[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Odense University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":723},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,47,81,107,134,168,198,234,262,297,334,359,383,404,435,465,485,510,536,559,590,614,642,667,695],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100651277","phase-2-teclistamab-in-combination-with-pomalidomide-administered-in-alternative-fashion-in-participants-with-relapsed-or-refractory-multiple-myeloma-100651277",false,"NCT07757412","Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With Relapsed or Refractory Multiple Myeloma.","A Phase II, Open-label, Multicenter Study Testing Teclistamab in Combination With Pomalidomide Administered in Alternative Fashion in Participants With RRMM, Who Received 1 - 3 Prior Lines of Therapy, Including Lenalidomide and Anti-CD38 Therapy.","ADAPTATION","Inclusion Criteria:\n\n1. ≥18 years of age (or the legal age of majority, if greater than 18, in the jurisdiction in which the study is taking place) at the time of informed consent.\n2. Documented diagnosis of multiple myeloma as defined by the criteria below:\n\n   1. Multiple myeloma diagnosis according to IMWG diagnostic criteria.\n   2. Measurable disease at screening as defined by any of the following:\n\n      1. Serum M-protein level ≥0.5 g\u002FdL; or Serum Ig FLC ≥10 mg\u002FdL and abnormal serum Ig kappa lambda FLC ratio.\n3. Relapsed or refractory disease as defined below : a. Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by IMWG criteria \\>60 days after cessation of treatment. b. Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria during previous treatment or ≤60 days after cessation of treatment.\n4. Received 1-3 prior lines of antimyeloma therapy including a minimum of 2 consecutive cycles of an anti-CD38 monoclonal antibody at the approved dosing schedule (or minimum of 6 doses if anti-CD38 monoclonal antibody was only part of a maintenance regimen) in any prior line and 2 consecutive cycles of lenalidomide in any prior line. NOTE: A single line of therapy may consist of 1 or more agents and may include induction, hematopoietic stem cell transplantation and maintenance therapy. Radiotherapy, bisphosphonates, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg\u002Fday for 4 days) would not be considered prior lines of therapy.\n5. Documented evidence of progressive disease or failure to achieve a response to last line of therapy based on investigator's determination of response by IMWG criteria.\n6. Have an ECOG performance status score of 0 to 2\n7. Have clinical laboratory values meeting the protocol criteria during the Screening Phase.\n8. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test within 14 days prior to first dose and again a negative serum pregnancy test within 24 hours of the start of study treatment and must agree to further serum pregnancy tests during the study.\n9. A female participant must be either of the following a. Not of childbearing potential, or b. Of childbearing potential and practicing at least 1 highly effective method of contraception.\n10. A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for a period of 6 months after\n11. A male participant must wear a condom (with or without spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 3 months after receiving the last dose of study treatment. If a male participant's partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception.\n12. A male participant must agree not to donate sperm for the purpose of reproduction during the study and a period of 3 months after receiving the last dose of study treatment. Male participants should consider preservation of sperm prior to study treatment as anti-cancer treatments may impair fertility.\n13. Must sign an ICF (or their legally designated representative must sign in accordance with local legislation) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n14. Must be willing and able to adhere to the lifestyle restrictions specified in this protocol.\n\nExclusion Criteria:\n\nAny potential participant who meets any of the following criteria will be excluded from participating in the study:\n\n1. Received any prior BCMA-directed therapy.\n2. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients (refer to the teclistamab IB and appropriate prescribing information).\n3. Participants will be excluded if intolerant to dexamethasone.\n4. Received the following prior antimyeloma therapy, within the specified time frame prior to enrollment:\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less\n   2. Investigational vaccine within 4 weeks\n   3. Monoclonal antibody therapy within 21 days\n   4. Cytotoxic therapy within 21 days\n   5. PI therapy within 14 days\n   6. IMiD agent therapy within 14 days\n   7. Radiotherapy within 14 days or focal radiation within 7 days\n   8. Gene-modified adoptive cell therapy (eg, chimeric antigen receptor modified T cells, NK cells) within 3 months\n   9. Plasmapheresis within 28 days\n   10. Received a maximum cumulative dose of corticosteroids of ≥140 mg of prednisone or equivalent within 14 days\n   11. Stem cell transplant within 6 months. Participants who received an\n5. Received a live, attenuated vaccine within 4 weeks of enrollment or if participant plans to receive such vaccines during the study. Non-live or non replicating vaccines authorized for emergency use are allowed.\n6. CNS involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain MRI and lumbar cytology may be required.\n7. Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary amyloid light chain amyloidosis.\n8. Excluded for any of the following:\n\n   1. Any ongoing myelodysplastic syndrome.\n   2. Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy.\n   3. Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured: Non-muscle invasive bladder cancer (solitary Ta-PUNLMP or low grade, \\\u003C3 cm, no CIS), Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.,Non-invasive cervical cancer, Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer (anti-hormonal therapy is permitted), Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP\u002FRT\u002Ffocal treatment), Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor.\n9. Stroke, transient ischemic attack, or seizure within 6 months prior to enrollment.\n10. Presence of the following cardiac conditions.\n\n    a. Unstable angina or New York Heart Association class III or IV congestive heart failure, b. Myocardial infarction or coronary artery bypass graft ≤6 months prior to enrollment,c. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration, d. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, e. TTE or MUGA scan showing left ventricular ejection fraction \\\u003C40%\n11. Participant had major surgery or had significant traumatic injury within 2 weeks prior to enrollment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study.\n\n    NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate sponsor representative and resolve any issues before enrolling a participant in the study.\n12. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or constitute a hazard for participating in the study (ie, those listed below) or any others that in the opinion of the investigator would constitute a hazard for participating in this study, such as: a. Acute diffuse infiltrative pulmonary disease or diagnosis of pulmonary hypertension. b. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy.\n\n    c. Active autoimmune disease requiring systemic immunosuppressive therapy within 6 months before start of study treatment. Exception: Participants with vitiligo. controlled type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed. Eligibility for participants with any other autoimmune disease(s) should be discussed with the medical monitor\u002Fsponsor. d. Disabling psychiatric conditions (eg, alcohol or drug abuse), severe dementia, or altered mental status. e. History of non-compliance with recommended medical treatments. f. Intolerance to hydration due to pre-existing pulmonary or cardiac impairment. g. Pleural effusions requiring thoracentesis within 14 days prior to enrollment. Ascites requiring paracentesis within 14 days prior to enrollment.\n13. Seropositive for hepatitis B: defined by a positive test for HbsAg. Participants with resolved infection (ie, participants who are HbsAg negative with antibodies to total anti-HBc with or without the presence of anti-HBs) must be screened using RT-PCR measurement of HBV-DNA levels. Participants with a known history of HBV infection must be screened using RT-PCR measurement of HBV-DNA levels irrespective of serological results. Those who have detectable HBV-DNA levels by RT-PCR will be excluded. Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV-DNA by RT-PCR.\n14. Active hepatitis C infection as measured by detectable HCV-RNA testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic hepatitis C infection (defined as both HCV antibody and HCV-RNA positive) completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study.