[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Karolinska University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":655},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,42,79,112,140,163,185,211,245,267,286,308,336,363,391,417,436,468,496,517,540,565,588,616,635],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100639569","soft-tissue-radiation-injury-patient-reported-evaluation-in-a-single-centre-cohort-study-stripe-100639569",false,"NCT07611864","Soft Tissue Radiation Injury; Patient Reported Evaluation in a Single Centre Cohort Study (STRIPE)","karolinskaUH","Inclusion Criteria:\n\n* Adult patients (\\>18 years old)\n* Late radiation tissue injury\n* Treated with HBOT\n\nExclusion Criteria:\n\n* Requested not to be included in the study (Retrospective cohort)\n* Not signed informed consent (Prospective cohort)","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","12 Months","OBSERVATIONAL","Radiotherapy cures many cancers but can cause late radiation-induced tissue injury (LRTI), leading to long-term symptoms from the bladder and bowel and reduced health-related quality of life (HRQoL). Hyperbaric oxygen therapy (HBOT) is an established treatment that reduces chronic inflammation and promotes tissue repair. Randomized studies have demonstrated improvements in symptoms and quality of life, but only a small proportion of affected patients receive HBOT.\n\nThis study aims to longitudinally describe a cohort of patients with LRTI treated with HBOT at Karolinska University Hospital and to analyze associations between treatment, timing, and patient characteristics. The goal is to improve understanding of which patients benefit most from HBOT and when treatment should be initiated.",[26,27,28],"Cystitis, Radio Induced","Soft Tissue Radionecrosis (STRN)","Radiation Proctitis","RECRUITING","2026-06-01",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":33},"2026-05-05",{"date":37,"type":21},"2040-12-31",{"name":39,"class":40},"Karolinska University Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":41},"100625596","catheter-ablation-vs-conservative-care-in-elderly-patients-with-atrial-fibrillation-100625596","NCT07424690","Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation","Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study","ACE-AF","Inclusion Criteria:\n\n1. Age ≥78 years.\n2. ECG-documented atrial fibrillation.\n3. AF type: paroxysmal, persistent, or longstanding persistent AF.\n4. Suitable candidate for catheter ablation according to ESC guidelines.\n5. Charlson's comorbidity index ≤7.\n\nExclusion Criteria:\n\n1. Left atrial (LA) dimension \\>55 mm, based on echocardiography within the previous year.\n2. Acute coronary syndrome or coronary artery bypass surgery within the last 12 weeks.\n3. Severe valvular heart disease (per ESC definitions) or congenital heart disease.\n4. Prior surgical or catheter AF ablation procedure, or prior AV-node (atrioventricular nodal) ablation.\n5. Contraindication to oral anticoagulation.\n6. AF due to a reversible cause.\n7. Medical condition likely to limit survival to \\\u003C12 months.\n8. Unable or unwilling to provide informed consent.\n9. History of non-compliance with medical therapy.\n10. BMI \\\u003C18 or \\>37 kg\u002Fm².","78 Years",{"count":52,"type":21},282,"INTERVENTIONAL",[55],"NA","ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure.\n\nThe study compares two established treatment strategies:\n\n1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and\n2. Optimized medical therapy without AF ablation (medications for rate and\u002For rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care).\n\nParticipants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time.\n\nThe study has two co-primary outcomes assessed over 24 months:\n\n1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and\n2. patient-reported health-related quality of life (HRQoL), measured by the SF-36 \"General Health\" domain.\n\nACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.",[58,59,60],"Atrial Fibrillation (AF)","Atrial Fibrillation Ablation","Elderly",[62,63,64,65,66,67,68,69],"atrial fibrillation","catheter ablation","rhtyhm control","rate control","implantable loop recorder","elderly","Health-related quality of life","Randomized controlled study","NOT_YET_RECRUITING","2026-02-14",{"date":73,"type":33},"2026-02-20",{"date":75,"type":21},"2026-05-20",{"date":77,"type":21},"2034-09-01",{"name":39,"class":40},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":53,"phases":89,"briefSummary":91,"conditions":92,"keywords":99,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":41},"100565208","early-phase-1-177lulu-akir001-first-in-human-study-100565208","NCT06639191","[177Lu]Lu-AKIR001 First-in-human Study","A Phase 1 Prospective, Open-label, First-in-human Study to Evaluate the Safety, Tolerability and Biodistribution of [177Lu]Lu-AKIR001 and Its Anti-tumour Effect in Adult Patients With CD44v6 Expressing Solid Tumours","AKIR001","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older\n2. Willing and able to provide written informed consent\n3. Participant has one of the following histologically confirmed metastatic or locally advanced irresectable CD44v6 expressing (confirmed in pre-screening according to the pathology manual (Appendix III) solid malignancy in one of the following groups, with documented disease progression in the last 8 weeks during\u002Fafter available standard of care treatment options as mentioned below:\n\n   * For anaplastic, poorly differentiated and radioiodine refractory differentiated thyroid cancer (ATC, PDTC, RAI-R DTC):\n\n     * For BRAFv600E mutated tumours: BRAF\u002FMEK inhibitors.\n     * For BRAF-wildtype tumours at least one of the following: anthracycline- or taxane containing chemotherapy\u002F chemoradiotherapy, or other targeted therapies including vascular endothelial growth factor (VEGF) tyrosine kinase inhibitors (TKI), targeted therapies aimed at specific moleculo-pathological features (e.g., targeting NTRK, RET, ALK, PD-L1)\n     * For PDTC or RAI-R DTC: Radio-iodine refractory disease as deemed by treating physician and disease progression after at least one line of systemic targeted therapy (including VEGF, TKI, NTRK, RET, BRAF inhibitors)\n   * For HNSCC:\n\n     \\- At least one prior treatment with combination chemotherapy (either platinum based + 5-Fluorouracil or platinum based + taxane) together with PD1-inhibitor pembrolizumab if combined positive score (CPS) ≥1 or EGFR-inhibitor if CPS \\\u003C1 (or if immunotherapy is contraindicated)\n   * For NSCLC\n\n     \\- Treatment with at least two lines of systemic therapy, including checkpoint inhibitor based on PD-L1 status and chemotherapy with a platinum-based regimen.\n   * For vulvar SCC:\n\n     \\- After treatment with first line platinum\u002Fpaclitaxel+\u002F-bevacizumab +\u002F- pembrolizumab (the latter in case of PD-L1 positivity), and second line with weekly paclitaxel\n   * For cervical SCC:\n\n     * After treatment with first line systemic therapy with platinum\u002Fpaclitaxel+\u002F-pembrolizumab (the latter in case of PD-L1 positivity)\n4. Measurable disease per Response Criteria for Solid Tumours (RECIST) v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n6. Life expectancy of at least three months as estimated by the investigator.\n7. Adequate organ and bone marrow function within eight days before the first \\[177Lu\\]Lu-AKIR001 infusion:\n\n   * Peripheral white blood cells (WBC) ≥3.0 x 109\u002FL\n   * Absolute neutrophil count (ANC) ≥ 2,000\u002Fmm3\n   * Platelet \\> 100 x 109\u002FL\n   * Hemoglobin \\> 100 g\u002FL.