[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Queen's University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":531},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,53,80,113,148,174,206,233,259,282,316,345,374,399,424,449,480,505],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100638709","prehabilitation-before-major-surgery-100638709",false,"NCT07590141","Prehabilitation Before Major Surgery","PRehabilitation In Advance of Major Elective Surgery: A Pilot Randomized Controlled Trial (PRIME Pilot)","PRIME","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Undergoing major elective intra-thoracic, intra-abdominal or orthopedic surgery. Major surgery is defined as any operation performed under general and\u002For spinal anesthesia requiring a skin incision extending beyond the subcutaneous tissue\n* More than 3 weeks from the date of scheduled operation\n\nExclusion Criteria:\n\n* Emergency Surgery\n* Operation in less than 3 weeks from time of initial research contact\n* Patients who are pregnant\n* Unable\u002Funwilling to sign written informed consent\n* Physical, cognitive or psychological impairment\n* Unable to understand\u002Fcommunication in English.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to learn if a virtually monitored, home-based prehabilitation program is feasible and acceptable for adults undergoing major elective surgery. The main questions it aims to answer are:\n\n1. Can researchers successfully recruit and retain participants across multiple sites?\n2. Will participants adhere to the prehabilitation program at a high enough rate to justify a larger trial?\n\nResearchers will compare the prehabilitation program to standard preoperative care to see if the intervention is feasible to implement and whether it may help reduce postoperative complications.\n\nParticipants will:\n\n* Be randomly assigned to receive either the prehabilitation program or usual care\n* Complete questionnaires and physical assessments before and after the intervention\n* (For those in the intervention group) Receive exercise, nutrition, and mindfulness guidance, protein supplements, and use the CloudDX virtual care platform to support their activities",[27,28,29,30,31],"Prehabilitation","Preoperative Care","Elective Surgical Procedures","Postoperative Complications","Surgical Procedures, Operative",[33,34,35,36,37,38,39],"Home-based Care","Virtual Care","Remote Health Monitoring","Exercise Therapy","Nutritional Support","Psychological Support","Postoperative Outcomes","NOT_YET_RECRUITING","2026-05-10",{"date":43,"type":44},"2026-05-15","ACTUAL",{"date":46,"type":21},"2026-06-01",{"date":48,"type":21},"2028-01-31",{"name":50,"class":51},"Queen's University","OTHER",3,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100633393","developing-a-colonoscopy-preparation-protocol-for-patients-with-diabetes-100633393","NCT07526103","Developing a Colonoscopy Preparation Protocol for Patients With Diabetes","Inclusion Criteria:\n\n1. Patients Age over the age of 18\n2. Able to read and understand the English language\n3. Confirmed diagnosis of diabetes (Type 1 or Type 2)\n\nExclusion Criteria:\n\n1. Patients without diabetes\n2. Patients with prior hospital admission due to hypoglycemic events\n3. Patients who have inflammatory bowel disease\n4. Patients with ileus or bowel obstruction\n5. Patients with history of colorectal resection\n6. Patients receiving combined upper and lower endoscopies\n7. Patients with ascites\n8. Patients with previously documented severe renal impairment\n9. Unable to provide consent\n10. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)\n11. Patients who have had a recent myocardial infarction(\\\u003C6months)\n12. Allergy to product ingredients","75 Years",{"count":61,"type":21},40,[24],"Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied.\n\nStudies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation.\n\nThis study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.",[65,66,67],"Hypoglycaemia","Diabete Mellitus","Colonoscopy (Ambulatory Patients)",[69,70,71],"glucose monitoring","diabetes protocol","bowel preparation","2026-04-21",{"date":74,"type":44},"2026-04-24",{"date":46,"type":21},{"date":77,"type":21},"2028-06-01",{"name":50,"class":51},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":79},"100628056","phase-2-caffeine-for-infants-born-at-28-to-34-weeks-receiving-respiratory-support-100628056","NCT07456670","Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support","Caffeine Therapy in Preterm Infants Born at 28-34 Weeks: A Pilot Placebo-Controlled Randomized Controlled Trial","CARES-Pilot","Inclusion Criteria:\n\n* Infant born at a gestational age between 28+0 and 34+6 weeks.\n* Admitted to the Neonatal Intensive Care Unit (NICU) within the first 72 hours of life.\n* Requiring either invasive respiratory support (mechanical ventilation) or non-invasive respiratory support (e.g., CPAP, High Flow Nasal Cannula) within the first 72 hours of life.\n* Informed consent obtained from parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n* Presence of dysmorphic features or major congenital malformations that adversely affect life expectancy.\n* Known or strongly suspected cyanotic heart disease.\n* Infants born at \\\u003C28 weeks' gestational age (due to high risk of apnea requiring routine caffeine).\n* Late preterm infants born at ≥35+0 weeks' gestational age (due to short NICU stay not allowing for a safe caffeine-free period before discharge).","0 Days","28 Days",{"count":91,"type":21},62,[93],"PHASE2","The goal of this pilot clinical trial is to test if it is possible to conduct a larger study on the use of caffeine in preterm infants who need help with their breathing. It will also look at whether caffeine helps these infants get healthy enough to leave the hospital sooner.\n\nThe main questions the researchers aim to answer are:\n\nCan the investigators successfully recruit and keep enough participants in the study? Do the medical teams follow the study drug instructions correctly? Does caffeine reduce the total time infants spend in the Neonatal Intensive Care Unit (NICU)? Researchers will compare caffeine to a placebo (a look-alike substance with no active medicine) to see if caffeine is a helpful treatment for babies born between 28 and 34 weeks of gestation who are using a breathing machine or oxygen.\n\nParticipants will:\n\nBe randomly assigned to receive either caffeine or a placebo through an IV or a feeding tube.\n\nReceive the study treatment once a day as long as they require respiratory support (and for 24 hours after they stop).