[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Sydney\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":679},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,50,83,109,131,153,185,209,228,252,291,316,352,387,409,437,464,488,514,541,575,600,630,652],{"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":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100570513","a-master-trial-assessing-the-technical-feasibility-of-first-in-human-real-time-image-guided-radiation-therapy-methods-100570513",false,"NCT06708221","A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods","Real-Time IGRT: A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods","Real-Time IGRT","Inclusion Criteria:\n\n* Patients 18 years or older to be treated with curative radiation therapy\n* Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer\n* ECOG performance status 0-2\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Pregnancy,\n* Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness\u002Fsocial situation\n* Additional inclusion and exclusion criteria may apply to a specific sub-study","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether Real-Time Image Guided Radiation Therapy is a feasible method for radiation therapy delivery for patients with cancer.\n\nThe main questions it aims to answer are:\n\n* Can all fractions per patient which are intended to be delivered with the real-time IGRT method be completed as planned?\n* Can the beam accurately hit the tumour in ≥85% of fractions?\n* Are there any unexpected grade \\>3 acute toxicities?\n\nParticipants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.",[27],"Cancer",[29,30,31,32,33,34,35,36],"cancer","IGRT","radiotherapy","radiation therapy","Image Guided Radiation Therapy","breast cancer","lung cancer","Australia","NOT_YET_RECRUITING","2026-05-18",{"date":40,"type":41},"2026-05-20","ACTUAL",{"date":43,"type":21},"2027-06",{"date":45,"type":21},"2030-12",{"name":47,"class":48},"University of Sydney","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":71,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100453457","learn-learning-environment-for-artificial-intelligence-in-radiotherapy-new-technology-100453457","NCT05184790","LEARN: Learning Environment for Artificial Intelligence in Radiotherapy New Technology","LEARN","Inclusion Criteria:\n\n* Will receive radiation therapy for brain, breast, head and neck, kidney, liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment at a participating centre.\n* Will receive CT planning, and a cone beam CT scan for at least one fraction of radiation therapy.\n* Will receive intrafraction x-ray imaging for the liver, pancreas, prostate, spine cancer treatment or cardiac arrhythmia treatment. As intrafraction imaging is not common standard of care for brain, breast, head and neck and kidney cancer treatments there is no requirement to have intrafraction x-ray imaging data for these anatomical sites.\n* Provides written informed consent.\n\nExclusion Criteria:\n\n* Less than 18 years of age",{"count":58,"type":21},300,"OBSERVATIONAL","This study will develop a whole-of-body markerless tracking method for measuring the motion of the tumour and surrounding organs during radiation therapy to enable real-time image guidance.\n\nRoutinely acquired patient data will be used to improve the training, testing and accuracy of a whole-of-body markerless tracking method. When the markerless tracking method is sufficiently advanced, according to the PI of each of the data collection sites, the markerless tracking method will be run in parallel to, but not intervening with, patient treatments during data acquisition.",[62,63,64,65,66,67,68,69,70],"Arrhythmias, Cardiac","Breast Cancer","Prostatic Cancer","Brain Cancer","Kidney Cancer","Head and Neck Cancer","Liver Cancer","Pancreatic Cancer","Spinal Neoplasm",[72,73],"Radiation Therapy","markerless tracking","RECRUITING",{"date":76,"type":41},"2026-05-19",{"date":78,"type":41},"2023-02-28",{"date":80,"type":21},"2028-01-31",{"name":47,"class":48},4,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":49},"100441579","respiratory-adaptive-computed-tomography-feasibility-study-on-real-time-gated-4dct-for-lung-cancer-radiotherapy-100441579","NCT05030207","Respiratory Adaptive Computed Tomography: Feasibility Study on Real-Time Gated 4DCT for Lung Cancer Radiotherapy","Respiratory Adaptive Computed Tomography: A Pilot Feasibility Study on the Use of Real-Time Gated 4DCT for Lung Cancer Radiation Therapy","REACT","Inclusion Criteria:\n\n* 18 years or older\n* Have the ability to give informed consent\n* A diagnosis of lung cancer with an indication for radiation therapy\n* Radiation therapy treatment involving the acquisition of a 4DCT scan for treatment planning\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients \\\u003C18 years\n* Patients who in the opinion of the treating physician could not tolerate the extra time on the CT couch for an extra scan",{"count":92,"type":21},30,[24],"This study does not involve a therapeutic intervention as standard radiation therapy treatment will be prescribed. This study involves one additional 4DCT scan (i.e. the Real-Time Gated 4DCT scan) acquired immediately before or following the conventional 4DCT scan. This will take place on the day of the patient's treatment simulation, as per the current standard of care. The scanning sequence (i.e. conventional first versus gated first) will be randomised.\n\nThe Real-Time Gated 4DCT is anticipated to take longer than the conventional 4DCT scan, due to its gated (beam-pause) nature. However, upper limits for timing will be implemented in the software, and the scan aborted for highly erratic breathing traces that would not benefit from a Real-Time Gated 4DCT scan.",[96],"Lung Cancer",[98,99,100,101,102],"Radiotherapy","4DCT","Real-time gated 4DCT","Imaging artifacts","Computed tomography",{"date":76,"type":41},{"date":105,"type":41},"2024-05-15",{"date":107,"type":21},"2026-12",{"name":47,"class":48},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":49},"100369112","markerless-image-guidance-using-intrafraction-kilovoltage-x-ray-imaging-100369112","NCT04086082","Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging","MAGIK: Using Implanted Markers to Determine the Feasibility of Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging: A Phase I Interventional Study of Lung Cancer Radiotherapy","MAGIK","Inclusion Criteria:\n\n* Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.\n* Patients undergoing external beam radiotherapy.\n* Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).\n* MRI\u002F4D-CT prior to insertion of fiducial markers.\n* Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).\n* ECOG performance status 0-2.\n* A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.\n* 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.\n* The distance between the tumour centroid and the top end of the diaphragm is \\\u003C=10 cm.\n\nExclusion Criteria:\n\n* Patient has low respiratory performance as evaluated by the physicians.\n* Previous high-dose thoracic radiotherapy.\n* Less than one fiducial marker implanted in the lung.\n* Fiducial markers are too far from the tumour centroid (\\>9 cm).\n* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).\n* Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.\n* Women who are pregnant or lactating.\n* Unwilling or unable to complete quality of life questionnaires.",{"count":92,"type":21},[24],"This trial will investigate the feasibility of the Markerless Tumour Tracking technology.",[96],[122,123,124],"Lung cancer","NSCLC","Oligometastases",{"date":40,"type":41},{"date":127,"type":41},"2023-05-24",{"date":129,"type":21},"2028-12",{"name":47,"class":48},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":49},"100554066","post-operative-prediction-of-pulmonary-function-100554066","NCT06494254","Post-Operative Prediction of PulmonarY Function","Post-Operative Prediction of PulmonarY Function A Pilot Study to Assess the Benefit of Incorporating Regional Ventilation Information in the Prediction of Post-operative Lung Function for Lung Cancer Surgery","POPPY","Inclusion Criteria:\n\n* Aged 18 years or older.\n* ECOG performance status 0-2.