[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-effect":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,50,79,125,146,168,188,210,242,272],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100604838","phase-4-glp-1r-actions-on-muscle-and-the-skeleton-100604838",false,"NCT07154719","GLP-1R Actions on Muscle and the Skeleton","GRAMS","Inclusion Criteria:\n\n* Subjects will have a BMI between 30kg\u002Fm2\n\n  * 40kg\u002Fm2 (inclusive)\n* Be between 18 and 50 years of age (inclusive).\n* Non-Hispanic Black males and females will be enrolled at PBRC.\n* Rural males and females will be enrolled at MaineHealth.\n* Female subjects will be premenopausal.\n* Females have had their last menstrual period less than 60 days before screening.\n* Females have the absence of menopausal-associated vasomotor symptoms.\n* All subjects must be able to use Lifestyle Toolkit as prescribed for intervention arm.\n\nExclusion Criteria:\n\n\\- Males and females over the age of 50 years of age\n\n* Menopausal females.\n* Subjects on systemic corticosteroids or other agents known to increase loss of muscle and bone mass.\n* Subjects who are on medications that increase or decrease weight status.\n* Subjects having contraindications to tirzepatide in the package insert.\n* Subjects with a history of malignancy other than non-melanoma skin cancer\n* Subjects with known osteoporosis or are on osteoporosis therapies (gonadal hormones or hormone antagonists).\n* Subjects with uncontrolled thyroid or parathyroid disease that may influence the study results.\n* Subjects with a clinically significant hematologic abnormality, kidney disease, liver disease, or diabetes.\n* Females of childbearing potential who do not agree to using an effective method of contraception during the study. Medically acceptable methods include oral contraceptive medication, an intrauterine device (IUD), an implantable contraceptive (such as Implanon), or a barrier method (such as condom or diaphragm with spermicide).\n\nInjectable contraceptives such as Depo-Provera are a cause for exclusion in that they can cause bone loss.\n\nAbstinence is acceptable, as is sexual activity exclusively with same sex partners.\n\nFertility Appreciation Based Methods (natural family planning) are also acceptable forms of addressing childbearing potential in all subjects. A urine pregnancy test (UPT) will be performed on all females of childbearing potential at the screening visit, 3 and 6 months.\n\n* Unable to follow Lifestyle Toolkit as prescribed for intervention arm.\n* Patient Health Questionnaire-9 (PHQ-9) Score equal to or greater than 15 (clinical depression).\n* Adults who are unable to consent.\n* Individuals who are not yet adults (infants, children and teenagers).\n* Pregnant females.\n* Incarcerated individuals.\n* Contraindication to MRI - including but not limited to non-removable metallic or electronic implants, claustrophobia or other fear of confinement, inability to tolerate loud scanner noise, body weight greater than 500 pounds.\n* Subjects with a baseline level of 25-OH vitamin D \\\u003C15 ng\u002Fml will be excluded from the trial. The subject's physician will be notified, and the subject will be referred to their primary care physician.\n* Any significant EKG abnormalities that are considered a risk for utilizing weight management therapies.","ALL","18 Years","50 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The GRAMS study objectives are to assess the musculoskeletal changes that occur after weight loss using GLP-1 based therapy. A lifestyle intervention with diet and exercise is included to assess any mitigating effects are provided, versus a control group with regular exercise and diet.",[27,28,29,30,31],"Musculoskeletal Abnormalities","Obesity","Sarcopenic Obesity","Osteoporosis","Drug Effect",[33,34,35,36],"GLP-1 agonists","Obesity treatments","Muscleskeletal loss","Tirzepatide","RECRUITING","2026-05-26",{"date":40,"type":41},"2026-05-29","ACTUAL",{"date":43,"type":41},"2025-10-09",{"date":45,"type":21},"2027-05-01",{"name":47,"class":48},"Pennington Biomedical Research Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":49},"100566670","phase-3-efficacy-and-safety-of-tenecteplase-bridging-mechanical-thrombectomy-for-acute-large-vessel-occlusion-stroke-100566670","NCT06658197","Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke","Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusive Stroke(TNK-LVO) :a Phase 3, Multicentre, Open-label, Randomised Controlled Trial","TNK-LVO","Inclusion Criteria:\n\n1. Age is ≥18 years.\n2. AIS symptom onset ≤4.5 hours, onset time refers to the time the patient was last known to be well. (Recommendation time from thrombolysis to puncture within 60 minutes).\n3. Arterial occlusion of the internal carotid artery (ICA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), M1 or M2 segment of the middle cerebral artery (MCA), or basilar artery on computed tomography angiography (CTA) or magnetic resonance angiography (MRA).