\n\nBe monitored by the research team for clinical outcomes like feeding progress, breathing stability, and growth until they are discharged from the hospital.",[96,97,98],"Preterm Birth","Caffeine","Neonatal Outcomes",[97,100,101,102,103,104],"Neonatal Intensive Care Unit","Prematurity","RCT","NICU","Pilot Study","2026-03-06",{"date":107,"type":44},"2026-03-10",{"date":109,"type":21},"2026-04-01",{"date":111,"type":21},"2028-03-31",{"name":50,"class":51},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":132,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":79},"100592896","does-a-virtual-program-for-pelvic-pain-improve-pain-and-sexual-outcomes-in-individuals-with-provoked-vestibulodynia-100592896","NCT06999395","Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?","Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial","PVD","Inclusion Criteria:\n\n* Self-reported physician diagnosis of provoked vestibulodynia (PVD)\n* PVD duration of at least 3 months\n* PVD pain intensity rating of at least 3 on a scale from 0 (no pain) to 10 (extreme pain)\n* Resides in North America (Canada or the United States)\n* Fluent in English\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Pregnancy or suspected pregnancy\n* Breastfeeding\n* Up to one year postpartum\n* Physical or mental health conditions that significantly interfere with activities of daily living","FEMALE",{"count":123,"type":21},250,[24],"The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are:\n\n* How well does the program work to improve pain and sexual wellbeing?\n* How well does the program work to improve pain anxiety and pain interference?\n* How do participants rate their improvement after completing the program?\n* How satisfied are participants with the program?\n\nResearchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will\n\n* Progress through the program at their own pace\n* Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain\n* Answer questions about their pain experiences and sexual wellbeing before and after the 3-month program, as well as 3 months after the end of the program\n* Provide information about their experiences with the program and progress through the program during and after the program",[127,128,129,130,131],"Vulvodynia (Chronic Vulvar Pain)","Vulvar Vestibulitis","Vestibulodynia","Provoked Vestibulodynia","Provoked Localized Vulvodynia",[133,134,135,136,137,138],"vulvodynia","provoked vestibulodynia","virtual pelvic health program","pain and sexual wellbeing outcomes","randomized controlled trial","intervention","RECRUITING","2026-02-09",{"date":142,"type":44},"2026-02-12",{"date":144,"type":44},"2025-12-17",{"date":146,"type":21},"2028-12",{"name":50,"class":51},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":17,"minAge":156,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":79},"100446324","connecting-families-100446324","NCT05091957","Connecting Families","CONNECTING FAMILIES: A Randomized Controlled Trial of Primary Care Poverty Screening and Financial Support Navigation for Families of Young Children","Inclusion Criteria:\n\n* Parents of children (younger than 3 years) attending a regularly scheduled primary care visit.\n* Parents respond affirmatively to the question \"Do you ever have difficulty making ends meet at the end of the month?\"\n* Informed parental consent. Only one child will be enrolled per family. For families with more than one child, we will enroll the youngest eligible child, since literature suggests that impact of reducing family stress may be greater at younger ages; for multiple births, one child will be randomly selected for inclusion.\n\nExclusion Criteria:\n\n1. Parents without legal status in Canada, as they are not eligible for many Canadian social programs.\n2. Families who are receiving system navigation support, such as from a social worker or public health nurse, or who have received system navigation support within one year prior to enrolment.\n3. Child with a previously diagnosed developmental disorder, genetic, chromosomal or syndromic condition.\n4. Child born prematurely (gestational age less than 32 weeks).",true,"1 Day","3 Years",{"count":159,"type":21},80,[24],"Living in poverty has a profound negative impact on parenting stress and children's health. When poverty occurs early in childhood and continues for a long time, the impact on child health can be lifelong. Child poverty is common, affecting about 20% of Canadian children. Many low income families may not be receiving all the social benefits for which they are eligible. There are calls for primary care providers to ask patients if they have difficulty making ends meet at the end of the month and to intervene if poverty is identified, but it is not known if intervening can improve parent's and children's health. This study will test whether a Community Support Worker who helps families with young children navigate the social service system by reviewing social needs (like food, housing or energy insecurity) and income supports can lead to increased family income, reduced parenting stress and an improvement in their child's health. The Community Support Worker will help families complete income tax, apply for benefits and community supports for which they are eligible. The investigators will also study the effect of this intervention on health care utilization. Our study will be conducted in Toronto and Kingston in primary care practices participating in the TARGet Kids! primary care research network. Results from this study will help health care providers and policy makers understand whether Community Support Workers are an effective way to integrate the health and social service systems to improve parent and child health.",[163,164,165],"Poverty","Primary Care","Intervention","2026-01-11",{"date":168,"type":44},"2026-01-13",{"date":170,"type":44},"2022-05-17",{"date":172,"type":21},"2026-04",{"name":50,"class":51},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":155,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":191,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":79},"100606653","human-skeletal-muscle-response-to-5-days-of-bedrest-in-young-adults-100606653","NCT07178353","Human Skeletal Muscle Response to 5 Days of Bedrest in Young Adults","Changes in Muscle Mass, Strength, and Muscle Protein Synthesis in Response to 5 Days of Bedrest in Young, Healthy Adults","FABRIC","Inclusion Criteria:\n\n* Males and females 18-30 years\n* BMI between 18.5-28 kg\u002Fm2\n* Weight stable (within ±2kg for 6 months)\n* Generally healthy as assessed by medical and physical activity questionnaires\n* recreationally active\n\nExclusion Criteria:\n\n* a BMI \\\u003C 18.5 and \\> 28 kg\u002Fm2\n* the use of insulin to control blood glucose levels\n* a history of any cardiovascular, respiratory, metabolic diseases, neuromuscular or bone-wasting diseases\n* the use of any medication that may affect muscle protein turnover (e.g. androgen or anabolic hormone therapy, chemotherapy)\n* a (family) history of thrombosis, platelet or coagulation disorders, or antiplatelet therapy and the use of anticoagulant medications\n* the presence of any unremoved, or partially removed metals underneath the skin\n* a history of head or eye injury involving metal fragments\n* have some type of implanted electrical device (such as a cardiac pacemaker or neurostimulator)\n* have implanted metal objects as a result of surgery, such as artificial joints, aneurysm clips, metal staples\n* are, or may be, pregnant\n* are wearing metal braces on their teeth.","30 Years",{"count":184,"type":21},12,[24],"The goal of this intervention trial is to characterize skeletal muscle atrophy in healthy, young adults during short term bedrest. The main questions it aims to answer are:\n\nHow much do skeletal muscle volume, strength, and fatigue resistance decline during bedrest? How much does whole-body insulin sensitivity change during bedrest? How do mitochondrial function and protein synthesis change during bedrest?