[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biomarkers--blood\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biomarkers--blood":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,55,90,122,146,172,199,230,265,309,340],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100619553","fluid-balance-guided-by-modified-venous-excess-ultrasonography-versus-standard-care-in-patients-with-acute-kidney-injury-receiving-continuous-renal-replacement-therapy-100619553",false,"NCT07346118","Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy","Fluid Balance Guided by Modified Venous Excess Ultrasonography Versus Standard Care in Patients With Acute Kidney Injury Receiving Continuous Renal Replacement Therapy: A Multicentre Randomised Controlled Trial","mVExUS-CRRT","Inclusion Criteria:\n\n* Adults (≥ 18 years of age)\n* Admitted to ICU\n* Acute kidney injury by KDIGO criteria\n* Initiated CRRT by at least one of the following indications for RRT initiation:\n* Serum potassium ≥ 6.0 mmol\u002FL, or\n* pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol\u002FL, or\n* Evidence of severe respiratory failure, based on a PaO2\u002FFiO2 ≤ 200 and clinical perception of volume overload, or\n* Persistent severe AKI (sCr remains \\> 50% the value recorded at randomization) for \\> 72 hours from randomization\n* Participants giving informed consent\n\nExclusion Criteria:\n\n* Refuse to participate\n* Previous diagnosis of end-stage kidney disease (ESKD) currently on kidney replacement therapy\n* Kidney transplant recipient\n* Receive RRT before ICU admission within 90 days\n* Structural kidney diseases which will interfere with intrarenal doppler ultrasound e.g. renal artery stenosis, autosomal dominant polycystic kidney disease\n* Patients with previously known conditions that interfere with portal doppler assessment, namely liver cirrhosis, severe tricuspid regurgitation with structural heart disease or massive ascites.\n* Underlying disease process with a life expectancy less than 90 days\n* Pregnancy\n* Severe cardiac rhythm disturbances (tachyarrhythmia, supraventricular tachycardia)\n* Intra-cardiac shunts; Ventricle septal defect, patent foramen ovale, atrial septal defect\n* Aortic aneurysm\n* Intra-abdominal hypertension (intraabdominal pressure ≥20 mmHg)\n* Expected life expectancy \\\u003C48 hours\n* Receiving extracorporeal membrane oxygenation (ECMO)","ALL","18 Years",{"count":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomised controlled trial is to compare the cumulative fluid balance over the first 72 h following inclusion guided by mVExUS versus standard of care in critically ill patients with acute kidney injury receiving CRKT . It will also compare the proportion of CRRT-related complications-including intradialytic hypotension and arrhythmias-between patients managed with mVExUS-guided fluid management and those receiving standard care.\n\nThe main questions it aims to answer are:\n\nDoes fluid removal rate guided by mVExUS will reduce cumulative fluid balance over the course of the first 72 h of CRRT in ICU patients compared to standard care\n\nParticipants will:\n\nGet fluid assessment by mVExUS protocol or a strandard care every 8 hours for 72 hours",[27,28,29,30,31,32,33],"AKI - Acute Kidney Injury","Fluid Balance","Acute Circulatory Failure","Continuous Renal Replacement Therapy (CRRT)","VExUS","Passive Leg Raising","Biomarkers \u002F Blood",[35,36,37,38,39,40,41,42],"Acute kidney injury","Fluid balance","Acute circulatory failure","Continuous kidney replacement therapy","mVExUS","Modified Venous Excess Ultrasound","Passive leg raising","Biomarker","NOT_YET_RECRUITING","2026-05-05",{"date":46,"type":47},"2026-05-07","ACTUAL",{"date":49,"type":21},"2026-07-01",{"date":51,"type":21},"2029-05-01",{"name":53,"class":54},"Chulalongkorn University","OTHER",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100630340","blood-eosinophil-guided-versus-usual-care-in-the-management-of-mild-to-moderate-asthma-at-primary-care-beam-100630340","NCT07486401","Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)","Randomised Controlled Trial Of Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)","BEAM","Inclusion Criteria:\n\n1. Singaporeans or Singapore Permanent Residents\n2. Patients aged ≥21 to 65 years old\n3. Physician diagnosed asthma for duration of at least 4 weeks\n4. On or will be initiated on Global Initiative for Asthma (GINA) 2025 step 1-3) treatment\n5. No asthma exacerbations\\* in the preceding 4 weeks before randomisation\n6. Able and willing to attend study appointments approximately every 4-monthly over a 1-year period\n7. Able to provide informed consent\n8. Stable cardiovascular status (i.e. controlled hypertension, no active symptoms of heart disease or arrhythmias) \\*Exacerbations are defined as worsening of asthma symptoms requiring systemic corticosteroid for 