed seizure disorder\n2. Documented brain lesions\n3. Contraindications to TMS (i.e., metallic skull plates, clips, stimulators, pacemakers)\n4. Current substance abuse disorder (e.g., schizophrenia)\n5. Pregnancy or lactation, or trying to conceive\n6. Advanced, incurable illness with an expected prognosis of \\\u003C3 months - bereaved family members are known to be at elevated risk of death from medical illness, but if death is expected in the near future, it would be difficult to justify using an entire week of their limited time for an unproven therapy.",{"count":234,"type":20},15,[23],"Grief is a normal response after the death of a loved one. With time, the grief response decreases and people learn to cope with their loss. However, for some, the response becomes more intense and distressing. This is called prolonged grief disorder (PGD). People with PGD experience emotional pain and a deep longing for their loved one. PGD normally occurs \\\u003C10% of people after a loss, but it has become more common since the COVID-19 pandemic (\\~30%). If left untreated, PGD leads to poor quality of life and increased risk of death. Treatment options such as medication and therapy are available; however, they can cause negative side effects and take a long time to work. To help individuals with PGD, we need treatments that work well and quickly.\n\nRepetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive treatment that delivers magnetic pulses to brain areas responsible for mood. rTMS has been approved in Canada to treat mood disorders. There is research to show that rTMS is safe and well-tolerated, and that works well in treating Post-Traumatic Stress Disorder (PTSD), a condition with similar symptoms to PGD. To determine whether rTMS is effective for treating PGD, we first need to determine if rTMS as a treatment for PGD is safe and feasible among grieving individuals.",[238,239],"Prolonged Grief Disorder","Complicated Grief",[241,242,243,244,245,246],"Neuromodulation","Repetitive Transcranial Magnetic Stimulation","Bereavement","Proof-of-Concept","Feasibility","Intermittent Theta Burst Stimulation (iTBS)","2025-04-29",{"date":249,"type":40},"2025-05-01",{"date":251,"type":20},"2025-07-01",{"date":253,"type":20},"2026-04-30",{"name":46,"class":47},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":156,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":21,"phases":264,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100425758","phase-1-effects-of-dexmedetomidine-in-patients-with-agitated-delirium-in-palliative-care-100425758","NCT04824144","Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care","Effects of Dexmedetomidine in Patients With Agitated Delirium in Palliative Care: an Open-label Phase 1\u002F2 Proof-of-concept, Feasibility, and Dose-finding Clinical Trial","Inclusion Criteria:\n\n1. Adult patients (≥18 years)\n2. Admitted to a participating inpatient palliative care unit\n3. Meeting one of the following criteria:\n\n   1. Agitated delirium: (i) Richmond Agitation-Sedation Scale for palliative care patients (RASS-PAL) score of +2 or greater and (ii) Confusion Assessment Method (CAM) positive status and (iii) Without a known potentially reversible cause (e.g. hypercalcemia, specific medication infection, etc.), or in whom the patient\u002FSubstitute Decision Maker (SDM) has requested not to treat the cause.\n   2. Previous history of delirium (in the last 6 months)\n   3. Patient is within the last two weeks of life and is expected to die during this admission (MRP judgement)\n\nExclusion Criteria:\n\n1. Hemodynamic instability (systolic blood pressure \\\u003C80mmHg)\n2. Bradyarrhythmia (heart rate \\\u003C 60) at baseline\n3. Patients on verapamil, diltiazem, or beta-blocker (patients are eligible if these medications are stopped prior to receiving dexmedetomidine)",{"count":263,"type":20},50,[265,266],"PHASE1","PHASE2","The goal of this multi-centre phase I\u002FII open-label, single-arm study is to determine the feasibility, optimal dose, and preliminary efficacy of dexmedetomidine to manage agitated delirium among patients near the end of life followed by a palliative care provider in a non-monitored setting. Fifty patients will receive dexmedetomidine (0.4 mcg\u002Fkg\u002Fhour, titrated up to 1.0 mcg\u002Fkg\u002Fhour) subcutaneously. Feasibility (recruitment rate, cost), safety (rate of adverse events), dosing, and preliminary efficacy (agitation, delirium severity) will be measured.",[269,270],"Hyperactive Delirium","Delirium of Mixed Origin",[272,273,274,275,276],"Dexmedetomidine","Agitation","Delirium","Palliative","End of life","2025-04-11",{"date":279,"type":40},"2025-04-15",{"date":281,"type":40},"2024-01-30",{"date":283,"type":20},"2026-03-31",{"name":46,"class":47},3,""]