\n\nParticipants will undergo the following tests before and after a free-living control period and before and after a 5 day period of strict horizontal bedrest:\n\n* Magnetic resonance imaging of the thigh muscles\n* Strength testing of the thigh muscles\n* Insulin sensitivity testing in response to a mixed meal\n* Exogenous glucose oxidation in response to a mixed meal\n* Muscle biopsies from the thigh muscles\n* Blood samples",[188,189,190],"Muscular Atrophy","Insulin Resistance","Muscle Protein Synthesis",[192,193,194,195,196,197],"magnetic resonance imaging","muscle protein syntheis","muscle disuse atrophy","bedrest","skeletal muscle","insulin sensitivity","2025-09-16",{"date":200,"type":44},"2025-09-22",{"date":202,"type":21},"2025-09",{"date":204,"type":21},"2027-06",{"name":50,"class":51},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":155,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":212,"targetDuration":156,"studyType":214,"phases":4,"briefSummary":215,"conditions":216,"keywords":220,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":4},"100595761","bone-enhanced-ultrasound-beus-data-library-development-project-100595761","NCT07036653","Bone Enhanced Ultrasound (BEUS) Data Library Development Project","Inclusion Criteria:\n\n* Individuals who have had previous CT or MRI scans of their spine in the past 5 years\n\nExclusion Criteria:\n\n* \\\u003C 18 years old",{"count":213,"type":21},100,"OBSERVATIONAL","A common treatment for low back pain involves fluoroscopy-guided spinal facet joint injections and\u002For medial branch nerve blocks. Unfortunately, fluoroscopy requires expensive equipment and personnel and exposes patients and healthcare providers to ionizing radiation. Ultrasound offers a safer, lower-cost alternative, but the traditional 2-dimensional (2D) ultrasound systems are limited due to poor image quality, particularly in patients with higher body mass index (BMI).\n\nAs an alternative, a novel Bone Enhanced Ultrasound (BEUS) technology uses artificial intelligence (AI) to create real-time 3-dimensional (3D) images of the spine to guide needle placement for these injections. The AI software is trained by overlaying computed tomography (CT) and ultrasound images from a patient dataset to recognize anatomical landmarks. BEUS aims to ultimately replace fluoroscopy for spinal injections, reducing radiation exposure, lowering healthcare costs, and improving accessibility, especially in rural settings where CT and fluoroscopy are unavailable.\n\nA key limitation, however, is that the current AI system is trained based primarily on patients (mostly pediatric) undergoing perioperative assessment of scoliosis. To address this, the current study aims to develop a new, more clinically relevant training AI dataset by collecting spinal ultrasounds from up to 100 adult participants (most\u002Fall of whom are followed at the local chronic pain clinic for low back pain) with existing spinal CT or magnetic resonance imaging (MRI) scans. This dataset will be used to retrain the current AI model to enhance the accuracy of 3D spinal reconstructions, thereby improving the clinical relevance of the BEUS system.",[217,218,219],"Lower Back Pain","Facet Joint Pain; Low Back Pain","Osteoarthritis (OA)",[221,222,223,224],"Facet joint injection","Spine ultrasound","3D ultrasound","Low back pain","2025-07-28",{"date":227,"type":44},"2025-07-29",{"date":229,"type":21},"2025-09-01",{"date":231,"type":21},"2025-12-31",{"name":50,"class":51},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":241,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":22,"phases":244,"briefSummary":246,"conditions":247,"keywords":249,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":52},"100572660","early-phase-1-early-genomic-testing-for-inherited-bleeding-disorders-100572660","NCT06736158","Early Genomic Testing for Inherited Bleeding Disorders","Early Genomic Testing for Inherited Bleeding Disorders in Patients Without a Diagnosis After First Line Testing: a Randomized Controlled Trial","GT4BD","Inclusion Criteria:\n\n* New patient referred for abnormal bleeding.\n* Hemostasis expert clinician determined abnormal bleeding history AND family history of bleeding\n* OR no family history of bleeding but hemostasis expert clinician determined severe bleeding history.\n\nExclusion Criteria:\n\n* Prior diagnosis of an inherited bleeding disorder.\n* Acquired cause of bleeding (i.e., medication known to cause bleeding, significant renal or hepatic disease)","12 Years",{"count":243,"type":21},212,[245],"EARLY_PHASE1","The investigators aim to test the introduction of genomic testing early in the diagnostic pathway for inherited bleeding disorders in patients who have not received a diagnosis after first-line testing.\n\nThe goal of this clinical trial is to test the introduction of genomic testing early in the diagnostic pathway for patients referred to Hematology for a suspected inherited bleeding disorder. The main questions it aims to answer are:\n\n1. Does adding early genomic testing increase the number of patients who are diagnosed?\n2. Does adding early genomic testing decrease the overall time to diagnosis?\n3. Is it cost-effective to include early genomic testing in the diagnostic pathway?\n\nThe investigators will compare with a control group of participants who are receiving standard care (no early genomic testing).