\n   * Serum creatinine of ≤ 1.5x ULN or calculated creatinine clearance of ≥ 60 mL\u002Fmin\u002F1.73 m2 by Cockcroft- Gault\n   * Total serum bilirubin ≤ 1.5x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)\n   * Serum AST and ALT ≤1.5x ULN (or ≤ 5x ULN if participant has liver metastases)\n   * Left Ventricular Ejection Fraction \\>50% on echocardiography\n8. Contraceptives\n\n   * Females of child-bearing potential must agree to use adequate contraception prior to study entry, for the duration of study treatment Phase and for six months after the last dose of study drug. Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone- releasing intrauterine devices (IUDs), and copper IUDs. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception. Women must refrain from donating eggs during this same period. Should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. If a female participant is of child-bearing potential (females are considered not of childbearing potential if they are at least one year postmenopausal and\u002For surgically sterile), she must have a documented negative serum pregnancy test before any \\[177Lu\\]Lu-AKIR001 infusion.\n   * Male participant must agree to practice effective barrier contraception (condom) during the entire study treatment period and through four months after the last dose of study drug or agree to completely abstain from heterosexual intercourse.\n\nExclusion Criteria:\n\n1. Symptomatic brain metastases that are not previously treated and\u002For that require ongoing steroid-treatment\n2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix\n3. Chemo-, targeted or radiotherapy within the last 4 weeks before enrolment in the study.\n4. Ongoing toxicities graded according to the Common Terminology Criteria for Adverse Events (CTCAE) \\> 1 from previous anti-cancer treatments.\n5. Pregnancy or lactation\n6. Uncontrolled hypertension, heart, liver, or kidney disease or other medical\u002F psychiatric disorders.\n7. Severe skin diseases requiring systemic anti-inflammatory treatment, including plaque psoriasis, Stevens Johnsons syndrome or dermatomyositis.\n8. A known history of Human Immunodeficiency Virus (HIV) infection, hepatitis B (HBsAg reactive) or hepatitis C (HCV RNA detected) infection or active tuberculosis.",{"count":88,"type":21},15,[90],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of increasing doses of \\[177Lu\\]Lu-AKIR001, both in relation to tolerable activity of lutetium-177 and the absorbed protein mass dose of AKIR-001 in patients with irresectable or metastatic CD44v6-expressing solid malignancies for whom no reasonable systemic treatment options are be available. The main question it aims to answer is:\n\n• What is the toxicity profile of the study drug \\[177Lu\\]Lu-AKIR001 according to the rate of Dose Limiting Toxicities and (Severe) Adverse Events? Participants will receive one \\[177Lu\\]Lu-AKIR001 infusion followed by a 6-week safety follow-up period, which can be extended up to 12 weeks. Possible additional infusions of the trial drug, up to a maximum number of four, can be given when clinical benefit is noted and toxicity is deemed acceptable.",[93,94,95,96,97,98],"Thyroid Gland Anaplastic Carcinoma","Poorly Differentiated Thyroid Carcinoma","Cancer Head and Neck","Cervix Carcinoma","Vulvar Cancer, Stage IV","Non-small Cell Lung Cancer Stage IV",[100,101,102,103,104],"Radiopharmaceutical","first-in-human","CD44v6","Lutetium-177","177Lu-AKIR001","2026-01-28",{"date":107,"type":33},"2026-01-30",{"date":105,"type":33},{"date":110,"type":21},"2028-11-01",{"name":39,"class":40},{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":118,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":4},"100621823","neurological-and-cognitive-dysfunction-following-car-t-treatment-icans-and-beyond-100621823","NCT07375628","Neurological and Cognitive Dysfunction Following CAR-T Treatment. ICANS and Beyond","Inclusion Criteria:\n\n* Age \\> 20\n\n  * Planned to undergo CAR-T treatment\n  * No known prior CNS diseases or head trauma\n  * Prior CNS involvement of lymphoma or acute lymphoblastic leukemia is allowed, provided it is well-controlled and treated at inclusion\n  * Capable of receiving tailored information about the research project and signing informed consent\n\nExclusion Criteria:\n\n* • Age under 20 years\n\n  * The patient has previously indicated they wish to refrain from research participation\n  * Another concurrent neuroinflammatory or neurodegenerative disease, or malignant disease (other than the underlying condition) in the central nervous system","20 Years",{"count":120,"type":21},10,"This is a phase 4 non-interventional single center trial. We aim to prospectively include patients scheduled to undergo CAR-T therapy at ME CAST, Karolinska University Hospital Huddinge, to study ICANS. Because ICANS develops rapidly, inclusion during this potentially life-threatening phase would not be feasible; patients must therefore be enrolled before they start treatment. We aim to include patients who are clinically at high risk of developing ICANS. The risk of ICANS is assessed based on diagnosis, tumor burden, CAR-T product, and inflammatory status prior to treatment initiation. We plan to compare patients who develop ICANS grade 2-4 with patients who develop no ICANS or at most grade 1. Patients will undergo Positron Emission Tomography (PET) with two different tracers: (1) PBR28 for TSPO, which provides a measure of brain inflammation-this ligand binds to microglial cells-and (2) 11C-UCB-J for SV2A, which provides a measure of synaptic density in the brain. The results will be compared with magnetic resonance imaging. We will collect blood, bone marrow and cerebrospinal fluid (CSF) samples from this patient cohort. Samples will be taken from all patients before, during, and after CAR-T treatment. Participation in the study also includes computer-based cognitive testing, neuropsychological evaluation and genetic testing to determine whether the patient has receptors allowing binding of the TSPO radioligand used during PET imaging.",[123,124,125],"CAR T Cell Therapy","ICANS","Cognitive and Executive Dysfunction",[127,128,129,130,131],"Icans","CAR T cell therapy","Fatigue","Cognitive dysfunction","PET scan","2026-01-22",{"date":134,"type":33},"2026-01-29",{"date":136,"type":21},"2026-02",{"date":138,"type":21},"2029-05",{"name":39,"class":40},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":147,"sex":17,"minAge":118,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":41},"100621059","fatigue-and-cognitive-dysfunction-due-to-synaptopathy-or-graft-versus-host-gvh-disease-in-the-brain-100621059","NCT07365696","Fatigue and Cognitive Dysfunction Due to Synaptopathy or Graft Versus Host (GVH) Disease in the Brain.","Fatigue Och Kognitiv Dysfunktion Till följd av Synaptopati Eller Graft Versus Host (GVH) Sjukdom i hjärnan.","Inclusion Criteria: PET images available retrospectively",true,"75 Years",{"count":150,"type":21},30,"Patients undergoing allogenic stem cell transplantation are regularly followed up in the outpatient clinic at Karolinska University Hospital. Here, patients are offered participation the fatigue study measuring both fatigue and cognitive impairment systematically by international standard. Meanwhile liquor samples and advanced PET imaging techniques are available for these patients as part of a research project allowing extensive immunological and radio-morphological studies.",[129,153,154],"Graft Vs Host Disease","Cognitive Dysfunction","2026-01-19",{"date":157,"type":33},"2026-01-26",{"date":159,"type":33},"2023-11-28",{"date":161,"type":21},"2028-12-28",{"name":39,"class":40},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":53,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":41},"100535024","robotic-assisted-contra-open-resection-for-suspected-or-confirmed-gallbladder-cancer-robocop-100535024","NCT06246448","Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer (ROBOCOP)","Robotic-assisted Contra Open Resection for Suspected or Confirmed Gallbladder Cancer - An International, Multi-centre, Single Blinded, Randomized Controlled Superiority Trial","ROBOCOP","Inclusion Criteria:\n\n* Patient with radiologically suspected or confirmed (≥T1b) incidental gallbladder cancer after cholecystectomy with an indication of radical cholecystectomy, without the need for resection of extrahepatic bile ducts, as decided at a multidisciplinary team conference.