\n15. Human immunodeficiency virus-positive with 1 or more of the following:\n\n    1. History of AIDS-defining conditions\n    2. CD4+ count \\\u003C350 cells\u002Fmm3 during screening\n    3. Detectable viral load during screening or within 6 months prior to screening\n    4. Not receiving highly active antiretroviral therapy\n    5. Had a change in antiretroviral therapy within 6 months of the start of screening\n    6. Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the sponsor.\n16. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.","ALL","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This Phase II, open-label, multicenter study will evaluate teclistamab in combination with pomalidomide administered using an alternative dosing approach in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy, including lenalidomide and anti-CD38 therapy. Teclistamab is a bispecific antibody that targets BCMA on myeloma cells and CD3 on T cells, bringing these cells into close proximity and activating T cells to induce targeted killing of BCMA-expressing myeloma cells. The study will assess the safety and efficacy of this treatment combination in participants with relapsed or refractory multiple myeloma.",[28],"Multiple Myeloma Progression",[30,31,32,33],"Multiple myeloma","Teclistamab","Pomalidomid","T-cell-engaging bispecific antibody","NOT_YET_RECRUITING","2026-08-07",{"date":37,"type":38},"2026-08-11","ACTUAL",{"date":40,"type":22},"2026-09-01",{"date":42,"type":22},"2032-01-01",{"name":44,"class":45},"Odense University Hospital","OTHER",9,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":55,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100649322","phase-1-normethermic-intraperitoneal-chemotherapy---a-novel-concept-for-local-treatment-of-the-elderly-and-fragile-women-with-advanced-ovarian-cancer-100649322","NCT07733505","Normethermic Intraperitoneal Chemotherapy - a Novel Concept for Local Treatment of the Elderly and Fragile Women With Advanced Ovarian Cancer?","Normothermic Intraperitoneal Chemotherapy (NIPEC) With Carboplatin Following Cytoreductive Surgery in Elderly and Frail Ovarian Cancer Patients: a Feasibility Study.","NICE-C","Inclusion Criteria:\n\n* Signed informed consent.\n* Patient capability of giving informed consent.\n* Age ≥ 70 years.\n* Women diagnosed with epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer FIGO stage III-IV with planned interval cytoreductive surgery. Stage IV patients will only be included if they have resectable metastases within the abdominal cavity and\u002For abdominal wall or if they have complete remission of extra-abdominal metastases after three series of neoadjuvant chemotherapy.\n* Performance status 1-3.\n* American Society of Anaesthesiologists (ASA) scores I-III.\n* Normal preoperative kidney, liver and bone marrow function (according to the CTCAE v.5.0): Normal kidney function definition: eGFR or GFR ≥ 60 ml\u002Fmin. Normal liver function: ALAT and\u002FOR ASAT ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 ×ULN. Normal bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 75 × 10⁹\u002FL; Haemoglobin level ≥ 6 mmol\u002FL;\n* Completeness of cytoreduction to less than 2.5 mm.\n* Demographically belonging to Region of Southern Denmark.\n\nExclusion Criteria:\n\n* Progression of disease during NACT.\n* Intrabdominal metastases not resectable upon NACT.\n* Former history of breast cancer or other malignancies within 5 years before inclusion, except from non-melanomatous skin cancer.\n* Contradictions to receive carboplatin according to the SmPC (the medical oncologist makes the decision): Drug allergy (active drug or components); Severe myelosuppression; Severe kidney deficiency (creatinin clearance ≤ 30 ml\u002Fmin); Bleeding tumours; Concurrent usage of vaccination against yellow fever; Severe allergic reaction to other platinum compounds in the medical history.","FEMALE","70 Years",{"count":58,"type":22},10,[60],"PHASE1","The purpose of this feasibility study is to investigate whether NIPEC with carboplatin after surgery is safe for the elderly and frail women with advanced ovarian cancer.\n\nTo achieve this, women with advanced ovarian cancer who receive surgery followed by NIPEC will be closely monitored in the period after treatment. We will assess complications, side effects, recovery after surgery and NIPEC, and whether standard chemotherapy can be started on time and completed as planned.\n\nIn addition, participants will be followed for six months using questionnaires and interviews to evaluate patient-reported outcomes, including quality of life.\n\nIn the more technical assessment of NIPEC, carboplatin tissue pharmacokinetics and inflammatory responses during and after NIPEC will be analysed using microdialysis and histology.",[63],"Ovarian Cancer",[65,66,67,68,69,70],"Ovarian cancer","Normothermic Intraperitoneal Chemotherapy","NIPEC","Elderly and frail patients","Intraperitoneal tissue pharmacokinetics","Intraperitoneal tissue responses","RECRUITING","2026-07-28",{"date":74,"type":38},"2026-07-29",{"date":76,"type":38},"2026-06-16",{"date":78,"type":22},"2028-05-01",{"name":44,"class":45},1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":23,"phases":91,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":80},"100468520","sacral-neuromodulation-for-neurogenic-lower-urinary-tract-bowel-and-sexual-dysfunction-100468520","NCT05380856","Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction","Sacral Neuromodulation for Patients With Multiple Sclerosis With Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction. A Multicenter Double-blind, Placebo-controlled Randomized Clinical Trial.","Inclusion Criteria:\n\n* Refractory neurogenic lower urinary tract dysfunction (nLUTD) defined by visual analogue scale on treatment satisfaction ranging from 0 to 100 (100 means maximal satisfaction with the current treatment). All patients indicating satisfaction less than 50 are considered non-responders\u002Fhaving refractory overactive bladder (OAB) to current treatment\n* No effect of medical treatment defined by antimuscarinics, beta3-agonist and alpha-blocker.\n* Patients having refractory nLUTD who intend to try SNM for relief of their symptoms\n* Expanded Disability Status Scale (EDSS) \\\u003C 5 and no progression of neurological disease within 6 months\n* Written informed consent\n* Able to understand the information given about the project\n\nExclusion Criteria:\n\n* EDSS \\> 5, neurological disease with severe progression within the last 6 months and\u002For unable to manage the electronic devices\n* Age \\\u003C 18 years\n* Any other urological pathology but nLUTD\n* Bladder Pain Syndrome\u002FInterstitial cystitis\n* Any other intestinal or gynecological pathology but neurological conditional symptoms\n* Current pelvic malignancy or clinically significant pelvic mass\n* Previous pelvis radiotherapy\n* Bladder injections with botulinum neurotoxin type A within 6 months before inclusion in trial\n* Unable to manage the electronic devices\n* Inability to give an informed consent","80 Years",{"count":90,"type":22},60,[92],"NA","A multi-center double-blinded placebo-controlled randomized clinical trial.\n\nThe patients will be randomized into two groups.\n\nTo investigate the efficacy of SNM to improve the key bladder diary variables compared to placebo (i.e. sham) for patients with MS having refractory neurogenic lower urinary tract dysfunction (NLUTD).\n\nAfter first step SNM-procedure and a 3-4 weeks test period patients with more than 50% improvement in the key bladder diary variables will have the IPG implanted. After a month of optimization patients will into two groups: IPG ON or IPG OFF.\n\nPeriod of randomization: four months. Number anticipated to be included: 60 patients",[95,96,97,98,99,100],"Neurogenic Dysfunction of the Urinary Bladder","Multiple Sclerosis","Sacral Neuromodulation","Bowel Dysfunction","Sexual Dysfunction","Quality of Life",{"date":74,"type":38},{"date":103,"type":38},"2023-09-26",{"date":105,"type":22},"2027-03-01",{"name":44,"class":45},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100646496","monitoring-mrd-in-multiple-myeloma-in-serum-by-mass-spectrometry-100646496","NCT07691034","Monitoring MRD in Multiple Myeloma in Serum by Mass Spectrometry","Monitoring Minimal Residual Disease in Multiple Myeloma in Serum by Mass Spectrometry","Inclusion Criteria:\n\n* Multiple Myeloma patients in sCR for more than 6 months\n* Diagnostic bone marrow and blood\u002Fserum material biobanked at diagnosis according to established diagnostic biobank\n* Informed, written consent\n\nExclusion Criteria:\n\n* Phychiatric disease or other condition where the subject may be non-compliant\n* Not able to read and understand Danish language\n* Bleeding disorder, thrombocyte counts below 20 mia\u002FL",{"count":115,"type":22},40,"OBSERVATIONAL","Multiple myeloma (MM) is a severe plasma cell cancer caused by proliferation and accumulation of malignant plasma cells in the bone marrow. Novel therapies have improved responses and survival considerably. Recently, it was shown that achieved and sustained minimal residual disease (MRD) negativity is the best predictor for long-term disease-free and overall survival. Achieving and maintaining MRD negativity will therefore be the new treatment goal for patients with MM. Two methods are established for MRD analysis; next-generation flowcytometry (NGF), e.g., the Euro-MRD flow assay, and next-generation sequencing (NGS), e.g., the ClonoSeq assay. Both methods are highly sensitive, with 10\\^-5 as the standard goal, and currently reaching for 10\\^-6. Both methods are based on bone marrow sampling, which is inconvenient and painful for the patients, particularly for serial analyses.