\n\nParticipants will randomized to a standardized diagnostic testing plus early genomic testing group or to the standardized diagnostic testing group only (with the possibility of being offered genomic testing after 1 year in the study).",[248],"Bleeding Disorder",[250,251],"blood coagulation disorders","bleeding disorder",{"date":253,"type":44},"2025-07-31",{"date":255,"type":44},"2025-05-31",{"date":257,"type":21},"2027-04-30",{"name":50,"class":51},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":155,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":79},"100550362","a-chinese-version-of-the-thinking-health-program-for-east-asian-pregnant-immigrant-people-in-canada-100550362","NCT06446089","A Chinese Version of the Thinking Health Program for East Asian Pregnant Immigrant People in Canada","The Feasibility of a Culturally Tailored Mobile App-based Thinking Healthy Program for Mental Health Support of East Asian Pregnant Immigrants in Canada","Inclusion Criteria:\n\n* pregnant women at ≥ 22 weeks of gestation; AND\n* ≥ 18 years old; AND\n* are first or second-generation Chinese immigrants residing in Canada (who identify as someone with East Asian cultural and ethnic background born outside of Canada or have at least one parent born outside of Canada); AND\n* understand both spoken and written Mandarin language; AND\n* have access to internet and a smartphone with Android operating system or willing to download an Android emulator to operate the App; AND\n* are willing to download and use the study mobile App with brief Chinese version of THP for \"talking therapy\" with accompanying activities.\n\nExclusion Criteria:\n\n* Women currently being treated for mental conditions, including depression",{"count":267,"type":21},50,[24],"The goal of this study is to determine the feasibility of using a psychosocial intervention culturally adapted in China to support perinatal mental well-being of Chinese immigrant pregnant women in Canada. The intervention is adapted from the Thinking Healthy Program (THP), available through a mobile application, and will be offered to Chinese immigrant pregnant women (22 weeks' gestation or greater) residing in Canada, who are over the age of 18, and speak Mandarin. The main questions this study aims to answer are:\n\n* Will the Chinese version of the THP be acceptable to Chinese immigrant pregnant women residing in Canada and will they use the program which is delivered through a mobile App?\n* How well does the process of recruiting, keeping participants in the study and helping them complete the activities work, so it can be used for a future larger study?\n\nWomen interested in the study and who meet the study criteria will complete a questionnaire at the start of the study, then use the THP for three weeks, complete questionnaires 3-4 weeks after completing the intervention and 6-8 weeks after having their baby(ies). Some may be asked to participate in an individual interview.",[271],"Perinatal Depression",[273,274],"immigrant women","East-Asian immigrants","2025-07-23",{"date":225,"type":44},{"date":278,"type":44},"2024-10-01",{"date":280,"type":21},"2025-12",{"name":50,"class":51},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":290,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":22,"phases":293,"briefSummary":295,"conditions":296,"keywords":301,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":79},"100597928","phase-1-a-tumor-immune-biomarker-guided-approach-for-improving-response-to-bcg-in-patients-with-high-risk-nmibc-100597928","NCT07064863","A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.","BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.","BCG-TIME","Inclusion Criteria:\n\n* Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).\n* Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.\n* Participants older than 65 years of age.\n\nExclusion Criteria:\n\n* Patients with prior exposure to BCG immunotherapy.\n* Immunosuppressed patients on steroids, transplants etc.","65 Years",{"count":292,"type":21},31,[294,93],"PHASE1","This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.",[297,298,299,300],"NMIBC","Non-Muscle Invasive Bladder Urothelial Carcinoma","Bladder (Urothelial, Transitional Cell) Cancer","Urothelial Carcinoma Bladder",[302,297,303,304,305,306,307],"BCG","Gemcitabine","Tumor Immune MicroEnvironment","Systemic immunity","Mucosal immune response","Immune Biomarker","2025-07-14",{"date":310,"type":44},"2025-07-17",{"date":312,"type":21},"2025-08-01",{"date":314,"type":21},"2027-07-31",{"name":50,"class":51},{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":121,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100595282","phase-3-vaginal-estrogen-for-improvement-of-outcomes-following-pelvic-organ-prolapse-surgery-100595282","NCT07030426","Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery","A Multi-center, Randomized, Open-label, Parallel-group, Feasibility-controlled Trial of Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery","VEPO","Inclusion Criteria\n\nParticipants must meet all the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Participant who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n2. The participant has given written consent after the study has been explained according to local regulatory requirements and before any study specific procedures.\n3. Age ≥18 years at the time of consent.\n4. Undergoing an apical suspension (vaginal or abdominal, mesh or native tissue) for pelvic organ prolapse at one of the participating centers.\n5. Primary or recurrent prolapse surgery without a history of mesh surgery.\n6. Willing to complete surveys related to demographics, pelvic health and function, and sexual health and function.\n7. Plans to reside in the study area for at least 2 years after their surgery.\n\nExclusion Criteria\n\nAny individual meeting any of the following criteria is not eligible for participation in this study:\n\n1. Participant undergoing anterior and\u002For posterior repair only (no apical prolapse repair).\n2. Participant undergoing obliterative procedures.\n3. Participant with a history of mesh surgery for prolapse.\n4. Participant undergoing uterine sparing surgery.\n5. Participant with a contraindication to vaginal estrogen use, including but not limited to the following list, at the discretion of the study investigator:\n\n   * Patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container.\n   * Liver dysfunction or disease as long as liver function tests have failed to return to normal.\n   * Known or suspected estrogen-dependent malignant neoplasia (e.g. endometrial cancer).\n   * Endometrial hyperplasia.\n   * Known, suspected, or past history of breast cancer.\n   * Undiagnosed abnormal genital bleeding.\n   * Known or suspected pregnancy\n   * Active or past history of arterial thromboembolic disease (e.g. stroke, myocardial infarction, coronary heart disease).\n   * Partial or complete loss of vision due to ophthalmic vascular disease.\n   * Known thrombophilic disorders (e.g., protein C, protein S OR antithrombin deficiency); prothrombin mutation or anticardiolipin antibodies).\n6. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of care, such as behavioral or cognitive impairment or neuropsychiatric illness.