\n* Lung cancer surgical candidates.\n* Undergo SPECT V\u002FQ scans within 8 weeks of registration.\n* Undergo BHCT scans within 8 weeks of registration.\n* Pulmonary function tests within 8 weeks of registration.\n* Willingness to give written informed consent.\n* Willingness and ability to comply with the study procedures and visit requirements.\n\nExclusion Criteria:\n\n* Interstitial lung disease.\n* Pregnant women.",{"count":140,"type":21},15,"Prediction of postoperative lung function is currently based on anatomical segment counting (ASC), which incorporates pulmonary function test (PFT) results. Standard PFTs such as spirometry can only measure pulmonary capacity as an average over the entire lung and do not take regional function differences into account. Nuclear medicine is recommended where regional functional imaging is required to inform surgical decisions. However, nuclear medicine scans are expensive, time consuming and not available in all institutions. CT-ventilation imaging is a cheaper and more accessible alternative to nuclear medicine for informing lung cancer patient treatment choices.\n\nThe primary aim is to quantify the difference between predicted postoperative values of pulmonary function metrics derived from CT ventilation imaging and standard anatomical segment counting method.",[96],[144,145,35,146],"ventilation imaging","CT ventilation imaging","lung imaging","2026-05-17",{"date":40,"type":41},{"date":150,"type":41},"2025-06-25",{"date":107,"type":21},{"name":47,"class":48},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":49},"100528353","ventilation-using-radiographic-examination-functional-lung-imaging-techniques-for-the-reduction-of-toxicity-in-functional-avoidance-radiation-therapy-100528353","NCT06159660","Ventilation Using Radiographic Examination: Functional Lung Imaging Techniques for the Reduction of Toxicity in Functional Avoidance Radiation Therapy","VENTURE","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Histologically proven Stage II-IV non-small cell lung cancer as determined using the IASLC International Association for the Study of Lung Cancer (IASLC) 8th edition lung cancer staging guidelines.\n* To be treated with curative intent (stage II-III) or palliative intent (stage IV) with non-SABR external beam radiotherapy (e.g. 60 Gy in 30 treatments for curative intent or 30 Gy in 5 treatments for palliative intent).\n* Pulmonary function tests within 8 weeks of registration.\n* 4DCT simulation for radiation therapy.\n* Willingness to give written informed consent.\n* Willingness and ability to comply with the study procedures and visit requirements.\n* Available for follow up for 1 year or until death, whichever occurs first.\n\nExclusion Criteria:\n\n* Prior radiation therapy to the thorax.\n* Prior surgery for this cancer.\n* Prior chemotherapy for this cancer.\n* Interstitial lung disease.\n* Pregnant women.",{"count":140,"type":21},"The goal of this observational validation study is to determine the best implementation of fluoroscopic and CT ventilation imaging in patients having non-stereotactic ablative body radiotherapy (non-SABR) radiotherapy for stages II-IV lung cancer. The main questions it aims to answer are:\n\n* Assess the dosimetric variation in functional avoidance radiation therapy (RT) plans produced using these ventilation imaging techniques,\n* Establish a quality assurance procedure for functional lung avoidance radiation therapy, and\n* Evaluate the clinical acceptable thresholds for accuracy of the method.\n\nParticipants will:\n\nPrior to radiation therapy treatment, patients will undergo:\n\n1. A standard of care 4DCT scan for radiation therapy simulation,\n2. Pulmonary Function Tests (PFT)\n3. A 4D attenuation correction CT\n4. Breath Hold Computed Tomography (BHCT) imaging where static end-inspiration and end-expiration BHCT scans will be acquired,\n5. Nuclear medicine imaging where a Tc-99m MAA SPECT perfusion scan and a Galligas PET ventilation scan will be acquired,\n6. Fluoroscopy where 1-breath cine-fluoroscope sequences will be acquired at five different angles across the chest,\n7. A 4D Cone Beam Computed Tomography (4DCBCT) scan.\n8. Scans in points 4 to 7 above will be repeated at the end of treatment. Individual participants provide their own internal control.\n\nGalligas PET ventilation images (control) are compared with ventilation images derived from additional scans (comparator) for each participant. Tc-99m MAA SPECT perfusion images (control) are compared with perfusion images derived from BHCT scans (comparator) for each patient.\n\nThere will be no change to patient treatment and patients will be treated using a standard of care anatomical based treatment plan. The pre-treatment 4DCBCT scan is part of standard of care.",[163],"Lung Neoplasm",[165,166,167,168,98,169,170,171,172,173,174,175,176,177],"CTVI","Computed tomography ventilation imaging","Ventilation imaging","Radiation therapy","External beam","Functional lung imaging","Pulmonary fibrosis","CTPI","Computed tomography perfusion imaging","MAA","Macroaggregated Albumin","SPECT","Single Photon Emission Computed Tomography","2026-05-15",{"date":76,"type":41},{"date":181,"type":41},"2025-02-17",{"date":183,"type":21},"2026-09-01",{"name":47,"class":48},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":197,"conditions":198,"keywords":199,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":208,"locationsCount":49},"100525893","phase-3-ventilation-imaging-to-improve-the-quality-of-life-for-patients-with-lung-cancer-treated-with-radiation-therapy-100525893","NCT06127654","Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy","VITaL: A Randomised Controlled Trial Investigating Ventilation Imaging to Improve the Quality of Life for Patients With Lung Cancer Treated With Radiation Therapy","VITaL","Inclusion Criteria\n\n1. Aged 18 years or older.\n2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n3. Histologically proven non-small cell lung cancer.\n4. Stage 3 as determined using the IASLC (International Association for the Study of Lung Cancer) 8th edition lung cancer staging guidelines.\n5. To be treated with curative intent external beam radiotherapy (60 Gy in 30 treatments or 55 Gy in 20 treatments) +\u002F- concurrent chemotherapy and adjuvant PD1\u002FPD-L1 inhibitors.\n6. Whole body Positron Emission Tomography (PET) scan within 8 weeks of registration.\n7. Pulmonary function tests within 8 weeks of registration.\n8. Willingness to give written informed consent.\n9. Willingness to comply with the study procedures and visit requirements.\n10. Available for follow up for a minimum of 12 months and up to 3 years.\n\nPost-inclusion criteria includes the results of a Quality of Life (QoL) assessment and treatment plan assessment, neither of which are known prior to consent. The post-inclusion criteria for the VITaL trial are:\n\n1. Functional Assessment of Cancer Therapy - Lung (FACT-L) Trial Outcome Index (TOI) score of ≥5, the clinically meaningful difference\n2. The standard treatment plan shows that at least 16% of volume of the lungs (minus the Gross Tumour Volume (GTV)) will receive more than 20 Gy. This criterion is based on the difference in pneumonitis risk between patients receiving below (\\~8%) and above (\\~34%) this threshold.\n\nThe QoL assessment is unlikely to eliminate any patients but is included for patients where no clinically meaningful difference will be possible. The treatment plan assessment may exclude 20% of otherwise eligible patients.\n\nExclusion Criteria:\n\n1. Serious medical comorbidities that may contraindicate curative radiotherapy.\n2. Inability to attend full course of radiotherapy or follow-up visits.\n3. A current or former diagnosis of interstitial lung disease.\n4. Prior history of lung cancer within 5 years.\n5. Prior thoracic radiotherapy at any time.\n6. Prior surgery for this cancer within a year.\n7. Prior chemotherapy for this cancer.