[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oslo University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":736},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,121,0,25,[9,56,89,126,160,192,219,246,273,300,328,353,378,406,436,472,495,525,555,575,603,623,656,680,713],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100644262","biomarker-development-for-autoimmune-disorders-involving-the-kidneys-100644262",false,"NCT07666711","Biomarker Development for Autoimmune Disorders Involving the Kidneys","SILENT_LN","Inclusion Criteria:\n\n* Age 18 years or older\n* Established diagnosis of systemic lupus erythematosus according to accepted classification criteria\n* Receiving routine clinical care at Oslo University Hospital or another participating center\n* Able to provide informed consent according to the approved consent procedure\n* Willing and able to provide blood and\u002For urine samples for biomarker analysis\n* For the biopsy-validation analysis population: predefined increase or persistent elevation in one or more blood or urine biomarkers prompting structured renal assessment, with integrated medical assessment indicating suspected renal involvement, possible renal flare, unresolved uncertainty regarding renal inflammatory activity, or discordance between biomarker findings and conventional clinical measures\n\nExclusion Criteria:\n\n* Inability to provide valid informed consent, unless an approved alternative consent procedure applies\n* Known kidney disease not related to systemic lupus erythematosus that would prevent interpretation of lupus nephritis-related biomarker findings\n* Previous kidney transplantation\n* Active infection or acute medical instability that would interfere with study procedures or interpretation of biomarker findings in the time of sampling\n* For the biopsy-validation analysis population: kidney biopsy or re-biopsy is considered unsafe or inappropriate by the treating specialist\n* For the biopsy-validation analysis population: contraindication to native kidney biopsy according to local hospital procedures or specialist assessment\n* For the biopsy-validation analysis population: participant declines kidney biopsy, re-biopsy, or participation in the biopsy-validation component","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","SILENT-LN is a prospective observational cohort study of adults with systemic lupus erythematosus, including participants with no renal involvement, suspected renal involvement, active lupus nephritis, previous lupus nephritis, or inactive lupus nephritis. The study will measure pre-specified blood and urine biomarkers longitudinally during routine clinical care.\n\nThe study will evaluate whether blood and urine biomarker concentrations and biomarker panel scores are associated with active lupus nephritis, incident lupus nephritis, renal flare, treatment response, remission or inactive renal disease, kidney biopsy findings, and long-term renal outcomes.\n\nParticipants will provide blood and urine samples during routine clinical follow-up visits and at visits where renal involvement is clinically suspected. Clinical data, standard laboratory tests, disease activity assessments, kidney function measures, treatment information, and kidney biopsy findings, when available, will be recorded.\n\nA predefined increase or persistent elevation in blood or urine biomarker levels will trigger a structured renal assessment, and kidney biopsy or re-biopsy may be performed if the integrated clinical assessment indicates suspected renal involvement, renal flare, or uncertainty regarding renal inflammatory activity and the procedure is considered safe and clinically appropriate.\n\nThe study is currently conducted at Oslo University Hospital, Riks Hospital and may expand to additional centers following funding and regulatory approvals.",[25,26],"Lupus Nephritis","Systemic Lupus Erythematosus",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Autoimmune kidney disease","Blood biomarkers","Urine biomarkers","Renal flare","Incident lupus nephritis","Active lupus nephritis","Treatment response","Renal remission","Kidney biopsy","Biomarker panel","Longitudinal monitoring","RECRUITING","2026-06-24",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":21},"2026-06-15",{"date":51,"type":21},"2031-06-14",{"name":53,"class":54},"Oslo University Hospital","OTHER",1,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100644531","the-lumbar-adjacent-segment-stenosis-trial-100644531","NCT07670533","The Lumbar Adjacent Segment Stenosis Trial","The Lumbar Adjacent Segment Stenosis (LASS) Trial","LASS","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for the study:\n\n1. Clinical symptoms of spinal stenosis, defined as neurogenic claudication or radiating pain into the lower limbs with duration \\>6 months\n2. MRI-confirmed adjacent segment stenosis, proximal to a previously fused lumbar segment (fusion of maximum two levels between L1 and S1, any type of previous lumbar fixation procedure).\n3. CT-verified solid fusion\n4. Minimum time since previous fusion: one year\n5. Eligible for both treatment alternatives: decompression with extended fusion and decompression alone.\n6. Age between 18 and 80 years.\n7. Insufficient improvement after at least 3 months of non-operative treatment.\n8. Understand Norwegian language, spoken and written.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following criteria are met:\n\n1. Previous surgery at the actual adjacent stenotic level.\n2. More than two fused lumbar levels.\n3. Non-union (pseudoarthrosis) at the previously surgically fused level, radiologically verified.\n4. Foraminal stenosis grade 3 at the adjacent level.\n5. Spinal fracture.\n6. Presence of cauda equina syndrome.\n7. Complete motor deficit.\n8. ASA physical status classification IV or V.\n9. Alcohol or drug abuse.\n10. Active cancer\n11. Contradictions to MRI (e.g., Cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia)\n12. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)\n13. Ongoing serious psychiatric disease\\&\n14. Any condition that in the view of the investigator would suggest that the patient is unable to comply with the study protocol and procedures\n15. Declining specific treatment arm\n16. Are participating in another clinical trial that may interfere with this trial","80 Years",{"count":66,"type":21},192,"INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if there are differences in the effectiveness of decompression surgery alone versus decompression combined with extended fusion in patients with a previous lumbar spinal fusion who now present with symptoms of lumbar adjacent segment stenosis (LASS). The main questions it aims to answer are:\n\n* Does decompression alone differ from decompression combined with extended fusion with regard to clinical outcomes two years after surgery?\n* Are there any clinical or radiological characteristics that can predict better or worse outcomes two years after surgery?\n* Are there any differences between the treatment groups in terms of health economics?\n\nResearchers will compare decompression surgery alone versus decompression combined with extended fusion to see if there are any differences in treatment effect.\n\nParticipants will:\n\n* Be randomized to one of the two surgical procedures\n* Visit the clinic four times postoperatively (at three months, 1, 2 and 5 years) for checkups and tests\n* Respond to questionnaires before surgery, and three months, 1, 2 and 5 years postoperatively",[72,73],"Lumbar Adjacent Spinal Stenosis","Chronic Low Back and Leg Pain",[75,76,77,78],"Randomized trial","Previous lumbar spinal fusion","Spinal stenosis","Surgery","NOT_YET_RECRUITING","2026-06-19",{"date":82,"type":47},"2026-06-26",{"date":84,"type":21},"2026-08",{"date":86,"type":21},"2032-10",{"name":53,"class":54},3,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":67,"phases":100,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100570532","personalized-training-for-people-with-rare-neuromuscular-disorders-100570532","NCT06708468","Personalized Training for People With Rare Neuromuscular Disorders","Personalized Exercise Training for People With Rare Neuromuscular Disorders: a Multi-center, Evaluator-blinded, Two Arm, Randomized Controlled Study to Assess the Effects on Physical Function From Personalized Strength and Balance Exercise in a Rehabilitation Setting.","PETRA-NMD","Inclusion Criteria:\n\n* A confirmed diagnosis of either FSHD, DM1 or CMT\n* 18-70 years of age at the time of signing the informed consent.