[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adverse-event\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adverse-event":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,46,79,109,136,161,194,222,248,275],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100549392","pause-sick-day-medication-management-mobile-app-study-100549392",false,"NCT06433414","PAUSE: Sick Day Medication Management Mobile App Study","Preventing Medication Complications During AcUte Illness Through Symptom Evaluation and Sick Day Guidance Mobile Application (PAUSE)","PAUSE","Inclusion Criteria:\n\n* ≥18 years of age and able to provide informed consent\n* be able to communicate (read, write, and speak) in English\n* have access to a smartphone\u002Ftablet with an Internet connection\n* be willing and able to download and use the PC Health app for the duration of the study\n* currently be taking 2 or more medications from the following classes: renin-angiotensin-aldosterone system (RAAS) antagonists, diuretics, oral NSAIDs, metformin, or 1 or more medications from the following classes: insulin, sulfonylureas, meglitinides, SGLT2 inhibitors.\n\nExclusion Criteria:\n\n* fail to meet the inclusion criteria\n* have kidney failure requiring maintenance dialysis\n* have had an organ transplant\n* are pregnant\n* receive qualifying medications in a blister pack or sachet\n* do not primarily manage their own medications and condition (i.e., receive home care, in a rehabilitation or medical respite facility)\n* cannot use the PC Health app independently\n* previously participated in studies that led to the development of the PAUSE App (including the PAUSE study usability testing or needs assessment focus groups)","ALL","18 Years","99 Years",{"count":21,"type":22},320,"ESTIMATED","INTERVENTIONAL",[25],"NA","Diabetes, heart disease and kidney disease have high morbidity and costs of care. Medications used to treat these conditions are effective. Yet, some have the risk of preventable adverse events when people are sick with the flu or stomach bug. These events include low blood sugar and acute kidney injury which can lead to extended hospital stays or death. Sick day medication guidance (SDMG) recommends stopping these medications temporarily when sick and restarted after symptoms subside. Unfortunately, many patients are not aware of these recommendations or find them hard to follow.\n\nThe investigator's previous research has shown that there is a lack of SDMG education and patient resources. Research on the development, implementation, usability and efficacy of these resources is also limited. In developing a SDMG tool, the investigators surveyed patients who expressed interest in an electronic health (eHealth) tool. As a result, the PAUSE App provides a timely and innovative way to provide continuity of care to patients that is linked to each patients' unique pharmacy record.\n\nIn the present pilot randomized control trial, the investigators will examine the outcomes of the PAUSE Initiative consisting of the PAUSE App and a SDMG educational handout. Approximately 16 Loblaw\u002FShoppers Drug Mart pharmacies across Alberta will take part. Patients of these pharmacies who take high-risk medications will be invited to participate. Each pharmacy will be randomized to provide their patients usual care (i.e. SDMG handout) or the intervention (i.e., PAUSE App + handout). Approximately 320 participants (20 per pharmacy) are expected to be recruited. The expected trial length is 9 months from recruitment to analysis.\n\nA simulated 'sick day' survey will be used to assess the fidelity and efficacy of the PAUSE Initiative. Feasibility of the study processes (i.e., recruitment, onboarding) will be assessed to inform a full-scale trial. The usability and acceptability of the PAUSE App will also be investigated. Pharmacists and participants will complete questionnaires and qualitative interviews to assess these outcomes. Additionally, PAUSE App user metrics will be collected. All participants will receive an honorarium for their time.",[28,29],"Chronic Condition","Adverse Event",[31,32,33],"chronic condition","medication safety","sick day medication guidance","NOT_YET_RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":22},"2027-01-01",{"date":42,"type":22},"2027-12",{"name":44,"class":45},"University