\n4. Prestroke mRS score ≤2.\n5. Informed consent from the patient or legally authorised representative.\n\nExclusion Criteria:\n\n1. Patients diagnosed with hemorrhagic stroke (including intraparenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural\u002Fextradural hematoma, etc.) or other related conditions identified by CT.\n2. Contraindication to imaging examinations involving contrast agent injection.\n3. Patients presenting with clinical symptoms of coma (NIHSS Score Item 1a = 3).\n4. History of intracranial hemorrhage.\n5. History of severe head trauma or stroke within the past 3 months.\n6. Intracranial or intraspinal surgery within the past 3 months.\n7. Major surgery within the past 2 weeks.\n8. Gastrointestinal or urinary tract bleeding within the past 3 weeks.\n9. Intracranial tumor, arteriovenous malformation, or giant intracranial aneurysm.\n10. Active visceral bleeding.\n11. Aortic arch dissection.\n12. Arterial puncture at a non-compressible site within the past week.\n13. Uncontrolled hypertension despite active antihypertensive treatment: Systolic Blood Pressure \\> 180 mmHg or Diastolic Blood Pressure \\> 100 mmHg.\n14. Acute hemorrhagic tendency, including platelet count \\\u003C 100 × 10⁹\u002FL or other conditions.\n15. Heparin treatment received within the past 24 hours.\n16. For patients on oral anticoagulants: INR \\> 1.7 or PT \\> 15 seconds.\n17. Use of direct thrombin inhibitors or direct Factor Xa inhibitors within the past 48 hours.\n18. Blood glucose \\\u003C 2.8 mmol\u002FL or \\> 22.2 mmol\u002FL.\n19. Hypodensity affecting \\> 1\u002F3 of the middle cerebral artery territory or an equivalent proportion of the basilar artery territory on non-contrast CT.\n20. Rapidly improving symptoms as determined by the investigator.\n21. Participation as a subject in another research study within the past 30 days.\n22. Any terminal illness where life expectancy is considered not to exceed 1 year.\n23. Any condition where, in the judgment of the investigator, the study treatment might pose a risk to the patient or affect the patient's participation in the study.\n24. Pregnant women.\n25. Known allergy to the active ingredients (Alteplase, Tenecteplase) or any excipients.",{"count":59,"type":21},850,[61],"PHASE3","A phase III, multicentre, prospective, randomised, open-label, blinded-endpoint clinical trial will evaluate two thrombolytic agents for the treatment of acute large vessel occlusion stroke within 4.5 hours from symptoms onset: intravenous tenecteplase bridging mechanical thrombectomy vs. intravenous alteplase bridging mechanical thrombectomy.",[64,65,66,31],"Stroke, Ischemic","Stroke, Acute","Thrombosis, Brain",[68,69],"Ischemic stroke","Tenecteplase","2026-04-08",{"date":72,"type":41},"2026-04-09",{"date":74,"type":41},"2025-12-25",{"date":76,"type":21},"2027-06-01",{"name":78,"class":48},"Xuanwu Hospital, Beijing",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":17,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":100,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100478607","pharmacogenomic-association-study-in-indian-children-with-acute-lymphoblastic-leukemia-100478607","NCT05512169","Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia","Molecular and Pharmacogenetic Marker Evaluation in Relation to the Toxicity and Clinical Response of Acute Lymphoblastic Leukemia Treatment in Indian Children (MPGx-INDALL)","MPGx-INDALL","Inclusion Criteria:\n\n* Age \\> 1 year old and ≤18 years old at enrolment\n* Previously untreated\n* ALL diagnosis confirmed by morphology and flow-cytometry\n* Indian origins\n* Fulfilling IciCle treatment protocol inclusion criteria and receiving treatment as per the protocol\n* Written Informed consent to participate in the study has to be signed by the participant\u002Fparent\u002Fguardian\n\nExclusion Criteria:\n\n* Previously tretaed patients\n* Patients with Down's syndrome\n* Patients with mature B-ALL","1 Year",{"count":89,"type":21},556,"OBSERVATIONAL","A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL). The project is an International multicenter setup. This collaborative research project between Switzerland and India includes one main center in Geneva that has conceptualized, designed, received grants for the study and two investigating centers in India (Puducherry and New-Delhi) involved in study design, patient care and recruitment for this specific study. All the participants for the study will be recruited form these two centers in India, and no patient recruitment is planned at main center i.e. Geneva.