3 or more days, emergency department visit, or hospitalization\n\nExclusion Criteria:\n\n1. History of life-threatening asthma requiring intubation or intensive care unit admission\n2. Severe asthma or difficult to treat asthma\n3. Current use of long-term immunosuppression, LTRA receptor antagonist (Montelukast) and Theophylline or long-term oral steroids\n4. Presence of other known causes of eosinophilia besides asthma (e.g. parasitic infection), based on physician's discretion and investigation as per clinical practice and suspicion\n5. Current use of beta-blocking agents including eye-drops\n6. Use of oral, rectal, or parenteral glucocorticoid within 30 days and\u002For depot parenteral glucocorticoid within 12 weeks prior to recruitment\n7. Known diagnosis of Chronic Obstructive Pulmonary Disease, Interstitial lung disease or bronchiectasis\n8. Any significant disease or disorder (eg. Cardiovascular, pulmonary other than asthma, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study\n9. Current enrolment in other interventional clinical trial for asthma\n10. Female subjects who are pregnant or planning pregnancy during the study period\n11. Planned travel outside of the country for ≥16 consecutive weeks during the study\n12. Investigator's assessment of poor capability of following study instructions or comply with study procedures","21 Years","65 Years",{"count":66,"type":21},240,[24],"The aim of this study is to evaluate usual care versus biomarker-directed care (using blood eosinophil counts) for the management of asthma patients in primary care setting.\n\nThe study hypothesizes that BEC is a valuable biomarker that can guide asthma treatment, and result in reduction in asthma exacerbations, better symptom control and improvement in quality of life compared to usual arm in mild to moderate asthma patients in the primary care setting.\n\nResearchers would compare using blood eosinophil count guided to usual care to see if biomarker-directed asthma treatment and management",[70,33,71],"Asthma Exacerbations","Eosinophil Blood Count",[73,74,75,76,77],"Asthma","Mild-moderate Asthma","Blood Biomarkers","Eosinophil","Primary Care","RECRUITING","2026-03-18",{"date":81,"type":47},"2026-03-20",{"date":83,"type":47},"2025-12-03",{"date":85,"type":21},"2029-12-31",{"name":87,"class":88},"National Healthcare Group Polyclinics","OTHER_GOV",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100623839","blood-biomarkers-for-early-and-accurate-diagnosis-of-alzheimers-disease-in-primary-care-100623839","NCT07401849","Blood Biomarkers for Early and Accurate Diagnosis of Alzheimer's Disease in Primary Care","BEAD-PC","Inclusion Criteria:\n\n* Age 55 years and above\n* Presence of self-reported symptoms indicative of cognitive decline or concerns family members\u002Fpartners indicative of cognitive decline\n* Capacity to consent\n* Be fluent in and able to read and write in English and have adequate hearing and visual acuity to complete the required psychometric tests.\n\nExclusion Criteria:\n\n* Insufficient vision and hearing\n* Prior diagnosis of ADRD. Prior diagnosis of Alzheimer's disease or related dementia (with or without evidence of pathology), through clinical diagnosis and\u002For as documented in their medical record\n* Pre-existing diagnosis of dementia\n* Incidental findings of brain pathologies on brain MRI, such as cancerous space occupying lesions and clinically significant vascular malformations and recent (within 12 months) macro-infarcts, that are, also exclusionary\n* Contraindication for Lumbar Puncture\n* Involvement in interventional research study within 3 months prior to screening\n* For any other reason, in the opinion of the Investigator, participating in the study is not in the best interest of the patient.","55 Years",{"count":99,"type":21},1000,"OBSERVATIONAL","Alzheimer's disease is a degenerative condition affecting the brain and is the most common form of dementia in older adults. Dementia is currently a major healthcare issue in the UK, affecting approximately a million people. The progression of the disease varies between individuals and the early stages may be characterised by only minimal changes in memory and thinking. These changes could remain undetected as the symptoms may be mistakenly regarded as normal age-related forgetfulness. However, dementia is not part of the normal ageing process.\n\nThe underlying biological disease process of Alzheimer's is now known to start at least 20 years prior to patients showing any symptoms. A protein called amyloid starts to deposit in the brain and forms clumps referred to as 'plaques'. Another protein called tau collects inside brain cells and forms structures called 'tangles'. These biological changes can disrupt the normal functioning of brain cells and ultimately destroy them, leading to a reduction in brain volume and ability.