\n* Patient sufficiently fit to undergo radical cholecystectomy according to surgeon and anaesthesiologist.\n\nExclusion Criteria:\n\n* Previous extensive surgery in the upper abdomen (for example open liver surgery)\n* Pregnancy\n* Intraoperative findings of dissemination (patient is then excluded after randomization)\n* Intraoperative findings of the need to perform resection of extrahepatic bile ducts (patient is then excluded after randomization).\n* Intraoperative findings leading to a simple cholecystectomy only (patient is then excluded after randomization)",{"count":172,"type":21},94,[55],"The Robocop trial is an international multi-centre, single blinded, randomized controlled superiority trial conducted in centres experienced in robotic-assisted liver surgery. Eligible patients for radical cholecystectomy will be randomized in a 1:1 ratio to undergo robotic-assisted or open resection within an enhanced recovery setting.\n\nThe primary endpoint is time to functional recovery. Secondary endpoints include length of hospital stay, resection margin, number of retrieved lymph nodes, postoperative complications, quality of life, abdominal wall complaints and direct and indirect costs.",[176],"Gall Bladder Cancer","2025-08-29",{"date":179,"type":33},"2025-09-05",{"date":181,"type":33},"2024-01-23",{"date":183,"type":21},"2027-03",{"name":39,"class":40},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":195,"studyType":23,"phases":4,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":41},"100334101","timing-of-renal-replacement-therapy-in-the-critically-ill-patients-100334101","NCT03629977","Timing of Renal Replacement Therapy in the Critically Ill Patients","Early vs Late CRRT, a Propensity Matched Multicenter Cohort Study","TORRT","Inclusion Criteria:\n\n\\*Critically ill patients admitted to intensive care units in Stockholm at: Karolinska University Hospital (Solna and Huddinge) and at Södersjukhuset.\n\n\\*Patients over 18 years of age\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years\n* Patients with DNAR (do not attempt resuscitation)-orders\n* Patients dying within 12 hours of commencing renal replacement therapy.",{"count":194,"type":21},50000,"1 Year","Background: Severe acute kidney injury (AKI) among critically ill patients is sometimes treated with renal replacement therapy (RRT), and in Sweden continuous RRT (CRRT) is the dominant modality used in this population.\n\n* The optimal timing of renal replacement therapy (RRT) initiation in critically ill patients with acute kidney injury (AKI) is unknown\n* No consensus to guide clinical practice on this issue\n* Lack of consistency regarding outcome measurements; should we look at morbidity or mortality?\n* Wide variability in the timing of RRT initiation in the intensive care unit (ICU) population\n\nHypothesis: This is an important knowledge gap in the support of critically ill patients with AKI and we hypothesize that early initiation of RRT is beneficial.\n\nMethods: The present study aims to test this hypothesis by using a large scale high resolution intensive care database, the Clinisoft repository. In this database, we have information on \\>60 000 patients from three different hospitals and five ICUs, during the years 2005 up until today. The repository will be crossmatched, using the unique Swedish national ID number, with hospital records; to gather information on preexisting illnesses, chronic medication and post-ICU outcomes. It is likely that over 5%, more than 3000 patients, have been treated with RRT. We will categorize these patients into \"early\" and \"late\" groups using both biomarker data and clinical data. Importantly, early and late RRT can be categorized using biomarkers, like urea and creatinine; using degree of fluid accumulation, by level of pH in blood and just by using hours-days after ICU admission. All possible definitions of early\u002Flate RRT initiation can be tested in this study.\n\nOutcomes: Our primary outcome is 90 day mortality. Secondary outcomes include: mortality at 30, 60, 180 and 365 days. Two- and three year mortality.\n\nMorbidity, measured as end-stage renal disease (ESRD) for 90-day survivors. ICU length of stay, hospital length of stay.",[198,199,200,201,202],"Acute Kidney Injury","Uremia","Fluid Overload","Dialysis; Complications","Critical Illness","2025-08-26",{"date":205,"type":33},"2025-09-03",{"date":207,"type":21},"2025-11-01",{"date":209,"type":21},"2027-04-01",{"name":39,"class":40},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":53,"phases":221,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},"100508421","phase-2-trastuzumab-deruxtecan-versus-standard-neoadjuvant-treatment-for-her2-positive-breast-cancer-100508421","NCT05900206","Trastuzumab Deruxtecan Versus Standard Neoadjuvant Treatment for HER2-positive Breast Cancer","A Randomized Trial of Trastuzumab Deruxtecan and Biology-Driven Selection of Neoadjuvant Treatment for HER2-positive Breast Cancer: ARIADNE","ARIADNE","To be eligible for the study, patients must fulfil all inclusion criteria:\n\n1. Women or men 18 years or older\n2. Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n3. Histologically confirmed breast cancer with an invasive component measuring ≥ 20 mm and\u002For with morphologically confirmed spread to regional lymph nodes (stage cT2-cT4 with any cN, or cN1-cN3 with any cT).\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of randomization (see Appendix B).\n5. Known estrogen-receptor and\u002For progesterone receptor status, as assessed locally by IHC. The cut-off for positivity for ER\u002FPR for this study is at least 10% of cell nuclei staining for ER or PR, respectively.\n6. Known HER2-positive breast cancer defined as an IHC status of 3+. If IHC is 2+, a positive in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. ISH positivity is defined as a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies.\n7. Left Ventricular Ejection Fraction (LVEF) ≥ 50%\n8. Adequate bone-marrow, hepatic and renal function defined as laboratory tests within 7 days prior to enrolment:\n\n   i. Hematology:\n   1. Absolute granulocytes \\> 1.5 x 109\u002FL\n   2. Platelets \\> 100 x 109\u002FL\n   3. Hb \\> 90 gr\u002FL ii. Biochemistry\n\n   \u003C!-- -->\n\n   1. Bilirubin ≤ upper limit of normal (ULN)\n   2. Serum creatinine ≤ 1.5 x ULN\n   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 x ULN\n   4. Albumin ≥ 30 gr\u002FL iii. Coagulation:\n\n   \u003C!-- -->\n\n   1. INR\u002FPT ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy and INR\u002FPT is within intended therapeutic range\n   2. aPTT ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy and aPTT is within intended therapeutic range\n9. Availability of tumor and blood samples as described in the protocol\n10. Negative serum pregnancy test for women of childbearing potential or for patients who have experienced menopause onset \\\u003C12 months prior to randomization.\n11. Patients of childbearing potential must be willing to use one highly effective contraception or two effective forms of nonhormonal contraception. See also 5.6 Precautions.