\n\nThe study will be conducted in two phases. The first aims to investigate genetic predisposition (static germline variants) to early chemotherapy treatment related toxicities (TRTs). The second aims to investigate somatic genetic markers associated with the efficacy of steroid treatment among patients undergoing the standardized IciCLe-ALL-14 treatment protocol. A total of 500 children with ALL will be recruited to investigate primary objective of the study i.e. TRT, and a subset of 250 patients will be included to investigate another research question i.e. response to steroid therapy.",[93,94,95,96,97,98,31,99],"ALL, Childhood","Pediatric Cancer","Toxicity, Drug","Adverse Drug Event","Relapse Leukemia","Drug Toxicity","Drug Interaction",[101,102,103,104,105,106,107,108,109,110,111,112,113,114],"Pharmacogenetics","Pharmacogenomics","Genetic polymorphism","Sequencing","Genotyping","Indian","Pediatrics","SNP","gene variant","germline genetic variant","somatic variant","biomarker","steroid response","genetic predisposition","2026-01-13",{"date":117,"type":41},"2026-01-15",{"date":119,"type":41},"2022-12-01",{"date":121,"type":21},"2027-03-30",{"name":123,"class":48},"University of Geneva, Switzerland",2,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":49},"100331296","pharmacokinetics-of-sedatives-and-analgesics-during-extracorporeal-membrane-oxygenation-ecmo-support-100331296","NCT03593408","Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support","Inclusion Criteria:\n\n* supported on ECMO\n* receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management\n\nExclusion Criteria:\n\n-none","0 Days","17 Years",{"count":134,"type":21},20,"This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.",[31],"2026-01-08",{"date":139,"type":41},"2026-01-09",{"date":141,"type":41},"2019-02-08",{"date":143,"type":21},"2026-12-01",{"name":145,"class":48},"Boston Children's Hospital",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":49},"100607006","phase-4-the-effect-and-mechanism-of-xiqing-regulating-intestinal-homeostasis-on-drug-efficacy-of-chronic-kidney-disease-100607006","NCT07182942","The Effect and Mechanism of Xiqing Regulating Intestinal Homeostasis on Drug Efficacy of Chronic Kidney Disease","Inclusion Criteria:\n\n1. Written informed consent was obtained;\n2. ranging in age from 18 to 75 years;\n3. CKD stage 3-5, that is, eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2 with non-dialysis stage, no dialysis indication, temporarily stable condition and drug control stage;\n4. tolerance of Xiqing and probiotics treatment.\n\nExclusion Criteria:\n\n1. with severe active infection, influence of nutritional status in patients with malignant tumor and other diseases;\n2. patients during pregnancy or lactation;\n3. unstable vital signs, the condition is not stable, need dialysis patients;\n4. patients with intolerance of Xiqing;\n5. patients with intolerance of probiotics;\n6. taking corticosteroids, antibiotics or other immunosuppressive agents within the past 3 months;\n7. taking adsorbent drugs, such as medicinal charcoal tablets, within the past 3 months.","75 Years",{"count":154,"type":21},120,[24],"Chronic kidney disease (CKD) has become a major public health problem worldwide. Patients with CKD are often accompanied by azotemia due to impaired renal function and excretion of nitrogen metabolic waste, which leads to multiple organ dysfunction, cardiac dysfunction and other complications. Therefore, it is an important strategy in the treatment of CKD to reduce the burden of kidney in CKD patients by removing nitrogen metabolic wastes in the body. Xiqing, which includes coated aldehyde oxystarch capsules, is a drug with adsorption effect. As an effective nitrogen metabolic waste adsorbent, it is widely used in the treatment of CKD patients. Gut is an important organ for the generation of nitrogen metabolic waste in the body. Intestinal homeostasis is an important regulator of nitrogen metabolism, and supplementation of probiotics is one of the main ways to regulate intestinal homeostasis. A study published by the team of investigators in the journal Cell Metabolism in 2021 confirmed that probiotics (Lactobacillus casei Zhang) reduced the BUN level in CKD mice, intestinal inflammation and the permeability of intestinal mucosal barrier, and delay the progression of CKD patients through animal experiments and clinical trials. So, whether the application of Xiqing changes intestinal homeostasis, including intestinal flora structure, function and function of intestinal mucosa, intestinal metabolites? Whether drug effect is affected by intestinal balance of CKD? What is the mechanism? Is Xiqing combined with probiotics more conducive to reducing BUN level and delaying the progression of CKD patients? The discussion of the problem and solution will help clinicians for the pioneering understanding of the use of Xiqing.