\n\nThe aim of the BEAD-PC study is to assess whether a specific blood test in primary care can help diagnose Alzheimer's disease at an early stage.",[103,33,104,105],"Alzheimer Disease","Biomarker in Early Diagnosis","Mild Cognitive Impairment (MCI)",[107,108,109,110,111,112],"Alzheimer's Disease","Memory complaints","Mild Cognitive Impairment","Primary care","Blood biomarkers","Neuropsychological assessment","2026-02-06",{"date":115,"type":47},"2026-02-11",{"date":117,"type":21},"2026-02",{"date":119,"type":21},"2026-11",{"name":121,"class":54},"Imperial College London",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":129,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":89},"100619238","contribution-of-gfap-and-uch-l1-assays-in-whole-blood-to-optimizing-personalized-care-for-repeated-fallers-hospitalized-in-geriatric-wards-100619238","NCT07342023","Contribution of GFAP and UCH-L1 Assays in Whole Blood to Optimizing Personalized Care for \"Repeated Fallers\" Hospitalized in Geriatric Wards","BACHUS","Inclusion Criteria:\n\n* Hospitalized patients aged 75 years and older, cared for in the short-stay geriatric unit at Guy Thomas Hospital in Riom\n* Recurrent fallers (more than one fall per week)\n* Informed consent from the patient or their designated representative for patients unable to write but capable of understanding and consenting to participate in the study\n* Enrollment in a Social Security health insurance scheme\n\nExclusion Criteria:\n\n* Fall occurring before the reference biomarker measurement\n* Presence of an intracranial hemorrhage confirmed by CT scan at admission\n* Ischemic or hemorrhagic stroke\n* Inability to perform the two blood samples required by the protocol due to very limited venous access\n* End-of-life situation\n* Adults under legal protection (guardianship, curatorship, deprivation of liberty, or judicial protection)","75 Years",{"count":131,"type":21},770,[24],"The BACHUS study focuses on a population of patients aged 75 years and older who are hospitalized after recurrent falls. The objective is to evaluate the performance of an innovative, personalized biological screening strategy to detect intracranial hemorrhages, as an alternative to brain CT scanning, which is often difficult to access within the required time frame in elderly patients.\n\nPatients included in the study will undergo two blood measurements of the biomarkers GFAP and UCH-L1 performed on whole blood using a portable device such as the i-Stat Alinity. The first measurement will be performed within 72 hours of admission in order to establish an individual baseline value, given the impossibility of relying on average reference values in this population, which is subject to variability in biomarker levels due to confounding factors.\n\nIn the event of a new fall during hospitalization, and when a brain CT scan is deemed necessary by the referring physician, a second measurement will be performed within the time window recommended by the French National Authority for Health (HAS) (6 to 12 hours after the fall), ideally before the CT scan. Apart from the addition of this blood sample, the study will not modify usual patient management, with the decision to perform a CT scan remaining at the clinician's discretion.\n\nThe primary endpoint is the diagnostic performance of this personalized strategy (sensitivity, specificity, predictive values) compared with brain CT scanning, which remains the reference standard. The results will make it possible to estimate the number of CT scans that could be avoided. Secondary endpoints will allow further refinement of the analysis according to patient profile (age, sex, cognitive status, anticoagulant therapy, nutritional status, etc.).",[135,33,136],"Fallers Aged 60 Years and Older","Intracranial Bleeding","2026-01-06",{"date":139,"type":47},"2026-01-15",{"date":141,"type":21},"2026-01",{"date":143,"type":21},"2028-08",{"name":145,"class":54},"University Hospital, Clermont-Ferrand",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":170,"locationsCount":89},"100611584","circulating-immune-markers-for-prognostic-evaluation-in-postoperative-lung-cancer-patients-100611584","NCT07242482","Circulating Immune Markers for Prognostic Evaluation in Postoperative Lung Cancer Patients","Study on the Clinical Value of Circulating Immune Markers in Prognostic Evaluation of Postoperative Lung Cancer Patients","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Diagnosed with primary non-small cell lung cancer (NSCLC) and scheduled to undergo curative lung resection at the Department of Thoracic Surgery of our institution.\n* Postoperative pathological stage is IB (with tumor size \\>4cm or high-risk factors: poor differentiation, vascular invasion, visceral pleural invasion, sub-lobar resection, etc.), IIA, IIB, or IIIB (according to the AJCC 8th edition).\n* ECOG performance status of 0 or 1.