\n\nBlood-based MRD analyses of high sensitivity would allow more frequent sampling and monitoring. Methods based on circulating free tumor DNA are found to have rather low sensitivity. Mass spectrometry (MS) based analysis of patient-specific M-protein is another potential candidate for sensitive and specific monitoring of patients in deep remission. This method is under development, e.g., at the Mayo Clinic, USA, but is not fully standardized. No commercial assays have been approved.\n\nThe investigators will assess and validate the sensitivity of MS-based MRD analyses in monitoring patients with MM in remission. Reproducibility and quality controls will be performed in collaboration with an international partner. The investigators will compare the sensitivity of MS-based analysis with Euro-flow MRD assay and NGS LymphoTrack assay, both performed on bone marrow aspirates. Prospectively, the investigators will monitor a cohort of 40 patients in stringent, complete remission. Imaging by FDG-PET\u002FCT (fluoro-deoxyglucose (FDG) positron-emission tomography (PET) combined with computerized tomography (CT)) is part of MRD assessment according to the International Myeloma Working Group (IMWG) and will be included in our studies.\n\nEstablishing a blood based MRD analysis will potentially not only be more convenient, it may, in some patients, be more sensitive. The blood reflects disease status in the whole body, whereas bone marrow sampling only allows examining what is present at this particular site. MRD in MM may be patchily located in the skeleton, highlighting the relevance of including FDG PET\u002FCT in the assessment.",[119,120],"Multiple Myeloma","Minimal Residual Disease",[120,122,123,124,125],"Mass Spectrometry","Flowcytometry","Next Generation Sequencing","Remission","2026-07-06",{"date":128,"type":38},"2026-07-08",{"date":130,"type":22},"2026-08-04",{"date":132,"type":22},"2035-06",{"name":44,"class":45},{"id":135,"slug":136,"hasResults":12,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":144,"briefSummary":145,"conditions":146,"keywords":153,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},"100645401","phase-2-sglt2i-effect-on-ptdm-development-and-kidney-allograft-function-in-non-diabetic-kidney-transplant-recipients-a-randomized-doubleblind-placebo-controlled-national-multicenter-trial-100645401","NCT07682350","SGLT2i Effect on PTDM Development and Kidney Allograft Function in Non-diabetic Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM: SGLT2i Effect on PTDM Development and Kidney Allograft Function in Kidney Transplant Recipients: A Randomized, Doubleblind, Placebo Controlled, National Multicenter Trial","SGL-TX-PTDM","Inclusion Criteria:\n\n* Obtained written informed consent\n* Male or female patients, age ≥ 18 years.\n* Non-diabetic KTR\n* Immunosuppressive must include Tacrolimus\n\nExclusion Criteria:\n\n* Patients who is treated (diet or antidiabetics) for diabetes type 1 or 2 before randomization\n* eGFR\\\u003C 25 ml\u002Fmin\u002F1.73m2 (before randomization)\n* Alanine aminotransferase (ALAT) \\> 3 x upper normal limit\n* Bilirubin \\> 2 x upper normal limit\n* Pregnancy\n* Positive plasma hCG\n* Breastfeeding\n* Known allergy towards SGLT2i or the content substance\n* Patients with chronic intestinal diseases, including inflammatory bowel diseases (e.g., Crohn's disease and ulcerative colitis) and structural conditions such as short bowel syndrome.",{"count":143,"type":22},184,[25],"The goal of this clinical trial is to find out whether 12 months of treatment with the SGLT2 inhibitor Forxiga® (dapagliflozin 10 mg once daily), compared with placebo, can reduce the risk of developing post-transplant diabetes in kidney transplant recipients who do not have diabetes at the time of transplantation.\n\nThe main questions it aims to answer are:\n\n* Does Forxiga reduce the risk of developing post-transplant diabetes and prediabetes compared with placebo?\n* Does Forxiga help preserve the function of the transplanted kidney compared with placebo?\n* Is Forxiga safe for kidney transplant recipients who do not have diabetes?\n* Does Forxiga affect the occurrence of urinary tract infections, the amount of protein in the urine, and other kidney- and heart-related health measures compared with placebo?\n\nResearchers will compare Forxiga with a placebo (a look-alike tablet containing no active medicine) to see whether it can reduce the risk of post-transplant diabetes while maintaining kidney function and remaining safe to use.\n\nAdults who have recently received a kidney transplant and do not have diabetes may take part if they meet the study requirements.\n\nParticipants will be randomly assigned to receive either Forxiga or placebo once daily for 12 months. They will attend study visits 3, 6, and 12 months after joining the study. These visits will include health checks, blood tests, and urine tests. Neither the participants nor the study doctors will know which treatment each participant is receiving.",[147,148,149,150,151,152],"Kidney Transplant Recipient","Sodium Glucose Co-Transporter 2 Inhibitors","Non-Diabetic Patients","Randomized Controlled Trial (RCT)","Placebo Control Design","Post Transplant Diabetes Mellitus",[154,155,156,157,158,159,140],"SGLT2i","Kidney Transplant","Kidney Transplant Recipients","non-diabetic patients","Sodium-glucose Transporter 2 inhibitors","RCT","2026-06-26",{"date":162,"type":38},"2026-07-02",{"date":40,"type":22},{"date":165,"type":22},"2029-10-01",{"name":44,"class":45},3,{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":177,"conditions":178,"keywords":185,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},"100644570","assessment-of-hysteroscopy-skills-with-a-new-assessment-tool-100644570","NCT07672288","Assessment of Hysteroscopy Skills With a New Assessment Tool","Assessment of Hysteroscopy Skills in an International Multicenter Trial - Gathering Validity Evidence for a Hysteroscopy Assessment Tool","Inclusion Criteria:\n\n* Medical doctors performing hysteroscopy\n* Novices during residency with no experience but permission to operate, and who rely on supervison\n* Experienced doctors with \\> 50 procedures\n* Assessment is done on procedures that are already planned. The evaluation does not change the treament of the patient in any way.\n\nExclusion Criteria:\n\n* Intermediate experienced doctors\n* If complication arrise during the procedure, evaluation is no longer within the scope of the HYSAT tool.",{"count":176,"type":22},24,"Objective To investigate validity of the hysteroscopy assessment tool (HYSAT) for assessment of competence in a clinical environment.\n\nMethods Novices and experienced gynecologists are recruited from three hospitals and observed and assessed while performing hysteroscopy. Performances are assessed using the HYSAT tool by two independent raters. Validity evidence is gathered in accordance with Messick's framework: validity evidence for content was ensured in previously published Delphi study, response process is ensured by standardization of written rater instructions. Internal structure is explored using Cronbach's alpha for internal consistency reliability; inter-rater reliability and test-retest reliability are calculated as Pearson's r independently across all ratings. Relationship to other variables is investigated by comparing performances of the participants in each group. Consequences evidence is explored by calculating a pass\u002Ffail standard using the contrasting groups' standard setting method.",[179,180,181,182,183,184],"Hysteroscopy","Assessment Methods in Medical Training","Medical Education","Diagnostic Hysteroscopy","Operative Hysteroscopy","Abnormal Uterine Bleeding",[179,186,180,187,188,189],"Medical education","Gynecology","Training","Assessment evaluation","2026-06-23",{"date":160,"type":38},{"date":193,"type":22},"2026-06-22",{"date":195,"type":22},"2026-09-22",{"name":44,"class":45},2,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":206,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},"100585686","phase-3-methylphenidate-in-pediatric-brain-tumor-survivors-with-cancer-related-fatigue-100585686","NCT06905587","Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue","Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial","EMBRAIN","Inclusion Criteria:\n\n1. Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).\n2. Treated for a PBT during the previous 10 years, starting from date of diagnosis.\n3. Aged ≥6 years 0 months at the start of the trial.\n4. Off therapy\u002Factive treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.\n5. No known signs of clinical or radiological tumor progression at last follow-up.\n6. Danish is the sole or primary language (enabling provision of validated assessment tools).\n7. Patient and family have provided consent for inclusion in the trial.\n8. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.\n9. History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.\n\nExclusion Criteria:\n\n1. Any known contraindications to methylphenidate as outlined below:\n\n   A) Hypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B) Glaucoma. C) Pheochromocytoma. D) Hyperthyroidism. E) Mania. F) Psychosis. G) Anorexia nervosa. H) Current or previous severe depression. I) Suicidal behavior. J) Poorly controlled type 1 bipolar affective disorder. K) Antisocial or borderline personality disorder. L) Pre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening cardiac arrhythmias and channelopathies. M) Pre-existing cerebrovascular disease, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. N) Treatment with irreversible MAO inhibitors within the last 14 days and reversible MAO inhibitors within the last 24 hours.\n2. History of recent poorly controlled seizures.\n3. Motor tics or Tourette syndrome (including family history of tic disorder).\n4. Known diagnosis of Attention Deficit\u002FHyperactivity Disorder or Autism Spectrum Disorder.\n5. Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \\\u003C50.\n6. Pregnancy. Participants known to be pregnant or breastfeeding at screening\u002Fregistration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test prior to the start of treatment. Acceptableeffective contraceptive must be used for the duration of the trial. No further testing is needed during trial, unless the participant suspects to have become pregnant.\n7. Concerns about family ability to safely store or administer MPH, or to report side effects appropriately\u002Fconcerns about familial substance abuse.\n8. Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).\n9. Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.","6 Years","27 Years",{"count":21,"type":22},[210],"PHASE3","Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.\n\nThe researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit\u002Fhyperactivity disorder (ADHD).\n\nIf methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.",[213,214,215],"Brain Tumor, Pediatric","Cancer-related Fatigue","Methylphenidate",[217,218,219,220,221,222,223,224,225,226],"methylphenidate","cancer-related fatigue","brain tumor","childhood cancer","pediatric cancer","childhood cancer survivor","late effect","long-term effects secondary to cancer therapy in children","long-term effects of cancer-treatment","pediatric brain tumor",{"date":160,"type":38},{"date":229,"type":38},"2025-09-02",{"date":231,"type":22},"2029-12",{"name":44,"class":45},4,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":23,"phases":242,"briefSummary":243,"conditions":244,"keywords":248,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":80},"100642956","coronary-thrombus-modification-to-prevent-microvascular-damage-in-patients-with-st-segment-elevation-myocardial-infarction-the-cormi-trial-100642956","NCT07646977","CORonary Thrombus Modification to Prevent MIcrovascular Damage in Patients With ST-segment Elevation Myocardial Infarction (The CORMI Trial)","Inclusion Criteria:\n\n* ST-elevation at the J-junction in a minimum of two contiguous ECG leads with a minimum of ≥ 0.1 mV in all leads, except for V2 and V3 (which required ≥ 0.2 for men ≥ 40 years old, ≥ 0.25 in men \\\u003C 40 years old, or ≥ 0.15 mV for all women) or new left bundle branch\n* Admission to hospital within 12 hours of symptom debut\n* Angiographic signs of a culprit lesion planned to be treated with primary percutaneous coronary intervention\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or inability to provide informed consent\n* Life expectancy of \\\u003C 12 months\n* Hemodynamically instability\n* Pregnancy or breastfeeding\n* Known asthma or severe chronic obstructive pulmonary disease\n* Expected inability to perform physiological measurements (due to severely tortuous arteries, ostial disease or very distal disease),\n* CMR contraindications (estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin, magnetic or mechanically activated implants, or any prior metal implants, severe claustrophobia)\n* Expected to or unavoidable to use thrombectomy",{"count":241,"type":22},100,[92],"The aim of this study is to evaluate the effects of coronary thrombus modification on preventing the microvascular damage associated with primary percutaneous coronary intervention (PCI), and to limit the associated myocardial damage assessed by myocardial salvage index after 3 months. Furthermore, the project will evaluate coronary microvascular damage assessed invasively using both continuous and bolus thermodilution before and after stent implantation. In addition, the project will evaluate the diagnostic ability and associations of pre-stenting invasive physiological measurement to cardiac magnetic resonance imaging measurements.",[245,246,247],"ST Elevation Myocardial Infarction","Coronary Microvascular Dysfunction","Percutaneous Coronary Intervention",[249,250,251,252,253],"Microvascular damage","Continuous thermodilution","Bolus thermodilution","Myocardial damage","Cardiac MRI","2026-06-19",{"date":256,"type":38},"2026-06-24",{"date":258,"type":22},"2026-06",{"date":260,"type":22},"2034-01",{"name":44,"class":45},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":56,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":116,"phases":4,"briefSummary":272,"conditions":273,"keywords":278,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":80},"100641778","early-cognitive-changes-after-same-day-discharge-hip-and-knee-arthroplasty-100641778","NCT07598552","Early Cognitive Changes After Same-day Discharge Hip and Knee Arthroplasty","Early Cognitive Changes in Patients Aged 70 Years or Older After Same-day Discharge Hip and Knee Arthroplasty: A Prospective Cohort Study","Inclusion Criteria:\n\n* Unilateral elective primary Total Hip Arthroplasty, Total Knee Arthroplasty, or Unicompartmental Knee\n* Native Danish speaker\n* Spinal anesthesia\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Inability to comply with virtual study procedures or follow-up sessions, including because of visual or hearing impairment\n* Known dementia or other diagnosed cognitive disorders or Brief Assessment of Impaired Cognition (BASIC)≤20\n* Parkinson's disease or other neurological conditions causing functional impairment\n* History of alcohol abuse (≥35 units per week)\n* Daily use of anxiolytics or hypnotics\n* Not discharged on the day of surgery",{"count":270,"type":22},48,"7 Days","The goal of this observational study is to explore early cognitive changes in patients aged 70 years or older undergoing same-day discharge after hip or knee replacement surgery. The main question it aims to answer is:\n\nDoes patients experience cognitive changes in cognitive test performance from before surgery to the first day after surgery?\n\nParticipants will:\n\n* Complete a cognitive test battery virtually about 14 days before surgery, and on the first and seventh day after their operation.