\n12. Participants must be able to communicate with the investigator and comply with the requirements of the study procedures\n\nTo be eligible for the study, patients must not fulfil any exclusion criteria:\n\n1. Participation in other interventional trials\n2. Presence of distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum\n3. Other malignancy diagnosed during the past five years, except adequately controlled limited basal cell carcinoma or squamous-cell carcinoma of the skin, in situ melanoma or carcinoma in situ of the cervix.\n4. History of invasive breast cancer\n5. History of DCIS, except for patients treated exclusively with mastectomy \\>5 years prior to diagnosis of current breast cancer\n6. Active cardiac disease or a history of cardiac dysfunction including any of the following:\n\n   1. History of unstable angina pectoris, myocardial infarction or recent (\\\u003C6 months) cardiovascular event including stroke and pericarditis\n   2. History of documented congestive heart failure (New York Heart Association functional classification II-IV)\n   3. Documented cardiomyopathy\n   4. QTc \\> 450 msec as measured by Fridericia's formula, family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes.\n   5. Uncontrolled hypertension\n   6. Symptomatic or uncontrolled arrhythmia, including atrial fibrillation.\n7. Patients with ER-positive BC being treated with drugs recognized as strong inhibitors or inducers of the isoenzyme CYP3A (see table 5) which cannot be discontinued at least 7 days prior to planned treatment with ribociclib.\n8. Concomitant medication(s) with a known risk to prolong the QT interval and\u002For known to cause Torsades de Pointes that cannot be discontinued or replaced by safe alternative medication\n9. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant\n10. History of (non-infectious) Interstitial Lung Disease (ILD) \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n11. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)\n12. Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.\n13. Prior pneumonectomy\n14. History of positive testing for HIV or known AIDS\n15. Acute or chronic infection with hepatitis B or C virus\n16. Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n17. Receipt of live, attenuated vaccine within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study drug.\n18. Any psychological, including substance abuse, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n19. Allergic reactions or hypersensitivity to the study drugs or other monoclonal antibodies\n20. Administration of other experimental drugs, either concomitantly or during the past 30 days before treatment initiation.\n21. Pre-treatment axillary surgery\n22. Recent major surgery (within 4 weeks from start of study treatment) or anticipated need for major surgery during the study.\n23. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).",{"count":220,"type":21},370,[222],"PHASE2","The goal of this clinical trial is to compare trastuzumab deruxtecan (T-DXd) to standard preoperative treatment in patients with non-metastatic HER2-positive breast cancer. The main questions it aims to answer are:\n\n* is T-DXd more effective than standard preoperative treatment?\n* are there markers in the tumor or blood of patients with HER2-positive breast cancer that can help us predict response to treatment?\n\nParticipants will be divided into two groups, where one group will be treated with three courses of T-DXd and the other group will be treated with three courses standard of care treatment. Thereafter, further treatment will be decided by the tumor's molecular subtype.",[225],"Breast Cancer",[227,228,229,230,231,232,233,234,235],"HER2-positive","neoadjuvant treatment","trastuzumab deruxtecan","T-DXd","PAM50","molecular subtype","ribociclib","HER2-enriched","breast cancer","2025-08-25",{"date":238,"type":33},"2025-09-02",{"date":240,"type":33},"2023-10-26",{"date":242,"type":21},"2032-04-30",{"name":39,"class":40},7,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":53,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":41},"100597553","endogenous-energy-production-in-critically-ill-patients-100597553","NCT07059988","Endogenous Energy Production in Critically Ill Patients","The Effect of Nutrition on Endogenous Energy Substrate Production in the Early and Late Acute Phase of Critical Illness","eEPIC","Inclusion Criteria:\n\nFor the ICU group:\n\n1. ≥18 years old and admitted to the ICU\n2. Invasive mechanical ventilation\n3. Arterial and central line in situ\n4. Expected to remain in ICU \\>72 hours\n\nFor the control group:\n\n1\\. ≥18 years old\n\nExclusion Criteria:\n\n1. Lack of informed consent by patient\u002Fnext of kin\n2. Liver transplant\n3. Acute or acute on chronic liver failure\n4. Cirrhosis\n5. Known diabetes mellitus\n6. Pancreatic surgery\n7. Acute or chronic pancreatitis\n8. Pregnancy\n9. Intubated only for airway protection or neurologic deficit\n10. Mitochondrial disease\n11. Disorder of amino acid metabolism\n12. Familial hypertriglyceridemia\n13. Severe acquired hypertriglyceridemia (≥10 mmol\u002FL)\n14. Requiring treatment of hypoglycemia in the last 72 hours before inclusion.\n15. Requiring ongoing large volume resuscitation of crystalloids or blood products\n16. \\>72 hours in ICU before enrollment\n17. Readmission to ICU within 1 week of ICU discharge.\n18. Morbidly obese (BMI ≥35)\n19. Limitations of treatment to best supportive care\n20. Ongoing treatment with insulin\u002Fglucose related to hyperkalemia",{"count":254,"type":21},40,[55],"The aim of this study is to investigate when critically ill patients transition from a non-suppressible catabolism to a normal response to feeding.\n\nEndogenous production of glucose, fat and protein will be studied on a minimum of two occasions in mechanically ventilated ICU patients, in a fasted state and during parenteral nutrition. Substrate kinetics are estimated by a tracer dilution method using infusions of isotopically labeled glucose, glycerol and phenylalanine. Blood sampling for metabolomics analysis will be performed to elucidate potential biomarkers indicating an anabolic response to nutrition.",[202,258],"Metabolism and Nutrition Disorder","2025-07-01",{"date":261,"type":33},"2025-07-11",{"date":263,"type":21},"2025-07",{"date":265,"type":21},"2027-05",{"name":39,"class":40},{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":4},"100591651","iatrogenic-deficiencies-in-icu-patients-with-prolonged-continuous-renal-replacement-therapy-100591651","NCT06983197","Iatrogenic Deficiencies in ICU Patients With Prolonged Continuous Renal Replacement Therapy","Iatrogena bristtillstånd Hos intensivvårdade Patienter Under långvarig Behandling Med Kontinuerlig Dialys","IBRIST","Inclusion Criteria CRRT group:\n\n* CRRT more than 5 days\n\nExclusion Criteria:\n\n* N\u002FA\n\nInclusion criteria non-CRRT group\n\n\\- ICU care 10-15 days without any dialysis treatment",{"count":150,"type":21},"ICU patients are recruited after at least 5 days treatment with continuous renal replacement therapy. Blood samples are drawn at time of recruitment and then every 3-5 days until ceseation of renal replacement therapy.\n\nSamples will be analyzed for concentrations of trace elements, vitamins and amino acids.