[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pilot-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pilot-study":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,68,90,139,168,214,246,286],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613359","two-post-operative-pain-protocols-at-discharge-for-orthopaedic-patients-100613359",false,"NCT07265557","Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients","A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study","Inclusion Criteria:\n\n1. Patients 18 years of age or older\n2. Underwent a major operative orthopaedic procedure\n\nExclusion Criteria:\n\n1. Contraindication for NSAIDs.\n2. Preoperative chronic opioid use (preoperative use of \\>14 days and average of \\>30 Morphine Milligram Equivalents per day).\n3. Active treatment for opioid use disorder.\n4. Previous or current illicit drug use.\n5. Major surgery for pathologic (cancer-related) condition.\n6. Hand surgery.\n7. Concurrent operative treatment by another specialty team.\n8. Discharged to an extended medical care facility.\n9. Incarceration.\n10. Women who are pregnant or planning to become pregnant in the next 6 weeks.\n11. Expected injury survival of less than 6 weeks.\n12. Terminal illness with expected survival of less than 6 weeks.\n13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n14. Currently enrolled in a trial that does not permit co-enrollment.\n15. Prior enrollment in the trial.\n16. Unable to obtain informed consent.\n17. Non-English speaking\n18. Eligible patient was not approached prior to hospital discharge (missed participant).\n19. Did not provide informed consent (declined participation).\n20. Other reason to exclude the patient, as approved by the Principal Investigator","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.",[26,27,28,29],"Orthopaedic Related Pain (Musculoskeletal Pain)","Opioid","Pain","Pilot Study",[27,31,32],"Pilot study","Musculoskeletal Pain","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-25","ACTUAL",{"date":39,"type":37},"2025-10-06",{"date":41,"type":20},"2026-12-31",{"name":43,"class":44},"Massachusetts General Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100612706","checkpoint-inhibitor-associated-diabetes-mellitus-early-recognition-and-treatment-cert-project-a-pilot-study-100612706","NCT07257068","Checkpoint Inhibitor Associated Diabetes Mellitus: Early Recognition and Treatment (CERT) Project: A Pilot Study","Eligibility Criteria\n\n* Participants on ICI referred to endocrine for new diagnosis of CIADM, will be included provided they are within 12 months of last dose of ICI and if they have:\n\n  * New onset diabetes≥ 200 mg\u002Fdl and\u002For A1c ≥6.5 OR\n  * Worsening glycemic control: requiring insulin per clinician assessment (fasting glucose or average glucose on CGM\\>20% and \u002For A1c \\>0.5% from prior to ICI use ) AND \u002FOR\n  * If Presenting with DKA\u002FHHS: include if within 6 weeks of presentation AND\n  * Must have detectable random c-peptide level 0.2 - 1 ng\u002FmL with blood glucose of 145 mg\u002Fdl\n* Age ≥18 years. Because adverse event data are currently available on the use of infliximab in combination within participants \\\u003C18 years of age, children are excluded from this study.\n* ECOG performance status ≤2 (Karnofsky ≥60%,).\n* Participants must have adequate organ and marrow function as defined below:\n\nabsolute neutrophil count ≥1,000\u002FmcL platelets ≥100,000\u002FmcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN creatinine ≤ institutional ULN\n\nCardiac ejection fraction \\> 50%\n\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of infliximab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n* Participants already on insulin for pre-existing type 1 or type 2 diabetes.\n* Participants with undetectable c-peptide levels i.e. \\\u003C0.2 with blood glucose of 145 mg\u002Fdl or higher.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Participants with a h\u002Fo active TB or latent TB will be excluded.\n* Participants with known history of any NYHA class heart failure or ejection fraction \\\u003C50% will be excluded.\n* Participants requiring supraphysiological doses of steroids i.e. prednisone \\>10mg of equivalent at the time of study entry, will be excluded\n* Participants who have ICI hepatitis and myocarditis will be excluded\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities ≥ Grade 2) with the exception of alopecia.\n* Participants who are receiving any other investigational agents for CIADM.\n* History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to Infliximab or other agents used in study.\n* Required: any concomitant drugs used as defined in section 5.7 will be excluded.