\n8. Pregnant or lactating women.",{"count":194,"type":21},165,[196],"PHASE3","This research project is testing a new treatment planning method for patients with lung cancer who will be treated with radiation therapy. This new method is called Computed Tomography (CT) ventilation imaging. It aims to help protect the healthiest parts of patient's lungs from being injured by the radiation therapy. The investigators will determine whether healthy lung sparing can improve the quality of life in these patients.",[96],[200,201,202,27,203],"Pneumonitis","Quality of Life","Curative treatment","Healthy lung sparing",{"date":76,"type":41},{"date":206,"type":41},"2026-01-01",{"date":129,"type":21},{"name":47,"class":48},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":222,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":226,"locationsCount":227},"100477718","mri-hypoxia-study-for-glioblastoma-multiforme-gbm-radiation-therapy-100477718","NCT05500612","MRI Hypoxia Study for Glioblastoma Multiforme (GBM) Radiation Therapy","Magnetic Resonance Imaging of Hypoxia for Radiation Treatment Guidance in Glioblastoma Multiforme (MANGO)","MANGO","Inclusion Criteria:\n\n* Suspected high-grade glioma (HGG) \u002F glioblastoma multiforme (WHO grade IV) at initial radiological examination\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2\n* Available for scanning on two separate days\n\nExclusion Criteria:\n\n* Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study\n* Patients with a history of severe renal disease(s) (eGFR \\\u003C20) that cannot tolerate gadolinium chelate contrast agents.\n* Geographically remote patients unable to agree to imaging schedule\n* Patients who have received anti - vascular endothelial growth factor (anti-VEGF) monoclonal antibody therapy the 3 months prior to recruitment\n* Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.\n* Patients with significant cardiac or pulmonary disease including cardiac arrythmias or Chronic Obstructive Pulmonary Disease (COPD) that are unable to tolerate high flow O2 for oxygen contrast.\n* Patients taking carbonic anhydrase inhibitors (Acetazolamide)\n* History of glaucoma\n* Any implant, foreign body, 3 Tesla (3T) MRI incompatible device, or other contraindication to MRI imaging.",{"count":218,"type":21},20,"This study is designed to evaluate the role of Oxygen Enhanced (OE) Magnetic resonance imaging (MRI) and Blood Oxygenation Level Dependent (BOLD) MRI in detecting regions of hypoxic tumour and to evaluate their use as imaging methods to selectively deliver targeted radiotherapy to regions of aggressive disease.",[221],"Glioblastoma Multiforme",{"date":76,"type":41},{"date":224,"type":41},"2024-08-14",{"date":107,"type":21},{"name":47,"class":48},2,{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},"100452259","radio-opaque-contrast-agents-for-liver-cancer-targeting-with-kim-during-radiation-therapy-100452259","NCT05169177","Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy","ROCK-RT","Inclusion Criteria:\n\n* Received or will receive stereotactic ablative body radiotherapy (SABR) treatment for liver cancer at a participating site.\n* Received a radio-opaque contrast agent (e.g. Lipiodol™ or DC Bead LUMI™) that is visible on the radiation treatment planning CT scan\n* The radio-opaque contrast agent mass is or will be within the x-ray imaging field of view during the CBCT scan and any planned intra-fraction imaging. Note that there is no requirement of the distance between the contrast agent mass and the treated tumour as the goal of the study is the contrast agent mass tracking.\n* Provides written informed consent (prospectively recruited) or meets criteria for waiving of the requirement for consent (retrospectively recruited)\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Minimum image dataset is not available\n* Image dataset is not in a compatible format",{"count":236,"type":21},50,"This observational study will investigate the properties of image files standardly collected during radiation therapy treatment in a cross-section of liver cancer patients who received stereotactic ablative body radiation therapy (SABR) after trans-catheter arterial chemo emobilisation (TACE). Specifically, it will determine whether the radio-opaque contrast agents in the image files can be detected by tumour-tracking software (KIM).",[239],"Liver Neoplasm",[72,241,242,243,244],"Stereotactic Ablative Body Radiation Therapy","SABR","Kilovoltage intrafraction monitoring","Radio opaque contrast",{"date":76,"type":41},{"date":247,"type":41},"2022-10-17",{"date":249,"type":21},"2026-10-31",{"name":47,"class":48},5,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":267,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":82},"100633852","comparative-effectiveness-of-exercise-cognitive-behavioural-therapy-and-their-combination-for-people-with-chronic-musculoskeletal-pain-and-poor-sleep-sleepfit-trial-100633852","NCT07532070","COMPARATIVE EFFECTIVENESS OF EXERCISE, COGNITIVE BEHAVIOURAL THERAPY, AND THEIR COMBINATION FOR PEOPLE WITH CHRONIC MUSCULOSKELETAL PAIN AND POOR SLEEP: SLEEPFIT TRIAL","SLEEPFIT","INCLUSION CRITERIA Participants will be included if they have persistent LBP defined as i) age ≥18 years; ii) sought or seriously considered care from a primary care clinician or specialist for their LBP within the past 6 weeks; iii) have at least moderate LBP-related interference with normal work or daily activity (including both work outside the home and housework), as assessed by item 8 of the 36-item Short Form Health Survey OR hip or knee OA defined by the National Institute for Health and Care Excellence as: i) age ≥45 years; ii) activity-related hip or knee joint pain; and iii) no morning hip or knee stiffness, or morning stiffness ≤30 minutes)\n\n* An average pain of ≥4 on an 11-point numerical rating scale (NRS); 0 equals no pain, 10 equals worst pain possible over the last week\n* ≥11 on the Insomnia Severity Index\n* Access to a computer\u002Flaptop\u002Ftablet with internet availability for videoconferencing consultations\n* Willing and able to participate in video consultations\n* Verification that participants recruited in the US are beneficiaries of the Military Health System.\n\nEXCLUSION CRITERIA\n\n* Self-report engagement in \\>120 minute per week of at least moderate intensity physical activity within the past 6 months\n* Current or previous engagement in CBT-I in the past 6 months\n* Cognitive impairment (based on ≥7 on the Short Orientation Memory Concentration Test\n* Received an injection of any substance into the study pain site in the previous 3 months\n* Waiting or planning to receive an injection in the study pain site in the next 12 months\n* Had within the past 12 months, or waiting or planning surgery in the next 12 months\n* Neurological or systemic conditions that may affect physical function (e.g. Parkinson's, Active cancers, multiple sclerosis, rheumatoid arthritis, ankylosing spondylitis)\n* Failing the American College of Sports Medicine pre-participation Health Screening Questionnaire without medical clearance to participate\n* Unable to give informed consent and\u002For participate in the intervention and assessment procedures.\n* Unable to speak or read English.",{"count":260,"type":21},384,[24],"This study aims to find out which lifestyle approach works best for people with chronic musculoskeletal pain (such as low back pain or hip\u002Fknee osteoarthritis) who also have poor sleep. Participants will be randomly assigned to one of three 12-month home-based programs: exercise, cognitive behavioral therapy for insomnia (CBT-I), or a combination of both. Each program includes up to 10 online sessions with a physiotherapist and guidance on managing pain, sleep, and physical activity. We will measure changes in pain, sleep quality, and overall health using questionnaires, wearable devices, sensory tests, and blood samples. The goal is to improve understanding of non-medication treatments for pain and sleep problems.",[264,265,266],"Osteo Arthritis Knee and Hip","Low Back Pain","Insomnia",[268,269,270,271,272,266,273,274,275,276,277,278,279,280,281,282],"Chronic musculoskeletal pain","Low back pain","Hip osteoarthritis","Knee osteoarthritis","Poor sleep","Cognitive Behavioral Therapy for Insomnia (CBT-I)","Exercise therapy","Lifestyle intervention","Non-pharmacological treatment","Randomized controlled trial","Sleep quality","Pain management","Physiotherapy","Wearable activity monitor","Sleep EEG","2026-05-04",{"date":285,"type":41},"2026-05-05",{"date":287,"type":21},"2026-04",{"date":289,"type":21},"2029-04",{"name":47,"class":48},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":17,"minAge":298,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100552529","phase-3-tackle-it-trial---treat-acute-t-cell-rejection-with-evidence-and-confidence-in-kidney-transplant-recipients-100552529","NCT06474273","TACKLE-IT Trial - Treat Acute T Cell Rejection With Evidence and Confidence in Kidney Transplant Recipients","A Multicenter Randomized Controlled Trial to Treat Acute t Cell Mediated Rejection in Kidney and Kidney-pancreas Transplant Recipients","Inclusion Criteria:\n\n* Participants or their legal guardian must be able to understand and provide written informed consent;\n* Stated willingness to comply with all study procedures and availability for the duration of the study;\n* All ethnic and gender groups will have equal access to the study;\n* All children (aged 2+ years) and adults who have received a kidney or SPK transplant with biopsy proven acute TCMR (≥ Banff borderline (minimum i1 score) whether clinical or subclinical).