\n* Any gender\n* Ability to stand, rise from a chair and walk at least 10 meters with or without any need of assistive devices\n* Indication for rehabilitation as confirmed by the treating neurologist or physiotherapist\n* Ability to understand and follow instructions in Norwegian\n* Capable of giving signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy or planning to become pregnant\n* Any other neurological or non-neurological disorders affecting physical capacity, such as disabling arthritis, severe heart-failure\u002Fcardiomyopathy, on-going cancer treatment\n* Alcohol or drug abuse as per their medical chart\n* History of non-compliance to medical advice\u002Ffollow-up","70 Years",{"count":99,"type":21},120,[69],"The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1).\n\nThe key objectives are:\n\n1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group\n2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up\n3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life.\n\nThis is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.",[103,104,105,106],"Neuromuscular Diseases (NMD)","Charcot Marie Tooth Disease (CMT)","Facioscapulohumeral Muscular Dystrophy","Myotonic Dystrophy Type 1 (DM1)",[108,109,110,111,112,113,114,115,116],"personalized training","rehabilitation","rare-neuromuscular disorders","motor unit number estimation","neuromuscular ultrasound","dual-energy x-ray absorptiometry","activity tracking","metabolomics","dynamic balance","2026-06-17",{"date":119,"type":47},"2026-06-18",{"date":121,"type":47},"2024-12-13",{"date":123,"type":21},"2028-12",{"name":53,"class":54},5,{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":67,"phases":135,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"100643589","elastography-based-brief-alcohol-intervention-in-hospitalized-individuals-100643589","NCT07637539","Elastography-based Brief Alcohol Intervention in Hospitalized Individuals","Proactive Liver Disease Assessment and Brief Intervention Among Hospitalized People With Harmful Alcohol Consumption: An Investigator-initiated, Pragmatic, Parallel-group, Open-label, 2-arm Randomized Controlled Trial to Investigate the Efficacy of Proactive Elastography-based Brief Alcohol Intervention Compared With Usual Care in Hospitalized Adult Participants at Risk of Alcohol-related Liver Disease","PREDILECTION","Inclusion Criteria:\n\n1. Emergency hospitalized for any reason in any participating centre\n2. Adults 18 years or older\n3. Harmful alcohol use, defined as AUDIT-C ≥6 (for men) or AUDIT-C ≥5 (for women)\n4. Moderate to high risk of liver fibrosis, defined as FIB-4 \\>1.3\n5. Signed informed consent\n\nExclusion Criteria:\n\n1. Decompensated liver disease that impedes intervention delivery, defined as one or more of the following:\n\n   1. Moderate or severe ascites\n   2. Overt hepatic encephalopathy (West Haven grade ≥2)\n   3. Acute-on-chronic liver failure requiring admission to intensive care unit\n2. Acute hepatitis of any aetiology, defined as ALT or AST \\>5 x upper limit of normal (ULN)\n3. Unable to participate for any reason in the opinion of the investigator",{"count":20,"type":21},[69],"Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.",[138,139],"Alcoholic Liver Disease (ALD)","Alcohol Use Disorder",[141,142,143,144,145,146,147,148,149,150],"alcohol","brief intervention","brief alcohol intervention","elastography","liver fibrosis","alcohol use disorder","alcoholic liver disease","ALD","BAI","proactive liver disease assessment","2026-06-04",{"date":153,"type":47},"2026-06-09",{"date":155,"type":21},"2026-08-15",{"date":157,"type":21},"2038-05-15",{"name":53,"class":54},8,{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":167,"maxAge":64,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":55},"100627085","mri-based-lesion-differentiation-in-older-patients-with-multiple-sclerosis-100627085","NCT07444047","MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis","Quantitative Susceptibility Mapping for Lesion Differentiation in Aging Multiple Sclerosis","Inclusion Criteria Multiple Sclerosis (MS) cohort (AgeMS):\n\n* Age 50-70 years\n* Clinically confirmed diagnosis of multiple sclerosis\n* Participation in the AgeMS study at Oslo University Hospital\n\nInclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:\n\n* Age 50-80 years\n* Radiological evidence of hypertensive small vessel disease on MRI\n* Good clinical recovery following transient ischemic attack (TIA), minor stroke, or stroke mimic diagnosis\n\nExclusion Criteria Multiple Sclerosis (MS) cohort:\n\n* MRI contraindications\n* Severe psychiatric comorbidity\n* Major functional disability unrelated to MS or CSVD\n\nExclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:\n\n* MRI contraindications\n* Probable or definite cerebral amyloid angiopathy according to Boston criteria 2.0\n* Genetic or inflammatory vasculopathies\n* Persistent neurological deficits\n* Severe psychiatric comorbidity\n* Major functional disability unrelated to CSVD","50 Years",{"count":169,"type":21},1000,"This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). In older individuals with MS, white matter changes seen on MRI may be related to MS or to other types of white matter changes, most commonly age-related changes or chronic small vessel disease. These conditions can appear similar on conventional MRI scans, making interpretation challenging.\n\nParticipants will undergo routine clinical MRI, including a short additional QSM sequence, as well as brief cognitive and physical assessments. A comparison group with cerebral small vessel disease will also be included.\n\nThe goal of the study is to determine whether QSM can provide more precise lesion characterization and support more accurate clinical interpretation of MRI findings in older patients with MS.",[172,173],"Multiple Sclerosis (MS)","Cerebral Small Vessel Diseases",[175,176,177,178,179,180,181,182,183],"Quantitative Susceptibility Mapping","QSM","White Matter Lesions","MRI","Lesion Differentiation","Aging","Neuroimaging","Demyelination","Small vessel Disease","2026-05-28",{"date":186,"type":47},"2026-06-01",{"date":188,"type":47},"2026-05-11",{"date":190,"type":21},"2031-12-31",{"name":53,"class":54},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":199,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100638649","return-to-cross-country-skiing-and-other-physical-activities-after-arthrodesis-of-the-first-metatarsophalangeal-joint-100638649","NCT07610330","Return to Cross Country Skiing and Other Physical Activities After Arthrodesis of the First Metatarsophalangeal Joint","Retur Til Fysisk Aktivitet Etter Avstivning av stortåens Grunnledd","Inclusion Criteria:\n\n* Patients who has underwent arthrodesis of the first metatarsofalangeal joint because of hallux rigidus or severe hallux valgus\n* Patients at age 18-60 at the date of surgery\n* At least one year follow-up, and maximum 5 years since surgery.\n\nExclusion Criteria:\n\n* Non-Norwegian-speaking patients.\n* Impaired walking function.\n* Inability to cooperate.\n* Concomitant osteotomy of other metatarsals.\n* Revision arthrodeses.