\n* Participants with uncontrolled intercurrent illness: active infection\u002F sepsis\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant and breastfeeding women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with infliximab. Breastfeeding should be discontinued if the mother is treated with infliximab. These potential risks may also apply to other agents used in this study",{"count":53,"type":20},14,[23],"To find out if taking a drug called infliximab (the \"study drug\") is safe and effective in reversing insulin dependence in CIADM.",[57,29,58],"Checkpoint Inhibitor","Diabetes Melletus","NOT_YET_RECRUITING","2026-06-22",{"date":34,"type":37},{"date":63,"type":20},"2026-09-14",{"date":65,"type":20},"2029-12-31",{"name":67,"class":44},"M.D. Anderson Cancer Center",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":45},"100617948","phase-2-a-pilot-study-to-correlate-4-18f--fluoro-1-naphthol-18f-4fn-petct-imaging-with-chronic-graft-versus-host-disease-manifestations-100617948","NCT07325253","A Pilot Study to Correlate 4-18F- Fluoro-1-naphthol 18F-4FN PET\u002FCT Imaging With Chronic Graft Versus Host Disease Manifestations","Eligibility Criteria\n\n1. Chronic GVHD involving the joints, defined as any limitation of range of motion measured by Photographic Range Of Motion (PROM). Criteria can be found at (Jagasia, et al. 2015).\n2. Able to give written informed consent.\n3. ≥18 years of age\n4. Creatinine clearance ≥ 30 mL\u002Fmin\u002F1.73m2\n5. Non-joint chronic GVHD diagnostic \u002F distinctive features are allowed.\n6. Subjects may be planned to receive a new systemic therapy for chronic GVHD\n7. Prior\u002Fcontinuing systemic therapy for chronic GVHD is allowed\n8. KPS ≥ 20\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. The effects of the study agent on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n      * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study agent administration.\n\nExclusion Criteria\n\n1. Unable to comply with all study procedures (for example, participants who are unable to come to all follow up visits because they live far away from the transplant center)\n2. Pregnant or lactating women: pregnant women are excluded from this study because the effects of \\[18F\\]4FN in pregnancy are not known.\n3. Subjects with contraindications to the use of \\[18F\\]4FN including confirmed allergy.\n4. Participants with a body weight of 400 pounds or more, or a body habitus which precludes their entry into the bore of the PET\u002FCT scanner, because the hardware is not intended to support that weight.\n5. Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.\n6. Children below the age of 18 are excluded because of the unknown but potential risks of administration of radiopharmaceuticals to minors.",{"count":75,"type":20},16,[77],"PHASE2","To study the safety and possible side effects of using the imaging agent 4-\\[18F\\]Fluoro-1-Naphthol (also called \\[18F\\]4FN) in PET\u002FCT scans for participants with chronic GVHD.",[29,80,81],"PET\u002FCT Imaging","Host Disease Manifestation","2026-06-09",{"date":84,"type":37},"2026-06-10",{"date":86,"type":37},"2025-11-18",{"date":88,"type":20},"2030-01-03",{"name":67,"class":44},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":122,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":45},"100634052","early-pregnancy-lifestyle-and-glucose-patterns-a-substudy-of-tofffy-100634052","NCT07534670","Early Pregnancy Lifestyle and Glucose Patterns: A Substudy of TOFFFY","Early-Pregnancy Chronobehavioural Profiles and Continuous Glucose Dynamics: A Nested Randomised Pilot Study of TOFFFY","Inclusion Criteria:\n\n* Enrolled in the Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) (NCT06293235)\n* Females who are currently pregnant and with viable intrauterine pregnancy at ≤13 weeks gestation at enrolment\n\nExclusion Criteria:\n\n* Females with pre-existing diabetes mellitus (Type 1 or Type 2) and\u002For chronic medical conditions affecting glucose metabolism\n* Females who are taking medications known to significantly affect glucose metabolism\n* Females with multiple pregnancy (e.g., twins or higher-order gestation)\n* Females who are unable to comply with study procedures, including: Inability to use smartphone-based applications and inability to wear wrist actigraphy device",true,"FEMALE","21 Years","39 Years",{"count":102,"type":20},140,[23],"The goal of this clinical trial is to examine how daily behavioral patterns in early pregnancy, including sleep, physical activity, and meal timing, influence continuous glucose dynamics and subsequent risk of gestational diabetes mellitus (GDM) in pregnant women without pre-existing diabetes.\n\nThe main questions it aims to answer are:\n\n1. Do early-pregnancy chronobehavioral patterns (e.g., irregular sleep, night eating, and unstable rest-activity rhythms) relate to continuous glucose patterns measured using continuous glucose monitoring (CGM)?