of Alberta","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100634686","sintilimab-chidamide-and-azacitidine-for-untreated-stage-i-ii-extranodal-nkt-cell-lymphoma-100634686","NCT07542912","Sintilimab, Chidamide, and Azacitidine for Untreated Stage I-II Extranodal NK\u002FT-Cell Lymphoma","A Single-Arm, Multicenter, Phase II Study of Sintilimab Combined With Chidamide and Azacitidine in Patients With Treatment-Naïve Stage I-II Extranodal Natural Killer\u002FT-Cell Lymphoma (SCENT-3)","SCENT-3","Inclusion Criteria:\n\n1. Willingness to participate in the clinical study.\n2. Age ≥ 18 years at the time of signing the Informed Consent Form (ICF).\n3. Newly diagnosed ENKTL confirmed by histopathology at the study center.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n5. At least one evaluable or measurable lesion\n6. Ann Arbor stage I-II disease.\n7. PINK-E score ≥ 1.\n8. Adequate organ and bone marrow function, with no severe hematopoietic dysfunction or abnormalities in cardiac, pulmonary, hepatic, renal, or thyroid function, and no immunodeficiency.\n\nExclusion Criteria:\n\n1. Aggressive natural killer cell leukemia.\n2. Presence of hemophagocytic syndrome.\n3. Primary central nervous system (CNS) lymphoma or secondary CNS involvement.\n4. Patients with a known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome (AIDS).\n5. Patients with active chronic hepatitis B or active hepatitis C.",{"count":55,"type":22},30,[25],"This is an open-label, single-arm, multi-center Phase II clinical trial evaluating the efficacy and safety of a novel sequential regimen as first-line therapy for treatment-naïve patients with Extranodal NK\u002FT-cell Lymphoma (ENKTL). The study consists of a Screening Phase, a Safety Lead-in Phase, and a Treatment Phase. During the Safety Lead-in Phase, 6 patients will be enrolled to receive a fixed dose of Sintilimab and Chidamide combined with Azacitidine to verify the dose (testing 100mg\u002Fd on days 1-3 versus days 1-5). Following the lead-in, all subjects will undergo a 2-cycle Immunotherapy Induction Phase with the SCA regimen (Sintilimab, Chidamide, and Azacitidine). Subsequently, treatment will be stratified based on response: patients achieving Complete Response (CR) or Partial Response (PR) will receive 4 additional cycles of SCA consolidation, while those with Stable Disease (SD) or Progressive Disease (PD) will switch to 4 cycles of P-GemOx chemotherapy. Upon completion of systemic therapy, all patients will undergo consolidative involved-field radiotherapy (≥50Gy).",[59,60,61,29,62],"Complete Remission Rate， CRR","Progression Free Survival","Overall Survival","Duration of Response",[64,65,66,67,68],"Extranodal NK\u002FT-cell Lymphoma","First-line Therapy","Sintilimab","Chidamide","Azacitidine","2026-04-17",{"date":71,"type":38},"2026-04-21",{"date":73,"type":22},"2026-06-01",{"date":75,"type":22},"2029-06-01",{"name":77,"class":45},"Sun Yat-sen University",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100460978","real-time-symptom-monitoring-using-epros-to-prevent-adverse-events-during-care-transitions-100460978","NCT05282654","Real-time Symptom Monitoring Using ePROs to Prevent Adverse Events During Care Transitions","Inclusion Criteria:\n\n* Adult (18 years or older)\n* Hospitalized on the general medicine services at Brigham and Women's Hospital or Brigham and Women's Faulkner Hospital for at least 24 hours\n* Have a discharge status of home, home with services, or facility\n* English-speaking patients or their English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)\n* Non-English-speaking patients who have an English-speaking legally designated healthcare proxy or next of kin (i.e., a family caregiver)\n* Two or more chronic conditions: Anxiety, Asthma\\*, Arthritis (Osteoarthritis, Rheumatoid), Atrial Fibrillation, Cancer\\*, Cerebral vascular accident, Chronic kidney disease\\*, Chronic obstructive pulmonary disease (COPD)\\*, Cirrhosis, Coronary artery disease\u002FIschemic heart disease, Dementia, Depression, Diabetes mellitus\\*, End-stage renal disease\\*, Heart failure\\*, Hepatitis B, C\\*, HIV\u002FAIDs, Hyperlipidemia, Hypertension, Inflammatory bowel disease, Osteoporosis, Sickle