\n* Patients undergoing follow-up or evaluation for pseudoarthrosis.",true,"60 Years",{"count":202,"type":21},150,"Patients who have undergone arthrodesis of the first metatarsophalangeal joint due to hallux valgus or hallux rigidus are invited to participate in this study, which aims to investigate how the foot functions after this operation. Patients between 18 and 60 years of age at the time of surgery are eligible to participate. Questionnaires will be distributed to assess current sports function compared with function prior to surgery. Particular focus will be placed on function during cross-country skiing.",[205,206],"Hallux Rigidus","Hallux Valgus",[208,209,210],"Return to sport","First metatarsophalangeal joint","Arthrodesis","2026-05-20",{"date":213,"type":47},"2026-05-27",{"date":215,"type":21},"2026-06",{"date":217,"type":21},"2027-12",{"name":53,"class":54},{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":227,"conditions":228,"keywords":233,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":55},"100637474","comparison-of-ct-and-mr-vi-rads-imaging-for-local-bladder-cancer-staging-100637474","NCT07602010","Comparison of CT and MR (VI-RADS) Imaging for Local Bladder Cancer Staging","Prospective Diagnostic Accuracy Study Comparing CT and MRI (VI-RADS) for Local Staging of Newly Diagnosed Bladder Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Newly diagnosed bladder cancer on cystoscopy\n* Planned TURBT or cystectomy within 6 weeks\n* Eligible for both CT and MRI within 6 weeks\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Contraindications to MRI or iodinated contrast media\n* Prior treatment for bladder cancer\n* Pregnancy\n* Non-malignant bladder lesions\n* Tumors located in bladder diverticula",{"count":202,"type":21},"This prospective diagnostic accuracy study compares computed tomography (CT) and multiparametric magnetic resonance imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) for local staging of newly diagnosed bladder cancer. All participants undergo both imaging modalities prior to transurethral resection of the bladder tumor (TURBT) or cystectomy. Histopathology serves as the reference standard.",[229,230,231,232],"Bladder Cancer","Urothelial Carcinoma (UC)","Muscle Invasive Bladder Cancer (MIBC)","Non Muscle Invasive Bladder Cancer",[178,234,235,236,237],"Computed Tomography","VI-RADS","Local Staging","Diagnostic Accuracy","2026-05-15",{"date":240,"type":47},"2026-05-22",{"date":242,"type":47},"2026-04-22",{"date":244,"type":21},"2028-10-31",{"name":53,"class":54},{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":253,"maxAge":200,"enrollmentInfo":254,"targetDuration":4,"studyType":67,"phases":256,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100486255","laparoscopic-single-anastomosis-sleeve-ileal-bypass-versus-laparoscopic-sleeve-gastrectomy-for-morbid-obesity-100486255","NCT05611697","Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity","Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity: A Randomized Trial","Inclusion Criteria:\n\n1. Morbid obesity at referral for bariatric surgery (i.e. a body-mass index \\[BMI\\] of ≥35 kg\u002Fm2 with obesity-related comorbid conditions or ≥40 kg\u002Fm2 with or without such comorbidities).\n2. Age 20-60 years.\n3. Previous failed attempts of weight loss.\n4. Norwegian speaking patients.\n\nExclusion Criteria:\n\n1. BMI ≥55 kg\u002Fm2.\n2. A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).\n3. Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.\n4. Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma.\n5. Achalasia\n6. Pregnancy.","20 Years",{"count":255,"type":21},220,[69],"This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.",[259],"Obesity, Morbid",[261,262,263],"procedure: sleeve gastrectomy","bariatric surgery","procedure: single anastomosis sleeve ileal bypass","2026-05-14",{"date":266,"type":47},"2026-05-18",{"date":268,"type":47},"2023-02-17",{"date":270,"type":21},"2031-12",{"name":53,"class":54},2,{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":17,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":67,"phases":285,"briefSummary":287,"conditions":288,"keywords":290,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100637063","phase-3-proton-versus-photon-therapy-in-head-and-neck-squamous-cell-carcinomas-100637063","NCT07580300","Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas.","PRORADNOR-RCT Proton Versus Photon Therapy in Head and Neck Squamous Cell Carcinomas. A Randomised, Multicentre, Phase III Clinical Trial.","PRORADNOR-RCT","Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 40 years.\n3. Histological or cytological verified squamous cell carcinoma of the following head and neck regions; oral cavity, oropharynx, hypopharynx or larynx.\n4. Planned for standard radiotherapy with curative intent, either as definitive or postoperative treatment with or without concomitant chemotherapy (cisplatin).\n5. ECOG performance status 0-2.\n6. Ability to fill in patient questionnaires and comply with study procedures.\n7. Able to answer questionnaires in Norwegian or English.\n8. Willing to travel to Oslo or Bergen for proton therapy if randomised to experimental arm.\n\nExclusion Criteria:\n\n1. Glottic cancers, cT1-T2 cN0 cM0.\n2. Nasopharyngeal carcinomas, sino-nasal cancers, and head and neck salivary gland carcinomas.\n3. Distant metastasis.\n4. Previous radiotherapy to the head and neck.\n5. Patients with pacemakers and\u002For implanted defibrillators.\n6. Prior malignancy within the last 5 years. Not including radically resected non-melanoma skin cancer or low-risk early-stage prostate cancer.\n7. Not able to participate due to equipment restrictions (weight limit treatment board 150 kg).\n8. Any serious and\u002For unstable pre-existing medical, psychiatric, or other condition that could, at the investigator's opinion, interfere with the participant's safety or study participation.","40 Years","90 Years",{"count":284,"type":21},400,[286],"PHASE3","A national, randomized, clinical trial (phase III) investigating radiotherapy with protons compared with photons for patients with squamous cell carcinoma of the head and neck area eligible for radiotherapy, either radical or postoperative, with curative intent. Comparative dose plans with protons and photons will be prepared, and the probability of toxicity evaluated with NTCP models. Patients with presumed benefit from protons will be randomized 1:1 to treatment with protons or photons. The number of randomized participants will be 400. The primary endpoint is \"combined toxicity burden\" - dry mouth, difficulty swallowing, pain and affected speech in the period after the end of radiotherapy to 12 months after treatment.",[289],"HNSCC",[289,291],"Proton","2026-05-13",{"date":238,"type":47},{"date":295,"type":47},"2026-04-28",{"date":297,"type":21},"2055-04-28",{"name":53,"class":54},4,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":67,"phases":309,"briefSummary":310,"conditions":311,"keywords":316,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":55},"100561776","free-fluid-detection-with-telementored-efast-100561776","NCT06594562","Free Fluid Detection With Telementored eFAST","Telementored eFAST in Patients Post-Liver Surgery: A Study of Diagnostic Accuracy for Detection of Free Fluid","Inclusion Criteria:\n\nPatients who have undergone laparoscopic liver surgery at the Oslo university hospital and are within 72 post-surgery\n\nExclusion Criteria:\n\nAllergy to ultrasound gel. Patients colonized with ESBL, MRSA and VRE will be excluded due to infection control. Significant postoperative pain that can exacerbated by probe pressure.",{"count":308,"type":21},40,[69],"This feasibility study will evaluate the accuracy of telementored eFAST (Extended Focused Assessment with Sonography in Trauma) in detecting abdominal free fluid in patients who have recently undergone liver surgery. The primary goal is to determine how well the remote-guided ultrasound can identify fluid accumulation compared to conventional ultrasound performed by a radiologist. Participants in this study will be examined with ultrasound, supported in real-time by a remote expert, to assess its accuracy and other relevant performance metrics.",[312,313,314,315],"Hemoperitoneum","Ascites","Intra-Abdominal Fluid Collection","Postoperative Complications",[317,318,319,320],"Teleultrasound","eFAST","Telemedicine","Ultrasound","2026-05-12",{"date":238,"type":47},{"date":324,"type":47},"2025-06-18",{"date":326,"type":21},"2026-10-01",{"name":53,"class":54},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":200,"enrollmentInfo":336,"targetDuration":4,"studyType":67,"phases":338,"briefSummary":339,"conditions":340,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":350,"leadSponsor":352,"locationsCount":55},"100623953","severe-chronic-neuropathic-pain-a-treatment-bundle-using-spinal-cord-stimulation-and-multidisciplinary-treatment-to-reduce-pain-and-improve-physical-function-100623953","NCT07403331","Severe Chronic Neuropathic Pain: A Treatment Bundle, Using Spinal Cord Stimulation and Multidisciplinary Treatment, to Reduce Pain and Improve Physical Function.","Optimizing Treatment for Chronic Neuropathic Pain: A Replicated Single Case Experimental Design Evaluating a Treatment Bundle Consisting of Multidisciplinary Rehabilitation and Spinal Cord Stimulation (SCS-R)","SCS-R","Inclusion criteria:\n\n* Peripheral neuropathic pain in one or both legs for \\>6 months due to:\n\n  * (1) Post Spinal Pain Syndrome (type 1 or 2).\n  * (2) Localized nerve damage.