\n* Record pain levels and pain medicine use during the first week after surgery",[274,275,276,277],"Postoperative Cognitive Dysfunction (POCD)","Cognitive Change","Total Knee Arthroplasty","Unicompartmental Knee Arthroplasty",[279,280,281,282,283,284,285,286,287,288,289],"Same-day discharge","Fast-track surgery","Hip arthroplasty","Knee arthroplasty","Unicompartmental knee arthroplasty","Cognitive function","SDMT","Stroop test","Verbal fluency","Older adults","recovery","2026-06-17",{"date":193,"type":38},{"date":293,"type":38},"2026-05-18",{"date":295,"type":22},"2026-11-30",{"name":44,"class":45},{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":305,"minAge":19,"maxAge":4,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":314,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":80},"100642127","mr-guided-single-fraction-sbrt-for-nodal-oligorecurrent-prostate-cancer-pinpoint-100642127","NCT07635108","MR-guided Single-fraction SBRT for Nodal Oligorecurrent Prostate Cancer (PINPOINT)","Improved MR-Guided Single-fraction Stereotactic Sblative Radiotherapy in Pelvic and Abdominal Nodal Oliorecurrent Prostate Cancer","PINPOINT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Signed informed consent\n* Histologically proven initial diagnosis of adenocarcinoma of the prostate\n* ECOG performance status 0-2\n* Biochemical recurrence after curatively intended local treatment (radical prostatectomy and\u002For radiotherapy), with PSMA-PET\u002FCT-verified nodal relapse in the pelvis or abdomen\n* Any additional sites of disease beyond the protocol-specified target lymph nodes must be considered suitable for ablative treatment\n* Life expectancy \\> 6 months\n* Lymph node size ≤ 2 cm\n\nExclusion Criteria:\n\n* Medical contraindications to MRI\n* Inability to tolerate the physical set-up required for SABR\n* Overlap between prior radiation fields and the current target area leading to high risk of clinically significant normal-tissue injury\n* Contraindications to pelvic radiotherapy (chronic pelvic inflammatory bowel disease)\n* Uncontrolled intercurrent illness","MALE",{"count":270,"type":22},[92],"This single-arm phase 2 trial investigates whether a single high-dose radiotherapy treatment can safely treat men whose prostate cancer has come back in a small number of lymph nodes in the pelvis or abdomen after curative treatment. Participants receive one fraction of 24 Gy delivered with MR-guided stereotactic body radiotherapy (SBRT), which uses MRI to visualise the tumour and surrounding organs during treatment. The main goal is to assess safety (severe side effects). The trial also evaluates local tumour control, longer-term side effects, time until hormone (androgen deprivation) therapy is needed, survival, and quality of life. The trial aims to enrol 48 patients.",[310,311,312,313],"Prostate Cancer","Oligo-metastatic Prostate Carcinoma","Oligometastatic Cancer","Nodal Oligorecurrent Prostate Cancer",[315,316,317,318,319,320,321,322,323,324,325],"Single-fraction SBRT","Nodal oligorecurrent prostate cancer","MR-guided SBRT","MR-Linac","Stereotactic body radiotherapy","Stereotactic ablative radiotherapy","Single-fraction radiotherapy","Oligometastasis \u002F oligorecurrence","Metastasis-directed therapy","PSMA-PET\u002FCT","Lymph node metastasis","2026-06-11",{"date":328,"type":38},"2026-06-15",{"date":330,"type":22},"2026-06-01",{"date":332,"type":22},"2035-09",{"name":44,"class":45},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":167},"100643428","why-patients-decline-or-are-being-deemed-ineligible-to-receive-home-based-treatment-a-mixed-methods-study-100643428","NCT07634263","Why Patients Decline or Are Being Deemed Ineligible to Receive Home-based Treatment: a Mixed Methods Study","Inclusion Criteria:\n\n* \\>=18 years old\n* diagnosed Multiple Myeloma or acute leukemia, and recieving treatment with either Daratumumab or Cytarabine.\n\nExclusion Criteria:\n\n\\- Dementia, psychotic disorders, or other cognitive impairments limiting participation.","100 Years",{"count":21,"type":22},"Treatment for blood cancers has improved significantly, and more patients are now living longer. However, these treatments are often intensive and long-lasting, and many patients experience serious side effects and symptoms. As more patients require ongoing treatment and long-term care, the demand for haematology services is increasing.\n\nHome-based treatment is expected to play an increasingly important role in the future. It can support more patient-centred care, help patients maintain their everyday lives, improve quality of life, and reduce pressure on hospitals. Despite these benefits, some patients are either not eligible for home-based treatment or choose to decline it. The reasons for this are not yet well understood.\n\nThis study combines quantitative data-such as medical information, sociodemographic characteristics, and questionnaire responses about quality of life and health literacy-with qualitative interviews involving patients, relatives, and healthcare professionals. The aim is to identify barriers and differences between patients, and to better understand why some patients opt out of or are unable to participate in home-based treatment.\n\nThe findings will help support the development of more inclusive and patient-centred care models, ensure more equal access to home-based treatment, and improve support for socially vulnerable patients. The results will be shared with patients and families through patient organisations, with hospitals through the Treat@Home programme, and at national and international conferences.",[344,28,345],"Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Multiple Myeloma Refractory",[347,348,349,350],"Hematologic Neoplasms","multiple myeloma","Home Care Services","Patient Acceptance of Health Care","2026-06-03",{"date":353,"type":38},"2026-06-08",{"date":355,"type":22},"2026-07-01",{"date":357,"type":22},"2028-06-30",{"name":44,"class":45},{"id":360,"slug":361,"hasResults":12,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":370,"conditions":371,"keywords":373,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":4},"100607655","phase-4-self-administered-subcutaneous-daratumumab-in-patients-with-multiple-myeloma-100607655","NCT07191379","Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma","Self-administered Subcutaneous Daratumumab in Patients With Multiple Myeloma. An Open Label, Phase Four, Prospective, Non-randomized, Sponsor-initiated Multicenter Feasibility Study","SCILLA","Inclusion Criteria:\n\n* Diagnosed with MM\n* Initiating treatment with SC daratumumab\n* Able to read and understand the Danish language\n* Are considered suitable for self-administration of SC daratumumab at home (in the opinion of the healthcare professional)\n* Willing and able to complete questionnaires and participate in an interview\n\nExclusion Criteria:\n\n* Resident on an unbridged island\n* Receiving co-treatment with other anti-myeloma treatments necessitating hospitals visits on days of home administration\n* Anything related to their ability to self-administer SC daratumumab at home e.g. physical inabilities or cognitive impairment",{"count":21,"type":22},[369],"PHASE4","The main goal in this open label, phase four, prospective, non-randomized, sponsor-initiated multicenter feasibility study is to evaluate the feasibility and safety of self-administration of subcutaneously (SC) daratumumab in the patients with multiple myeloma in their own home. The study intervention is self-administration of SC daratumumab by the patient, thereby changing the administration from an outpatient setting to a home setting. To reduce potential bias, patients will function as their own controls by receiving alternating treatments at home and in the outpatient clinic. To participate, patients must be scheduled for SC daratumumab alone or in combination with other drugs not necessitating outpatient visits on days of planned SC daratumumab self-administration. Patients can be included and trained during cycle 1 and 2, but only treatments administered in cycle 3-6 are considered protocol treatments. Here, patients will receive SC daratumumab once every second week with treatments at day 1 administered in the outpatient clinic and treatments at day 15 administered at home. From cycle 7 onwards, patients continues SC daratumumab outside protocol according to local standards.\n\nAt inclusion, baseline demographic and clinical data should be registered for included patients. For each SC daratumumab administration in the protocol, planned treatment location (home\u002Fhospital) should be registered together with information on whether the dose was administered as planned. For each protocol treatment, regardless of treatment location, patients, caregivers, and healthcare professionals should register their time spent. In addition, patients should complete the Health Literacy Questionnaire (HLQ) and caregivers are to complete the Caregiver Roles and Responsibilities Scale (CRRS). Throughout the study, patient will also register all unplanned contacts to the healthcare system. Patient will also be asked to complete an evaluation form. Lastly, qualitative evaluations of the experience of self-administration will be conducted through semi-structured interviews with patients and caregivers, as well as focus group interviews with involved healthcare professionals.",[372],"Multiple Myeloma in Relapse",[374,375,119],"Treatment at home","Daratumumab",{"date":377,"type":38},"2026-06-05",{"date":379,"type":22},"2026-08-01",{"date":381,"type":22},"2028-01-01",{"name":44,"class":45},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":23,"phases":391,"briefSummary":392,"conditions":393,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":197},"100580979","diagnosing-peripheral-lung-lesions-with-cryo-biopsies-100580979","NCT06844344","Diagnosing peRipheral Lung Lesions With CRYO Biopsies","DR CRYO","Inclusion Criteria:\n\n* \\- Patients undergoing diagnostic work-up for lung cancer due to a lung lesion surrounded by normal lung tissue (identified by CT)\n* Age 18 or above\n* Bronchoscopy with planned forceps sampling from the lesion\n\nExclusion Criteria:\n\n* \\- Pregnancy\n* Not able to provide informed consent.",{"count":241,"type":22},[92],"Lung cancer is the leading course of cancer related deaths world-wide. Lung cancer screening will increase the number of small lung lesion in need of biopsy to confirm the diagnosis. Obtaining lung biopsies with a bronchoscopy has the lowest risk of complications (1-2%) compared to other modalities such as transthoracic needle biopsy (20%), however diagnostic yield needs improvement. Currently a diagnosis is established in 50- 70% of the bronchoscopic procedures depending on the step-up. One way to improve the yield would be by using a cryo probe through the bronchoscope which freezes a small part of the lung for extraction, and thereby provides larger biopsies for examination. This will increase the chances of obtaining sufficient material from a small lesion to determine the diagnosis.