\n7. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct.",{"count":325,"type":21},180,[327],"PHASE3","This open-label randomized control trial will study the use of vaginal estrogen in the first six weeks after pelvic organ prolapse (POP) repair surgery. This is a pilot trial that will examine the feasibility of the study, focussing on recruitment rates. Participants will be randomized to one of three groups; (1) no vaginal estrogen for 6 weeks, (2) vaginal estrogen twice weekly for 6 weeks, or (3) vaginal estrogen daily for 6 weeks. Participants will be seen at 6 weeks post surgery, 6 months post surgery, 1 year and 2 years post surgery. Additional outcomes will include patient satisfaction, Genitourinary Syndrome of Menopause (GSM) symptoms, post-operative complications, adherence and safety.",[330],"Pelvic Organ Prolapse (POP)",[332,333,334,335],"pelvic organ prolapse","vaginal estrogen","pelvic organ prolapse surgery","pelvic organ prolapse repair","2025-06-20",{"date":338,"type":44},"2025-06-26",{"date":340,"type":21},"2025-10-01",{"date":342,"type":21},"2029-09-30",{"name":50,"class":51},2,{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":121,"minAge":353,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":361,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":371,"leadSponsor":373,"locationsCount":79},"100577163","phase-2-a-probiotic-based-intervention-in-pregnancies-complicated-by-gdm-100577163","NCT06794723","A Probiotic Based Intervention in Pregnancies Complicated by GDM","A Single-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of a Probiotic-based Intervention to Improve Glycemic Control in Pregnancies Complicated by Gestational Diabetes.","ProbioGDM","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n2. Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.\n3. Age ≥16 years at the time of consent.\n4. Singleton pregnancy.\n5. Live fetus (documented positive fetal heartbeat prior to recruitment)\n6. Diagnosis of Gestational Diabetes (GDM) at the time of inclusion (documented 50g glucose challenge test (\\>11.1 mmol\u002FL) and\u002For 75g oral glucose tolerance test with results exceeding the normal range (fasting \\>5.3 mmol\u002FL, 1 hour \\>10.6 mmol\u002FL, or 2 hour \\> 8.9 mmol\u002FL)\n7. Willing to provide fecal swab samples.\n8. Willing to wear a continuous glucose monitor from enrollment until delivery and for 14 days at 6 weeks postpartum.\n9. Willing to provide results from the continuous glucose monitor using the associated app on their mobile device.\n10. Willing to complete surveys related to diet, pregnancy history, and health history.\n11. Plan to reside in the study area at least until delivery and to deliver at Kingston Health Sciences Center (KHSC).\n12. Willing to test for Group B Strep during pregnancy\n\nExclusion Criteria:\n\nAny individual meeting any of the following criteria is not eligible for participation in this study:\n\n1. Current diagnosis of severe gestational hypertension, preeclampsia, HELLP, intrauterine growth restriction, or other clinically significant pregnancy complication(s) at the time of enrollment.\n2. Sustained use of substances, such as alcohol, cannabis, nicotine, and other recreational drugs. This is defined as any use after the patient is aware that they are pregnant OR as per the discretion of the investigator.\n3. Systemic antibiotic or antifungal use ≤3 months prior to enrollment.\n4. Active clinical infection(s), such as sexually transmitted infections, urinary tract infectionss, systemic infections, periodontal disease or positive blood cultures ≤3 months prior to enrollment\n5. Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities, such as autoimmune disease, inflammatory bowel disease (IBD), Crohn's, colitis, or other conditions, that, in the opinion of the investigator, might confound study results.\n6. Prescription medications, especially relating to gastric function, or immunosuppressants, that, in the opinion of the investigator, might confound study results.\n7. Known hypersensitivity to \\>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin.\n8. Known hypersensitivity to \\>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin.\n9. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.\n10. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct.\n11. Pill swallowing phobia or inability to swallow pills.\n12. Not taking any other probiotic supplements during the study intervention period.","16 Years",{"count":355,"type":21},173,[93],"This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes. A healthy gut microbiome is now recognized as a key component of human health and dysbiosis of the gut microbiome, including lack of diversity, is believed to contribute to the development of many diseases and alter glucose control. The study aims to explore whether this probiotic intervention will improve glucose control and change the gut microbiome. Participants may be enrolled and randomized after diagnosis of gestational diabetes between 24 and 31 weeks gestation. 115 participants will be randomized in a ratio of 2 in the probiotic intervention group to 1 in the placebo group. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum.",[359,360],"Gestational Diabetes Mellitus (GDM)","Microbiome, Human",[362,363,364,365,366],"Microbiome","Gestational Diabetes","Probiotic","Glucose Control","Pregnancy","2025-06-03",{"date":369,"type":44},"2025-06-06",{"date":340,"type":21},{"date":372,"type":21},"2029-12-31",{"name":50,"class":51},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":384,"briefSummary":385,"conditions":386,"keywords":389,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":4},"100593647","phase-1-ketamine-assisted-psychotherapy-for-treating-comorbid-chronic-pain-and-ptsd-100593647","NCT07009158","Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD","Ketamine Assisted Psychotherapy to Improve Quality of Life in Veterans and Civilians With Comorbid Chronic Pain and Posttraumatic Stress Disorder: an Open-label Randomized Controlled Trial.","Inclusion Criteria:\n\ni) A current DSM-5 diagnosis of PTSD (confirmed by the Mini International Neuropsychiatric Interview (66)) ii) Chronic pain (\\> 4\u002F10 average pain reported for longer than 3 months (per (67)).\n\niii) 18-65 years of age. iv) Capacity to consent\n\nExclusion Criteria:\n\ni) Currently receiving or received ketamine or psychotherapy to treat PTSD in previous 8 weeks.\n\nii) Meeting DSM-5 criteria for substance abuse disorder within the past month or lifetime history of ketamine abuse.\n\niii) Concomitant unstable major medical or neurological conditions, or laboratory\u002Fimaging results as considered by the study treating physician to interfere with trial participation (e.g. poorly controlled blood pressure, BMI \\>35).