\n2. Can early behavioral and CGM-derived measures predict glucose regulation and metabolic outcomes later in pregnancy (24-28 weeks)?\n3. Does real-time self-monitoring using wearable devices and food logging improve glycemic outcomes compared to usual care?\n\nThis study is a prospective, nested randomized pilot trial embedded within the ongoing Towards Optimal Fertility, Fathering and Fatherhood studY (TOFFFY) cohort (NCT06293235) at KK Women's and Children's Hospital, Singapore. A total of 140 pregnant women without pre-existing diabetes, recruited at ≤13 weeks gestation, will be randomized in a 1:1 ratio to either a pilot arm (wearable-based self-monitoring) or a control arm (usual care).\n\nParticipants in the pilot arm (n=70) will undergo intensive behavioral and metabolic monitoring over a 14-day period in early pregnancy, including continuous glucose monitoring using a CGM device, wrist actigraphy to assess sleep-wake and rest-activity patterns, and an AI-supported mobile application to record meal timing and dietary intake. Participants will have real-time access to their glucose data and behavioral feedback, enabling self-monitoring and potential behavioral adjustments.",[106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,29],"Continuous Glucose Monitoring","Diabetes, Gestational","Diet During Pregnancy","Meal Time","Actigraphy","Pregnancy","Glucose Intolerance During Pregnancy","Gestational Diabetes Mellitus in Pregnancy","Circadian Rhythm","Sleep","Chronobiology","Wearable Electronic Devices","Mobile Applications","Blood Glucose Profile","Metabolic Diseases","Randomized Controlled Trial",[123,124,125,126,127,128],"Risk factor","Lifestyle","Early pregnancy","Chrono-disruptive behaviours","Maternal health","Lifestyle intervention","2026-04-22",{"date":131,"type":37},"2026-04-27",{"date":133,"type":20},"2026-05-01",{"date":135,"type":20},"2027-06-30",{"name":137,"class":138},"KK Women's and Children's Hospital","OTHER_GOV",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":97,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100570174","protective-ventilation-with-flow-controlled-ventilation-100570174","NCT06703814","PROtective Ventilation With FLOW-Controlled Ventilation","PROtective Ventilation With FLOW-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After ROBOT-Assisted Laparoscopic Surgery - an International Multicenter Pilot Randomized Clinical Trial.","PROFLOW","Inclusion Criteria:\n\n* undergoing elective robot-assisted laparoscopic surgery in supine or Trendelenburg position (either abdominal, urologic or gynecologic surgery);\n* AND increased risk of PPCs according to the ARISCAT risk score (≥ 26 points);\n* OR the combination of age \\> 40 years, scheduled surgery lasting \\> 2 hours and planned to receive an intra-arterial catheter for blood pressure monitoring during the surgery;\n* aged ≥ 18 years; and\n* able to give written informed consent to participate in the study and agree to comply with the study protocol prior to initiation of any study-mandated procedure and study intervention.\n\nExclusion Criteria:\n\n* ideal body weight \\\u003C 40 kg;\n* ASA Physical Status Classification System score IV - VI;\n* previous enrolment into the current study;\n* being the study investigator, his\u002Fher family members, employees and other dependent persons;\n* if female and of childbearing potential, known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating; or\n* No informed consent",{"count":19,"type":20},[23],"The investigators want to investigate in patients undergoing robot-assisted laparoscopic surgery (a minimally invasive procedure) how applicable flow-controlled ventilation is, and whether it might also be safer than the current ventilation techniques, as well as its impact on potentially reducing the risk of lung-specific complications.\n\nFlow-controlled ventilation has already been tested in several studies on animals and humans and has proven to be a safe form of ventilation for patients undergoing surgery under general anesthesia.\n\nWhen patients undergo major surgery, general anesthesia is required and, as a result, mechanical ventilation of the lungs. Especially in long and complex surgeries, ventilation can become more difficult or lead to complications postoperatively. These patients may then experience shortness of breath, coughing, or require medication to improve lung function. In some cases, reintubation or additional mechanical ventilation may be necessary for support.\n\nPrevious human studies have shown that flow-controlled ventilation is less stressful and, therefore, potentially safer for the lungs compared to traditional ventilation techniques, and that less supplemental oxygen is required. This effect and the safety of flow-controlled ventilation have been demonstrated in several studies.