\n* The area of the neuropathic pain in the leg(s) must be the dominant pain component.\n* Age ranges from 18-60 years.\n* Previous standard conservative (or surgical) treatment attempted.\n* Opioid use within permissible limits at implantation time (daily opioid dose \\\u003C50 mg OMEQ).\n* Willingness to actively participate in the treatment bundle.\n* Living within reasonable travelling distance from Oslo.\n* Proficiency in understanding oral and written Norwegian, essential to benefit from the program that relies on mutual comprehension, nuanced conversation, and emotional expression, which are language-dependent.\n* Cognitive capacity to provide informed consent.\n* Ability to master the technical aspects of the SCS system (switching programs on the remote control).\n\nExclusion criteria:\n\n* Currently undergoing the claims process for health benefits (e.g., disability pensions from NAV (Norwegian Labour and Welfare Administration).\n* Presenting a psychological or psychiatric disorder that may impact treatment efficacy.\n* Chronic generalized pain conditions.\n* Other pain conditions in the affected area, such as osteoarthritis.\n* Pregnancy.",{"count":337,"type":21},10,[69],"People with nerve damage can develop nerve pain. The pain can sometimes be severe and unpredictable, causing odd or alarming sensations - for example, lightning-like or electric shock feelings in the area served by the damaged nerve.\n\nThe investigators will examine a treatment for nerve pain in the legs caused by nerve damage, which can occur after a herniated disc or a bone fracture, with or without surgery.\n\nPrevious research suggests that spinal cord stimulation can relieve nerve pain in the legs after surgery or injury, but its effectiveness is still debated. Other studies show that multidisciplinary treatment helps people with long-term pain to improve their quality of life and to better cope in life. National and international guidelines recommend this kind of multidisciplinary care for long-term pain.\n\nThere has yet been published research on spinal cord stimulation combined with multidisciplinary treatment as a bundle intervention. The investigators therefore want to find out whether this combined approach can reduce nerve pain in the legs and improve physical functioning.",[341,342,343,344,345],"Neuropathic Pain","Multidisciplinary Approach","Rehabilitation Exercise","Acceptance & Commitment Therapy","Spinal Cord Stimulation (SCS)","2026-05-04",{"date":348,"type":47},"2026-05-06",{"date":346,"type":21},{"date":351,"type":21},"2027-07-01",{"name":53,"class":54},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":67,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":55},"100636409","two-week-intensive-outpatient-trauma-treatment-100636409","NCT07565311","Two-week Intensive Outpatient Trauma Treatment.","Inclusion Criteria:\n\n* PTSD\n* 18-65 years\n* Able to give written informed consent.\n\nExclusion Criteria:\n\n* Active substance abuse\n* psychotic or bipolar disorder\n* organic brain disorder\n* IQ\\\u003C 70\n* Currently in a life-threating situation.\n* Serious suicide risk.","65 Years",{"count":361,"type":21},42,[69],"The objective of the study is to obtain knowledge about the treatment of patients who are offered intensive trauma treatment at Nydalen DPS (NDPS) and Søndre Oslo DPS (SODPS). The treatment takes place on an outpatient basis over two weeks. Up to 42 patients will be recruited. The efficacy of treatment will be investigated using validated self-report forms, which measure PTSD symptoms (PCL-5 and ITQ) and quality of life\u002Ffunction (WHO-5, and WSAS). The measurements will be done before the treatment and one and twelve weeks after treatment.In-depth interviews will also be conducted with up to 30 patients to investigate the outcome and any need for adjustments with focus on patients with minority backgrounds, men and patients with limited benefit. The study uses a mixed methods design, where quantitative measures and information from qualitative interviews are combined to map participants' experience, benefits and feasibility.",[365],"Posttraumatic Stress Disorder (PTSD)",[367,368,369,370],"Intensive trauma treatment","qualitative study","EMDR","Prolonged exposure","2026-04-27",{"date":346,"type":47},{"date":374,"type":47},"2026-01-26",{"date":376,"type":21},"2027-12-31",{"name":53,"class":54},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":385,"targetDuration":4,"studyType":67,"phases":387,"briefSummary":388,"conditions":389,"keywords":393,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":55},"100453871","pro-glio-proton-versus-photon-therapy-in-idh-mutated-diffuse-grade-ii-and-iii-gliomas-100453871","NCT05190172","PRO-GLIO: PROton Versus Photon Therapy in IDH-mutated Diffuse Grade II and III GLIOmas","PRO-GLIO","1. Patients must be 18 to 65 years old on the day of consent.\n2. IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3 according to WHO 2021.\n3. Indication for radiotherapy.\n4. WHO\u002FECOG performance status 0-2.\n5. Ability to undergo MRI.\n6. No significant contrast enhancing tumour (more than 1 or 2 punctate contrast enhancing foci) at the time of randomization. In recurrence patients, no contrast enhancement is allowed unless a new biopsy confirms the diagnosis of IDH-mutated astrocytoma grade 2 or 3, or oligodendroglioma grade 2 or 3.\n7. Ability and willingness to travel to a proton therapy centre if randomized to the proton therapy arm.\n8. Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception during radiotherapy, chemotherapy and 1 year after completion of chemotherapy. Pregnancy is not an ineligibility criterium if radiotherapy is indicated and cannot be postponed\n9. Ability to understand the information about the study and included treatment.\n10. Signed informed consent.\n11. Ability to speak and understand Norwegian or Swedish language.\n\nExclusion Criteria:\n\n1. Prior treatment (except surgery) for diffuse glioma\n2. Concomitant or previous malignancies. Exceptions are adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix uteri with a follow-up time of at least 3 years, or other previous malignancy with a disease-free interval of at least 5 years\n3. Known CDKN2A\u002FB homozygous deletion\n4. Presence of any medical, psychological, familial, sociological, or geographical characteristic that might impair patient compliance for study protocol procedures including follow-up\n5. Body weight \\> 150 kg",{"count":386,"type":21},225,[69],"Proton therapy is a powerful tool enabling oncologists to spare normal tissue around the target for irradiation much better than what can be achieved with photon irradiation. The infiltrative nature of IDH-mutated grade II and III diffuse glioma, however, renders proton therapy a potential problem. A randomized controlled trial (RCT) is the only option when trying to ensure that chances of long-term survival are not impaired seeking to reduce unwanted late treatment effects. Non-inferiority of proton therapy compared to photon irradiation is the primary endpoint of the RCT.\n\nHence, PRO-GLIO has two main objectives. First, PRO-GLIO will evaluate if proton therapy is safe in patients with IDH-mutated grade II and III diffuse glioma, showing that survival figures at 2 years from radiotherapy are not poorer in the proton arm than in the photon arm. Second, we want to find the true number of patients in need of rehabilitation in both arms, and evaluate if proton therapy conveys a higher QoL than photon irradiation at 2 years from radiotherapy.",[390,391,392],"Oligodendroglioma","Oligodendroglioma, Anaplastic","Diffuse Astrocytoma, IDH-Mutant",[394,395,396,397,398],"proton therapy","radiotherapy","IDH-mutated diffuse grade II astrocytoma","IDH-mutated diffuse grade III astrocytoma","oligodendroglioma",{"date":400,"type":47},"2026-05-01",{"date":402,"type":47},"2022-01-14",{"date":404,"type":21},"2045-12-31",{"name":53,"class":54},{"id":407,"slug":408,"hasResults":12,"nctId":409,"briefTitle":410,"officialTitle":411,"acronym":412,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":414,"targetDuration":4,"studyType":67,"phases":416,"briefSummary":417,"conditions":418,"keywords":420,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":272},"100596001","gluten-challenge-in-celiac-disease---which-formulation-of-gluten-gives-the-best-response-100596001","NCT07039773","Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?","Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration","SHAKE","Inclusion Criteria:\n\n* BMI 18-33 kg\u002Fm2\n* Willingness to comply with the study procedure and having signed informed, written consent\n* Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and\u002For IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .\n* Strict adherence to a gluten-free diet at least the 12 last months.\n\nExclusion Criteria:\n\n* Positive serology (IgA-TG2 below upper level of normal) at screening visit\n* Pregnancy or breast feeding. Fertile women must use effective contraception.\n* Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study\n* Using of immunosuppressive\u002Fsteroid medications\n* Wheat allergy\n* Severe acute infection",{"count":415,"type":21},30,[69],"The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:\n\n* Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?\n* What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?\n\nResearchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.\n\nParticipants will be asked to:\n\n* Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.\n* Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.\n* Report any symptoms experienced following each gluten challenge.",[419],"Celiac Disease",[421,422,423,424,425,426,427],"Gluten challenge","Interleukin-2","Shake","Cookie","T cells","Whole blood cytokine release assay","GI Symptoms","2026-04-14",{"date":430,"type":47},"2026-04-17",{"date":432,"type":47},"2025-08-01",{"date":434,"type":21},"2026-12",{"name":53,"class":54},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":444,"maxAge":4,"enrollmentInfo":445,"targetDuration":447,"studyType":22,"phases":4,"briefSummary":448,"conditions":449,"keywords":456,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":55},"100630343","shoulder-dislocation-assessment-of-lesions-trajectories-and-outcomes-salto-100630343","NCT07486440","Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes (SALTO)","SALTO: Shoulder Dislocation: Assessment of Lesions, Trajectories and Outcomes. A Prospective Cohort of First-Time Anterior Shoulder Dislocations","SALTO","Inclusion Criteria\n\n* Age ≥16 years\n* Diagnosis of first-time traumatic anterior shoulder dislocation\n* Resident in the Oslo region who presents to Oslo Accident and Emergency Outpatient Clinic for treatment or follow-up within two weeks after initial injury\n* Ability to provide informed consent\n\nExclusion Criteria\n\n* Previous shoulder dislocation requiring reduction (Patients uncertain about prior dislocation are excluded)\n* Age \\\u003C 16 years\n* Chronic substance abuse affecting compliance\n* Inability to understand Norwegian or English\n* Adult not able to provide consent or severe medical or psychiatric condition precluding follow-up","16 Years",{"count":446,"type":21},180,"10 Years","The goal of this prospective observational cohort study is to provide epidemiological and prognostic data from a defined urban population and to improve understanding of risk factors and long-term outcomes following first-time anterior shoulder dislocation in patients aged 16 years and older presenting to the Oslo Accident and Emergency Outpatient Clinic.\n\nThe main questions the study aims to answer are:\n\n* What is the incidence of first-time anterior shoulder dislocations in the Oslo region?\n* What is the prevalence and extent of bipolar bone loss and soft tissue injuries measured by CT and MR after a first-time shoulder dislocation?\n* Does bone loss increase the risk of recurrent shoulder instability?\n* How do imaging findings and recurrence influence long-term shoulder function and quality of life?\n\nParticipants will:\n\n* Undergo standard clinical evaluation and conventional radiographs as part of routine care and asked to participate and followed longitudinally\n* Be offered additional CT and MRI imaging to assess glenoid and humeral bone loss and to evaluate soft tissue injuries.\n* Complete electronic questionnaires (WOSI, EQ-5D-5L, pain score, Rowe score, return to sport\u002Fwork) at 3 months, 1 year, 5 years, and 10 years.\n* Be invited to long-term follow-up, including radiographs at 10 years to evaluate signs of osteoarthritis.",[450,451,452,453,454,455],"Anterior Shoulder Dislocation","Shoulder Dislocation Closed Traumatic","First Time Shoulder Dislocation","Shoulder Instability","Hill Sach Lesion","Bankart Lesion",[457,458,459,460,461,462,463],"First time shoulder dislocation","Shoulder instability","Primary shoulder dislocation","Recurrence","Bone loss","traumatic anterior shoulder dislocation","prospective","2026-03-18",{"date":466,"type":47},"2026-03-20",{"date":468,"type":21},"2026-04-15",{"date":470,"type":21},"2037-04",{"name":53,"class":54},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":478,"targetDuration":480,"studyType":22,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":55},"100378163","sepsis-from-syndrome-to-personalized-care-100378163","NCT04203979","Sepsis: From Syndrome to Personalized Care","Inclusion Criteria:\n\n* admitted to emergency department OUH, Ullevål.\n* managed by the medical rapid response team or the sepsis rapid response team\n\nExclusion Criteria:\n\n* Not given informed consent by patient or next of kin (if patient is not able to)",{"count":479,"type":21},1950,"1 Year","This is a prospective, observational study designed to examine the performance of biomarkers, molecular biological methods and other analysis in blood from patient with suspected sepsis in the Emergency department, as well as identidying novel sepsis endotypes. Around 1500 patients will be enrolled.",[483,484,485,486],"Sepsis Syndrome","Sepsis","Sepsis, Severe","Septic Shock","2026-03-17",{"date":489,"type":47},"2026-03-19",{"date":491,"type":47},"2020-01-06",{"date":493,"type":21},"2027-09-30",{"name":53,"class":54},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":253,"maxAge":359,"enrollmentInfo":502,"targetDuration":4,"studyType":67,"phases":504,"briefSummary":505,"conditions":506,"keywords":508,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":125},"100529108","the-lumbar-interbody-fusion-vs-multidisciplinary-rehabilitation-lifehab-trial-100529108","NCT06169488","The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial","LIFEHAB","Inclusion Criteria:\n\n1. Male and non-pregnant female patients between 20 and 65 years of age with persistent low back pain of at least one year's duration at inclusion\n2. Received non-operative treatment in line with national \\[50\\] and international \\[49\\] guidelines, including at least self-management, exercise, and physical therapy, without satisfactory effect before study enrolment\n3. Back-related disability: ODI 30 - 60 points at baseline\n4. Back pain \\> leg pain\n5. One- or two-level disc degeneration between L2 and sacrum with any of the following:\n\n   * High-intensity zone (HiZ)\n   * Modic changes\n   * Severe disc height reduction exceeding 50% of the cranial disc\n\nExclusion Criteria:\n\n1. Multilevel disc degeneration requiring intervention beyond two levels\n2. Spondylolysis or lytic spondylolisthesis\n3. History of previous spondylodiscitis\n4. Previous lumbar fusion surgery\n5. Scoliosis \\>20 degrees\n6. Signs of a vertebral fracture at the planned level of fusion or its adjacent levels\n7. Active smokers\n8. Unlikely to adhere to treatment or complete follow-up (e.g., ongoing serious psychiatric disease, drug abuse, plans to move outside the catchment areas of the trial centers)\n9. Significant nerve root compression assessed by MRI and clinical examination\n10. BMI \\> 40\n11. Not understanding the Norwegian language.\n12. Generalized myalgia, including history or signs of fibromyalgia and myalgic encephalitis\n13. Contraindications to MRI (e.g., cardiac pacemaker electrodes, metal implants in the eye or brain, claustrophobia).\n14. Active cancer\n15. Disabling chronic neurological disease (e.g., Parkinson's disease, ALS, MS)\n16. Disabling osteoarthritis of the hip or knee (Kellgren \\& Lawrence grade III or higher)\n17. Daily use of morphine equivalents ≥ 60mg or regular use of morphine-containing pain patches\n18. Decline specific treatment arm",{"count":503,"type":21},202,[69],"The goal of this randomized controlled trial is to compare lumbar interbody fusion surgery with multidisciplinary rehabilitation in participants aged 20-65 years with persisting (≥ one year) low back pain. The main question it aims to answer is:\n\n• Is lumbar fusion surgery superior to multidisciplinary rehabilitation in alleviating persisting low back pain?