\n\nIn this study, the investigators designed a prospective, randomized, open-label, blinded end-point clinical trial, using microbial diversity, metagenomics, targeted and non-targeted metabolomics detection and other technologies, through the joint analysis of multi-omics data, to explore the effect of the use of Xiqing on the intestinal homeostasis of CKD, and the extent of the drug efficacy of Xiqing is affected by the intestinal homeostasis of CKD. The effect of Xiqing combined the probiotics regulating intestinal homeostasis on CKD and the molecular mechanism, which provide more research references for the clinical application of Xiqing.",[158,31],"CKD","2025-09-12",{"date":161,"type":41},"2025-09-19",{"date":163,"type":41},"2024-06-07",{"date":165,"type":21},"2025-12-31",{"name":167,"class":48},"Chujin Cao",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":132,"enrollmentInfo":174,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":49},"100326619","pharmacokinetics-of-bivalirudin-for-pediatric-anticoagulation-100326619","NCT03532399","Pharmacokinetics of Bivalirudin for Pediatric Anticoagulation","Inclusion Criteria:\n\n* pediatric patient (age less than 18 years)\n* weight \\> 3kg\n* scheduled to undergo 1) cardiac catheterization, 2)cardiac surgical procedure utilizing CPB, and\u002For 3) the institution of extracorporeal support\n* must already require the administration of bivalirudin as part of their treatment plan\n\nExclusion Criteria:\n\n* Age equal to or greater than 18 years,\n* weight less than 3kg\n* end-stage renal failure requiring renal replacement therapy.",{"count":175,"type":21},30,"This study will measure plasma concentrations of bivalirudin in pediatric patients undergoing cardiac catheterization, cardiac surgical procedures utilizing cardiopulmonary bypass (CPB), or extracorporeal support with ECMO, ventricular support devices (VAD) or lung-assist devices (LAD). The aim is to understand the pharmacokinetics of bivalirudin in these settings.",[31],[179],"Bivalirudin","2025-06-28",{"date":182,"type":41},"2025-07-02",{"date":184,"type":41},"2018-07-12",{"date":186,"type":21},"2026-05",{"name":145,"class":48},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":199,"conditions":200,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":49},"100483711","a-pilot-study-for-optimizing-meropenem-administration-in-the-icu-100483711","NCT05578586","A Pilot Study for Optimizing Meropenem Administration in the ICU","A Pilot Study for Optimizing Meropenem Administration in the Intensive Care Unit - Short Six Times vs Prolonged Three Times Courses Daily","MER6","Inclusion Criteria:\n\n1. Patients ≥ 18 years admitted to the ICU at Oslo University Hospital, Rikshospitalet and\n2. who shall be treated with meropenem because of proven or suspected serious infection and\n3. who give their written informed consent either directly or through next of kin\n\nExclusion Criteria: Patients\n\n1. with known hypersensistivity to betalactam antibiotics or\n2. who use of valproat or\n3. who are pregnant or\n4. the lack of consent.",{"count":20,"type":21},[198],"NA","Can antibiotic drugs be administered faster and make acceptable serum concentrations if we give short but multiple infusions compared to long and fewer infusions? In this study we will compare giving meropenem 1 gram 6 times daily in 15 minutes infusions to the recommended 2 gram 3 times daily in 3 hours infusions. In patients in the intensive care unit, the need for intravenous access is of essence. If 6 short infusions results in the same serum concentrations as 3 long infusions, we will increase intravenous access from 15 to 22.5 hours daily.",[31],"2025-04-23",{"date":203,"type":41},"2025-04-24",{"date":205,"type":41},"2021-12-14",{"date":207,"type":21},"2027-06",{"name":209,"class":48},"Oslo University Hospital",{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":220,"conditions":221,"keywords":224,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":49},"100581935","phase-4-randomized-comparison-of-morning-versus-bedtime-administration-of-statins-a-cardiovascular-circadian-chronotherapy-c3-trial-100581935","NCT06856772","Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial","STATIN-C3","Inclusion Criteria:\n\n* Age \\>=18 years\n* Current treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)\n* Signed informed consent\n\nExclusion Criteria:\n\n* none",{"count":218,"type":21},42000,[24],"Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.\n\nThe primary objective of this study is to examine whether statin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking statin.",[222,31,223],"Cardiovascular Diseases (CVD)","Atherosclerosis Cardiovascular Disease",[225,226,227,228,229,230,231],"Statin","Circadian Rhythm","Randomized Controlled Trial","Pragmatic","Outcomes","Cardiovascular disease","Prevention","NOT_YET_RECRUITING","2025-02-26",{"date":235,"type":41},"2025-03-04",{"date":237,"type":21},"2025-02-28",{"date":239,"type":21},"2028-03-28",{"name":241,"class":48},"Tor Biering-Sørensen",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":4},"100561746","phase-2-early-application-of-memantine-and-pioglitazone-to-protect-cognitive-function-after-radiotherapy-100561746","NCT06594172","Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy","A Phase II Clinical Trial of of Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy","Inclusion Criteria:\n\n* Recursive Partitioning Analysis (RPA), Class I \\~ Class II\n* Karnofsky Performance Status of ≥70\n* The primary tumor must be pathologically confirmed. For newly diagnosed brain metastases, the number of metastases is not limited, but the brain metastases could not have been within 5 mm of hippocampus. Additionally, there must be no hard or soft meningeal metastases.