\n* Voluntarily signs the informed consent form.\n\nExclusion Criteria:\n\n* Received any neoadjuvant therapy prior to surgery.\n* History of other active malignancies.\n* Diagnosed with severe autoimmune diseases, active infections, or immunodeficiency disorders.\n* Presence of severe cardiac, hepatic, or renal dysfunction.\n* Pregnant or lactating women.","80 Years",{"count":155,"type":21},200,"Investigating the Clinical Value of Tumor Antigen-Specific T Cells and Immune Cell Balance in Peripheral Blood of Non-Small Cell Lung Cancer Patients for Prognostic Evaluation.",[158,33],"Lung Cancer (Diagnosis)",[160,161,162,163],"Peripheral Blood","Tumor antigen specific T cells","Teff\u002FTreg ratio","Prognostic Evaluation","2025-11-17",{"date":166,"type":47},"2025-11-21",{"date":168,"type":21},"2025-12-17",{"date":85,"type":21},{"name":171,"class":54},"Zhao Jun",{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":89},"100609229","correlative-analysis-between-magnetic-resonance-spectroscopy-mrs-and-essential-clinicobiological-data-in-glioblatoma-multiforme-gbm-100609229","NCT07211841","Correlative Analysis Between Magnetic Resonance Spectroscopy (MRS) and Essential Clinicobiological Data in Glioblatoma Multiforme (GBM)","GLIOMIT","Inclusion Criteria:\n\n* Patients consecutively identified in the multidisciplinary consultation meeting of neurooncology with a new diagnosis of GBM \u002F a probable diagnosis of GBM. - Patients that have not started radiochemotherapy ;\n* Adult \\> 18 yrs\n* socially-insured,\n* having given consent.\n\nExclusion Criteria:\n\n* minor patients,\n* pregnant\u002Flactating women,\n* patients under guardianship,\n* curatorship,\n* protection of justice or deprived of liberty",{"count":180,"type":21},30,[24],"Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. By allowing for MRS studies, MRI permits a non-invasive characterization of the TME of GBM, including their metabolic characterization. The investigators propose to address the link between the MRS profile of GBM and basic clinical and biological parameters, with the aim of : i) identifying correlations between these parameters, ii) attempting to integrate clinical, biological and spectroscopic profiles of GBM. The investigators plan to recruit 30 newly diagnosed GBM patients for which surgery \u002F radiochemotherapy will be proposed in the Medical oncology unit of Amiens University Hospital. Following inclusion of patients with probable GBM, MRS study will be performed during the first (pre-therapeutic) MRI examination. Basic clinical and biological parameters of the blood (CRP, complete blood count, fibrinogen, lactate and choline) will be assessed. A metabolomic study will also be performed on the plasma of GBM patients before any therapeutics. A second biological, post-therapeutic assesment (one month after surgery\u002Fradiochemotherapy) will allow the same analyses (basic biological parameters + plasma metabolomics), in order to examine the stability of the blood parameters.",[184,185,186,33],"Glioblastoma","MRI Spectroscopy","Tumor Microenvironment",[184,188,189,190],"MRI spectroscopy","Tumor microenvironment","biomarkers",{"date":192,"type":47},"2025-11-19",{"date":194,"type":21},"2025-12",{"date":196,"type":21},"2029-04",{"name":198,"class":54},"Centre Hospitalier Universitaire, Amiens",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100610726","pioneer-trial-post-transplant-application-of-trugraf-and-trac-molecular-panel-in-renal-transplant-recipients-100610726","NCT07231328","PIONEER Trial (Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients)","Post-Transplant Application of TruGraf and TRAC Molecular Panel in Renal Transplant Recipients","PIONEER","Inclusion Criteria:\n\n* Able to understand the key components of the study as described in the written informed consent document and willing and able to provide written informed consent.\n* At least 18 years of age at the time of screening.\n* Enrollment begins 30 days prior to transplant till day 29 post-transplantation.\n* Recipient of a kidney transplant (either primary or repeat), from either deceased or living donor.\n* Receiving any immunosuppressive regimen.\n* Able and willing to comply with all study procedures, as assessed by the Investigator.\n* Selected by the treating provider to undergo TruGraf and TRAC™ testing as part of routine post-transplant care\n\nExclusion Criteria:\n\nHistory of previous non-kidney solid organ, vascular composite allograft, pancreatic islet, stem cell, or bone marrow transplant.\n\n* History of dual or en-bloc kidney transplants.\n* Recipient or donor with positive test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis B virus (HBV) nucleic acid testing (NAT), hepatitis C virus (HCV) antibody, HCV NAT, human immunodeficiency virus (HIV), or HIV NAT.\n* Patients known to be pregnant or with plans to become pregnant over the 24 months after enrollment.