\n\nParticipants will be randomized to either lumbar interbody fusion surgery or a multidisciplinary rehabilitation program.\n\nIf randomized to lumbar fusion interbody surgery, the participants will:\n\n* undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy\n* provide blood samples at four intervals including postoperatively\n* complete PROMs at five intervals\n* have their activity monitored through the ActivePAL accelerometer\n* undergo lumbar fusion surgery\n\nIf randomized to multidisciplinary rehabilitation, the participants will:\n\n* undergo radiologic examinations, including X-ray, MRI, and MRI spectroscopy\n* provide blood samples at three intervals\n* complete PROMs at five intervals\n* have their activity monitored through the ActivePAL accelerometer\n* undergo multidisciplinary rehabilitation",[507],"Chronic Low-back Pain",[509,510,511,512,513,514,515,516,109,517,500],"persisting","chronic","low back pain","MRI spectroscopy","multidisciplinary rehabilitation","lumbar fusion surgery","lumbar interbody fusion","TLIF","ALIF","2026-03-13",{"date":487,"type":47},{"date":521,"type":47},"2024-04-15",{"date":523,"type":21},"2030-12",{"name":53,"class":54},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":67,"phases":535,"briefSummary":536,"conditions":537,"keywords":540,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":554,"locationsCount":4},"100628611","spontaneous-vs-controlled-mechanical-ventilation-in-acute-hypoxemic-respiratory-failure-100628611","NCT07463885","Spontaneous vs Controlled Mechanical Ventilation in Acute Hypoxemic Respiratory Failure","Spontaneous Versus Controlled Mechanical Ventilation in Patients With Acute Hypoxemic Respiratory Failure: A Feasibility Study and Pilot Trial","SVALBARD","Inclusion Criteria:\n\nWe will include patients who fulfil all the following criteria:\n\n* Acutely admitted to the ICU\n* AND age ≥ 18 years\n* AND invasive mechanical ventilation via endotracheal tube or tracheostomy for less than 24 hours\n* AND moderate acute hypoxemic respiratory failure, defined as a PaO₂-FiO₂ ratio between 13.3-26.6 kPa (100-200 mmHg) with PEEP ≥ 5 cm H2O, based on arterial blood gas analysis obtained within 2 hours before randomisation.\n* AND new pulmonary infiltrate (uni- or bilateral) on chest x-ray or CT-scan obtained no more than 24 hours before randomisation.\n\nExclusion Criteria:\n\n* Previously randomised into the SVALBARD trial.\n* Informed consent following inclusion expected to be unobtainable\n* Patient under coercive measures\n* Withdrawal from active therapy or brain death deemed imminent.\n* Chronic hypercapnic respiratory failure defined as PaCO2 \\> 8 kPa (60 mm Hg) in the outpatient setting.\n* Listed for lung transplant.\n* Acute heart failure \u002F acute myocardial infarction \u002F cardiac arrest during or causing index ICU admission.\n* Use of home oxygen.\n* Chronic mechanical ventilation for any reason except for non-invasive mechanical ventilation (CPAP\u002FBIPAP) used solely for sleep apnoea disorder.\n* Currently receiving ECMO therapy.\n* Burns \\>70 % total body surface.\n* Acute brain injury or stroke (any, including subarachnoid haemorrhage, SAH).\n* Intracranial hypertension.\n* Patients with planned repeat surgical interventions during current stay in ICU.",{"count":534,"type":21},80,[69],"Acute hypoxemic respiratory failure may progress to acute respiratory distress syndrome, a life-threatening condition that often requires mechanical ventilation. The optimal ventilation strategy in this patient population remains uncertain.\n\nThe SVALBARD trial is a feasibility and pilot study designed to compare spontaneous versus controlled mechanical ventilation in patients with acute hypoxemia respiratory failure.\n\nThe primary objective is to assess the feasibility of the study procedures and interventions, while also collecting descriptive data on key clinical variables to inform the design of a future randomized controlled trial.",[538,539],"Acute Respiratory Distress Syndrome (ARDS)","Acute Hypoxemic Respiratory Failure",[541,542,543,544,545,546,547],"Acute respiratory distress syndrome","Acute hypoxemic respiratory failure","Mechanical ventilation","assisted ventilation","controlled ventilation","feasibility trial","randomised clinical trial","2026-03-11",{"date":518,"type":47},{"date":551,"type":21},"2026-09-01",{"date":553,"type":21},"2028-03-30",{"name":53,"class":54},{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":55},"100627535","cholecystectomy-with-intraoperative-management-of-bile-duct-stones-in-norway---the-bilnor-study-100627535","NCT07449897","Cholecystectomy With Intraoperative Management of Bile Duct Stones in Norway - the BILNOR Study","Bilnor","Inclusion criteria:\n\n* Age over 18 years\n* Preoperatively image proven choledocholithiasis or bile duct sludge (US \u002F CT \u002F MRI)\n\n  * ≤ 8 mm size\n  * ≤ 5 stones\n  * Not proximal bile duct stones\n* Planned cholecystectomy with intraoperative bile duct clearance (LCBDE or intraoperative ERCP)\n\nExclusion criteria:\n\n* Previous cholecystectomy\n* Medically unfit for surgery (frailty, comorbidity)\n* Technically inoperable (hostile abdomen, inflammatory processes, bleeding conditions, cirrhosis)\n* Pregnancy",{"count":563,"type":21},340,"The BILNOR study is a prospective multicenter observational study evaluating how common bile duct stones are best managed in patients undergoing cholecystectomy. The study focuses particularly on transcystic laparoscopic common bile duct exploration (LCBDE) and assesses stone clearance, technical success, complications, and health-economic outcomes in routine clinical practice. A secondary aim is to compare LCBDE with intraoperative ERCP regarding efficacy, complication rates, and costs. Approximately 340 patients from several Norwegian centers are planned to be included starting in March 2026.",[566],"Bile Duct Stones","2026-03-04",{"date":569,"type":47},"2026-03-06",{"date":571,"type":47},"2026-02-01",{"date":573,"type":21},"2036-12-01",{"name":53,"class":54},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":602},"100626489","novel-technologies-to-improve-echocardiographic-estimates-of-left-ventricular-filling-pressure-in-heart-failure-combined-with-atrial-fibrillation-100626489","NCT07436299","Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation","Novel Technologies to Improve Echocardiographic Estimates of Left Ventricular Filling Pressure in Heart Failure Combined With Atrial Fibrillation: A Prospective Multicenter Study","HFcAF","Inclusion Criteria:\n\n* Atrial fibrillation (paroxysmal, persistent, or permanent)\n* Scheduled for RHC or LHC for clinical reasons\n* Able to undergo echocardiography and invasive pressure measurement within 8 hours\n* No cardiovascular medication changes between echo and catheterization\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Mitral stenosis or mitral annular calcification causing severe functional stenosis\n* Severe mitral or severe tricuspid regurgitation\n* Prosthetic mitral valve\n* Atrial fibrillation with rapid ventricular response \\>120 bpm\n* Suboptimal echocardiographic imaging\n* Conditions rendering PCWP or LVEDP unreliable\n* Pregnant women\n* Complex congenital heart disease\n* LV assist device and patients with severe non-cardiac disease with poor prognosis\n* Cardiac transplant patients\n* End-stage liver disease",{"count":284,"type":21},"Heart failure and atrial fibrillation are two of the most common heart diseases globally. Nearly half of all patients with heart failure also have atrial fibrillation. When heart failure and atrial fibrillation occur together, the risk of hospitalization and premature death increases significantly. However, there is a lack of reliable tools to assess how severely the heart is affected in these patients. This makes it difficult both to establish the correct diagnosis, tailor treatment, and predict who is at greatest risk of hospital admission or death from the disease.\n\nOne of the most important targets in heart failure is the filling pressure in the left ventricle. When this pressure is high, it means that the heart has difficulty receiving blood, leading to shortness of breath and fluid retention in the body. Today, filling pressure is usually estimated using ultrasound (echocardiography), but the available methods are primarily developed for patients without atrial fibrillation. In patients with both heart failure and atrial fibrillation, the measurements are so uncertain that they cannot be used as a reliable basis for clinical decision-making.