[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"consolidation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:consolidation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,75,105,134],{"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":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100642541","phase-2-heme-25-open-label-feasibility-study-of-elranatamab-utilized-in-newly-diagnosed-plasmablastic-lymphoma-with-or-without-hiv-100642541",false,"NCT07647432","HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV","HEME-25: Open-Label Feasibility Study of Elranatamab Utilized in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV in Consolidation After Definitive Therapy","HEME-25","Inclusion Criteria:\n\n* Age ≥ 18 years at time of consent\n* ECOG performance status (PS) 0 or 1\n* Histologically and immunophenotypically confirmed PBL\n* Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) \\> upper limit of normal (ULN) and\u002For bulky disease \\>7.5 cm or stage II-IV\n* Received definitive front-line therapy for PBL with end-of-treatment PR or CR\n* Adequate bone marrow function with recovery from prior therapy, defined as:\n\n  * ANC ≥ 500 cells\u002FmcL\n  * Platelet count ≥ 50,000 cells\u002FmcL\n* Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* If capable of becoming pregnant: Negative serum or urine pregnancy test\n* If HIV-positive:\n\n  * Receiving effective combined antiretroviral therapy\n  * CD4+ T-cell count ≥ 50 cells\u002FmcL within 4 weeks before enrollment\n\nExclusion Criteria:\n\nKey inclusion criteria:\n\n* Age ≥ 18 years at time of consent\n* ECOG performance status (PS) 0 or 1\n* Histologically and immunophenotypically confirmed PBL\n* Ann Arbor stage at initial diagnosis: stage I with lactate dehydrogenase (LDH) \\> upper limit of normal (ULN) and\u002For bulky disease \\>7.5 cm or stage II-IV\n* Received definitive front-line therapy for PBL with end-of-treatment PR or CR\n* Adequate bone marrow function with recovery from prior therapy, defined as:\n\n  * ANC ≥ 500 cells\u002FmcL\n  * Platelet count ≥ 50,000 cells\u002FmcL\n* Availability of archival tumor tissue (block or unstained slides) for mandatory central pathology review and correlative BCMA testing. Central pathology review and BCMA testing may be completed after enrollment.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a LAR may provide consent on their behalf.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* If capable of becoming pregnant: Negative serum or urine pregnancy test\n* If HIV-positive:\n\n  * Receiving effective combined antiretroviral therapy\n  * CD4+ T-cell count ≥ 50 cells\u002FmcL within 4 weeks before enrollment\n\nKey exclusion criteria:\n\n* Prior BCMA bispecific therapy\n* Stable or progressive disease following front-line therapy as determined by the investigator\n* Receiving any other investigational agents\n* Expected survival \\\u003C 2 months\n* Known or suspected PBL involvement of the parenchymal brain or spinal cord at diagnosis. Asymptomatic leptomeningeal disease only will be allowed.\n* Uncontrolled intercurrent illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Concurrent malignancy requiring active therapy within the last 3 years, except for the following:\n\n  * Basal cell carcinoma limited to the skin\n  * Squamous cell carcinoma limited to the skin\n  * Carcinoma in situ of the cervix or breast\n  * Adequately treated lentigo malignant melanoma\n  * Localized prostate cancer\n  * Active therapy consists of adjuvant or maintenance therapy to reduce the risk of recurrence of a malignancy that was previously treated with curative intent and with no evidence of active disease within 2 years prior to screening\n* Pregnant or nursing\n* PWH with a history of AIDS-defining opportunistic infection within the past year\n* Receipt of a live vaccine within 28 days prior to the first dose of study treatment","ALL","18 Years",{"count":20,"type":21},17,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This is a single-arm feasibility trial in which patients with histologically confirmed plasmablastic lymphoma (PBL) with or without HIV, who have achieved a Complete Response or Partial Response after definitive frontline chemotherapy, will receive Elranatamab (Elra) consolidation.",[28,29,30],"Plasmablastic Lymphoma","Hiv","Consolidation","NOT_YET_RECRUITING","2026-06-09",{"date":34,"type":35},"2026-06-15","ACTUAL",{"date":37,"type":21},"2026-12-01",{"date":39,"type":21},"2030-12-01",{"name":41,"class":42},"University of Illinois at Chicago","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":72,"locationsCount":74},"100568824","evaluation-of-the-efficacy-of-diagnostic-support-algorithms-in-chest-x-rays--luana-trial-100568824","NCT06686251","Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial","Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial","Inclusion Criteria:\n\n* Non-reported chest X-rays (XRts) of individuals aged over 18 years.\n* Individuals images with respiratory complaints.\n* Chest X-rays taken during the presence of these respiratory symptoms or while being followed up for respiratory disease.\n* Chest X-rays taken on any X-ray machine.\n* Chest X-rays that include at least one frontal view of the chest.