\n\nTherefore, in this study, the investigators aim to explore whether flow-controlled ventilation is potentially safer and easier to apply than traditional ventilation techniques and whether it can reduce the risk of lung-specific complications following robot-assisted surgeries, thereby improving the recovery process postoperatively.",[151,152,29],"Postoperative Pulmonary Complications (PPCs)","Feasibility Studies",[154,155,156,157],"flow-controlled ventilation","postoperative pulmonary complications","mechanical ventilation","intraoperative ventilation","2026-04-16",{"date":160,"type":37},"2026-04-21",{"date":162,"type":37},"2025-08-02",{"date":164,"type":20},"2026-05-31",{"name":166,"class":44},"Cantonal Hospital of St. Gallen",3,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":97,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":21,"phases":177,"briefSummary":178,"conditions":179,"keywords":189,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100628100","probiotic-research-open-label-functional-intervention-and-longitudinal-evaluation-in-healthy-adults-100628100","NCT07457242","Probiotic Research: Open-label Functional Intervention and Longitudinal Evaluation in Healthy Adults","PROFILE","Inclusion Criteria:\n\n* Aged 18 years or older at the time of providing informed consent.\n* In generally good health, with no known medical conditions that could interfere with the aims of the study or participant safety, as judged by self-report and screening questionnaire.\n* No history of significant psychiatric or neurological illness\n* Ability to complete study specific tasks, including:\n* Daily oral intake of a probiotic capsule\n* Self-collection of stool samples\n* Completion of online questionnaires and simple cognitive tasks\n* Able to read, understand, and communicate in English, in order to give informed consent and follow study instructions.\n* Access to the internet and a suitable device (e.g., smartphone, tablet, or computer) for completing online aspects of the study.\n\nExclusion Criteria:\n\n* Participants will be excluded from the study if any of the following criteria apply:\n* Use of any systemic antibiotic or systemic immunosuppressive medication within the past 8 weeks, including but not limited to:\n* β-lactam antibiotics, macrolides, tetracyclines, fluoroquinolones, aminoglycosides, glycopeptides, sulfonamides, antimycobacterial agents, systemic antifungals or antivirals\n* Use of any systemic immunosuppressants within the past 16 weeks, including, but not limited to:\n* Systemic corticosteroids, conventional immunosuppressants, biologic immunomodulators, targeted synthetic immunosuppressants, cytotoxic chemotherapy, or transplant-related immunosuppression.\n* A longer exclusion window is applied for systemic immunosuppressive therapies due to their prolonged and potentially lasting effects on immune function and gut microbial composition compared with systemic antibiotics.\n* Participants who commence systemic antibiotics or immunosuppressive therapy after enrolment will not be withdrawn from safety monitoring but will stop the supplement and will not continue the intervention phase of the study. With participant consent, data collected may still be used.\n* Major gastrointestinal disease or surgery:\n* Any history of significant gastrointestinal disease or surgery that may alter gut microbiome composition, immune function, or nutrient absorption, including but not limited to inflammatory bowel disease (Crohn's disease, ulcerative colitis, indeterminate colitis); coeliac disease or other chronic malabsorptive disorders; chronic liver, biliary, or pancreatic disease; moderate-to-severe or unstable irritable bowel syndrome; gastrointestinal malignancy; chronic gastrointestinal motility disorders; recurrent Clostridioides difficile infection; or any major gastrointestinal surgery such as bowel resection, bariatric surgery, colectomy, ileostomy or colostomy. Prior appendectomy or cholecystectomy alone is not exclusionary.\n* Current pregnancy or development of pregnancy, breastfeeding\n* Known allergy to probiotic or compounding ingredients:\n* Vitamin D3\n* Isomaltooligosaccharide\n* Yeast extract",{"count":176,"type":20},180,[23],"This study is a pre-post, open-label cohort study designed to investigate how a food-grade probiotic supplement affects biological measurements and wellbeing in healthy adults. Participants will take one capsule daily for either 1 month or 6 months.\n\nDuring the study, participants will complete online cognitive tasks and provide blood and stool samples collected during home visits by trained staff. The samples will be analysed to explore changes in gut bacteria and other biological markers.