\n\niv) Pregnancy or the intention to become pregnant and breastfeeding during the study as confirmed by self-report. Participants must be willing to use a medically acceptable method of birth control which include abstinence, hormonal (birth control pills, patch, hormone injections or implants), diaphragm with spermicide or cervical cap, IUD, condom used together with spermicide, surgical sterilization (hysterectomy or partner's vasectomy) and post-menopausal more than 2 years.\n\nv) DSM-5 diagnosis of bipolar disorder, psychotic disorder, or a severe personality disorder which may interfere with the trial. Patients with lifelong diagnosis of Bipolar Disorder, Schizophrenia or Schizoaffective disorder will be excluded. Patients with primary Obsessive Compulsive Disorder, Substance Use Disorder (dependence and abuse), Seasonal Affective Disorder, or Generalized Anxiety Disorder at time of assessment will be excluded. Primary severe borderline personality disorder and any other personality disorders that potentially may interfere with treatment administration will also be excluded.\n\nvi) Deemed to be high suicidal risk during the baseline assessment as per treating physician. Chronic persistent suicidality is not an exclusion.\n\nvii) Use of medications that might interfere with ketamine efficacy such as benzodiazepines with a dose equivalent to lorazepam 2mg\u002Fday or higher, and anti-convulsant (except for pregabalin and gabapentin).\n\nviii) Deemed not appropriate to engage in group psychotherapy. ix) Inability to communicate in spoken and written English fluently enough to complete the required study assessments or a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete clinical assessments).\n\nx) Cognitive or physical impairment severe enough to interfere with IV ketamine administration and the subject's ability to stay in the same place for a 2-hr monitoring supervision.\n\nxi) Inability to secure a responsible adult to accompany them back home after ketamine sessions.\n\nxii) Inability to take part in virtual care, no valid email address. xiii) Inability to safely secure IV access.","64 Years",{"count":383,"type":21},30,[294,93],"The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions. The objectives of the pilot study are to 1) assess the feasibility of the trial methods and 2) assess the feasibility and tolerability of ketamine treatment in combination with psychotherapy. The main questions the future full trial would aim to answer are:\n\n* Does the combination of ketamine infusion treatment and mindfulness therapy improve the quality of life in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?\"\n* Does the combination of ketamine infusion treatment and mindfulness therapy improve disability, and depressive, PTSD and pain symptoms in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?\"\n* Does implementing a brief ketamine infusion protocol safe and tolerable to treat chronic pain and PTSD?\n\nResearchers will compare ketamine infusion treatment combined with mindfulness therapy to mindfulness therapy alone to see if the combined treatment works better to treat chronic pain and PTSD.\n\nParticipants will:\n\n* Attend 6 visits with a research team member to complete assessments and questionnaires.\n* Attend 4 ketamine treatment over 2 weeks, if allocated to the experimental group.\n* Attend 8 mindfulness therapy group sessions online (1 per week).\n* Log mindfulness exercises completed during the study period.",[387,388],"Chronic Pain","Posttraumatic Stress Disorder (PTSD)",[390,391],"Ketamine","Mindfulness-based Cognitive Therapy","2025-05-28",{"date":369,"type":44},{"date":395,"type":21},"2025-10",{"date":397,"type":21},"2029-09",{"name":50,"class":51},{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":290,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":79},"100532839","phase-4-adjunctive-treatment-with-l-methylfolate-for-treatment-resistant-generalized-anxiety-disorder-a-pilot-study-100532839","NCT06218030","Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study","PSIY-744-23: Adjunctive Treatment With L-methylfolate for Treatment-Resistant Generalized Anxiety Disorder: a Pilot Study","Inclusion Criteria:\n\n* Adults.\n* Patients on a stable dose of an selective serotonin uptake inhibitors (SSRI) or serotonin and noradrenaline reuptake inhibitors (SNRI) for at least 8 weeks.\n* Treatment-resistant GAD, defined by lack of response to at least two drugs, from two different classes of drugs considered first-line or second-line for GAD according to the Canadian Clinical Practice Guidelines for the Management of Anxiety, Posttraumatic Stress and Obsessive-Compulsive Disorders (Katzman et al., 2014). Only trials lasting at least 8 weeks and with at least the minimum effective dose of the given medication will be considered failed trials.\n\nExclusion Criteria:\n\n* Patients with moderate to severe major depressive disorder based on the Patient Health Questionnaire - Nine Item (PHQ-9) scale (score of 15 or above) at baseline.\n* Mini International Neuropsychiatric Interview version (MINI) 7.0 indicates moderate to high current suicidality or \"suicide likely in near future\" or current suicidal behavior disorder.\n* Patients diagnosed with obsessive-compulsive disorder (OCD), bipolar disorder, schizophrenia, schizoaffective disorder, personality disorders, substance use disorders, intellectual disabilities, dementia, epilepsy or other severe neurological diseases.\n* Patients with cardiovascular diseases, infections, inflammatory diseases, recent surgeries, recent physical trauma and other medical issues that could produce elevation of c-reactive protein (CRP) or homocysteine.\n* Consumption of cannabis, any cannabis by-products, illicit drugs, or alcohol above 3 drinks per week.\n* Supplementation of diet with vitamins or consumption of natural health products that may affect anxiety or depression symptoms.\n* Reading competence below Grade 5.\n* Participants who do not have capacity to conduct consent process.",{"count":407,"type":21},10,[409],"PHASE4","The goal of this feasibility study is to determine the tolerability and safety of add on treatment with L-methylfolate in patients with treatment-resistant generalized anxiety disorder (GAD). The primary objective is to monitor for side effects and other risks associated with the treatment. Secondary objectives are to compare the severity of symptoms, serum levels of folate, vitamin B12, C-reactive protein, homocysteine, tumor necrosis factor alpha and interleukin 6 before and after treatment. Participants will continue with their usual treatment for GAD and receive add on treatment with L-methylfolate 15 mg per day for 8 weeks. All participants will receive the same intervention.",[412],"Generalized Anxiety Disorder",[414,415],"generalized anxiety disorder","anxiety disorder","2025-05-21",{"date":418,"type":44},"2025-05-25",{"date":420,"type":44},"2024-10-22",{"date":422,"type":21},"2026-05-01",{"name":50,"class":51},{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":79},"100590573","phase-2-safety-tolerability-and-preliminary-efficacy-of-psilocybin-oral-solution-in-adults-with-generalized-anxiety-disorder-100590573","NCT06969170","Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","Inclusion Criteria:\n\n1. Must provide written informed consent prior to the initiation of any protocol-specific procedures.