\n\nExclusion Criteria:\n\n* Those whose chest X-ray was performed due to a history of trauma, pre-operative risk assessment, lung cancer screening, or exclusively for verifying the correct positioning of a peripheral intravenous catheter (PICC).\n* Chest X-rays with technical quality below the minimum required for proper interpretation and diagnosis.\n* Cases without at least one frontal view.\n* X-rays printed on regular paper.",{"count":51,"type":21},1470,[53],"NA","This study aims to evaluate whether the use of AI as a physician support tool is associated with an increase in the detection rate of chest radiographic findings in adults with respiratory complaints, compared to diagnosis performed exclusively by doctors, without AI support. This is a cluster-randomized clinical trial, following the stepped wedge design, and adhering to the guidelines of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). In this study, the Diagnostic Support Solution for Chest X-rays - LungAnalysis (LuAna), developed by the Hospital Israelita Albert Einstein (HIAE) within the PROADI-SUS Banco de Imagens, was used.\n\nThe clinical trial will be conducted in multiple centers with a diverse population from the public health system, to ensure that the algorithms are validated across a broad demographic profile. The expected benefits are significant, providing greater security for patients, increasing doctors' confidence in interpreting chest X-rays, promoting efficiency and cost savings for healthcare services, and offering promising prospects for other AI applications in imaging diagnostics.",[30,56,57,58,59,60],"Lung Injury","Pleural Effusion","Pneumothorax","Cardiomegaly","Edema Lung",[62,63,64],"Artificial Intelligence","Chest X-ray","Stepped wedge trial","RECRUITING","2026-01-29",{"date":68,"type":35},"2026-02-02",{"date":70,"type":35},"2026-01-05",{"date":37,"type":21},{"name":73,"class":42},"Hospital Israelita Albert Einstein",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":74},"100509233","human-learning-of-new-structured-information-across-time-and-sleep-100509233","NCT05910762","Human Learning of New Structured Information Across Time and Sleep","Learning Novel Structure Across Time and Sleep","Inclusion Criteria:\n\n* Between 18 and 35 years of age (all aims)\n* Not a member of a vulnerable population (all aims)\n* Normal or corrected-to-normal vision (all aims)\n* Normal hearing (all aims)\n* Able to speak English fluently (all aims)\n* No prior history of major psychiatric or neurological disorders (Aims 1 and 2; MRI-specific)\n* Not currently taking any antidepressants or sedatives (Aims 1 and 2; MRI-specific)\n* No known neurological disorders (Aim 3; EEG-specific)\n\nExclusion Criteria:\n\n* The investigators will exclude individuals with MR contraindications such as non-removable biomedical devices or metal in or on the body (Aims 1 and 2; MRI-specific)\n* Claustrophobia (Aims 1 and 2; MRI-specific)\n* Pregnant women will also be excluded from neuroimaging, as the effects of MR on pregnancy are not fully understood (Aims 1 and 2; MRI-specific)",true,"35 Years",{"count":85,"type":21},105,[53],"Acting adaptively requires quickly picking up on structure in the environment and storing the acquired knowledge for effective future use. Dominant theories of the hippocampus have focused on its ability to encode individual snapshots of experience, but the investigators and others have found evidence that it is also crucial for finding structure across experiences. The mechanisms of this essential form of learning have not been established. The investigators have developed a neural network model of the hippocampus instantiating the theory that one of its subfields can quickly encode structure using distributed representations, a powerful form of representation in which populations of neurons become responsive to multiple related features of the environment.\n\nThe first aim of this project is to test predictions of this model using high resolution functional magnetic resonance imaging (fMRI) in paradigms requiring integration of information across experiences. The results will clarify fundamental mechanisms of how humans learn novel structure, adjudicating between existing models of this process, and informing further model development. There are also competing theories as to the eventual fate of new hippocampal representations. One view posits that during sleep, the hippocampus replays recent information to build longer-term distributed representations in neocortex. Another view claims that memories are directly and independently formed and consolidated within the hippocampus and neocortex.\n\nThe second aim of this project is to test between these theories. The investigators will assess changes in hippocampal and cortical representations over time by re-scanning participants and tracking changes in memory at a one-week delay. Any observed changes in the brain and behavior across time, however, may be due to generic effects of time or to active processing during sleep.