\n\nThis study aims to understand whether the supplement is well tolerated and whether measurable biological changes occur. The study does not involve any experimental drugs or invasive procedures beyond blood sampling and stool collection, and participants will not be asked to change any current prescribed medications or treatments; with eligibility exclusions applying for recent antibiotics or immunosuppressants. The supplement is being studied for research purposes only and is not intended to diagnose, treat, or prevent disease. Participants will be invited to participate in a follow-up visit to assess long-term effects.",[180,181,182,183,184,185,186,187,29,188,115],"Cognition","Multiomics","Microbiome Analysis","Metabolome","Proteome","Metagenome","Probiotics Supplement","Gut-brain Axis","Adult",[190,191,192,193,194,195,196,197,198,199,200,31,201,202,203],"Probiotics","Dietary Supplements","Microbiome","Multi-omics","Metabolomics","Proteomics","Mitochondrial Function","Cellular Metabolism","Short-Chain Fatty Acids","Bioinformatics","Healthy volunteers","feasibility study","cognitive function","mental health","2026-03-03",{"date":206,"type":37},"2026-03-09",{"date":208,"type":20},"2026-07-01",{"date":210,"type":20},"2027-07-01",{"name":212,"class":213},"OneCarbon","INDUSTRY",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":221,"maxAge":17,"enrollmentInfo":222,"targetDuration":4,"studyType":21,"phases":224,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":45},"100591285","phase-4-model-informed-dose-optimization-for-rivaroxaban-in-children-with-giant-coronary-artery-aneurysm-after-kawasaki-disease-100591285","NCT06978439","Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease","Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;\n3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;\n4. Children aged 1 Month to\\\u003C18 years, bodyweight ≥ 2600g.\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.\n3. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n4. An eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)\n5. Platelet count \\\u003C 100 x 109\u002FL\n6. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \\> 5x ULN or total bilirubin \\> 2x ULN with direct bilirubin \\> 20% of the total\n7. Sustained uncontrolled hypertension defined as systolic and\u002For diastolic blood pressure \\>95 th age percentile\n8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)\n9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine\n10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n11. Inability to cooperate with the study procedures and follow-up visits\n12. Refuse to provide informed consent\n\neGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4","1 Month",{"count":223,"type":20},10,[225],"PHASE4","Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size.\n\nPatients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.",[228,29,229,230],"Kawasaki Disease","Coronary Artery Aneurysm","Rivaroxaban",[232,233,234,235,236],"kawasaki disease","giant coronary artery aneurysm","rivaroxaban","model-informed dose optimization","anticoagulant","2025-09-01",{"date":239,"type":37},"2025-09-08",{"date":241,"type":37},"2024-01-10",{"date":243,"type":20},"2025-12-31",{"name":245,"class":44},"Children's Hospital of Fudan University",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":97,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":267,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100591772","the-family-cares-trial-100591772","NCT06984770","The Family Cares Trial","Caring for the Caregiver: A Pilot Randomized Controlled Trial (The Family Cares Trial)","Family Cares","Inclusion Criteria:\n\n* (1) Family member of a person admitted to an ICU for \\>48 hours and survived to hospital discharge. \"Family\" is anyone with a biological, legal, or emotional relationship with the patient and whom the patient wants involved in their care\n* (2) Planned or current part or full-time caregiver of the ICU survivor\n* (3) Age ≥ 18 years\n* (4) Within 6 months of ICU survivor's hospital discharge.\n\nExclusion Criteria:\n\n* (1) Another family member participating in the study\n* (2) Inability to communicate in English or French.",{"count":255,"type":20},60,[23],"The goal of this pilot study is to learn if virtual peer support groups and strengths-based skills training can help family caregivers of ICU survivors providing ongoing support to ICU survivors after hospital discharge. The main question it aims to answer is:\n\n\\- Are virtual peer support groups and\u002For strengths-based skills support feasible and acceptable for family caregivers of ICU survivors? Researchers will compare the intervention group (virtual peer support groups or strengths-based skills training) to the control group (no intervention) to see if the interventions improve caregiver outcomes and assess feasibility and acceptability.