\n2. Male and female adults, between 18 and 60 years of age, inclusive.\n3. Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI.\n4. Clinician-rated GAD-7 score ≥14 at Screening (Visit 1).\n5. Clinician-rated HAM-A score ≥14 at Screening (Visit1).\n6. Females must be non-pregnant and non-lactating and must fulfil at least one of the following:\n\n   * Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).\n   * Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test).\n   * Agree to avoid pregnancy and use a medically acceptable method of contraception with male sexual partners from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).\n   * Medically acceptable methods of contraception include any of the following:\n   * Double-barrier methods (e.g., male condom, spermicide with diaphragm or spermicide with cervical cap)\n   * Oral contraceptives; hormonal patch, implant or injection; or hormonal or non-hormonal intrauterine device. The male partner should use, at all times, a male condom with spermicide, should the female Patient choose to use any of these methods\n   * Complete abstinence, should it be in line with the Patient's preferred and usual lifestyle.\n7. Males who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration. If a patient's partner should become pregnant during his participation in the study and for 30 days after he has completed his last study drug administration, the patient must inform study staff immediately. Medically acceptable methods of contraception include:\n\n   * Using a condom with a female partner of child-bearing potential who is using oral contraceptives; hormonal patch, implant or injection; hormonal or non-hormonal intrauterine device; or diaphragm or cervical cap with spermicide\n   * Complete abstinence, should it be in line with the patient's preferred and usual lifestyle.\n8. Males must refrain from sperm donation from clinic admission to at least 30 days after the last dose of study drug.\n9. Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.\n10. Must be willing to comply with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n1. Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or severe social anxiety disorder, schizoaffective disorder, moderate or severe obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, moderate or severe post-traumatic stress disorder (as assessed by the IES-R), moderate or severe personality disorder (Cluster B and Cluster C only), moderate or severe MDD (as assessed by the MINI and total scores on the MADRS \\> 19).\n2. History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results.\n3. Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., \\\u003C4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen \\>4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolled in the study.\n4. Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baseline will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).\n5. Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \\>440 milliseconds in males and \\>460 milliseconds in females.\n6. History of allergies to the investigational product or excipients.\n7. History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies.\n8. Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.\n9. Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g\u002Fday or 3g\u002Fweek;\n\n   \\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency\u002Famount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms.\n10. Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation).\n11. Has used CNS drugs with perception-altering properties (e.g., ketamine, lysergic acid diethylamide \\[LSD\\], phencyclidine \\[PCP\\], 3,4 methylenedioxymethamphetamine \\[MDMA\\], mescaline, psilocybin, tryptamine derivatives, or ring-substituted amphetamines with perception-altering effects) on more than 1 occasion for therapeutic or non-therapeutic purposes (i.e., for psychoactive effects) within the past 6 months. History of single or episodic use will not be considered exclusionary.\n12. History of suicidal ideation in the past 12 months or active\u002Fcurrent suicidality, based on C-SSRS results.\n13. Is currently using an investigational drug or device or has used such in the 30 days prior to receiving study drug.\n14. Female patient is pregnant or breastfeeding.\n15. Patient, in the investigator's opinion, is unsuitable for clinical study participation.\n\nCriteria for Randomization into the Double-Blind Treatment Phase\n\n1\\. Minimum 50% reduction in GAD-7 score from Open-Label Baseline Visit (Visit 1) to Double-Blind Baseline Visit","60 Years",{"count":267,"type":21},[93],"This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD).\n\nThe study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks)\n\nScreening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. To qualify, patients must have a clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥14. Additionally, participants must not be on regular anxiolytic treatment or must have discontinued such treatment at least 4 weeks prior to the start of the Open-label Run-in Phase.\n\nOpen-label Run-in Phase Eligible patients will proceed to the 4-week Open-label Run-in Phase. During this phase, patients will attend four weekly clinic visits, supplemented by weekly remote contacts (via phone or email).\n\nAt different timepoints during the OL Run-in Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nDouble-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 score from baseline-will be randomized 1:1 to receive either psilocybin oral solution or placebo at the Double-blind Baseline Visit. Patients not meeting the response criteria will undergo End-of-Treatment (ET) procedures at this visit.