\n* History or presence of coagulopathy, thrombophilia, unexplained bleeding or clotting disorders, or use of or documented plans for use of systemic anticoagulants at the time of screening, with the exception of uremic coagulopathy or prophylactic heparin preparations.\n* History or presence, upon clinical evaluation, of any illness or condition that, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions",{"count":208,"type":21},600,"This is an observational, prospective, multi-center trial designed to evaluate clinical outcomes in kidney transplant recipients undergoing TruGraf and TRAC monitoring.\n\nApproximately 15 U.S. sites",[211,33,212,213,214],"Immunosuppression Management","Subclinical Rejection","Biopsy","Kidney Transplant Rejection",[216,217,218,219,220],"TRAC-ID ASSAY","Kidney Transplant rejection","TruGraf, TRAC\u002FTRAC ID biomarker panel","TruGraf","TRAC","2025-11-13",{"date":164,"type":47},{"date":224,"type":21},"2025-11-20",{"date":226,"type":21},"2029-03-31",{"name":228,"class":229},"Transplant Genomics, Inc.","INDUSTRY",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":89},"100569296","the-effects-of-endotracheal-suctioning-on-pain-and-serum-markers-100569296","NCT06692400","The Effects of Endotracheal Suctioning on Pain and Serum Markers","The Impact of Endotracheal Suctioning on Pain, Hypoxia, and Oxidative Stress Biomarkers in Intubated Adult ICU Patients: A Controlled Trial","Inclusion Criteria:\n\n* Adults (aged 18 years and older)\n* Current diagnosis of flu, pneumonia, COVID, or sepsis\n* Intubated and receiving mechanical ventilation.\n* Have arterial lines placed\n* Require endotracheal suctioning as part of their care\n\nExclusion Criteria:\n\n* Patients receiving neuromuscular blocking agents\n* Contraindications for blood draws (hemoglobin levels below 8.0 g\u002FdL; Jehovah's Witness)",{"count":238,"type":21},110,[24],"The goal of this experimental study is to understand if endotracheal tube (ETT) suctioning increases pain and causes stress on the body in intubated adult ICU patients. These patients are already on ventilators, which means they need suctioning to keep their airways clear, but this procedure may be uncomfortable and cause stress.\n\nThe main questions this study aims to answer are:\n\nDoes ETT suctioning raise pain levels as measured by the Critical-Care Pain Observation Tool (CPOT)? Does ETT suctioning increase certain chemicals in the blood (hypoxanthine, xanthine, and uric acid) that show stress and lack of oxygen in the body? Researchers will compare patients who have ETT suctioning (intervention group) with those who do not have suctioning during the study period (control group) to see if there are differences in pain and blood markers of stress.\n\nParticipants will:\n\nHave pain measured before and after suctioning using the CPOT. Have blood samples taken from an existing line at three time points: 5 minutes before, 5 minutes after, and 30 minutes after suctioning.\n\nProvide demographic information (like age, gender, and diagnosis) from medical records.\n\nThis research will help improve how pain is managed for ICU patients who cannot speak for themselves, potentially leading to better pain relief methods in the future.",[242,243,244,245,246,247,248,249,33,250,251,252,253,254,255],"Intensive Care Unit ICU","Intubation","Critical Illness","Mechanical Ventilation","Pain Measurement","Pain, Procedural","Oxidative Stress","Hypoxia","Adult","Uric Acid","Sepsis","COVID","Influenza","Pneumonia","2025-05-19",{"date":258,"type":47},"2025-05-21",{"date":260,"type":47},"2025-01-30",{"date":262,"type":21},"2026-04",{"name":264,"class":54},"Loma Linda University",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":100,"phases":4,"briefSummary":276,"conditions":277,"keywords":283,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":308},"100571207","genomic-and-methylation-markers-in-sclc-and-lcnec-for-chemo-immunotherapy-resistance-prediction-stratus-100571207","NCT06717243","Genomic and Methylation Markers in SCLC and LCNEC for Chemo-Immunotherapy Resistance Prediction (STRATUS)","A Prospective Observational Study on Genomic and Methylation Signatures in Patients with Extensive-Stage Small Cell Lung Cancer and Metastatic Large Cell Neuroendocrine Carcinoma Undergoing Chemo-Immunotherapy","STRATUS","Inclusion Criteria:\n\n* Age: Adults aged 18-85 years.\n* Histologically confirmed locally advanced extensive-stage small cell lung cancer (ES-SCLC).\n* Histologically confirmed locally advanced or metastatic large cell neuroendocrine carcinoma (LCNEC).\n* Treatment Plan: Eligible patients must be initiating standard-of-care chemo-immunotherapy, including platinum-based chemotherapy (cisplatin or carboplatin) combined with immune checkpoint inhibitors (atezolizumab or durvalumab).