cell disease, Substance abuse (Alcohol\u002FOpioid)\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Less than two chronic conditions\n* Hospitalized less than 24 hours\n* No identifiable healthcare proxy or next of kin (i.e., a family caregiver)",{"count":86,"type":22},1300,[25],"This study aims to predict and minimize post-discharge adverse events (AEs) during care transitions through early identification and escalation of patient-reported symptoms to inpatient and ambulatory clinicians by way of predictive algorithms and clinically integrated digital health apps. We will (1) develop and prospectively validate a predictive model of post-discharge AEs for patients with multiple chronic conditions (MCC); (2) combine, adapt, extend, and iteratively refine our EHR-integrated digital health infrastructure in a series of design sessions with patient and clinician participants; (3) conduct a RCT to evaluate the impact of ePRO monitoring on post-discharge AEs for MCC patients discharged from the general medicine service across Brigham Health; and (4) use mixed methods to evaluate barriers and facilitators of implementation and use as we develop a plan for sustainability, scale, and dissemination.",[90,29],"Multiple Chronic Conditions",[92,93,94,95,96,97],"Digital Health","Patient Reported Outcomes","Symptom Monitoring","Predictive Model","Care Transitions","Post Acute Care","RECRUITING","2026-04-15",{"date":101,"type":38},"2026-04-20",{"date":103,"type":38},"2022-02-01",{"date":105,"type":22},"2026-10-15",{"name":107,"class":45},"Brigham and Women's Hospital",2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100505493","long-term-follow-up-in-patients-with-acute-myocardial-infarction-cohort-100505493","NCT05862103","Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort","Long-Term Follow-Up in Patients With Acute Myocardial Infarction Cohort - a Prospective, Multicenter Study","Inclusion Criteria:\n\n* AMI survivors who participated in the project \"Construction and key technology research of the whole myocardial protection system for acute myocardial infarction\" and completed the 1-year visit.\n* Telephone to obtain informed consent from the subjects\u002Ffamily members of the subjects.\n\nExclusion Criteria:\n\n* Not available",{"count":117,"type":22},15000,"OBSERVATIONAL","AMI Survivors who participated in the project \"Construction and key technology research of the whole myocardial protection system for acute myocardial infarction\" (project number 2016YFC1301100) and completed the 1-year visit were followed up by telephone at 3 years (within the corresponding follow-up time window) and 5 years after discharge to acquire the patients' medication, health status, and major adverse cardiovascular and cerebrovascular events, including death, heart failure, rehospitalization, re-myocardial infarction, revascularization, stroke, malignant arrhythmia, and bleeding events.",[121,29],"Acute Myocardial Infarction",[123,124,125],"Acute myocardial infarction","Major adverse cardiac and cerebrovascular event","Optimized treatment","2025-08-31",{"date":128,"type":38},"2025-09-03",{"date":130,"type":38},"2022-12-21",{"date":132,"type":22},"2026-12-30",{"name":134,"class":45},"Yu Bo",18,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":23,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":78},"100600504","efficacy-and-safety-of-nalfurafine-hydrochloride-odt-for-moderate-to-severe-pruritus-in-patients-on-peritoneal-dialysis-100600504","NCT07098351","Efficacy and Safety of Nalfurafine Hydrochloride ODT for Moderate-to-Severe Pruritus in Patients on Peritoneal Dialysis","A Clinical Study on the Efficacy and Safety of Nalfurafine Hydrochloride Orally Disintegrating Tablets in the Treatment of Moderate to Severe Pruritus in Peritoneal Dialysis Patients","KARE-PD","Inclusion Criteria:\n\nAt the time of signing informed consent:\n\n* Aged 18-85 years (inclusive), regardless of gender.\n* Chronic renal failure patients on regular peritoneal dialysis for ≥3 months, with no anticipated major treatment changes or rapid disease progression during the trial.\n* Able to understand and comply with study procedures, voluntarily participate, and provide written informed consent.