\n\nAt different timepoints during the DB Treatment Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nCompletion of the End of Treatment (ET) phase will be 2 weeks to further assess safety and PROs.",[436],"Generalized Anxiety Disorder (GAD)",[438,439,440,412],"Psilocybin","Double-Blind","Psychedelic","2025-05-08",{"date":443,"type":44},"2025-05-13",{"date":445,"type":21},"2025-05-06",{"date":447,"type":21},"2026-08-30",{"name":50,"class":51},{"id":450,"slug":451,"hasResults":11,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":11,"sex":17,"minAge":456,"maxAge":457,"enrollmentInfo":458,"targetDuration":4,"studyType":22,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":4},"100545273","using-healthcare-financing-and-digital-technology-to-improve-hypertension-prevention-and-control-in-tanzania-100545273","NCT06379750","Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania","STOP NCDs: Scaling Up Evidence-based Health System Interventions Through the Use of Sustainable Healthcare Financing and Digital TechnOlogy Platforms to Improve Non- Communicable Disease Prevention and Control in Tanzania","Inclusion Criteria:\n\n* All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.\n\nExclusion Criteria:\n\n* Adults with controlled HTN or those without a diagnosis of HTN\n* Unable or unwilling to provide informed consent","21 Years","70 Years",{"count":459,"type":21},1320,[24],"The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and\u002For adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.",[463,464],"Hypertension","Diabetes",[466,467,468,469,470,471],"hypertension","diabetes","NCD management","NCD prevention","mHealth","healthcare financing","2025-02-12",{"date":474,"type":44},"2025-02-14",{"date":476,"type":21},"2025-04-01",{"date":478,"type":21},"2028-03-01",{"name":50,"class":51},{"id":481,"slug":482,"hasResults":11,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":11,"sex":17,"minAge":487,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":79},"100574687","exploring-feasibility-acceptability-and-impact-of-using-neurofeedback-with-persons-with-mild-cognitive-impairment-100574687","NCT06762522","Exploring Feasibility, Acceptability and Impact of Using Neurofeedback with Persons with Mild Cognitive Impairment","Exploring Feasibility and Acceptability of Using Neurofeedback Interventions to Manage Cognitive, Affective and Behavioural Symptoms in Persons with Mild Cognitive Impairment","Inclusion Criteria:\n\n* Adults with mild cognitive impairment (MCI) attending the Memory Clinic at Providence Care Hospital in Kingston, Ontario\n\nExclusion Criteria:\n\n* Adults with cognitive issues related to a psychiatric diagnosis or acute brain injury","55 Years",{"count":489,"type":21},20,[24],"The goal of this pilot study is to determine the feasibility, acceptability and potential impact of using neurofeedback interventions to manage cognitive, emotional, and behavioural symptoms in individuals with mild cognitive impairment (MCI). The main question\\[s\\] it aims to answer are: (1) What is the feasibility, acceptability, and appropriateness of using the Nonlinear Dynamical Neurofeedback intervention for persons living with MCI? (2) What is the feasibility, acceptability, and appropriateness of using the Low Energy Neurofeedback System (LENS) intervention for persons living with MCI? (3) What is the feasibility, acceptability, and appropriateness of using the Brain Music neurofeedback intervention for persons living with MCI? (4) What is the potential impact of five weeks of a neurofeedback intervention on cognitive, affective, and behavioural symptoms experienced by persons living with MCI? Participants will be randomly assigned to either the Nonlinear Dynamical (NLD), Low Energy Neurofeedback System (LENS), or Brain Music neurofeedback intervention groups or a control group receiving usual care.",[493],"Mild Cognitive Impairment",[495,496],"Neurofeedback","Feasibility","2025-01-05",{"date":499,"type":44},"2025-01-07",{"date":501,"type":21},"2025-01-27",{"date":503,"type":21},"2026-01-30",{"name":50,"class":51},{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":511,"eligibilityCriteria":512,"healthyVolunteers":155,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":513,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":79},"100568470","pilot-feasibility-study-of-a-pragmatic-mixed-methods-randomized-controlled-trial-on-a-follow-up-bundle-of-care-for-icu-survivors-and-caregivers-100568470","NCT06681649","Pilot Feasibility Study of a Pragmatic Mixed-Methods Randomized Controlled Trial on a Follow-Up Bundle of Care for ICU Survivors and Caregivers","Improving Medical and Psychological Outcomes After Discharge - Feasibility Study for a Pragmatic, Mixed-methods, Open-label Randomized Controlled Trial Examining the Effectiveness of a Follow-up Clinic for ICU Survivors and Caregivers","IMPACT-ICU","Inclusion criteria - ICU survivors\n\n1. Adult patients (age greater than or equal to 18 years)\n2. Life expectancy greater than or equal to 6 months as determined by the attending physician\n3. High risk for long-term functional sequelae following ICU discharge, defined as ICU stay greater than or equal to 4 days, or involving at least one of:\n\n   * mechanical ventilation (any, i.e., invasive or non-invasive)\n   * tracheostomy\n   * delirium (defined as Confusion Assessment Method (CAM) positive or documented history of delirium in the patient's medical record by the clinical care team at some point during their ICU admission)\n   * lack of access to a primary care physician for clinical follow-up\n   * access to email or mail to complete follow-up questionnaires\n   * presence of an informal caregiver\n\nInclusion criteria - Caregivers\n\n1. Informal caregiver (e.g., spouse, offspring) for ICU survivor as defined above\n2. Adult (age greater than or equal to 18 years)\n\nExclusion criteria - ICU survivors and caregivers\n\n* Neurological or communication difficulties which would preclude completion of follow-up assessments or participation in focus groups\n* Inability to speak or read English (required for completion of standardized questionnaires, clinical assessments, and for participation in focus groups)\n* Failure to provide consent\u002Ffailure to have consent provided by a substitute decision maker",{"count":61,"type":21},[24],"\\~80% of ICU survivors experience profound long-term cognitive, physical, and psychiatric impairments known as post-intensive care syndrome (PICS). Caregivers additionally experience similar detrimental psychosocial effects following discharge. Despite this knowledge, follow-up care is almost non-existent. ICU follow-up clinics may mitigate these long-term impacts, but lack evaluation of their effectiveness. This trial will evaluate the effectiveness of ICU follow-up clinics vs. standard-of-care in improving qualitative\u002Fclinical outcomes of ICU survivors and caregivers, with those receiving follow-up care hypothesized to have improved outcomes.",[517,518],"Critical Illness","Delirium in the Intensive Care Unit",[520,521,522],"critical illness","delirium","post-intensive care syndrome","2024-11-29",{"date":525,"type":44},"2024-12-04",{"date":527,"type":44},"2024-06-01",{"date":529,"type":21},"2025-06-01",{"name":50,"class":51},""]