\n\n10 adult ICU patients treated for two weeks without renal replacement therapy will be sampled at one time point to serve as controls.",[198],"2025-05-20",{"date":280,"type":33},"2025-05-21",{"date":282,"type":21},"2025-06-01",{"date":284,"type":21},"2029-12-31",{"name":39,"class":40},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":53,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":41},"100466103","lactate-kinetics-in-septic-shock-100466103","NCT05349370","Lactate Kinetics in Septic Shock","Lactate Kinetics in Patients Treated for Septic Shock","LKISS","Inclusion Criteria:\n\n* Sepsis\n* Age \\>17 years\n* Arterial catheter\n* Lactate \\> 2 mmol at any time point prior to inclusion\n\nExclusion Criteria:\n\n* Mitochondrial defect\n* Degenerative muscle disease\n* Terminal liver failure",{"count":295,"type":21},60,[55],"Lactate kinetics will be studied in hospitalized septic patients using a bolus injection of stable isotopically labeled lactate.",[299,300],"Sepsis","Septic Shock",{"date":302,"type":33},"2025-05-23",{"date":304,"type":33},"2022-12-28",{"date":306,"type":21},"2026-12-31",{"name":39,"class":40},{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":316,"conditions":317,"keywords":321,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":41},"100498798","qol-after-complex-endovascular-aortic-repair-100498798","NCT05774938","QoL After Complex Endovascular Aortic Repair","Inclusion Criteria:\n\n* Men and women.\n* Any age (≥18 years)\n* Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR.\n* Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately.\n\nExclusion Criteria:\n\n* Inability to understand and\u002For respond to the study questionnaires that are in Swedish.\n* Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation).\n* Participation in other ongoing studies concerning quality of life.",{"count":315,"type":21},90,"The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:\n\n* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR)\n* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR) at one year.\n* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-\u002FBEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.\n\nParticipants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.\n\nThe different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).",[318,319,320],"Quality of Life","Aortic Aneurysm","Aortic Aneurysm, Abdominal",[322,323,324,325,326,327],"Endovascular aneurysm repair","Pararenal aortic aneurysm","Quality of life","Paravisceral aortic aneurysm","Fenestrated endovascular aortic repair","Branched endovascular aortic repair","2025-04-08",{"date":330,"type":33},"2025-04-10",{"date":332,"type":33},"2023-02-28",{"date":334,"type":21},"2030-01",{"name":39,"class":40},{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":53,"phases":344,"briefSummary":345,"conditions":346,"keywords":350,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":41},"100583703","optimization-of-patient-preparation-and-imaging-techniques-for-cardiac-ct-100583703","NCT06879769","Optimization of Patient Preparation and Imaging Techniques for Cardiac CT","Inclusion Criteria:\n\n* Participant with a preexisting referral for a Cardiac CT examination\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Age under 18 years\n* Atrial fibrillation\n* Pacemaker\n* Participation in clinical drug trials\n* Contraindications to beta-blockers\n* Severe medical conditions\n* Challenges in comprehending study information\n* Pregnancy",{"count":343,"type":21},240,[55],"The goal of this clinical trial is to compare four different methods of reducing heart rate before cardiac imaging. The diagnostic imaging technique used in this study is called Computed Tomography (CT) of the coronary vessels (CCTA). Globally, approximately one-third of patients experience heart-related conditions. Because the heart is a moving organ, imaging presents challenges. A higher heart rate requires increased scanning power, which results in more images and, in some cases, higher radiation exposure that may be harmful. To address this issue, beta-blocker medication is administered before the examination to lower the heart rate. This medication can be given orally, intravenously, or both. While this approach is effective, the most optimal method remains uncertain.\n\nThe objectives of this study are:\n\n* To determine whether oral administration of beta-blockers is as effective as intravenous administration in maintaining a stable heart rate during CT imaging.\n* To assess whether listening to music during the procedure improves patient comfort and overall experience.\n\nParticipants will:\n\n* Be randomly assigned to one of four groups:\n* One group will receive beta-blocker medication orally.\n* Another group will receive beta-blocker medication intravenously.\n* One group will listen to music during the procedure. Participants will report their sensations and experiences before, during, and after the examination.\n\nThe study investigators will compare the effectiveness of oral and intravenous beta-blockers, as well as the impact of music, in terms of:\n\n* Heart rate stability and reduction.\n* Participant-reported comfort and overall experience.",[347,348,349],"Coronary Computed Tomography Angiography","Contrast Media","Cardiac Output",[351,349,352,353,354],"Music intervention","CCTA","Beta blockers","Metoprolol","2025-03-14",{"date":357,"type":33},"2025-03-17",{"date":359,"type":33},"2021-01-01",{"date":361,"type":21},"2027-12-01",{"name":39,"class":40},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":53,"phases":374,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":390},"100397840","phase-3-chemoradiotherapy-followed-by-planned-surgery-or-by-surveillance-and-surgery-only-when-needed-for-oesophageal-cancer-100397840","NCT04460352","Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer","NEoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma Versus Definitive Chemoradiotherapy With Salvage Surgery as Needed (NEEDS Trial)","NEEDS","Inclusion Criteria:\n\n* Histopathologically confirmed SCC of the esophagus in locally advanced stages cT1 N+ or cT2-4a any N, M0, according to current (8th) version of of the AJCC TNM classification.\n* Technically resectable disease according to the local multidisciplinary team conference (MDT)\u002Ftumor board.\n* Performance status ECOG 0-1.\n* Adequate organ function.\n* Women of childbearing potential (WOCBP\\*) must have a negative serum or urine pregnancy test.\n* Patients of childbearing\u002Freproductive potential should use highly effective method of birth control measures during the study treatment period and for at least five months after the last study treatment.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment.\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP\u002FGDPR and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* M1 according to current (8th) version of of the AJCC TNM classification.\n* cT4b according to current (8th) version of of the AJCC TNM classification.\n* Primary tumor not resectable without laryngectomy.\n* Impaired renal, hepatic, cardiac, pulmonary or endocrine status that compromises the eligibility of the patient for multimodality treatment with chemoradiotherapy followed by esophagectomy.\n* Subjects not considered likely to tolerate multimodality treatment with chemoradiotherapy followed by esophagectomy.\n* Subjects with previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.\n* Prior or concomitant treatment with radiotherapy or chemoradiotherapy with potential overlap of radiotherapy fields.\n* Known uncontrollable hypersensitivity to the components of the chemotherapeutic agents used in the trial regimens.\n* Inability to fully understand and digest study patient information or to comply with study instructions due to language difficulty or cognitive failure such as dementia or severe psychiatric disorder.\n\n(Criteria slightly shortened)","80 Years",{"count":373,"type":21},1020,[375],"PHASE3","NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation.\n\nThe aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.",[378],"Esophageal Squamous Cell Carcinoma",[380,381],"Neoadjuvant chemoradiotherapy","Definitive chemoradiotherapy with salvage surgery as needed","2025-03-04",{"date":384,"type":33},"2025-03-06",{"date":386,"type":33},"2020-11-27",{"date":388,"type":21},"2031-12-31",{"name":39,"class":40},12,{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":395,"acronym":396,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":53,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":41},"100423429","precision-radiation-of-immune-checkpoint-therapy-resistant-melanoma-metastases-100423429","NCT04793737","Precision Radiation of Immune Checkpoint Therapy Resistant Melanoma Metastases","PROMMEL","Inclusion Criteria:\n\n1. Age 18 and above\n2. ECOG performance status of 0-1\n3. Signed and dated written informed consent before the start of specific protocol procedures.\n4. Patient has initiated PD-1 inhibitor treatment (alone or in combination with CTLA-4 inhibitor) as the first line of therapy for unresectable metastatic cutaneous melanoma and been on the treatment for at least 3 months and progressed on the treatment. Patients with primary or secondary resistance to the PD-1 inhibitor treatment will be included. Progression is defined as at least 30% enlargement of at least one metastasis or appearance of new metastasis. A fine-needle aspiration (FNA) biopsy from a progressing lesion or a new lesion is recommended to confirm the presence of viable tumor cells.\n5. Patients on adjuvant treatment with PD-1 inhibitors that during the treatment develop unresectable biopsy confirmed metastases can also be included in the study.\n6. Have at least one new or progressing lesion safely amenable to irradiation in the opinion of the treating radiation oncologist AND at least one, not-to-be-irradiated new or progressing lesion measurable by CT or MRI per RECIST 1.1 criteria where up to four radiation target fields are allowed\n7. No contraindication for continuing immunotherapy after the radiotherapy intervention\n\nExclusion Criteria:\n\n1. Inability to understand given information or undergo study procedures according to protocol\n2. Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.\n3. A condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 30 days before start of study treatment. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted.\n4. Has an active infection requiring systemic therapy.\n5. Concomitant therapy with any anti-tumor medications, other than PD-1\u002FCTLA-4 inhibitors or 30 days before and after treatment in this trial.\n6. Prior radiotherapy preventing the study intervention with precision radiotherapy\n7. Location, size or number of metastases is deemed as excessive or not appropriate for precision radiotherapy\n8. Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or anticonvulsants.\n9. Prior malignancy. Subjects who have had another malignancy should be disease-free for 5 years, or should have a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma",{"count":399,"type":21},27,[55],"To evaluate tumor response, survival and adverse effects after precision radiotherapy (SBRT) in melanoma patients with ongoing PD-1 inhibitor treatment that have tumor progression.",[403],"Metastatic Melanoma",[405,406,407,408],"Precision radiation","PD-1 inhibitor","SBRT","Immune Checkpoint Inhibitor","2025-03-03",{"date":411,"type":33},"2025-03-05",{"date":413,"type":33},"2021-03-08",{"date":415,"type":21},"2025-12",{"name":39,"class":40},{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":53,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":41},"100580324","amino-acid-supplementation-in-continuous-renal-replacement-therapy-100580324","NCT06835816","Amino Acid Supplementation in Continuous Renal Replacement Therapy","AARRT","Inclusion Criteria:\n\n* Dialysis where amino acid supplementation is planned by treating physician\n\nExclusion Criteria:\n\n* Liver failure\n* Muscle disease\n* Neurodegenerative disease",{"count":150,"type":21},[55],"ICU patients treated with continuous renal replacement therapy is recruited prior to start of treatment.\n\nBlood samples are drawn and then dialysis start without amino acid supplementation. After a few hours samples are drawn from blood and dialysate. Then patients are given amino acid supplementation (33.5g\u002F24hrs) for 20-24 hours. New samples are drawn and amino acid supplementation is increased to 67g\u002F24hrs and new samples are drawn after additional 24 hours. Then CRRT will continue with the full amino acid supplementation (standars of care).",[198],"2025-02-14",{"date":430,"type":33},"2025-02-19",{"date":432,"type":33},"2025-02-03",{"date":434,"type":21},"2028-12-31",{"name":39,"class":40},{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":147,"sex":17,"minAge":18,"maxAge":444,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":447,"conditions":448,"keywords":454,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},"100508869","diaphragm-dysfunction-and-ultrasound-perioperatively-100508869","NCT05906030","Diaphragm Dysfunction and Ultrasound Perioperatively","Diaphragm Dysfunction and Respiratory Complications in the Perioperative Setting- Can Diaphragm Ultrasound Aid Prediction?","DiaphPeriop","Inclusion Criteria:\n\nAdults undergoing elective (study 1) or acute (study 2) abdominal, pelvic or vascular surgery\n\nExclusion Criteria:\n\n* \\\u003C18 years\n* Underlying chronic respiratory disease\n* Patients not able to give informed consent","100 Years",{"count":446,"type":21},160,"This study aims at determining whether diaphragm ultrasound examining diaphragm thickening fraction, excursion and density before and after surgery can predict respiratory complications in the postoperative period.\n\nPatients scheduled for major elective abdominal, pelvic or vascular surgery will be included in the study and diaphragm ultrasound is performed before surgery and after surgery in the postoperative ward. Physiological parameters, laboratory parameters, data on surgery and anesthesia and comorbidities will be registered. Complications such as pneumonia, desaturation, need for intubation and other respiratory events up to 30 days will be registered and later correlated with the diaphragm measurements.",[449,450,451,452,453],"Respiratory Insufficiency","Pneumonia","Desaturation of Blood","Tachypnea","Atelectasis, Postoperative",[455,456,457,450,458],"Diaphragm dysfunction","Postoperative complication","Respiratory complication","Respiratory insufficiency","2025-01-27",{"date":461,"type":33},"2025-01-29",{"date":463,"type":33},"2024-09-01",{"date":465,"type":21},"2027-09-01",{"name":39,"class":40},2,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":148,"enrollmentInfo":476,"targetDuration":4,"studyType":53,"phases":478,"briefSummary":479,"conditions":480,"keywords":485,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":4},"100562278","achilles-tendon-rupture---intervention-with-electrical-stimulation-100562278","NCT06601088","Achilles Tendon Rupture - Intervention With Electrical Stimulation","Acute Achilles Tendon Rupture - Intervention With Neuromuscular Electrical Stimulation","C-NMES-ATR","Inclusion Criteria:\n\n* Diagnosed with acute unilateral Achilles tendon rupture\n* Included within 10 days after injury.\n\nExclusion Criteria:\n\n* Inability to give consent to participate,\n* ongoing treatment with anticoagulants,\n* known allergy to contrast agents,\n* planned follow-up at another hospital,\n* inability to follow instructions,\n* known renal failure,\n* heart failure with pitting edema,\n* thrombophlebitis,\n* thromboembolic disease within the last 3 months,\n* previous surgery of the tendon,\n* known malignancy,\n* hemophilia,\n* pregnancy,\n* treatment with high doses of acetylsalicylic acid.",{"count":477,"type":21},220,[55],"Acute Achilles tendon rupture (ATR) is an injury that is commonly associated with complications, such as blood clotting, muscle loss and tendon lengthening, all of which affect the long-term outcome and return to sports. These complication are related to the treatment of ATR with lower leg immobilization in a boot.