\n\nExclusion Criteria:\n\n* Mixed rejection.\n* Active or chronic active ABMR.\n* Chronic active TCMR. \\*Patients with concomitant acute TCMR and chronic active TCMR will not be excluded from the trial.\n* Isolated v1 without inflammation.\n* Concurrent renal disease, such as recurrent glomerulonephritis or polyomavirus nephropathy.\n* Active malignancies or active infection that preclude immunosuppression augmentation.\n* Use of other immunomodulatory agents, including, but not limited to, Rituximab, Anti-TNF monoclonal antibody, Belatacept, Abatacept, Janus kinase inhibitors, Eculizumab, Pegcetacoplan.\n* Enrolment in other interventional drug trials.\n* Use of other investigational agents.\n* Unable to adhere to the study protocol.","2 Years",{"count":300,"type":21},540,[196],"After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.\n\nDoctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this.\n\nTACKLE-IT is a study that will try to find the right steroid dose for treating rejection.",[304,305],"Rejection; Transplant, Kidney","Rejection; Transplant, Pancreas",[307],"Acute T cell mediated rejection",{"date":309,"type":41},"2026-05-06",{"date":311,"type":41},"2026-03-13",{"date":313,"type":21},"2030-06",{"name":47,"class":48},25,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":22,"phases":326,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":49},"100606267","integrated-healthy-lifestyle-and-pain-care-for-people-with-musculoskeletal-conditions-living-in-rural-areas-100606267","NCT07173335","Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.","Comparison of In-person and Virtual Delivery of Healthy Lifestyle Focused Care for People With Chronic Musculoskeletal Conditions Living in Rural Areas: a Non-interiority Randomised Trial.","HeLP-R","Inclusion criteria:\n\n* Age 18 years and over, with one or more of the following chronic musculoskeletal conditions (pain or disability due to knee or hip, or non-specific low back pain) present for more than three months;\n* Average pain intensity over the last week of 3 or more on a 11-point numerical rating scale OR pain interference of at least 'somewhat' (3 out 5) on item 27 of the PROMIS 29;\n* At least one of the following lifestyle risk factors: Body Mass Index of greater than 25kg\u002Fm2, less than 30mins of physical activity on five or more days of the week, current smoker or vaper, consumes less than two serves of fruits or five serves of vegetables per day, drinks more than 10 standard drinks in a week, or more than 4 standard drinks on any one day, or 'poor' or 'very poor' sleep quality for item 6 of the Pittsburg Sleep Quality Index.\n\nExclusion criteria:\n\n* Receiving healthcare for ALL eligible lifestyle risks;\n* Had bariatric surgery in the last 12 months or have planned bariatric surgery in the next 6 months;\n* Have planned orthopaedic surgery in the next 6 months;\n* Cannot actively or safely engage in the intervention or study procedures due to a medical comorbidity or constraint (e.g. impaired cognition, unable to use telehealth services, attend appointments, or adapt meals or activity);\n* Pain due to suspected serious cause, (e.g spinal infection, cancers, fracture, systemic rheumatic disease, cauda equina syndrome, diagnosis of radiculopathy);\n* Pregnant or planning pregnancy in the next 6 months.",{"count":325,"type":21},354,[24],"This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks.\n\nAdults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation.\n\nParticipants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care.\n\nParticipant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.",[329,330,265],"Musculoskeletal Pain","Osteoarthritis",[332,333,334,335,336,337,338,339,340,341,342,343],"nutrition","smoking","alcohol","osteoarthritis","low back pain","chronic pain","overweight","obesity","physical activity","lifestyle risk factors","sleep","physiotherapy","2025-09-08",{"date":346,"type":41},"2025-09-15",{"date":348,"type":21},"2025-09-30",{"date":350,"type":21},"2028-02-29",{"name":47,"class":48},{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":362,"conditions":363,"keywords":367,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":49},"100593422","a-novel-approach-to-manage-symptoms-of-narcolepsy-and-idiopathic-hypersomnia-100593422","NCT07006233","A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia","A Novel Dietary Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia","COMPANION","Inclusion Criteria:\n\n* Evidence (from multiple sleep latency test, 24-hour polysomnography, or actigraphy) of diagnosis of narcolepsy type 1, narcolepsy type 2 or idiopathic hypersomnia that meets ICSD-3 criteria.\n* For the NT1 subtype, patients must have been screened positive for the HLA DQB10602 genotype.\n* Body mass index \\>18.5 kg\u002Fm2\n* 18 years or over\n* Be willing to be involved in dietary change that may include animal protein and fat.\n* Be willing to monitor ketones via finger-prick and urinary dipstick.\n* Habitual diet is a standard diet consuming a moderate or high carbohydrate level (defined for the study as above 130g carbohydrate\u002Fday).\n* Willingness to provide informed consent and willingness to participate and comply with the study requirements.\n* Access to a computer, laptop, tablet, or smartphone and stable internet access.\n* Proficient comprehension of English language (able to independently read information sheet) and availability of a support person during consultations if English comprehension is challenged.\n\nExclusion Criteria:\n\n* Body mass index \\\u003C18.5 kg\u002Fm2, history of an eating disorder with an EDE-Q score greater than 3.\n* Participants who have sustained significant weight loss in the last 3 months (\\>5% change in total body weight).\n* Previous bariatric surgery or current prescription of weight loss medication.\n* Diagnosis of unstable psychiatric disorders (excluding anxiety or depression).\n* Cognitive impairment that limits ability to understand the study requirements or provide informed consent.\n* Physical impairment that limits ability to meet the study requirements.\n* Non-English speaking and inability to read the Participant Information Sheet.\n* No access to stable internet and device on which to participate in telehealth consultations and complete study questionnaires.\n* Person lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study period.\n* Habitual diet is currently low carbohydrate\u002Fketogenic (defined for the study as \\\u003C130g carbohydrate\u002Fday based on screening 24 food hour recall).\n* Habitual diet excludes animal products (e.g. Vegan diet).\n* Laboratory parameters that may indicate alternate catalyst for hypersomnolence in the opinion of the study physician, including abnormal: full blood count, thyroid function, Epstein-Barr Virus, erythrocyte sedimentation rate, cortisol, antinuclear antibodies, extractable nuclear antigen test, positive rheumatoid factor, Antistreptolysin O positive, Iron studies or multiple biochemistry panel.\n* Participants who have changed their medication prescription or dose within the preceding 4 weeks.