\n* Measurable Disease: At least one measurable or evaluable lesion as defined by RECIST 1.1 criteria.\n* Baseline Biospecimen Availability: Patients must agree to provide baseline blood and tumor biopsy samples for molecular and genomic analyses.\n* Treatment Naïve for Study Indication: Patients should not have received prior systemic therapy for ES-SCLC or LCNEC.\n* Life Expectancy: Estimated life expectancy of at least 3 months, as determined by the treating physician.\n* Follow-Up Commitment: Willingness to attend scheduled follow-up visits and provide additional biospecimens (blood and\u002For tissue) during treatment and at progression.\n* Performance Status: ECOG performance status of 0-2.\n* Organ Function: Adequate hematologic, renal, and hepatic function as per the treating physician's discretion.\n* Consent: Ability and willingness to provide written informed consent for participation in the study and collection of biospecimens (e.g., blood and tumor tissue).\n* Compliance with Study Protocol: Demonstrated ability and willingness to comply with all study-related procedures, including biospecimen collection and follow-up visits.\n* Non-Pregnant and Non-Lactating: Women of childbearing potential must have a negative pregnancy test at baseline and agree to use effective contraception during the study period.\n* Immunotherapy Eligibility: Patients must not have contraindications to immune checkpoint inhibitors (e.g., autoimmune diseases requiring systemic immunosuppressive therapy).\n* Platinum-Based Therapy Tolerance: Patients must be deemed medically fit to receive platinum-based chemotherapy (cisplatin or carboplatin) as determined by the treating physician.\n* No Active Infections: Patients must not have active, uncontrolled infections, including but not limited to tuberculosis, hepatitis B, hepatitis C, or HIV.\n* Psychosocial Stability: Patients must have adequate psychosocial support and the mental capacity to understand and provide informed consent for participation in the study.\n* Stable Brain Metastases: Patients with brain metastases are eligible if the metastases have been treated (e.g., surgery or radiotherapy) and are stable for at least 4 weeks prior to enrollment, as confirmed by imaging.\n* Steroid Use for Brain Metastases: Patients requiring corticosteroids for brain metastases are eligible only if they are on a stable or tapering dose equivalent to ≤10 mg\u002Fday of prednisone for at least 2 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Uncontrolled Brain Metastases: Patients with untreated or progressive brain metastases causing significant neurological symptoms.\n* Concurrent Malignancies: Presence of any active malignancy other than ES-SCLC or LCNEC within the past 3 years, except for treated non-melanoma skin cancer or in situ cervical carcinoma.\n* Previous Systemic Therapy: Prior systemic chemotherapy or immunotherapy for ES-SCLC or LCNEC.\n* Severe Comorbidities: Significant comorbidities, such as uncontrolled cardiovascular, respiratory, or autoimmune diseases, that could interfere with study participation or treatment.\n* Active Infection: Patients with active infections requiring systemic therapy, including tuberculosis, hepatitis B or C, or HIV.\n* Pregnancy or Lactation: Pregnant or lactating women, or women of childbearing potential who are not using effective contraception.\n* Immunosuppressive Therapy: Patients requiring systemic immunosuppressive therapy, including high-dose corticosteroids (equivalent to \\>10 mg\u002Fday prednisone), within 2 weeks prior to enrollment.\n* Severe Allergic Reactions: History of severe hypersensitivity reactions to any component of the planned treatment regimen, including platinum-based chemotherapy or immune checkpoint inhibitors.\n* Life-Threatening Conditions: Life expectancy less than 3 months, as assessed by the treating physician.\n* Inability to Comply: Patients unable or unwilling to adhere to study protocols, including biospecimen collection and follow-up visits.","85 Years",{"count":275,"type":21},111,"The goal of this observational study is to understand how genomic and epigenetic factors contribute to resistance against chemo-immunotherapy in adults diagnosed with extensive-stage small cell lung cancer (ES-SCLC) or metastatic large cell neuroendocrine carcinoma (LCNEC). Both ES-SCLC and LCNEC are aggressive forms of lung cancer with limited treatment options and poor prognosis. While initial responses to chemo-immunotherapy are often promising, most patients develop resistance within a few months, resulting in disease progression and limited survival. This study seeks to explore the molecular and cellular changes that drive resistance, providing insights that could guide more personalized and effective treatment strategies in the future.