\n\nThe investigators aim to demonstrate that an intervention with calf neuromuscular electrical stimulation (C-NMES) during leg immobilization after ATR can 1) reduce blood clots, 2) lower the degree of muscle loss, 3) decrease tendon lengthening and 4) improve long-term outcome.",[481,482,483,484],"Achilles Tendon Ruptures","Immobilization","Venous Thromboembolism (VTE)","Muscle Atrophy",[486,487],"neuromuscular electrical stimulation","duplex ultrasound","2024-09-15",{"date":490,"type":33},"2024-09-19",{"date":492,"type":21},"2025-01-15",{"date":494,"type":21},"2026-12-30",{"name":39,"class":40},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":505,"conditions":506,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":41},"100549558","responders-and-non-responders-in-the-management-of-heart-failure---significance-of-genetic-influence-and-identification-of-novel-informative-biomarkers-100549558","NCT06435585","Responders and Non-responders in the Management of Heart Failure - Significance of Genetic Influence and Identification of Novel Informative Biomarkers","Responders","Inclusion Criteria:\n\n1. Written informed consent\n2. Heart failure defined by symptoms and signs of heart failure as judged by the local investigator\n3. Registered in SwedeHF\n\nExclusion Criteria:\n\n1. Plasma donation within 1 month of enrolment or any blood donation\u002Fblood loss \\>500 mL during the 3 months prior to enrolment\n2. Previous allogeneic bone marrow transplant (genetics)\n3. In the opinion of the investigator, condition\u002Fs that may either put the patient at risk on participation or influence the results or the patient's ability to participate in the study.",{"count":504,"type":21},5000,"A biobank within the Swedish national heart failure quality registry SwedeHF.",[507,508],"Heart Failure","Pathophysiology","2024-05-24",{"date":511,"type":33},"2024-05-30",{"date":513,"type":33},"2021-02-17",{"date":515,"type":21},"2030-12-31",{"name":39,"class":40},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":53,"phases":528,"briefSummary":529,"conditions":530,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":41},"100537490","resection-or-ablation-of-small-kidney-tumors-100537490","NCT06278506","Resection or Ablation of Small Kidney Tumors","Resection or Ablative Treatment of Small Renal Tumors, a Multicenter Randomized Clinical Trial","RESTART","Inclusion Criteria:\n\n* Age 18 - 99 years\n* Patient suitable based on clinical status for both ablative treatment and surgery\n* Primary kidney tumor\n* Tumor size ≤ 3 cm\n* Clinical stage of the tumor T1a (no macroscopic vascular or extrarenal invasion)\n* Tumor location suitable for both ablative treatment and resection\n* Absence of radiological signs of metastasis\n* Biopsy with malignant pathological analysis (PAD)\n* ISUP grade I-III\"\n\nExclusion Criteria:\n\n* Radiological signs of metastasis\n* Synchronous kidney tumors\n* ISUP grade IV or sarcomatoid growth in the biopsy\n* Other metastasized cancer in the last 5 years\n* Patient unable to make an informed decision to participate in the study","99 Years",{"count":527,"type":21},300,[55],"Ablative treatments are believed to have a lower rate of complications, shorter hospital stays, and fewer interventions with benign PAD compared to partial nephrectomies in small kidney cancer lesions. The purpose of the study is to compare complications, the frequency of residual tumors, impact on kidney function, differences in quality of life, and health economic factors in a randomised study. We will also compare the oncological outcomes, including survival and recurrence of kidney cancer.",[531],"Kidney Cancer","2024-02-19",{"date":534,"type":33},"2024-02-26",{"date":536,"type":33},"2024-01-31",{"date":538,"type":21},"2037-12",{"name":39,"class":40},{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":548,"enrollmentInfo":549,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":4},"100534709","coagulopathy-in-childhood-acute-lymphoblastic-leukaemia-100534709","NCT06242353","Coagulopathy in Childhood Acute Lymphoblastic Leukaemia","Coagulopathy in Childhood Acute Lymphoblastic Leukaemia, Underlying Mechanisms and Ways to Optimise Treatment","CoagCALL","Inclusion Criteria:\n\n* Diagnosis of Acute Lymphoblastic Leukaemia (ALL) in Sweden\n* Age 1-17.99 years at diagnosis\n* Planned\u002FInitiated treatment for ALL according to the ALLTogether1 protocol\n* Signed informed consent from parents and patients (from 12 years - voluntary if \\\u003C15 years)\n\nExclusion Criteria:\n\n* Other underlying diseases which according to examiner's clinical assessment may increase the risk of bleeding or thrombosis and which are expected to lead to adaption of the therapy protocol for ALL (e g APS, moderate\u002Fsevere v Willebrand disease, haemophilia)\n* Patient not treated according to the ALLTogether1 protocol (including patients with BCR::ABL1, mixed phenotype acute leukaemia - MPAL)","17 Years",{"count":550,"type":21},100,"The goal of this study is to investigate the hemostatic balance in children with acute lymphoblastic leukaemia (ALL) treated according to the ALLTogether1 protocol with focus on the early treatment period including concomitant use of steroids and asparaginase.\n\nThe investigators aim to determine if complement proteins or microparticles can be used as clinically relevant predictive or diagnostic biomarkers for thrombosis and if global hemostatic assays can predict bleeding or thrombosis. Characterization of proteins connected to hemostasis before and during ALL treatment may provide pathophysiological insights regarding ALL- and treatment related coagulopathy. The ultimate goal of the study is to minimize the morbidity and mortality related to thrombosis and bleeding complications in children with ALL.\n\nSeveral pediatric oncology centers in Sweden will be participating in this study, which will enroll approximately 100 pediatric patients.",[553,554,555,556],"Acute Lymphoblastic Leukemia","Thrombosis","Bleeding","Hemostatic Disorder","2024-02-02",{"date":559,"type":33},"2024-02-05",{"date":561,"type":21},"2024-03-01",{"date":563,"type":21},"2028-11",{"name":39,"class":40},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":53,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":41},"100499855","phase-2-a-study-using-subject-specific-mrd-to-adopt-treatment-after-hsct-for-subjects-with-mds-100499855","NCT05788679","A Study Using Subject-specific MRD to Adopt Treatment After HSCT for Subjects With MDS","A Phase II Multicenter Single-armed Study Using Subject-specific Minimal Residual Disease Markers to Adopt Treatment After Allogeneic Stem Cell Transplantation for Subjects With Myelodysplastic Syndrome","Inclusion Criteria:\n\nSigned informed consent\n\n* Age ≥ 18 years\n* Subjects eligible for SCT\n* Subjects having the disease MDS, mixed myelodysplastic\u002Fmyeloproliferative syndrome or AML with myelodysplasia related dysplasia and 20-29% marrow blasts\n* All female subjects of childbearing potential have to have negative pregnancy test within 2 weeks prior to inclusion to the study\n\nExclusion Criteria:\n\n* No traceable genetic aberration identified either in screening next generation sequencing panel or next generation sequencing panel performed at diagnosis\n* Uncontrolled hypertension, heart, liver, kidney related or other uncontrolled medical or psychiatric disorders\n* Mental