\n\nAt formal enrollment:\n\n* During the baseline period, ≥5 days with both morning and evening VAS scores recorded, and the average of the higher VAS values (morning\u002Fevening) ≥50 mm.\n* During the baseline period, ≥5 days with Xie-Kawashima itching severity assessed both morning and evening, including ≥2 days where the maximum itching score (morning\u002Fevening) was ≥3 (moderate).\n\nExclusion Criteria:\n\n* Poor dialysis compliance, deemed by the investigator to affect efficacy\u002Fsafety assessments.\n* Poor dialysis compliance, deemed by the investigator to affect efficacy\u002Fsafety assessments.\n* Peritoneal dialysis regimen adjusted within 2 weeks prior to screening.\n* Currently on or planning hemodialysis within 2 months.\n* Planned kidney transplant or elective surgery during the study.\n* Peritonitis within 4 weeks prior to screening, unable to continue peritoneal dialysis.\n* ALT, AST, GGT, or total bilirubin \\>2× upper limit of normal (ULN) during screening.\n* Pruritus not caused by chronic kidney disease (e.g., allergic, physical, infectious skin diseases, cholestatic liver disease).\n* Severe cardiovascular disease (NYHA Class III\u002FIV, acute MI, unstable angina, large pericardial effusion, severe arrhythmia, or ECG abnormalities deemed unsafe for participation).\n* Active malignancy within 12 months prior to screening, or recent radiotherapy\u002Fchemotherapy\u002Ftargeted\u002Fimmunotherapy.\n* Uncontrolled or drug-treated fungal\u002Fbacterial\u002Fviral infections (e.g., active TB, HIV).\n* Uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg).\n* Current systemic corticosteroids\u002Fimmunosuppressants (topical excluded).\n* Psychiatric or cognitive disorders.\n* Initiated\u002Fadjusted restricted medications (antihistamines, systemic\u002Flocal corticosteroids \\[excluding ear\u002Feye\\], calcineurin inhibitors, gabapentin, pregabalin) within 7 days prior to screening, or anticipated changes during the study.\n* Initiated\u002Fadjusted medications affecting pruritus assessment (antipsychotics, hypnotics, SSRIs, anxiolytics, TCAs) within 2 weeks prior to screening, or anticipated changes during the study.\n* Opioid agonists\u002Fantagonists used within 2 weeks prior to screening.\n* Phototherapy for pruritus within 1 month prior to screening.\n* History of drug abuse, dependence, or alcoholism within 12 months prior to screening.\n* Allergy to opioids or trial drug excipients.\n* Participation in another clinical trial with investigational drugs\u002Fdevices within 28 days prior to screening, or residual investigational drug within 5 half-lives.\n* Pregnant, breastfeeding, positive pregnancy test, or unwilling to use contraception during the study.\n* Other conditions deemed unsuitable by the investigator.","85 Years",{"count":146,"type":22},93,[25],"Moderate to severe pruritus significantly impairs the quality of life in peritoneal dialysis patients, and effective treatment options remain limited. κ-opioid receptor agonists may alleviate itching by modulating neural signaling pathways. This study is a multicenter, prospective, single-arm clinical trial, planning to enroll 93 patients. It aims to test the hypothesis that nalfurafine hydrochloride orally disintegrating tablets compared to baseline, with acceptable safety.",[29,150,151,152],"Peritoneal Dialysis","Moderate-to-severe Pruritus","Chronic Kidney Disease-associated Itch","2025-08-26",{"date":128,"type":38},{"date":156,"type":38},"2025-08-07",{"date":158,"type":22},"2026-06-30",{"name":160,"class":45},"Guangdong Provincial People's Hospital",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":168,"enrollmentInfo":169,"targetDuration":171,"studyType":118,"phases":4,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":78},"100586439","metabolomic-and-lipidomic-analysis-predicts-immunotherapy-related-adverse-events-in-gastric-cancer-patients-100586439","NCT06915389","Metabolomic and Lipidomic Analysis Predicts Immunotherapy-related Adverse Events in Gastric Cancer Patients","Comprehensive Plasma Metabolomic and Lipidomic Profiling for Predictive Modeling and Biomarker Discovery of Immune-Related Adverse Events in PD-1\u002FPD-L1 Inhibitor-Treated Gastric Cancer Patients: A Prospective Cohort Study","Inclusion Criteria:\n\n* Age≥ 18 years\n\n  * ECOG PS 0-2\n\n    * Gastric cancer diagnosed by histology or cytology\n\n      * Untreatment with PD-1\u002FPD-L1 inhibitors\n\n        * Expected survival≥3 months\n\n          * Exhibits a favorable adherence to treatment and follow-up,demonstrates compliance with the research protocol, and willingly signs the informed consent form.