\n* No history of whole-brain radiation therapy; patients who are eligible for surgical resection of brain metastases prior to radiation therapy are allowed.\n* Bone marrow function: White blood cell count ≥ 4 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, and platelet count ≥ 100 × 10⁹\u002FL.\n* Adequate hepatic function: Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal); ALT (alanine aminotransferase), AST (aspartate aminotransferase) ≤ 2.5 × ULN; ALP (alkaline phosphatase) ≤ 2.5 × ULN and total bilirubin ≤ ULN.\n* Adequate renal function: creatinine clearance rate ≥ 30 ml\u002Fmin.\n* Patients or their legal guardians voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt.\n* Planned cytotoxic chemotherapy during the WBRT.\n* Pregnant or lactating women (Women of childbearing age must undergo a pregnancy test; effective contraception must be enforced during the treatment period).\n* Previous cranial radiation therapy (Except for patients with head and neck cancer where the disease site is outside the cranial radiation field).\n* Severe or active symptomatic cardiopulmonary diseases; clinically significant psychiatric disorders; Personality or psychiatric disease; Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease;\n* Intolerant to or allergic to Memantine or pioglitazone.\n* Difficulty swallowing, chronic diarrhea, or bowel obstruction.\n* NYHA class III or IV heart failure or symptomatic peripheral edema (grade 2 or higher); those treated with insulin or oral hypoglycemic agents for steroid-induced hyperglycemia, or those currently using other NMDA antagonists.","65 Years",{"count":251,"type":21},67,[253],"PHASE2","This clinical trial aims to evaluate the efficacy of early intervention with Memantine and Pioglitazone in preventing Radiation-Induced Brain Injury (RIBI) in patients undergoing cranial radiotherapy.\n\nRIBI, a significant complication of radiation therapy for primary and metastatic brain tumors, as well as head and neck cancers, often presents with delayed and irreversible neurological damage, severely affecting patients' quality of life.\n\nOur previous studies have indicated that Memantine, an NMDAR antagonist, and Pioglitazone, a PPAR-γ agonist, play crucial roles in modulating the neuroprotective immune microenvironment by targeting key mechanisms of neuron-astrocyte fatty acid metabolism coupling. These findings suggest that early administration of these drugs could protect cognitive function and reduce neuroinflammation in patients post-radiation.\n\nThis prospective phase II clinical trial will assess the combined efficacy of Memantine and Pioglitazone in improving cognitive outcomes and preventing RIBI without adversely impacting the anti-tumor efficacy of radiation therapy. The study will also explore the synergistic effects of these two FDA-approved drugs in early-stage RIBI prevention, providing a new therapeutic strategy for enhancing the quality of life in cancer patients receiving radiotherapy.",[256,257,31],"Radiation Disease","Cognitive Impairment",[259,260,261,262],"radiation induced brain injury","Memantine","Pioglitazone","cognitive function","2024-09-16",{"date":265,"type":41},"2024-09-19",{"date":267,"type":21},"2024-09-10",{"date":269,"type":21},"2027-06-30",{"name":271,"class":48},"Affiliated Cancer Hospital & Institute of Guangzhou Medical University",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":49},"100510902","phase-4-randomized-comparison-of-morning-versus-bedtime-administration-of-aspirin-a-cardiovascular-circadian-chronotherapy-c3-trial-100510902","NCT05932472","Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial","ASPIRIN-C3","Inclusion Criteria:\n\n* Age \\>=18 years\n* Current chronic treatment with aspirin (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)\n* Signed informed consent\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this trial",{"count":280,"type":21},32706,[24],"Wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. Several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. The primary objective of this study is to examine whether aspirin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking aspirin.",[284,285,31],"Atherosclerosis","Cardiovascular Diseases",[287,288,231,226,227,228,229],"Aspirin","Cardiovascular Disease","2024-02-05",{"date":291,"type":41},"2024-02-06",{"date":293,"type":41},"2024-01-15",{"date":295,"type":21},"2027-02-15",{"name":241,"class":48}]