\n* Participants with inherited metabolic disorders, prior history of hypoglycaemia or insulinoma\n* Participants with insulin dependent Type 1 or Type 2 diabetics prescribed insulin which may interfere with the participant's ability to meet the study requirements.\n* Participants with uncontrolled medical conditions or patients with significant medical co-morbidities who in the opinion of the study physician, would be at risk of adverse health consequences due to the study intervention (e.g. poorly controlled type 2 diabetic patients who are not prescribed insulin)\n* Current cancer diagnosis (excluding skin cancers or benign cancers)\n* Current active enrolment in a pharmaceutical or intervention based clinical trial or participant who may have received an investigational new drug within the last 12 weeks.",{"count":92,"type":21},[24],"The aim of this project is to learn about how a change in diet will affect sleepiness, quality of life and metabolic health in people living with narcolepsy and idiopathic hypersomnia. The dietary changes we will be testing are well researched and safe in a wide range of patient groups (such as in obesity, type one and two diabetes, cancer and dysfunction related to the nervous system) but has not been researched in conditions of hypersomnolence such as narcolepsy and idiopathic hypersomnia. It is important to test adjunct therapies and lifestyle changes such as dietary interventions to ensure that people living with hypersomnolence have a range of options in addition to medications, to improve their health.\n\nIf effective, this project will be tested in more people and may become a part of routine patient care. These dietary approaches have been shown to improve health and quality of life in people living with chronic pain, neurological conditions such as epilepsy and have been shown to be safe in these populations as well as people living with type one diabetes. This is a new area of research for people living with hypersomnolence.",[364,365,366],"Idiopathic Hypersomnia","Narcolepsy Type 1 (NT 1)","Narcolepsy Type 2 (NT2)",[368,369,370,371,372,373,374,375,376,377,378],"keto diet","ketogenic","keto","whole food diet","narcolepsy","idiopathic hypersomnia","low carb","hypersomnolence","diet","dietary intervention","diet intervention","2025-08-20",{"date":381,"type":41},"2025-08-27",{"date":383,"type":41},"2025-06-23",{"date":385,"type":21},"2026-06",{"name":47,"class":48},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":408},"100440663","phase-3-better-evidence-and-translation-for-calciphylaxis-100440663","NCT05018221","Better Evidence and Translation for Calciphylaxis","BEAT-Calci","Inclusion Criteria:\n\n1. Currently receiving haemodialysis, or peritoneal dialysis that can be converted to haemodialysis, with planned ongoing haemodialysis a minimum of three times per week for at least the duration of the protocolised calciphylaxis treatments within this trial\n2. Have a new calciphylaxis ulcer present for less than 10 weeks\n3. Age ≥ 18 years\n4. Eligible for randomisation in at least one recruiting domain\n5. The participant and treating physician are willing and able to perform trial procedures\n\nExclusion Criteria:\n\nNil",{"count":395,"type":21},350,[196],"This global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.",[399],"Calciphylaxis","2025-08-08",{"date":402,"type":41},"2025-08-13",{"date":404,"type":41},"2021-08-26",{"date":406,"type":21},"2029-12",{"name":47,"class":48},21,{"id":410,"slug":411,"hasResults":11,"nctId":412,"briefTitle":413,"officialTitle":414,"acronym":415,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":17,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":436},"100253804","phase-3-accelerated-vs-standard-bep-chemotherapy-for-patients-with-intermediate-and-poor-risk-metastatic-germ-cell-tumours-100253804","NCT02582697","Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","Phase 3 Accelerated BEP: A Randomised Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours","P3BEP","Inclusion Criteria:\n\n1. Age ≥ 11 years and ≤ 50 years on the date of randomisation\n2. Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng\u002FmL and\u002For HCG ≥ 5000 IU\u002FL) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with GCT, high tumour burden, and a need to start therapy urgently\n3. Primary arising in testis, ovary, retro-peritoneum, or mediastinum\n4. Metastatic disease or non-testicular primary\n5. Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).\n6. Adequate bone marrow function with ANC ≥1.0 x 10\\^9\u002FL, Platelet count ≥100 x 10\\^9\u002FL\n7. Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic metastases, in which case ALT and AST must be ≤ 5 x ULN\n8. Adequate renal function with estimated creatinine clearance of ≥60 ml\u002Fmin according to the Cockcroft-Gault formula, unless calculated to be \\\u003C 60 ml\u002Fmin or borderline in which case GFR should be formally measured, eg. with EDTA scan\n9. ECOG Performance Status of 0, 1, 2, or 3\n10. Study treatment both planned and able to start within 14 days of randomisation.\n11. Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments\n12. Able to provide signed, written informed consent\n\nExclusion Criteria:\n\n1. Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)\n2. Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by IGCCC criteria or stage IV malignant ovarian germ cell tumour in the rare case where low-dose induction chemotherapy is given prior to registration because patient is not fit enough to receive protocol chemotherapy (eg. organ failure, vena cava obstruction, overwhelming burden of disease). Acceptable regimens include cisplatin 20 mg\u002Fm2 days 1-2 and etoposide 100 mg\u002Fm2 days 1-2; carboplatin AUC 3 days 1-2 and etoposide 100 mg\u002Fm2 days 1-2; or baby-BOP.43 Patients must meet all other inclusion and exclusion criteria at the time of registration.\n\n   Additionally participants who need to start therapy urgently prior to completing study-specific baseline investigations may commence study chemotherapy prior to registration and randomisation. Such patients must be discussed with the coordinating centre prior to registration, and must be registered within 10 days of commencing study chemotherapy.\n3. Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin\n4. Significant co-morbid respiratory disease that contraindicates the use of bleomycin\n5. Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus\n6. Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety\n7. Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.\n8. Known allergy or hypersensitivity to any of the study drugs\n9. Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse\n\nThe above inclusion and exclusion criteria will apply to stage 1 (n=150) and stage 2 (n=500 including stage 1) of the study. All sites will participate in both stages of the study with the exception of the Children's Oncology Group who will be participate in stage 1 only.","11 Years","50 Years",{"count":420,"type":21},500,[196],"The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.",[424],"Germ Cell Tumor",[426,427],"Germ Cell","Intermediate and poor-risk metastatic germ cell tumours","2025-06-11",{"date":430,"type":41},"2025-06-15",{"date":432,"type":41},"2014-02",{"date":434,"type":21},"2029-12-31",{"name":47,"class":48},28,{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":49},"100585908","cognitive-bias-modification-for-interpretation-cbm-i-in-people-with-type-2-diabetes-and-persistent-pain-100585908","NCT06908486","Cognitive Bias Modification for Interpretation (CBM-I) in People With Type 2 Diabetes and Persistent Pain","Assessing Cognitive Bias Modification for Interpretation (CBM-I) on Pain Severity and Interference in People With Type 2 Diabetes and Persistent Pain","Inclusion Criteria:\n\n* Over 18 years of age\n* Have a diagnosis of Type 2 diabetes.\n* Have persistent pain (pain present on more days than not, for 3 months or longer).\n* Score ≥ 3 on average pain severity on the Brief Pain Inventory (BPI).\n* Fluent in English\n* Have access to internet and ability to use a computer over a three month period.