\n\nExclusion Criteria:\n\n* Unable to obtain an organization or due to insufficient organizational material, unable to diagnose gastric cancer\n\n  * Refusal to receive PD-1\u002FPD-L1 inhibitor treatment\n\n    * Baseline (before immunotherapy) plasma samples are unavailable\n\n      * Combined with autoimmune diseases\n\n        * Baseline (before immunotherapy) there are severe diseases in the heart, lungs, thyroid gland and other organs\n\n          * Baseline (before immunotherapy) there are severe abnormalities in liver and kidney functions, pancreatic enzymes and other indicators\n\n            ⑦ Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study","80 Years",{"count":170,"type":22},100,"1 Year","This study comprehensively examines metabolic and lipidomic dynamics in gastric cancer patients initiating PD-1\u002FPD-L1 inhibitor therapy, employing a longitudinal design with pre- and post-treatment patients. The primary objectives include identifying irAE-associated metabolic and lipid biomarkers, developing predictive risk models, and evaluating the prognostic value of these molecular profiles. The findings are expected to contribute significantly to personalized treatment strategies and improved clinical decision-making in immunooncology.",[174,175,29,176,177],"Gastric Cancer","Immunotherapy","Metabonomics","Lipidomics",[179,180,181,182,183,184],"Immune-related adverse events (irAEs)","PD-1\u002FPD-L1 inhibitors","Gastric cancer","Biomarkers","Metabolic","Lipidomic","2025-04-03",{"date":187,"type":38},"2025-04-08",{"date":189,"type":38},"2025-02-22",{"date":191,"type":22},"2027-06-30",{"name":193,"class":45},"Qinghai Red Cross Hospital",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":201,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":23,"phases":205,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":78},"100306063","phase-4-intervention-for-high-normal-blood-pressure-in-adults-with-type-2-diabetes-100306063","NCT03264352","Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes","IPAD","Inclusion Criteria:\n\n* irrespective of sex;\n* aged between 45 and 79 years;\n* with office-measured seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic;\n* diagnosed of type 2 diabetes mellitus (T2DM), currently on diabetic therapy;\n* informed consent provided and long-term follow-up possible\n\nExclusion Criteria:\n\n* poor control of blood glucose, HbA1c \\> 10.0%\n* administration of any antihypertensive medications within 1 month;\n* a history of hypoglycemic coma \u002F seizure;\n* confirmed diagnosis of type 1 diabetes mellitus;\n* alanine-aminotransferase (ALT) or aspartate-aminotransferase (AST) over three times the upper limit of normal;\n* estimated glomerular filtration rate \\\u003C 45 ml\u002Fmin\u002F1.73m2;\n* a history of congestive heart failure with left ventricular ejection fraction \\\u003C 40%;\n* coronary artery disease requiring RAS blockers for secondary prevention;\n* acute on-set of stroke within 6 months prior to randomization;\n* a ratio of urinary albumin (in mg\u002FL) to urinary creatinine (in g\u002FL) (ACR) ≥ 300 mg\u002Fg;\n* known contraindications for the active study medications;\n* a history of psychological or mental disorder;\n* pregnancy or currently planning to have babies or lactation;\n* severe diseases such as severe heart diseases;\n* an expected residual life span less than 3 years;\n* a malignancy that clinical investigators consider as unsuitable to participate;\n* currently participating in another clinical trial.","45 Years","79 Years",{"count":204,"type":22},11414,[206],"PHASE4","Lowering of blood pressure (BP) in high-risk hypertensive individuals reduces major adverse cardiovascular and cerebrovascular events. Diabetic patients with hypertension benefit from BP lowering treatment. The present trial, IPAD in brief, is a randomized, open-label, parallel-designed, multicenter study involving nearly 12,000 patients