\n\nThe DR CRYO study will compare cryo biopsies to forceps biopsies for the diagnosis of peripheral lung lesions.\n\nWe hope that the cryo biopsies can improve the diagnostic capabilities of bronchoscopy and provide better biopsies for tumor marker analyses. The project is relevant both for patients undergoing diagnostic work-up for lung cancer in early stages .",[394,395],"Lung Cancer","Peripheral Lung Lesions","2026-05-16",{"date":398,"type":38},"2026-05-20",{"date":400,"type":38},"2025-03-01",{"date":402,"type":22},"2027-02-01",{"name":44,"class":45},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":420,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":434},"100605482","bracing-after-ankle-fracture-100605482","NCT07163091","Bracing After Ankle Fracture","Bracing After Ankle Fracture (BAF): a Randomised Multicenter Non-inferiority Trial Comparing Ankle Stirrups to Walkers on Pain, Function and Social Interaction for Adults After Ankle Fracture - Study Protocol","BAF","Inclusion Criteria:\n\n* 18 years or older\n* Surgically or non-surgically treated ankle fracture\n\nExclusion Criteria:\n\n* Pathological fractures\n* Inadequacy to read or speak danish\n* Open fractures\n* Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)\n* Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)\n* Restricted weightbearing\n* Uninterest in participating",{"count":413,"type":22},1400,[92],"Ankle fractures are common, debilitating and usually treated with immobilisation using a foot-ankle brace (walker). Emerging evidence suggests that a less restrictive brace may reduce recovery time without increasing the risk of complications, and patients tend to prefer ankle stirrups. However, evidence supporting their non-inferiority remains limited and inconclusive. Thus, the aim is assess if an ankle stirrup is non-inferior to a standard walker in reducing pain and function measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The hypothesis is that ankel stirrups align better with patients preferenes for less immobilising braces and offer sufficient stability while the fracture heals. Secondarily it may lead to faster recovery of function, return to work and reduced cost. The sample size of a maximum of 1400 patients allow us to assess non-inferiority in age and sex specific subgroups and treatment (surgical or non-sugical). Non-inferiority will be assessed in a pragmatic, multicenter, randomised controlled trial involving Scandinavian orthopedic departments.",[417,418,419],"Ankle Fracture","Rehabilitation","Recovery",[421,422,423,424,425,159],"ankle fracture","Brace","walker","ankle stirrup","intervention","2026-04-28",{"date":428,"type":38},"2026-04-29",{"date":430,"type":38},"2026-04-23",{"date":432,"type":22},"2029-09-30",{"name":44,"class":45},16,{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":443,"maxAge":19,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":453,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":80},"100634740","frame-running-for-exercise-and-participation-for-children-and-young-people-with-physical-disabilities-100634740","NCT07543614","Frame Running for Exercise and Participation for Children and Young People With Physical Disabilities","'FRAME-EX´ - FRAME Running for EXercise in Children and Young People With Disabilities - a Study Protocol for a Quasi-Experimental Single-Arm Trial","FRAME-EX","Inclusion Criteria\n\n* Children and adolescents aged 8-18 years.\n* Diagnosed with cerebral palsy (CP) or another condition resulting in a physical disability affecting mobility.\n* Some prior Frame Running experience, such as informal use or occasional training, but must not have taken part in structured, organized, or performance-oriented Frame Running training within the past 12 weeks.\n* Able to propel the Frame Running bike forward independently\n* Able to understand and follow instructions related to Frame Running activities.\n\nExclusion Criteria:\n\n* Severe visual and\u002For cognitive impairments that would compromise safe participation\n* Known medical conditions that could limit or contraindicate involvement in the study (e.g., significant cardiovascular or pulmonary disease).","8 Years",{"count":445,"type":22},35,[92],"The goal of this quasi-experimental single-arm trial is to evaluate whether a structured Frame Running training program can improve functional ability, participation, and quality of life in children and young people with physical disabilities. The study includes participants aged 8-18 years with cerebral palsy or other conditions causing physical disabilities.\n\nThe aim of the study is to investigate changes in the primary outcome measure; functional ability using the Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT), and a series of secondary outcome measures on mobility capacity, physical endurance, performance of everyday activities, and health-related quality of life in children and young people with physical disabilities.\n\nParticipants will complete a 24-week training program carried out in community athletics clubs:\n\n12-week low-intensity control period with one supervised weekly Frame Running session focused on familiarization.\n\n12-week moderate-to-high intensity intervention period with two weekly training sessions, including warm-up, technique training, endurance and speed intervals, and participation-focused activities.\n\nData collection comprises four standardized questionnaires, four physical performance tests conducted at multiple time points, an electronic training diary, and Rating of Perceived Exertion-Pediatric Scale (RPE-P) obtained before and after selected endurance tests.",[449,450,451,100,452],"Physical Disability","Physical Activity","Physical Function","Participation",[454,455,456,457,458,452,451],"Frame Running","Physical activity","Physical disability","Children","Quality of life",{"date":428,"type":38},{"date":461,"type":38},"2026-04-22",{"date":463,"type":22},"2027-12-31",{"name":44,"class":45},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":469,"acronym":4,"eligibilityCriteria":470,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":471,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":477,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":80},"100606018","positioning-of-children-with-acute-respiratory-insufficiency-100606018","NCT07170085","Positioning of Children With Acute Respiratory Insufficiency","Inclusion Criteria:\n\n* Age 0-12 months\n* Clinical respiratory infection\n* Physician-ordered High-Flow oxygen or CPAP\n* Consent from the legal guardian\n\nExclusion Criteria:\n\n* Significant chronic pulmonary, cardiac, or neurological disorders\n* Children admitted to intensive care","12 Months",{"count":115,"type":22},[92],"Acute respiratory insufficiency is one of the most common causes of hospitalization and death among young children. It often affects small children who, due to infections with RSV (respiratory syncytial virus), other cold viruses, or bacteria, experience difficulty breathing, rapid breathing, increased heart rate, low oxygen levels in the blood, and reduced appetite. If left untreated, a child can become exhausted, lose consciousness, and ultimately die from the condition. Children with severe acute respiratory insufficiency occupy most of the acute care beds in the pediatric wards of hospitals during the winter months. Some children are treated simply with saline inhalations, nasal saline drops, and suctioning of the nose, but many require respiratory support in the form of Continuous Positive Airway Pressure (CPAP) or high-flow oxygen therapy.\n\nIn adults, it has been observed that prone positioning can improve blood oxygenation compared to supine positioning in cases of acute respiratory insufficiency.\n\nThe purpose of this study is to investigate whether there are benefits or drawbacks to positioning small children admitted for difficulty breathing due to respiratory infections in a prone position instead of a supine position.\n\nThe study will include a total of 40 children with acute airway disease who have been prescribed respiratory support in the form of CPAP or high-flow oxygen. The study will last a total of 2 hours and will not involve any uncomfortable procedures or pose any risks to the child.