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* No diagnosis of Type 2 diabetes\n* No persistent pain\n* Not fluent in English\n* No access to internet nor ability to use a computer.",{"count":445,"type":21},319,[24],"The goal of this clinical trial is to examine the efficacy of cognitive bias modification for interpretation (CBM-I) in people with Type 2 Diabetes and persistent pain. The main question\\[s\\] it aims to answer is whether interpretation bias training away from pain improves pain outcomes.\n\nParticipants in the CBM-I group will complete 4 online training sessions approximately half an hour each. Each session will present participants with ambiguous scenarios which may be pain-related, however the final word of the sentence will resolve the scenario as benign (thus training participants to make benign interpretations). A measure of interpretation bias will be administered following the fourth training session, and pain severity and interference will be measured at baseline, post-training, two week follow up, and three month follow up.\n\nThe study hypothesises that participants in the CBM-I group will demonstrate a greater reduction in the co-primary outcomes of pain severity and pain interference over time compared to those in the placebo control.",[449,450],"Type 2 Diabetes","Persistent Pain",[452,453,454,455],"cognitive bias modification","interpretation bias","type 2 diabetes","pain","2025-05-27",{"date":458,"type":41},"2025-06-02",{"date":460,"type":41},"2025-04-15",{"date":462,"type":21},"2025-10-15",{"name":47,"class":48},{"id":465,"slug":466,"hasResults":11,"nctId":467,"briefTitle":468,"officialTitle":468,"acronym":4,"eligibilityCriteria":469,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":22,"phases":472,"briefSummary":473,"conditions":474,"keywords":477,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":82},"100525476","a-randomised-clinical-trial-of-a-digital-self-management-package-for-people-with-interstitial-lung-disease-100525476","NCT06122233","A Randomised Clinical Trial of a Digital Self-management Package for People With Interstitial Lung Disease","Inclusion Criteria:\n\n* Diagnosis of fibrotic ILD\n* In possession of a smartphone\u002Ftablet and an email address\n* Able to understand written and spoken English\n* Adequate digital literacy to complete requirements of trial\n* On stable ILD treatment for 30 days prior to enrolment\n\nExclusion Criteria:\n\n* Not in possession of a smartphone\u002Ftablet\n* Insufficient digital literacy to complete requirements of trial\n* Unable to communicate in written\u002Fspoken English\n* Not on stable ILD treatment for 30 days prior to enrolment\n* Acute exacerbation within 30 days prior to enrolment\n* Participating in pulmonary rehab at enrolment or during 12-week intervention period\n* Unable to provide informed consent",{"count":471,"type":21},400,[24],"The goal of this clinical trial is to compare REBUILD-SM (a purpose-built smartphone app and self-management package) with standard care in people with interstitial lung disease (ILD). The main question it aims to answer is:\n\n• Does REBUILD-SM improve health-related quality of life, symptoms, anxiety, self-efficacy and physical activity for people with ILD?\n\nParticipants in the intervention group will work through the self-management package with support from a healthcare professional via phone or Zoom. They will also enter deidentified health data into the RE-BUILD smartphone app to track their progress over time. Participants in the control group will use a reduced functionality version of the smartphone app only.\n\nResearchers will compare both groups to see if there is any difference in health-related quality of life, symptoms, anxiety, self-efficacy and level of physical activity.",[475,476],"Lung Diseases, Interstitial","Pulmonary Fibrosis",[478,479],"Self-Management","Chronic diseases","2025-04-01",{"date":482,"type":41},"2025-04-04",{"date":484,"type":41},"2024-06-03",{"date":486,"type":21},"2027-08",{"name":47,"class":48},{"id":489,"slug":490,"hasResults":11,"nctId":491,"briefTitle":492,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":22,"phases":497,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":512,"locationsCount":513},"100272258","phase-4-randomised-evaluation-of-sodium-dialysate-levels-on-vascular-events-100272258","NCT02823821","Randomised Evaluation of Sodium Dialysate Levels on Vascular Events","RESOLVE","The site inclusion criteria are:\n\n* Predominantly dialyses adults (≥18 years old) receiving maintenance haemodialysis\n* Rates of withdrawal within the first two years of commencing dialysis for social reasons have been less than 15% for the 2 years prior to recruitment and are not expected to increase above 15%\n* Has a minimum of 10 dialysis recipients at time of randomisation\n* Utilises a default dialysate sodium concentration at the time of recruitment (a substantial majority of dialysis sessions are conducted with the default dialysate sodium concentration)\n* Is a self-contained unit (i.e. unit patients do not regularly rotate through another unit. Brief trips by patients to a parent or other unit do not exclude a site)\n* Willing to accept randomisation to either intervention (as determined by nominated Director of Unit)\n* Is not a home dialysis training or support unit. \\[Sites that include both in-center\u002Fsatellite dialysis patients and home patients may participate but the study procedures and assessments will only be conducted in the incenter\u002Fsatellite component of the site\\].\n\nThe exclusion criteria are:\n\n* Not able to comply with data collection methods",{"count":496,"type":21},50000,[498],"PHASE4","This global study will assess the effect of randomising dialysis sites to one of two default dialysate sodium concentrations in current practice, 140mmol\u002Fl and 137mmol\u002Fl, on major cardiovascular events and death in patients receiving maintenance haemodialysis.",[501],"End-Stage Kidney Disease",[501,503,504,505,506,507,493],"Hemodialysis","Dialysate","Sodium","Cluster-randomisation","Dialysis",{"date":482,"type":41},{"date":510,"type":41},"2016-06",{"date":107,"type":21},{"name":47,"class":48},264,{"id":515,"slug":516,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":520,"eligibilityCriteria":521,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":522,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":49},"100579896","neurological-impact-of-weight-reduction-and-fitness-interventions-100579896","NCT06830252","Neurological Impact of Weight Reduction and Fitness Interventions","A Randomised Controlled Trial To Evaluate the Effects of Marked Weight Loss Combined With Exercise Training on Metabolic, Immunological, and Imaging Biomarkers of Systemic and Brain Inflammation in Participants Undergoing Bariatric Surgery","NeuroFit","Inclusion Criteria:\n\n* 18-80 years of age.\n* Eligible for bariatric surgery.\n* Willingness to provide informed consent and willingness to participate and comply with the study requirements\n\nExclusion Criteria:\n\n* Unable to undertake MRI due to size restrictions i.e., shoulder width more than 70 cm.\n* History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardio- vascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic, muscular, and joint disorders, or cancer that, in the opinion of the investigator, would make the candidate ineligible for the study. For example, significant joint pain could interfere with adherence to the exercise program.\n* Have objectively assessed cognitive impairment as assessed by the Montreal Cognitive Assessment (MoCA) i.e., total score less than 26.\n* Non-MRI-compatible implanted devices or implants.\n* Inability to exercise via supine ergometer.\n* Claustrophobia.\n* Psychiatric or behavioural problems (history of drug and alcohol abuse, eating disorder).\n* Breastfeeding or pregnant women, or those intending to become pregnant before the scheduled end of the intervention.\n* Unwilling to be assigned at random to the exercise or control intervention.\n* Unwilling or unable to adhere to the rigors of the exercise intervention or evaluation schedule over the entire one-year period.