inability, reluctance or language difficulties that results in difficulty understanding the meaning of study participation",{"count":573,"type":21},200,[222],"The goal of this interventional study is to evaluate if pre-emptive intervention using Azacitidine and \u002F or donor lymphocytes or tapering of immune suppression in measurable residual disease (MRD) positive subjects can prevent clinical relapse. Participants will undergo MRD surveillance and be subjected to intervention in case of MRD positivity. Results will be compared with NMDSG14B, part one, in which MRD was analyzed in included patients without recieving intervention.",[577,578,579],"Myelodysplastic Syndromes","Acute Myeloid Leukemia With Myelodysplasia Related Disease and \u003C 30% Blasts","Mixed Myelodysplastic\u002FMyeloproliferative Disease","2023-12-04",{"date":582,"type":33},"2023-12-05",{"date":584,"type":33},"2022-11-22",{"date":586,"type":21},"2026-12",{"name":39,"class":40},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":118,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":53,"phases":598,"briefSummary":599,"conditions":600,"keywords":604,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":41},"100494886","alectinib-followed-by-concomitant-consolidation-radiation-therapy-in-advanced-nsclc-with-alk-rearrangement-a-sab-100494886","NCT05724004","Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)","A-SAB - Alectinib Followed by Concomitant Consolidation SBRT\u002FHypofractionated Radiation Therapy\u002FSRS in Advanced NSCLC With ALK-rearrangement","A-SAB","Inclusion Criteria:\n\n1. Histological or cytological confirmed NSCLC:\n\n   * Stage IV NSCLC OR\n   * Stage III NSCLC not suitable for surgery or radiochemotherapy OR\n   * Recurrent NSCLC after previous surgery (not amendable for curative multimodal therapy)\n2. ALK-rearrangement\n3. Adequate organ function to tolerate alectinib and clinical tolerance to alectinib\n4. Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib\n5. Maximum 5 tumour lesions +\u002F- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib\n6. All active tumour lesions amendable to RT under the following conditions:\n\n   * All metastases possible to treat with\n\n     * Extracranial metastases: SBRT of at least 7 Gy x 5 (corresponding to 50 Gy EQD2 using alfa\u002Fbeta 10Gy)\n     * Intracranial metastases: SRS or f-SRS\n   * The primary tumour and\u002For lymph nodes and\u002For pulmonary metastases amendable to SBRT (≥ 7Gy x 5, see above) or moderately hypofractionated RT of 3 Gy x 15 (corresponding to 49 Gy EQD2 using alfa\u002Fbeta 10Gy)\n7. Adequate organ function to tolerate SBRT\u002FRT:\n\n   * Fulfilment of dose constraints to adequate organs at risk\n8. ECOG performance status (PS) 0-2\n9. FEV1 ≥1 litre (only applicable for lung targets)\n10. Age ≥ 20 years\n11. Measurable lesions according to RECIST v 1.1\n12. Signed written informed consent\n\nExclusion Criteria:\n\n1. Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))\n2. Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction treatment\n3. PD after 2-3-month-induction treatment with alectinib\n4. Previous TKI, chemotherapy or immunotherapy (previous adjuvant chemotherapy for early stage NSCLC is allowed) for metastatic NSCLC\n5. Previous RT for NSCLC (any stage)\n6. Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study\n7. Life expectancy of less than 6 months\n8. Inability to understand given information or undergo study procedures according to protocol.\n9. Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis.\n10. Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.",{"count":597,"type":21},70,[55],"The goal of this clinical trial is to learn evaluate the safety and efficacy of the addition of radiation therapy to all tumour lesions, to first line medical treatment with alectinib in non-small cell lung cancer harbouring ALK-rearrangements.\n\nThe main aims of the trial are to evaluate:\n\n* if the treatment combination is safe\n* if the treatment combination can inhibit progression\n\nParticipants who have responded to 1st line alectinib will be treated with consolidation radiation therapy to all remaining tumour lesions while continuing on alectinib until disease progression, unacceptable toxicity or another discontinuation criterion is met.",[601,602,603],"Radiotherapy Side Effect","Non-small Cell Lung Cancer","ALK Gene Mutation",[605,407,606,602,607],"Stereotactic body radiation therapy","Radiotherapy","ALK-rearrangement","2023-10-06",{"date":610,"type":33},"2023-10-10",{"date":612,"type":33},"2023-10-05",{"date":614,"type":21},"2031-06-20",{"name":39,"class":40},{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":623,"targetDuration":4,"studyType":53,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":634,"locationsCount":41},"100443989","instructed-home-based-physical-exercise-for-patients-with-liver-cirrhosis-100443989","NCT05061576","Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis","INSPEL","Inclusion Criteria:\n\n* Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly \\>12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.6.\n* MELD \\\u003C 25\n* Understanding the Swedish language.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Performance status ≥3.\n* Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.\n* Previously liver transplanted\n* Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.",{"count":550,"type":21},[55],"The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.",[627],"Liver Cirrhosis","2023-10-02",{"date":630,"type":33},"2023-10-04",{"date":632,"type":33},"2022-08-16",{"date":306,"type":21},{"name":39,"class":40},{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":645,"conditions":646,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":648,"lastUpdatePostDateStruct":649,"startDateStruct":651,"completionDateStruct":652,"leadSponsor":654,"locationsCount":41},"100520014","study-to-evaluate-efficacy-safety-and-biomarkers-of-bulevirtide-treatment-in-chronic-hepatitis-d-patients-100520014","NCT06051045","Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients","Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients With Chronic Hepatitis D","SEE-D","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Diagnosis of chronic HBV\u002FHDV co-infection.\n3. Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation as ascites, variceal bleeding and hepatic encephalopathy allowed).\n4. Have indication for treatment of BLV, or already treated with BLV.\n5. For female\\* participants:\n\n   1. Postmenopausal for at least one year, or\n   2. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or\n   3. Abstinence from heterosexual intercourse throughout the treatment period, or\n   4. Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.\n6. Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after last dose of the drugs in the study.\n7. Participants who are willing to give written informed consent\n\nExclusion Criteria:\n\n1. Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.\n2. Pregnant or breast-feeding women.\n3. Patients with predictable difficulties of follow-up according to the investigator.\n4. Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.",{"count":644,"type":21},400,"The aim is to assess the efficacy and specific safety in an observational study of patients with Chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +\u002F- PEG-IFNα-2a and +\u002F- NA given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and\u002For intrahepatic markers\u002Fsignatures, and quality of life outcomes will be assessed.",[647],"Chronic Hepatitis D","2023-09-27",{"date":650,"type":33},"2023-09-29",{"date":648,"type":33},{"date":653,"type":21},"2033-03",{"name":39,"class":40},""]