\n\nThe Study Itself:\n\nOnce the child has CPAP or high-flow oxygen administered via the nose, the child will be positioned for 1 hour in the prone position and 1 hour in the supine position. The order will be random and determined by lottery. A nurse will record the child's breathing in both the prone and supine positions. After the two hours, the child will be placed in the supine position, which is standard practice in the department. The child will have a pulse oximeter on both during the study and afterwards.",[476],"Acute Respiratory Disease",[478],"positioning",{"date":430,"type":38},{"date":481,"type":38},"2025-11-24",{"date":483,"type":22},"2028-04-01",{"name":44,"class":45},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":494,"briefSummary":495,"conditions":496,"keywords":498,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":509,"locationsCount":4},"100633201","phase-2-fap-petct-for-staging-patients-with-breast-cancer-100633201","NCT07523607","FAP PET\u002FCT for Staging Patients With Breast Cancer","[⁶⁸Ga]Ga-FAP-2286 PET\u002FCT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)","Inclusion Criteria:\n\n* Male and females ≥ 18 years\n* Biopsy-verified newly diagnosed breast cancer\n* Can read and understand Danish\n* Capable of providing written and informed consent\n* Undergoing a routine \\[¹⁸F\\]FDG PET\u002FCT scan as part of the clinical standard diagnostic workup\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Not able to participate in the conduct of the scan due to any reason ( e.g., claustrophobia or inability to lie still for entire imaging time)\n* Ongoing oncological treatment for another cancer\n* History of allergic reactions \u002F hypersensitivity attributed to \\[⁶⁸Ga\\]Ga-FAP-2286.",{"count":493,"type":22},65,[25],"This study aims to evaluate the clinical utility of \\[68Ga\\]Ga-FAP-2268 PET\u002FCT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.",[497],"Breast Cancer Detection",[499,500,501,502],"Breast cancer","PET\u002FCT","FAP","FAPI","2026-04-08",{"date":505,"type":38},"2026-04-13",{"date":330,"type":22},{"date":508,"type":22},"2029-01",{"name":44,"class":45},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":518,"enrollmentInfo":519,"targetDuration":4,"studyType":23,"phases":520,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":167},"100588045","type-1-diabetes-and-diabetes-distress-100588045","NCT06936280","Type 1 Diabetes and Diabetes Distress","A Group-based Psychological Intervention for Emerging Adults With Type 1 Diabetes and Diabetes Distress","ACTnow","Inclusion Criteria:\n\n* Type 1 diabetes for at least 6 months\n* Age between 18 and 35\n* T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2\n* Treated in a diabetes clinic in the Region of Southern Denmark\n* Proficient in Danish\n\nExclusion Criteria:\n\n* Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention\n* Cognitive disorders such as brain injury\n* Complex challenges best suited to individual treatment\n* Current therapeutic treatment for depression, anxiety or stress\n* Not stable medication for anxiety\u002Fdepression for the past two months or planned change in medication for anxiety\u002Fdepression during the project period","35 Years",{"count":241,"type":22},[92],"The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.\n\nThe expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.\n\nThe intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.\n\nThe main research questions are:\n\n* Does a group-based psychological intervention reduce diabetes distress?\n* Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?\n\nResearchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).\n\nParticipants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.",[523,524],"Diabetes Distress","Diabetes Mellitus Type 1",[526,527,528,516],"RCT study","type 1 diabetes","diabetes distress",{"date":530,"type":38},"2026-04-09",{"date":532,"type":38},"2025-04-01",{"date":534,"type":22},"2027-05-31",{"name":44,"class":45},{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":558,"locationsCount":80},"100633054","physical-recovery-during-bracing-after-ankle-fracture-re-baf-100633054","NCT07521696","Physical Recovery During Bracing After Ankle Fracture (Re-BAF)","Physical Recovery During Bracing After Ankle Fracture (Re-BAF): A Multi-Center Superiority Analysis Nested Within a Non-inferiority Randomised Controlled Trial (BAF; NCT07163091)","Re-BAF","Inclusion Criteria:\n\n* 18 years or older\n* Surgically or non-surgically treated ankle fracture\n\nExclusion Criteria:\n\n* Pathological fractures\n* Open fractures (skin perforation)\n* Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)\n* Non-weight bearing treatment\n* Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)\n* Allergy to SENS Motion adhesive patches\n* Inability to read or speak Danish\n* Uninterest in participating",{"count":545,"type":22},280,[92],"Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels.\n\nStandard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications.\n\nHowever, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity.\n\nThe Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \\[BAF\\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\\[MOXFQ\\], primary BAF outcome) after ankle fracture.\n\nThe aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.",[417,419,450,418],[550,419,418,551,455,552],"Ankle Fractures","Braces","Randomized Controlled Trial","2026-04-07",{"date":505,"type":38},{"date":556,"type":22},"2026-04-01",{"date":432,"type":22},{"name":44,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":566,"sex":55,"minAge":567,"maxAge":568,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":572,"conditions":573,"keywords":577,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":583,"lastUpdatePostDateStruct":584,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":589,"locationsCount":197},"100607653","phase-2-resistance-training-and-rapamycin-to-enhance-bone-formation-in-postmenopausal-women-100607653","NCT07191353","Resistance Training and Rapamycin to Enhance Bone Formation in Postmenopausal Women","StrongBone","Inclusion Criteria:\n\n* Women aged 60-75 years old, any ethnicity.\n* Participants with T- score between \\\u003C 1.0 and \\> -2.5 measured by DXA scan within 6 months of the first day of the study.\n* Adequate cognitive function to be able to give informed consent.\n\nExclusion Criteria:\n\n* Osteoporosis and fracture history\n\n  * Participants with osteoporosis (defined by DXA scan \\\u003C 6 months old: low bone mass, T-score \\\u003C -2.5 or hip fracture or clinical compression fracture of the spine).\n  * History of low energy fractures within last 6 months. Health conditions limiting exercise\n  * Health conditions that could limit walking and weightbearing exercise (for instance recent surgery, mobility limitation)\n  * Participants with impaired wound healing or history of a chronic open wound Bone metabolism disorders\n  * Primary hyperparathyroidism.\n  * Known vitamin D deficiency (\\\u003C25 nM) (re-test after substitution acceptable).\n  * Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \\\u003C 30) or impaired liver function (baseline phosphatase higher than twice upper limit (105 U\u002FL)), active rheumatic diseases, celiac disease, severe chronic obstructive lung disease (COPD), hypopituitarism, or Cushing's disease.\n  * Previous use of bone antiresorptive or bone anabolic drugs within the last 5 years.\n\nMedication use and health conditions\n\n* Use of anabolic steroids in the previous year.\n* Use of antiresorptive therapy in the previous year.\n* Known medication\u002Fsupplements affecting bone in the previous year.\n* Diabetes type 1 and 2.\n* Heart failure similar to NYHA Class IV.\n* Treatment with drugs known to affect cytochrome P450 3A due to its role in everolimus metabolism, excluding strong CYP3A4 inhibitors or inducers, while allowing weak and intermediate inhibitors or inducers. Patients on the following drugs will be excluded from the trial: Ketoconazole, Itraconazole, Posaconazole, Voriconazole, Telithromycin, Clarithromycin, Nedazodone, Ritonavir, Atazanavir, Saquinavir, Darunavir, Indinavir, Nelfinavir, Rifampicin, Dexamethasone, Carbamazepine, phenobarbital, Phenytoin, Efavirenz and Nivirapine.\n* History of coagulopathy or medical condition requiring long-term anticoagulation.\n\nBlood disorders and other health concerns\n\n* Anemia - Hg \\\u003C 5,59 mmol\u002FL, Leukopenia - white blood cells (WBC) \\\u003C 3,5 x 10⁹\u002FL, Neutropenia absolute neutrophil count \\\u003C 2,0 x 10⁹\u002FL, or Platelet count - platelet count \\\u003C 125 x 10⁹\u002FL.\n* Insufficiently treated dyslipidemia with LDL-c \\> 4,9 mmol\u002FL and family history of dyslipidemia, Total cholesterol \\> 9,1 mmol\u002FL, or triglycerides \\> 9,9 mmol\u002FL.