to be recruited and to be followed up for a median of four years. IPAD tests the hypothesis that antihypertensive medications in adults with type 2 diabetes, whose seated BP 120-139 mm Hg systolic and below 90 mm Hg diastolic, results in 20% difference in the incidence of major adverse cardiovascular and cerebrovascular events. During follow-up for participants in the intensive group, the sitting systolic pressure should be decreased to below 120 mm Hg, by titration and combination of the study medications of an angiotensin type-1 receptor blocker Allisartan (240 mg\u002Fday), a dihydropyridine calcium-channel blocker (amlodipine 5-10 mg\u002Fday), and\u002For other medications if necessary. For those in the standard group, the sitting systolic pressure should be monitored and controlled below 140 mm Hg.",[209,29,210,211,212],"Diabetes Mellitus, Type 2","Blood Pressure","Prehypertension","Cardiovascular Risk Factor","2025-03-10",{"date":215,"type":38},"2025-03-12",{"date":217,"type":38},"2018-02-01",{"date":219,"type":22},"2025-09",{"name":221,"class":45},"XueQing Yu",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":118,"phases":4,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":78},"100569376","the-immune-assessment-of-pd-1-antibody-therapy-in-tumor-100569376","NCT06693440","The Immune Assessment of PD-1 Antibody Therapy in Tumor","The Immune Assessment of PD-1 Antibody Therapy in Tumor - A Case-Control Study","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Pathologically confirmed malignant tumors.\n3. Complete medical records.\n4. Assessable immune function test data.\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years.\n2. No confirmed tumor pathology.\n3. Untraceable medical records.\n4. Non-assessable immune function tests.",{"count":230,"type":22},3000,"This retrospective study will leverage previous immune function monitoring results in conjunction with clinical case data at this medical center.",[233,29],"Efficacy, Team",[235,236,237],"PD(L)-1 inhibitor","efficacy","adverse event","2024-11-14",{"date":240,"type":38},"2024-11-18",{"date":242,"type":38},"2021-07-01",{"date":244,"type":22},"2030-11-13",{"name":246,"class":247},"Quanli Gao","OTHER_GOV",{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":4},"100533786","patient-safety-incidents-in-coordinated-primary-care-teams-a-multi-method-study-100533786","NCT06230341","Patient Safety Incidents in Coordinated Primary Care Teams: a Multi-method Study","EVIDENS-Prim","Inclusion Criteria:\n\n* Characteristics of the MSPs included in the study:\n* Located in the Pays de la Loire region;\n* Having a contract with a health insurance (specifications and financing defined nationally) for at least 1 year;\n* Agreeing to take part in the project;\n* Having a quality representative or committing to appoint one when they join the project.\n\nCharacteristics of professionals working in MSPs included:\n\n* All independent health professionals involved in the MSP: general practitioners and, depending on the MSP, nurses, pharmacists, podiatrists, physiotherapists, midwives, speech therapists, dentists, occupational therapists, psychomotor therapists, etc,)\n* All professionals involved in MSP outside the health sector: (coordinators, medical assistants, independent psychologists, etc.),\n* agree to take part in the project.\n\nExclusion Criteria:\n\nOther group exercise modalities or other forms of coordinated exercise (other than MSP) do not have a quality representative on their team and will not be considered for inclusion.\n\nCharacteristics of MSPs not included in the research:\n\n\\- Where the members of the research team work.\n\nCharacteristics of professionals working in MSPs included:\n\n\\- Not included.",{"count":256,"type":22},15,[25],"In France, improving the practice of health professionals working in coordinated primary care teams (health centres called Maisons de Santé Pluriprofessionnelles - MSPs) could be facilitated by a learning system consisting of (i) a risk management support programme and (ii) the provision of a comprehensive online system combining training, reporting and support for the analysis and management of patient safety incidents (PSIs).