\n\nThe study focuses on identifying genomic and methylation signatures, as well as analyzing circulating tumor cells (CTCs) and tumor DNA (ctDNA), to better understand the mechanisms of resistance. By collecting and analyzing these biomarkers over time, researchers aim to identify patterns that distinguish patients who benefit long-term from therapy from those who experience early resistance. These findings may pave the way for new diagnostic tools and therapies to predict and overcome resistance to chemo-immunotherapy.\n\nThe main questions this study seeks to answer are:\n\nAre there specific genomic or methylation patterns that predict resistance to chemo-immunotherapy in ES-SCLC and LCNEC? How are circulating tumor cells (CTCs) and tumor DNA (ctDNA) associated with disease progression, treatment response, and survival? What molecular differences exist between patients who respond long-term and those who develop resistance early in their treatment?\n\nParticipants will:\n\nProvide blood and tumor tissue samples before treatment to establish baseline molecular profiles.\n\nUndergo follow-up visits every 9 weeks during treatment, where additional blood samples and imaging tests will be collected to monitor disease progression and treatment response.\n\nOptionally provide tissue samples through re-biopsy if the disease progresses, enabling researchers to compare changes in tumor biology over time.\n\nAll blood and tissue samples will be de-identified and securely stored for genomic and epigenetic analyses. Blood samples will be examined for circulating tumor cells and tumor DNA, while tumor tissue samples will undergo in-depth genomic and methylation profiling. Researchers will use advanced molecular and bioinformatics techniques to uncover specific patterns associated with resistance, aiming to improve current treatment strategies and develop more precise therapies.\n\nThe study will analyze data from patients over three years, encompassing various stages of treatment and disease progression. By examining longitudinal samples, the study aims to capture the dynamic changes that occur in the tumor microenvironment and how these relate to treatment outcomes.\n\nThis research is particularly important because current treatment options for ES-SCLC and LCNEC are limited, and there are no established methods to predict which patients will respond to chemo-immunotherapy. Identifying biomarkers of resistance could transform clinical care, allowing oncologists to tailor treatments to individual patients' molecular profiles and improve survival outcomes.\n\nUltimately, the findings from this study could lead to the development of new biomarkers for resistance, improve early detection of treatment failure, and provide the foundation for novel therapies targeting resistant cancer cells. By addressing a critical gap in the understanding of resistance mechanisms, the STRATUS trial has the potential to significantly advance the field of personalized oncology.",[278,279,280,33,281,282],"Small Cell Lung Cancer","Large Cell Neuroendocrine (NE) Tumors","Treatment Failure","Biomarkers","Immunotherapy",[284,285,286,287,288,289,290,291,292,293,294,295,296,297,298],"Small Cell Lung Cancer (SCLC)","Large Cell Neuroendocrine Carcinoma (LCNEC)","Chemo-Immunotherapy","Treatment Resistance","Circulating Tumor Cells (CTCs)","Circulating Tumor DNA (ctDNA)","Liquid Biopsy","Genomic Profiling","Epigenetics","Biomarker Discovery","Lung Cancer","Molecular Signatures","Clonal Evolution","Personalized Oncology","Cancer Immunotherapy","2025-03-18",{"date":301,"type":47},"2025-03-19",{"date":303,"type":47},"2025-02-20",{"date":305,"type":21},"2028-12-01",{"name":307,"class":54},"Oncology Center of Biochemical Education And Research",2,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":320,"conditions":321,"keywords":327,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":336,"leadSponsor":338,"locationsCount":89},"100564990","phase-2-nitrous-oxide-in-the-treatment-of-acute-suicidal-ideation-100564990","NCT06636357","Nitrous Oxide in the Treatment of Acute Suicidal Ideation","NITOS","Inclusion criteria:\n\n* Ability to give written informed consent\n* Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide item (item #10) as well as a self-report Beck Scale for Suicide Ideation (BSS; Kliem et al., 2017) items #4 plus #5 score ≥ 2\n* Plasma homocysteine level ≤ 14 µmol\u002Fl\n\nExclusion criteria:\n\n* Organic, including symptomatic, mental disorders (F00-F09; lifetime diagnosis)\n* Schizophrenia, schizotypal and delusional disorders (F20-F29; lifetime diagnosis)\n* Mental and behavioral disorders due to psychoactive substance use. Nicotine and cannabis will be ignored (F10-F19)\n* Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months\n* Past intolerance or hypersensitivity to N2O\n* Critical illness\n* Severe cardiac disease\n* Pregnancy or breastfeeding\n* Pulmonary hypertension\n* Chronic cobalamin or folate deficiency unless treated with folic acid