\n\nIn this study, entitled Heart Failure combined with Atrial Fibrillation (HFcAF), the investigators will test new ultrasound methods that combine novel measures of cardiac chamber function with established techniques. Artificial intelligence will be used to identify the most useful combinations of parameters, select cardiac cycles that are best suited for analysis in atrial fibrillation, and automate and optimize the measurements. This approach may provide both more accurate and faster assessments, while also making the methods easier to implement in clinical practice. The aim is to improve the estimation of filling pressure so that it becomes more precise also in patients with atrial fibrillation. The investigators will then examine whether these improved methods can be used to predict which patients are at highest risk of hospitalization or death due to heart failure.\n\nThe study is designed as a prospective multicenter study, in which patients are recruited from several hospitals in different countries. This will make the results robust and generalizable to a wide range of patient populations. The investigators anticipate that the project will pave the way for better diagnostics and risk stratification in heart failure combined with atrial fibrillation and, in the longer term, contribute to improved guidelines and treatment for a large number of patients. If successful, the project will provide a new tool that can contribute to earlier and more targeted treatment, thereby improving quality of life and prognosis for a large group of patients.",[586,587],"Heart Failure (HF)","Atrial Fibrillation (AF)",[589,590,591,592,593],"Heart failure","Atrial fibrillation","Echocardiography","Filling pressure","Diastolic function","2026-03-03",{"date":596,"type":47},"2026-03-05",{"date":598,"type":21},"2026-02",{"date":600,"type":21},"2029-12",{"name":53,"class":54},15,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":67,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":55},"100554285","effectiveness-trial-of-temperament-based-therapy-with-support-tbt-s-100554285","NCT06497101","Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)","Effectiveness of Temperament Based Therapy With Support (TBT-S): A Novel 5-day Treatment for Anorexia Nervosa","Inclusion Criteria:\n\n* Age ≥18, all genders\n* A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)\n* Willingness to have Support(s) participate in treatment\n* Medically stable\n\nExclusion Criteria:\n\n* Intellectual developmental disorder or intellectual disability; psychotic disorder or other psychopathology that may affect or prevent participation in the study\n* diagnosed alcohol or other substance use disorder within 3 months prior to study initiation\n* ongoing inpatient treatment at the time of study enrollment (participants currently in inpatient care must be discharged and engaged in outpatient treatment before participating in the TBT-S week",{"count":99,"type":21},[69],"The main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.",[614],"Anorexia Nervosa","2026-02-26",{"date":617,"type":47},"2026-03-02",{"date":619,"type":47},"2024-11-15",{"date":621,"type":21},"2028-09-01",{"name":53,"class":54},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":630,"maxAge":253,"enrollmentInfo":631,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":633,"conditions":634,"keywords":639,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":653,"leadSponsor":655,"locationsCount":55},"100625829","retinopathy-of-prematurity---visual-function-and-retinal-structure-100625829","NCT07427719","Retinopathy of Prematurity - Visual Function and Retinal Structure","Children Treated for Retinopathy of Prematurity - Study of Visual Function and Retinal Structure","Inclusion criteria:\n\n* Patients treated for ROP with either laser or injection of A-VEGF.\n* Patients previously diagnosed with ROP but not treated for the condition.\n\nExclusion criteria:\n\n* Age below six years at date of examination.\n* A developmental level not compatible with performing the study examinations.\n* Patients born or treated outside Norway\n* Known ocular or systemic disease that can give structural or functional changes in the retina.","6 Years",{"count":632,"type":21},140,"Children born prematurely may develop a characteristic retinal disease named retinopathy of prematurity (ROP). This disease could lead to retinal detachment and blindness. ROP was traditionally treated with laser, but injection with a medication (A-VEGF) has become more common.\n\nIn this study, the researchers will explore whether treatment of ROP affects visual function and retinal development. To explore this, the study group will examine children with ROP (but not treated) with children treated with either laser or injection. The researchers will compare the children's visual functions (e.g. visual acuity and visual field) and their retinas (e.g. central and peripheral retina).",[635,636,637,638],"Retinopathy of Prematurity (ROP)","Prematurity Complications","Cerebral Visual Impairment","Visual Field Defect",[640,641,642,643,644,645,646,647],"Retinopathy of Prematurity","Treatment","Laser","anti-vascular endothelial growth factor","Visual field defect","Cerebral visual impairment","Refractive errors","Prematurity","2026-02-16",{"date":650,"type":47},"2026-02-23",{"date":652,"type":21},"2026-04-01",{"date":654,"type":21},"2029-06-01",{"name":53,"class":54},{"id":657,"slug":658,"hasResults":12,"nctId":659,"briefTitle":660,"officialTitle":661,"acronym":662,"eligibilityCriteria":663,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":664,"targetDuration":4,"studyType":67,"phases":666,"briefSummary":668,"conditions":669,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":672,"lastUpdatePostDateStruct":673,"startDateStruct":675,"completionDateStruct":677,"leadSponsor":679,"locationsCount":55},"100540158","phase-2-hai-floxuridine-or-sirt-combined-with-gemox-for-patients-with-intra-hepatic-cholangiocarcinoma-not-amenable-to-resection-tomcat-100540158","NCT06313203","HAI-Floxuridine, or SIRT, Combined With Gemox For Patients With Intra-Hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","Trans-arterial Treatment of Patients With Intra-hepatic Cholangiocarcinoma Not Amenable to Resection (TOMCAT)","TOMCAT","Inclusion Criteria:\n\n1. Intra-hepatic cholangiocarcinoma. Diagnosis confirmed by biopsy, cytology or previous resection.\n2. Not amenable for upfront resection. Defined as:\n\n   1. A tumour that is technically not resectable with R0 margins (i.e. where resection will not yield an FLR of sufficient size and function) without reconstruction of portal or liver vein, or artery.\n   2. Any multifocality (more than one tumour) irrespective of distance between assumed primary and other lesions\n   3. Recurrent tumour following resection\n   4. Radiologically or cytology-proven malignant regional lymph nodes\n3. Disease confined to the liver or associated with limited, resectable porta hepatis lymph node metastases\n4. Radiologically measurable disease with at least one lesion \\> 2 cm in greatest diameter\n5. Physical performance score WHO\u002FECOG stage 0\u002F1\n6. Age \\> 18 years\n7. Assumed ability to tolerate at least one full cycle of GemOx\n8. For eligibility to HAI-FUDR\u002FDEX treatment, patients must be willing and able to go to Oslo every fortnight\n9. Women of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Male patients or male patients who have female partners of childbearing age and potential must be willing to use highly effective contraception during the study and for a period after the study, as defined in this protocol. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\nExclusion Criteria:\n\n1. Any non-liver malignant deposit (except for resectable, hilar lymph nodes)\n2. Serum bilirubin, creatinine or INR outside of normal range\n3. Haemoglobin \\\u003C 7 g\u002FdL and thrombocytes \\\u003C 75 × 109\u002FL\n4. Liver failure (if cirrhosis, Child-Pugh B or C)\n5. Clinical evidence of portal hypertension (non-surgically related ascites, gastro-oesophageal varices, portal vein thrombosis)\n6. History of peripheral neuropathy\n7. More than 70 % of liver consisting of tumour\n8. History of other malignancy past three years except localized\u002Fearly stage cancer that has been adequately resected.