\n\nEVIDENS-Prim is a multi-method, multi-centre, prospective study. It aims to describe the PSIs that occur in MSPs, using an international classification system, and to describe the ways in which professionals have adopted a global approach to PSIs management, from PSI reporting to feedback.",[29],[261,262,263,264,265],"Healthcare","Adverse event","Safety culture","Patient safety","Learning","2024-01-19",{"date":268,"type":38},"2024-01-30",{"date":270,"type":22},"2024-04-01",{"date":272,"type":22},"2026-08-01",{"name":274,"class":45},"Nantes University Hospital",{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":23,"phases":284,"briefSummary":286,"conditions":287,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100409720","phase-3-18f-2-fluoro-2-deoxy-d-glucose-in-positron-emission-tomography-computed-tomography-100409720","NCT04615156","18F-2-fluoro-2-deoxy-D-glucose in Positron Emission Tomography Computed Tomography","Evaluation of 18F-2-fluoro-2-deoxy-D-glucose Produced by a New Manufacturer, for Safety, Through the Identification of Adverse Events, and Efficacy, Through the Evaluation of Its Ability, When Utilized in Performance of a Positron Emission Tomography Computed Tomography Scan, to Correctly Distinguish Benign From Malignant Solitary Pulmonary Nodules.","Inclusion Criteria:\n\n* Known or suspected disease for which 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography Computed Tomography is appropriate for the investigation of. This includes, but is not limited to: Known or suspected cancer, neurological disorders (dementia or epilepsy), cardiac conditions (inflammation or myocardial viability), known or suspected presence of infection\u002Finflammation process\n\nPatients must satisfy all the following:\n\n* Able to provide written informed consent, or consent obtained from appropriate guardian\n* Able to tolerate the physical and logistic requirements of completing a Positron Emission Tomography Computed Tomography scan\n\nExclusion Criteria:\n\n* Pregnant women: if there is any possibility of pregnancy, a blood Beta Human Chorionic Gonadotropin level will be obtained as per Eastern Health policy.\n* Patients unwilling or unable to stop breast feeding for 12 hours\n* Patients who are too medically unstable to tolerate the uptake period or lie flat for the duration of the scan\n* Patients who exceed the safe weight limit of the Positron Emission Tomography Computed Tomography scanner bed (500 lbs.) or who cannot fit through the bore (70 cm diameter)\n* Patients unwilling to proceed with scan (I.e. claustrophobia) prior to injection\n* If patients inability to follow staff direction causes a safety hazard prior to injection",{"count":283,"type":22},10000,[285],"PHASE3","The study objectives are as follows:\n\n* To determine the safety of trial 18F-2-fluoro-2-deoxy-D-glucose, produced by a new manufacturer, by surveillance for adverse events in patients having Positron Emission Tomography Computed Tomography scans in a comprehensive program for indications including, but not limited to, oncology, neurology, cardiac and infectious\u002Finflammatory processes.\n* To determine the efficacy of 18F-2-fluoro-2-deoxy-D-glucose Positron Emission Tomography in differentiating benign from malignant solitary pulmonary nodules and calculate sensitivity, specificity, and accuracy using pathologic confirmation as the gold standard when available, or greater than 6 month follow up stability on Computed Tomography scan when not.\n\nThe purpose of performing this clinical trial is to provide local access of 18F-2-fluoro-2-deoxy-D-glucose to the patients of Newfoundland and Labrador. This product has been offered to patients over the last three years by transporting from facilities outside of the province. There have been significant delays in access and in fact, times where 18F-2-fluoro-2-deoxy-D-glucose has not been available through this process. This has caused delays and limitations of treatments for patients who rely on Positron Emission Tomography Computed Tomography scans for diagnosis.",[288,289,290,29],"Solitary Pulmonary Nodule","Oncology","18F-2-fluoro-2-deoxy-D-glucose",[290,29,288,289],"2020-11-02",{"date":294,"type":38},"2020-11-04",{"date":296,"type":22},"2020-11-01",{"date":298,"type":22},"2027-11-01",{"name":300,"class":45},"Eastern Health, Canada"]