\n* Concurrent participation in any other interventional study.","80 Years",{"count":236,"type":21},[24],"This study will test how significant weight loss through bariatric surgery, combined with a personalised exercise program, affects brain inflammation. Th investigators want to understand the connection between obesity-related body inflammation, metabolic issues, and brain inflammation and function.",[527],"Obesity and Overweight",[529,530,531,532,533],"Obesity","Bariatric Surgery","Exercise","Neuroinflammation","Cognitive Function","2025-02-11",{"date":181,"type":41},{"date":537,"type":21},"2025-02",{"date":539,"type":21},"2027-12",{"name":47,"class":48},{"id":542,"slug":543,"hasResults":11,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":22,"phases":551,"briefSummary":552,"conditions":553,"keywords":556,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":574},"100362371","phase-3-a-study-of-low-dose-intracoronary-thrombolytic-therapy-in-stemi-heart-attack-patients-100362371","NCT03998319","A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.","A Randomised Trial to Evaluate the Efficacy of Low-dose Intracoronary Tenecteplase in ST-Elevation Myocardial Infarction (STEMI) Patients With High Microvascular Resistance Post-percutaneous Coronary Intervention (PCI).","RESTORE-MI","Inclusion Criteria:\n\n1. Adult men and women aged over 18 who present with STEMI within 6 hours of symptom onset. Patients will be eligible if they have symptoms consistent with myocardial ischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definite ECGs indicating STEMI as defined by Australian National Heart Foundation (NHF) guidelines\n2. Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances\n3. Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study\n4. (At time of PCI) Patient has received metallic drug-eluting stent\n5. Participant consents to have a 3-7 day (discharge) and 6 month follow up cardiac MRI\n\nExclusion Criteria:\n\nAt the time of screening and\u002For prior to randomisation, no known;\n\n1. Previous coronary bypass grafting\n2. Other residual lesions with ≥50% diameter stenosis in the culprit vessel\n3. Prior myocardial infarction in the target territory\n4. Presence of contraindications to thrombolytic therapy (including history of stroke and recent brain surgery active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension)\n5. Presence of contraindications to adenosine infusion for IMR measurement including sinus node disease, moderate to severe bronchoconstrictive disease and second or third-degree atrioventricular (AV) block\n6. Diagnosis of metastatic disease\n7. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety\n8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol\n9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.\n10. Participation in any investigational study in the previous 30 days\n\n    Other exclusion criteria:\n11. (Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRI including severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysm clips, defibrillators and estimated glomerular filtration rate of \\<30mL\u002Fmin.\n\n    (At time of PCI)\n12. Patients who received GpIIb\u002FIIIa treatment prior to IMR measurement\n13. Patients who do not undergo primary PCI due to lack of severity of culprit lesion or other reasons.",{"count":550,"type":21},445,[196],"Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving can cause this clot to break up and get washed downstream, which can make the heart attack worse. The investigators can measure the amount of damage caused to the microcirculation by calculating the IMR (Index of Microcirculatory resistance).\n\nThis can be measured by a wire in the coronary artery with a pressure sensor at the tip. If the IMR is elevated, it is suggestive of extensive microcirculatory damage. A clot dissolving medicine can be administered in the artery to try and reduce the IMR which can reduce damage to the heart muscle and improve outcomes.\n\nImpaired microcirculatory perfusion in patients as a result of ST-elevation myocardial infarction (STEMI) is associated with poor clinical outcomes. This project seeks to identify patients with impaired microcirculatory perfusion after STEMI and to assess whether acute improvement in microcirculatory perfusion in these patients by the use of intracoronary thrombolytic therapy results in improved clinical outcomes.",[554,555],"STEMI","Elevated IMR (>32)",[554,557,558,559,560,561,562,563,564,565],"IMR","microcirculation","microvascular obstruction","myocardial infarction","physiology","angioplasty","PCI","thrombolysis treatment","thrombolysis","2024-09-25",{"date":568,"type":41},"2024-09-27",{"date":570,"type":41},"2021-10-14",{"date":572,"type":21},"2026-12-31",{"name":47,"class":48},22,{"id":576,"slug":577,"hasResults":11,"nctId":578,"briefTitle":579,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":49},"100382945","surface-monitoring-technology-to-remove-the-mask---stage-1-100382945","NCT04266223","Surface Monitoring Technology to Remove The Mask - Stage 1","SMART","Inclusion Criteria\n\n* A diagnosis of head and neck cancer, any stage\n* ≥ 18 years of age\n* ECOG performance status 0-2\n* Receiving radiation therapy for HNC with a thermoplastic immobilisation mask\n* Any other prior therapy allowed\n* Willing and able to comply with all study requirements\n* Must be able to read and complete questionnaires in English\n\nExclusion Criteria\n\n* People with cognitive impairment which would preclude them from providing informed consent\n* People who are unable to speak and read English and for whom obtaining consent would be difficult.\n\nWithdrawal Criteria\n\n* Participants may withdraw from the study at any time before, during or after participation, and do not have to provide a reason. They may do so by advising any member of the study team, research office or their treating team, by completing the withdrawal of consent form, verbally or in writing.\n* Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely experience physical or mental harm\n* No additional study data will be collected for a participant after they withdraw from the study\n* Withdrawing participants' data will be used unless the participant specifies they no longer give permission for the data to be stored or used, however, their data will not be removed from any analysis or publication that has already occurred, or from study databases once it has been de-identified\n* Participant will be replaced if they withdraw or are withdrawn from the study prior to starting the second couch session. This will be done by recruitment of an additional participant.\n* If a couch session is ended by the researcher or participant for reasons unrelated to the study (e.g. not related to equipment failure or participant non-acceptance), the session may be rescheduled, or participant replaced.\n* Reasons for withdrawal will be reported in any outcome publications.",{"count":218,"type":21},[24],"A pilot-stage device feasibility study investigating a mask-free motion-monitoring patient immobilisation system for use during radiation therapy treatment of head and neck cancer (HNC). This mask-free system combines the standard radiation therapy (RT) head rest to help the patient remain still with a surface guidance detection system that uses sensors to detect and track patient movement.\n\nPatients who will have RT treatment for head and neck cancer involving an immobilisation mask will be asked to lie on the treatment couch for the normal treatment fraction time while the surface monitoring system is activated. We will then assess:\n\ni) The level of acceptance of the system by HNC patients currently being treated with RT using an immobilisation mask, and ii) The ability of the surface guidance system to monitor movement of the patients",[67,586,587],"Radiation Therapy Complication","Anxiety",[72,589,587,590,591],"Mask","Motion sickness","Claustrophobia","2024-07-08",{"date":594,"type":41},"2024-07-09",{"date":596,"type":41},"2023-03-28",{"date":598,"type":21},"2024-12",{"name":47,"class":48},{"id":601,"slug":602,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":609,"briefSummary":611,"conditions":612,"keywords":616,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":4},"100550220","phase-2-psilocybin-assisted-therapy-for-alcohol-use-disorder-100550220","NCT06444243","Psilocybin-assisted Therapy for Alcohol Use Disorder","A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n1. Moderate to severe AUD according to the DSM-5 criteria\n2. A desire to reduce or stop drinking\n3. Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks\u002Fday for men; ≥4 for women) in the past week prior to screening\n4. Aged ≥18 years old\n5. Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)\n6. Received prior treatment for AUD (not including study interventions)\n7. Stable housing within reasonable distance to a clinical site for the duration of the study\n8. Able to identify a significant other (such as a family\u002Ffriend\u002Fpartner) who could accompany them from clinic\u002Fprovide transport and\u002For be contacted by the study team if required\n9. Willing to give written informed consent\n\nExclusion Criteria:\n\n* a. History of or currently meeting DSM-5 criteria for:\n\n  * Any psychotic disorder\n  * Bipolar disorder type 1 or 2\n  * Major depression with psychotic features\n  * Any personality disorders\n  * Post-traumatic stress disorder\n  * Hallucinogen persisting perception disorder b. A family history of:\n  * Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or\n  * Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV.\n\n    d. Abnormal and\u002For serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort\u002Ftryptophan), lithium, anticonvulsants).\n  * Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion).\n  * Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures).\n\n    h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and\u002For defined by DSM-5 criteria (measured by SCID-RV).\n\n    i. Substantial lifetime use (\\>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month.\n\n    k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.",{"count":608,"type":21},90,[610],"PHASE2","To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.",[613,614,615,587],"Alcohol Use Disorder","Alcohol Dependence","Depression",[617,618,619,620,621],"Psilocybin-assisted therapy","Randomised-Controlled Trial","Psilocybin","Psychedelic-Assisted Therapy","Alcohol Use Disorder Therapy","2024-06-07",{"date":624,"type":41},"2024-06-10",{"date":626,"type":21},"2024-09",{"date":628,"type":21},"2025-12",{"name":47,"class":48},{"id":631,"slug":632,"hasResults":11,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":11,"sex":17,"minAge":638,"maxAge":639,"enrollmentInfo":640,"targetDuration":4,"studyType":22,"phases":641,"briefSummary":642,"conditions":643,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":251},"100493736","phase-3-fosfomycin-versus-standard-of-care-in-children-with-antibiotic-resistant-urinary-tract-infections-100493736","NCT05709028","Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections","Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections: A Non-inferiority, Pragmatic, Multi-centre Adaptive Trial to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Oral Fosfomycin in Children With Antibiotic-resistant Urinary Tract Infections.","FosUTI","Inclusion Criteria:\n\nChildren aged ≥6 months to \\\u003C18 years with:\n\n1. Symptoms consistent with a clinical diagnosis of a UTI (as per the treating clinician); AND\n2. Microbiological confirmation: Defined as a urine culture revealing a predominant growth of a bacterial uropathogen \\[≥10\\^6 CFU\u002FL, or ≥10\\^3 CFU\u002FmL\\] together with ≥10x10\\^6 white blood cells on microscopy; AND\n3. The bacterial uropathogen is a non-pseudomonal gram-negative organism likely to cause urinary tract infections in children; being one of either: Escherichia coli, Proteus spp., Klebsiella spp., Enterobacter spp., Serratia spp., or Citrobacter spp., AND\n4. The uropathogen has in vitro evidence of resistance to all oral penicillins and oral first- and second- generation cephalosporins (or is presumed to be resistant based on the pattern of phenotypic testing); AND\n5. The patient has not yet received \\>48 hours of antibiotics with in vitro activity against the urinary pathogen prior to enrolment.\n\n   Exclusion Criteria:\n6. Evidence of bacteraemia due to the same uropathogen within the same clinical illness; OR\n7. Evidence of infection at a secondary site (such as meningitis or endocarditis); OR\n8. Children with features suggestive of sepsis (defined as requiring inotropic support, or \\>20ml\u002Fkg fluid bolus); OR\n9. Children who are unable to tolerate or absorb oral antibiotics; OR\n10. Children with severe renal unsifficiency (creatinine clearance \\\u003C10ml\u002Fminute\u002F1.73m\\^2); OR\n11. Known allergy to fosfomycin; OR\n12. A decision by the primary treating physician that enrolment in the trial is not in the child's best interest.","6 Months","17 Years",{"count":58,"type":21},[196],"Urinary tract infections (UTIs) are among the most common bacterial infections in children. Up to 50% of UTI's are caused by multi-drug resistant ESBL-producing gram negative bacteria that do not respond to treatment with oral penicillin's or cephalosporins. Instead, children often require hospital admission to receive broad-spectrum intravenous antibiotics when they may otherwise be safely managed at home; resulting in prolonged hospital stays and an increased use of health resources. Fosfomycin is a broad-spectrum antibiotic discovered in 1969 that remains susceptible to a large number of organisms due to its low international use. Fosfomycin can be prepared as an oral solution with an orange\u002Ftangerine flavour and is currently approved for use in females \\>12 years old. Despite extensive evidence of its efficacy in adults and safety in neonates, the use of fosfomycin in children remains limited and fosfomycin is not currently licensed for use in children \\\u003C12 years old in Australia.\n\nThe aim of this clinical trial is to compare the use of oral fosfomycin against standard of care antibiotics for the treatment of antibiotic resistant urinary tract infections in children. The main questions the trial aims to answer are:\n\n1. Is oral fosfomycin non-inferior in efficacy to the current standard of care for the treatment of antibiotic-resistant urinary tract infections in children?\n2. Is oral fosfomycin a safe and well-tolerated antibiotic in children?\n3. What is the best dosing regimen of oral fosfomycin for the treatment of antibiotic-resistant UTIs in children?",[644],"Urinary Tract Infections","2024-06-04",{"date":647,"type":41},"2024-06-06",{"date":649,"type":41},"2023-08-02",{"date":486,"type":21},{"name":47,"class":48},{"id":653,"slug":654,"hasResults":11,"nctId":655,"briefTitle":656,"officialTitle":656,"acronym":657,"eligibilityCriteria":658,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":659,"enrollmentInfo":660,"targetDuration":4,"studyType":22,"phases":662,"briefSummary":663,"conditions":664,"keywords":666,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":673,"completionDateStruct":675,"leadSponsor":677,"locationsCount":678},"100470621","phase-4-a-randomised-controlled-trial-of-n-acetylcysteine-for-the-management-of-alcohol-use-disorder-100470621","NCT05408247","A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder","NAC-AUD","Inclusion Criteria:\n\n* Alcohol Use Disorder according to the DSM-V criteria\n* A desire to reduce or stop drinking\n* Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD: ≥ 5 standard drinks\u002Fday for men; ≥4 for women) in the month prior to screening\n* Adequate cognition and English language skills to give valid consent and complete research interviews\n* Stable housing\n* Willingness to give written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)\n* Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)\n* Any substance dependence other than nicotine\n* Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation\n* Concurrent use of selenium, vitamin D or other anti-oxidants\n* Any alcohol pharmacotherapy within the past month","70 Years",{"count":661,"type":21},280,[498],"To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.",[665],"Alcohol Use Disorder (AUD)",[667,668,614,669],"N-acetyl Cysteine","NAC","N-acetylcysteine","2023-03-14",{"date":672,"type":41},"2023-03-16",{"date":674,"type":41},"2023-02-16",{"date":676,"type":21},"2026-11",{"name":47,"class":48},3,""]