\n9. Pregnant or lactating women\n10. Expected life expectancy less than three months.\n11. Inability to comply with study routines or follow-up procedures\n12. Inability to read and comprehend Norwegian\n13. Arterial anatomy unsuited for SIRT or HAI, respectively\n14. Any reason why, in the view of the investigators, the patient should not be included",{"count":665,"type":21},39,[667],"PHASE2","Patients with intrahepatic cholangiocarcinoma (IHC) have relatively aggressive tumors, and the prognosis for most of these patients is dismal. Surgery is the only option that can offer potential cure, but only an estimated 20-25 % are amenable to resection. Down-staging conventional chemotherapy has a relatively low response rate (\\\u003C 50 %). Patients will be included into the respective treatment arms based on their tumour characteristics and disease stage, but also based on their ability\u002Fpreferences, as HAI-FUDR\u002FDEX requires going to Oslo every fortnight for the duration of the treatment and SIRT has some limitations regarding tumour distribution.\n\nData from the MSKCC has suggested a clinically relevant benefit from adding intrahepatic chemotherapy to systemic therapy. HAI-FUDR\u002FDEX is not approved in Norway and can only be evaluated in a protocolized trial. Given the risk of distant disease progression with IHC, the addition of conventional systemic chemotherapy makes good clinical sense, and data from MSKCC supports this approach. SIRT is another modality also applied trans-arterially and directly into the tumour. This treatment is approved in Norway and available in Bergen and in Oslo. It is far less cumbersome to deliver and maintain than HAI-FUDR\u002FDEX. The efficacy and safety of the two treatment groups, HAI-FUDR\u002FDEX and SIRT, will be compared in a parallel cohort (non-randomized) design",[670,671],"Intrahepatic Cholangiocarcinoma","Chemotherapy Effect","2026-01-29",{"date":674,"type":47},"2026-02-02",{"date":676,"type":47},"2024-02-13",{"date":678,"type":21},"2034-01",{"name":53,"class":54},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":67,"phases":690,"briefSummary":691,"conditions":692,"keywords":702,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":710,"leadSponsor":712,"locationsCount":299},"100605961","phase-2-hypofractionated-3-week-preoperative-proton-or-x-ray-radiotherapy-for-patients-with-localized-soft-tissue-sarcoma-100605961","NCT07169344","Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma","PROSARC-1. Hypofractionated, 3-week, Preoperative Proton or X-ray Radiotherapy for Patients With Localized Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-1","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of STS, except rhabdomyosarcoma and Ewing sarcoma. Pleomorphic rhabdomyosarcomas are eligible.\n3. Primary tumor localized in head, neck, extremity, girdle and\u002For trunk wall.\n4. Measurable disease according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for PBT.\n\nExclusion Criteria:\n\n1. Locoregional or distant metastasis as assessed by CT and\u002For MRI at time of diagnosis. Patients with lung nodules \\\u003C10 mm of uncertain etiology may be included.\n2. Prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n3. Previous radiotherapy to the primary tumor region.\n4. Patients with pacemakers and\u002For implanted defibrillators.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.\n6. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.",{"count":689,"type":21},110,[667],"The purpose of the study is to investigate whether a personalized selection of patients with localized soft tissue sarcoma for preoperative proton radiation therapy can reduce long-term radiation side effects without increasing surgical complications or reducing the effectiveness of the treatment. Two radiation plans will be created for each patient-one for protons and one for photons-and through a national meeting, we will determine which type of radiation therapy each patient will receive. The radiation dose will be the same for both photons and protons.\n\nThe primary endpoint is surgical complications 120 days after surgery. Secondary endpoints include overall survival, local recurrence-free survival, disease-free survival, side effects, and quality of life. Furthermore, the study will investigate biomarkers that may predict response to radiation therapy, including changes in the tumor's genetic material (DNA), measurement of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe study will be conducted in Norway, with a planned inclusion of 110 patients.",[693,694,695,696,697,698,699,700,701],"Soft Tissue Sarcoma (Excluding GIST)","Soft Tissue Sarcoma Adult","Soft Tissue Sarcoma of the Trunk and Extremities","Synovial Sarcomas","Leiomyosarcoma","Undifferentiated Pleomorphic Sarcoma (UPS)","Myxofibrosarcoma (MFS)","Liposarcoma","Pleomorphic Rhabdomyosarcoma",[703,704,705,706],"Soft tissue sarcoma","proton radiotherapy","x-ray radiotherapy","surgical complications",{"date":708,"type":47},"2026-01-28",{"date":374,"type":47},{"date":711,"type":21},"2035-11-01",{"name":53,"class":54},{"id":714,"slug":715,"hasResults":12,"nctId":716,"briefTitle":717,"officialTitle":718,"acronym":719,"eligibilityCriteria":720,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":721,"targetDuration":4,"studyType":67,"phases":722,"briefSummary":723,"conditions":724,"keywords":729,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":732,"startDateStruct":733,"completionDateStruct":734,"leadSponsor":735,"locationsCount":272},"100606316","phase-2-dose-escalated-hypofractionated-definitive-proton-radiotherapy-for-patients-with-inoperable-soft-tissue-sarcoma-100606316","NCT07173972","Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.","PROSARC-2. Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma. A Single-arm, Multicenter, Phase II Clinical Trial.","PROSARC-2","Inclusion Criteria:\n\n1. ≥ 18 years of age at the time of informed consent.\n2. Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).\n3. Measurable disease according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n5. For patients with metastatic disease a life-expectancy greater than 2 years should be expected.\n6. Before patient registration, written informed consent must be given according to national and local regulations.\n7. Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy.\n\nExclusion Criteria:\n\n1. Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible. Patients with a history of breast cancer, requiring continued hormonal treatment (e.g. anti-estrogen or an aromatase inhibitor) may be included. Patients with a history of prostate cancer, requiring continued support with luteinizing hormone releasing hormone (LHRH) agonists, with or without androgens, may be included.\n2. Previous radiotherapy to the tumor site.\n3. Patients with pacemakers and\u002For implanted defibrillators.\n4. Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.\n5. Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.",{"count":308,"type":21},[667],"The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation. By using proton radiotherapy instead, the hypothesis is that the dose can be increased to enhance treatment effectiveness without increasing side effects.\n\nThe planned radiation dose is 56 Gy in 16 fractions (treatments) over 4 weeks (4 fractions per week), with a maximum dose escalation centrally in the tumor up to 80 Gy (5 Gy per fraction).\n\nAt the same time, the study will investigate biomarkers that can predict treatment response, including changes in the tumor's genetic material (DNA), measurements of various molecules in the bloodstream, and the tumor's appearance on MRI scans.\n\nThe primary endpoint is local control after 2 years, meaning that the treated tumor has not grown during this period. Secondary endpoints include overall survival, progression-free survival, radiological response rates, side effects, and quality of life.\n\nThe study will be conducted in Norway, with a planned inclusion of 40 patients.",[725,694,695,696,698,726,727,728,701,700],"Soft Tissue Sarcoma (STS)","Myxofibrosarcoma","Leiomyosarcoma (LMS)","Pleomorphic Liposarcoma",[730,704,731],"soft tissue sarcoma","inoperable soft tissue sarcoma",{"date":708,"type":47},{"date":374,"type":47},{"date":711,"type":21},{"name":53,"class":54},""]