\n\nThe third aim is thus to assess the specific causal contributions of sleep to the consolidation of structured information. The investigators will use real-time sleep electroencephalography to play sound cues to bias memory reactivation. The investigators expect that this work will clarify the anatomical substrates and, critically, the nature of the representations that support encoding and consolidation of novel structure in the environment.",[89,90,30,91],"Learning","Humans","Sleep",[93,94,95],"memory","sleep","learning","2025-07-29",{"date":98,"type":35},"2025-08-01",{"date":100,"type":35},"2023-06-05",{"date":102,"type":21},"2028-03",{"name":104,"class":42},"University of Pennsylvania",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100439315","chemoradiation-and-consolidation-chemotherapy-with-or-without-oxaliplatin-for-distal-rectal-cancer-and-watch-and-wait-100439315","NCT05000697","Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait","Chemoradiation and Consolidation Chemotherapy With or Without Oxaliplatin for Distal Rectal Cancer and Watch and Wait. A Multi-center Prospective Randomized Controlled Trial. (CCHOWW)","CCHOWW","Inclusion Criteria:\n\n1. Age ≥18 years;\n2. ECOG 0-2 or KPS≥70;\n3. Primary rectal adenocarcinoma (biopsy confirmed) within the reach of digital rectal examination (at least lower tip\u002Fborder) by the attending colorectal surgeon;\n4. Endoscopic documentation;\n5. Abdominal and chest CT scans showing no evidence of metastatic disease;\n6. High-resolution magnetic resonance images performed at either 1.5T or 3.0T system using a phased array surface coil with: sagittal T2 images including the anal verge and the sacrum; axial oblique T2 weighted images acquired in a plane perpendicular to the long axis of the rectal wall guided by the sagittal images; coronal images acquired in parallel to the anal canal plane. Small field of view (16-18cm), 3mm section thickness, increased matrix size and increased number of signal averages are required;\n7. Radiological defining criteria (centralized):\n\n   1. Lower edge of tumor at the level (max. 1cm distance) or below the anorectal ring defined at sagittal or coronal views;\n   2. mrT2, mrT3 (any subclassification)\n   3. mrN0-1 (≤3 radiologically positive lymph nodes)\n   4. mrEMVI: any status\n   5. mrMRF: any status\n\nExclusion Criteria:\n\n1. Pregnancy\n2. ECOG ≥3 or KPS\\\u003C70\n3. Unwilling to consent\n4. Metastatic disease (any kind; internal iliac and obturator nodes are considered local disease and not metastatic disease and therefore will not be considered as exclusion criteria)\n5. mrT4 or mrN2\n6. Previous pelvic irradiation\n7. Baseline neuropathy\n8. Receiving treatment of other anti-cancer drug or methods\n9. Presence of uncontrolled life threatening diseases",{"count":114,"type":21},216,[53],"Background: Neoadjuvant chemoradiation (nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait - WW). Consolidation chemotherapy (cCT) regimens using fluoropyrimidine-based with or without oxaliplatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCt compared to fluoropyrimidine alone regimens in terms of primary tumor response remains unclear. Since oxaliplatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine+oxaliplatin) for patients with distal rectal cancer.\n\nMethods: In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine+oxaliplatin. Magnetic resonance (MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy (RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) will be enrolled in an organ-preservation program (WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion.\n\nDiscussion: Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.",[118,30],"Rectal Cancer",[120,121,122,123],"Rectal cancer","Consolidation Chemotherapy","Complete Response","Watch and Wait","2024-11-25",{"date":126,"type":35},"2024-11-27",{"date":128,"type":35},"2021-07-14",{"date":130,"type":21},"2027-04",{"name":132,"class":42},"Hospital Alemão Oswaldo Cruz",24,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":74},"100430774","standardizing-right-hemicolectomy-for-colon-cancer-100430774","NCT04889456","Standardizing Right Hemicolectomy for Colon Cancer","Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period","Right","Inclusion Criteria:\n\n* Planned laparoscopic (extended) right hemicolectomy for colon cancer of the caecum, ascending colon or hepatic flexure;\n* Age above 18 years;\n* cTNM stage 1-3 (CT-staged);\n* No prior midline or transverse laparotomy;\n* ASA1-3;\n* No immune modulating medication.\n\nExclusion Criteria:\n\n* cT4b;\n* Perforated disease;\n* Acute obstruction;\n* Emergency operation;\n* Appendiceal cancer;\n* Other primary malignancy treated within 5 years from diagnosis of colon cancer, except for curatively treated prostate, breast, skin and cervical cancer.",{"count":143,"type":21},930,[53],"A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.\n\nFor right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.\n\nGiven the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.\n\nThe main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.",[147,148,149,150,151,152,30,153],"Colonic Carcinoma","Laparoscopic Right Hemicolectomy","Standardisation","Training","Delphi Study","Implementation","Assessment","2021-05-13",{"date":156,"type":35},"2021-05-17",{"date":158,"type":21},"2021-07-01",{"date":160,"type":21},"2027-07-01",{"name":162,"class":42},"Amsterdam UMC, location VUmc"]