and\u002For vitamin B12\n* History or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the investigator\n* Treatment with ketamine\u002Fesketamine during the last 4 weeks\n* Treatment with opioid medications during the last 3 months\n* Treatment with vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT) within the last 3 months\n* Recent (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day\n* Finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.",{"count":317,"type":21},85,[319],"PHASE2","The primary aim of the NITOS study is to investigate the potential rapid antisuicidal effects of N2O in the transdiagnostic treatment of suicidal ideation. On day 1, patients will receive either nitrous oxide (50% N2O balanced with oxygen) or placebo (50% oxygen balanced with air). Seven days after the first inhalation, a second inhalation will be performed. All patients will receive N2O at least once during this trial. While the first inhalation will be double-blind, only the patients but not the raters will be blinded to the second inhalation (day 8). For mechanism of action and prediction, a nested biomarker substudy will employ multimodal techniques including analysis of hair and blood samples, and EEG.",[322,323,324,325,33,326],"Suicidality","EEG","Suicidal Ideation","Nitrous Oxide","Biomarkers \u002F Hair",[328,329,330,331],"suicidality","nitrous oxide","suicidal ideation","depression","2025-01-13",{"date":334,"type":47},"2025-01-16",{"date":332,"type":47},{"date":337,"type":21},"2026-09-30",{"name":339,"class":54},"University of Zurich",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":347,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":354,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":89},"100534667","phase-2-neoadjuvant-camrelizumab-combined-with-chemotherapy-for-resectable-stage-iiia-iiib-nsclc-100534667","NCT06241807","Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB NSCLC","A Phase II Trial of Neoadjuvant Camrelizumab Combined With Chemotherapy for Resectable Stage IIIA-IIIB Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75\n* Pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC\n* Absence of EGFR, ALK, and ROS1 gene mutations\n* Eastern Cooperative Oncology Group (ECOG) status 0-1\n* Signed written informed consent prior to the implementation of any trial-related rocedures\n* Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy: Absolute neutrophil count ≥ 1,500 х109\u002FL, Thrombocytes ≥ 100 х 109\u002FL, Hemoglobin ≥ 90 mg\u002FL, Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥ 40 mL\u002Fmin, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 2.5 x upper limit of normal (ULN), Alkaline phosphatase (ALP) \\> 5 x ULN, Bilirubin \\> 1.5 х ULN\n\nExclusion Criteria:\n\n* Patients diagnosed with any other malignant tumor\n* Have received prior therapy with chemotherapy or immune checkpoint inhibitor\n* Insufficient caloric and\u002For fluid intake despite consultation with a dietitian and\u002For tube feeding\n* Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment\n* Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction\n* A history of interstitial lung disease or non-infectious pneumonia\n* Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years\n* Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibody) and various viral hepatitis infections\n* Patients who have received allogeneic stem cell or solid organ transplantation\n* Women during pregnancy or lactation",{"count":180,"type":21},[319],"This study aims to evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy in resectable stage IIIA and IIIB (T3-4N2) non-small cell lung cancer (NSCLC) patients. Inclusion criteria are: age 18-75, pathologically confirmed resectable stage IIIA-IIIB (T3-4N2) NSCLC, absence of EGFR, ALK, and ROS1 gene mutations, and Eastern Cooperative Oncology Group (ECOG) status 0-1. All patients receive three cycles of camrelizumab combined with platinum-based doublet chemotherapy, followed by curative surgery within 4-6 weeks after completion of chemotherapy. Patients undergo 18F-fluorodeoxyglucose (FDG) PET\u002FCT scans in 1 week before treatment and 1 week before surgery, and peripheral blood samples are collected for biomarker analysis. The primary endpoints for follow-up are pathologic complete response (pCR) rate and major pathological response (MPR) rate, while secondary endpoints include safety and progression-free survival. Exploratory endpoints include molecular imaging research and biomarker analysis.",[351,352,353,33],"IMMUNOTHERAPY","Neoadjuvant Therapy","Resectable Lung Non-Small Cell Carcinoma",[355,356,352,357],"Camrelizumab","Non-Small Cell Lung Cancer","Biomarkers Analysis","2024-02-12",{"date":360,"type":47},"2024-02-14",{"date":362,"type":47},"2022-12-02",{"date":364,"type":21},"2026-12-31",{"name":366,"class":54},"Shandong Cancer Hospital and Institute"]