\n\nParticipants will:\n\n* Participate in either virtual peer support groups or strengths-based skills training sessions (if assigned to the intervention arm).\n* Provide feedback on the feasibility and acceptability of the interventions (if assigned to the intervention arm).\n* Complete surveys and follow-up questionnaires (either online or by phone) to measure outcomes.",[259,260,261,262,263,29,264,265,266],"Family Engagement","Critical Care, Intensive Care","Patient and Family Engagement","Health Care Delivery","Family-centered Care","Caregiver","Caregiver Burden","Family Caregivers",[268,259,269,270,271,272,273,274,275],"Patient- and Family-Centered Care","Critical Care","Intensive Care Unit","Person-Centered Care","Delivery of Health Care","Post-ICU","Caregivers","Family Caregiver","2025-05-14",{"date":278,"type":37},"2025-05-22",{"date":280,"type":20},"2025-08",{"date":282,"type":20},"2027-08",{"name":284,"class":44},"Lady Davis Institute",2,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":45},"100566178","feasibility-and-acceptability-of-group-medical-visits-for-anxiety-and-depression-100566178","NCT06651801","Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression","A Pilot Randomized Controlled Trial Assessing the Feasibility and Acceptability of Group Medical Visits for Anxiety and Depression","Inclusion Criteria:\n\n* Adult Central Intake patients (patients referred for psychiatric consultation by their primary care provider) whose primary mental health issue is an anxiety disorder (social anxiety, generalized anxiety, or panic disorder) or depression (major depressive disorder or persistent depressive disorder)\n* Able to participate in English language group with up to 10 participants\n* Able to commit to a virtual biweekly group for about 1.5 hours each group\n* Able to do virtual group from a private location with camera access\n* Live in community in Manitoba and plan to stay for 6-month period\n\nExclusion Criteria:\n\n* Patients with Bipolar 1 or 2 Disorder (even if current episode depression)\n* Primary diagnosis of a personality disorder leading to anxiety\u002Fdepression symptoms (personality disorder traits are not an exclusion criteria)\n* Patients who already have established longitudinal care with a psychiatrist\n* Received ECT treatment within past 6 months\n* Any diagnosis that would significantly impact ability to participate in the group. For example:\n* Moderate-to-severe substance use disorders (in particular substance use throughout day or inability to attend group without using substances before)\n* Current psychotic symptoms\n* Moderate-to-severe intellectual disability or neurocognitive disorder\n* Current significant eating disorder symptoms (for example resulting in significant weight loss\u002Fmalnutrition or that take up a significant part of the day either mentally or physically)\n* Self harm behaviour requiring medical\u002Fpsychiatric attention or active suicidal ideation\u002Fsuicide attempts within the past 6 months\n* Concern about safety of other group members\u002Ffacilitators if this patient were to join",{"count":294,"type":20},20,[23],"The goal of this clinical trial is to evaluate the feasibility and acceptability of the intervention, Group Medical Visits (GMVs), for patients with depression and anxiety. It also aims to get some initial information on the effectiveness of GMVs on reducing depression and anxiety scores, which will help inform power calculations for a future larger randomized controlled trial (RCT). The main question it aims to answer is:\n\n* Are GMVs feasible and acceptable to patients with depression and anxiety?\n\nThis study consists of a pilot RCT with an intervention and control arm. At enrollment, participants will be randomized to the intervention group, 6 months of GMVs, or to the control group, which consists of \"standard client services\". For the GMV group, participants will engage in a biweekly virtual group that is similar to a standard psychiatric follow-up. Participants in the control group will receive standard care after a psychiatric assessment, which includes follow-up with their primary care provider (family physician or nurse practitioner), individual psychiatric care if suggested by the psychiatrist who did their psychiatric assessment, and\u002For a referral to publicly funded therapy groups if interested.",[298,299,29],"Mental Health Care","Anxiety and Depression",[301,302,303,304,29],"Group Medical Visits","Anxiety","Depression","Shared Medical Appointments","2025-05-09",{"date":307,"type":37},"2025-05-13",{"date":309,"type":37},"2025-04-15",{"date":311,"type":20},"2025-11",{"name":313,"class":44},"University of Manitoba"]