\n\nImmunosuppressive and current cancer Treatment\n\n* Scheduled for immunosuppressant therapy for transplant or scheduled to undergo chemotherapy or any other treatment for malignancy\n* Any form of clinically relevant primary or secondary immune dysfunction or deficiency Cardiovascular and heart conditions\n* Unstable ischemic heart disease.\n\nAllergies\n\n* Known allergy to rapamycin or rapalogs. Language limitations\n* The study will exclude participants with inability to speak and understand Danish and with inability to cooperate.",true,"60 Years","75 Years",{"count":570,"type":22},148,[25],"The aim of the present clinical trial is to examine the effects of everolimus, resistance training, or their combination on bone and muscle health formation in elderly women aged 60-75 years. The main questions it aims to answer are:\n\nCan rapamycin's analog (Everolimus), resistance training, or their combination, enhance bone formation and muscle functions in elderly women compared to non-treatment controls.\n\nParticipants will be randomized 1:1:1:1 to one of the following treatment regimens:\n\n* Oral everolimus 5 mg once a week.\n* Oral placebo once a week.\n* Oral everolimus 5 mg once a week plus resistance training RT 1 hour, 3 times weekly.\n* Oral placebo once a week plus resistance training RT 1 hour, 3 times weekly.\n\nDuring the study there will be a total of 5-7 visits, where the participants will undergo the following:\n\n* Blood samles\n* DXA-, HRpQCT- (only Odense Universitetshospital) and MRI-scans\n* Muscle- and bone biopsies\n* Quality of life questionnaires\n* Testing of muscle funtion\n* Metabolic studies of muscle and bone protein turnover using labelling with deuturated water",[574,575,576],"Healthy","Osteopenia","Osteoporosis Risk",[578,579,580,581,582],"Postmenopausal Women","Rapamycin","Bone formation","Muscle functions","Healthy aging","2026-03-31",{"date":585,"type":38},"2026-04-06",{"date":587,"type":38},"2025-10-20",{"date":105,"type":22},{"name":44,"class":45},{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":566,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":116,"phases":4,"briefSummary":598,"conditions":599,"keywords":605,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":80},"100632253","calciphylaxis-in-patients-with-chronic-kidney-disease---a-study-of-the-danish-calciphylaxis-research-initiative-dancari-100632253","NCT07511283","Calciphylaxis in Patients With Chronic Kidney Disease - A Study of the Danish Calciphylaxis Research Initiative (DanCaRI)","Inclusion Criteria:\n\nCases\n\n* Age ≥18 years.\n* CKD.\n* Suspicion of calciphylaxis or newly diagnosed calciphylaxis episode. The suspicion or diagnosis of calciphylaxis is a mutual decision of the involved medical specialties (nephrologist, dermatologist, pathologist, other).\n* Ability to give informed consent.\n* Ability to participate in a clinical study as assessed by the local investigator.\n* Provides written informed consent.\n\nControls\n\n* Age ≥18 years.\n* CKD\n* Ability to give informed consent.\n* Ability to participate in a clinical study as assessed by the local investigator.\n* Provides written informed consent.\n\nHealthy reference group\n\n* Age ≥18 years.\n* Self-assessed as healthy, confirmed by local investigators at inclusion\n\nExclusion Criteria:\n\nCases\n\n\\- the calciphylaxis diagnosis becomes excluded\n\nControls - Being diagnosed with calciphylaxis\n\nHealthy controls Up to 60 years of age: eGFR below 60 ml\u002Fmin\u002F1.72m2.\n\n\\- Over 60 years of age: eGFR below the 95% confidence interval for eGFR adjusted for age (Danish Society of Nephrology references ranges)",{"count":597,"type":22},860,"Calciphylaxis is a rare yet life-threatening condition involving pronounced calcification in small blood vessels of the skin.\n\nKnowledge about its underlying mechanisms and contributing risk factors remains limited. Chronic kidney disease is one of the strongest disease predictors. No evidence based effective therapy is currently available. Research on the topic is mainly hindered by the condition's rarity.\n\nThe study Calciphylaxis in patients with chronic kidney disease - A study of the Danish Calciphylaxis Research Initiative (DanCaRI) is set up to facilitate the systematic retrospective and prospective comparison of patients with chronic kidney disease and calciphylaxis to matched patients with chronic kidney disease who did not develop calciphylaxis thereby providing new knowledge that can support prevention, early detection, and new treatment approaches.",[600,601,602,603,604],"Calciphylaxis","Calcific Uremic Arteriolopathy","End Stage Renal Disease (ESRD)","Chronic Kidney Diseases","Nephrogenic Calciphylaxis",[600,601,604,606,603],"End Stage Renal Disease","2026-03-30",{"date":585,"type":38},{"date":610,"type":22},"2026-04",{"date":612,"type":22},"2040-06",{"name":44,"class":45},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":628,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":635,"lastUpdatePostDateStruct":636,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":641,"locationsCount":80},"100630539","phase-2-scarfree-001-verteporfin-for-scar-prevention-100630539","NCT07488988","SCARFREE-001: Verteporfin for Scar Prevention","SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds","SCARFREE-001","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Scheduled to undergo elective abdominoplasty amenable to primary closure\n* ASA class I-II\n* Fitzpatrick skin type I-IV\n* Ability to provide written and informed consent and willing to comply with study procedures\n\nExclusion Criteria:\n\n* Pregnancy or planned pregnancy within the next 6 months at the time of inclusion\n* Breastfeeding\n* Smoking within the previous 6 months\n* Excessive alcohol intake (\\>10 units\u002Fweek for women, \\>14 units\u002Fweek for men)\n* Participants who are unable to read, understand and communicate in Danish sufficiently to provide informed consent and comply with study procedures\n* Known conditions of pathological scarring or other conditions affecting wound healing\n* Known hypersensitivity to verteporfin or any excipients\n* Porphyria or other photosensitivity disorders\n* Moderate hepatic dysfunction, defined as:\n\n  1. AST or ALT \\>1.2 × ULN\n  2. Hypoalbuminemia or prolonged PT\n* Biliary obstruction, defined as:\n\n  1. ALP or GGT \\>1.2 × ULN\n  2. Abnormal bilirubin\n* Autoimmune or fibrotic skin conditions including (but not limited to):\n\n  1\\. Keloids or hypertrophic scars, scleroderma, lupus, GVD, morphea, lichen sclerosus, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome\n* Current use of photosensitizing medications (e.g. tetracyclines, thiazides, phenothiazines)\n* Any medical condition deemed by the investigator to pose a risk to safety or data integrity",{"count":623,"type":22},12,[25],"The purpose of this clinical trial is to investigate whether the drug verteporfin can reduce the formation of scars in adult patients undergoing a tummy tuck procedure (abdominoplasty).\n\nThe main questions the study aims to answer are:\n\n* Whether treatment with verteporfin can reduce scar formation in surgical wounds that are closed with sutures, compared with placebo (saline). This will be assessed based on how the scars look after 3 months using a standardized scar assessment questionnaire (Patient and Observer Scar Assessment Scale).\n* Whether treatment with verteporfin can reduce scar formation in small open wounds created after taking small tissue samples (4 mm), compared with placebo. This will also be assessed after 3 months using the same questionnaire.\n\nThe researchers will compare three different doses of verteporfin (0.5 mg\u002FmL, 1.0 mg\u002FmL, and 2.0 mg\u002FmL) with placebo. Each participant will receive all three doses as well as placebo, but in different areas of the surgical wound and in different small wounds, allowing comparisons to be made within the same person.\n\nParticipants will:\n\n* Undergo a planned abdominoplasty procedure\n* During surgery, receive small injections in the skin with either verteporfin or placebo in different parts of the surgical wound.\n* Have four small wounds (4 mm) created from tissue samples, which will also be treated with verteporfin or placebo.\n* Attend follow-up visits after 1 week, 1 month, and 3 months, where the scars will be examined.\n* Have photographs and ultrasound measurements taken of the scars.\n* Complete questionnaires about their own assessment of the appearance of the scars.",[627],"Surgical Scar",[629,630,631,632,633,634],"Scar","Scar formation","Scar prevention","Scar therapy","Verteporfin","Visudyne","2026-03-18",{"date":637,"type":38},"2026-03-23",{"date":258,"type":22},{"date":640,"type":22},"2028-02",{"name":44,"class":45},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":652,"conditions":653,"keywords":655,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":80},"100552628","camera-capsule-endoscopy-in-the-routine-diagnostic-pathway-for-colorectal-diseases-100552628","NCT06475560","Camera Capsule Endoscopy in the Routine Diagnostic Pathway for Colorectal Diseases","DanCap","Inclusion Criteria:\n\n* Older than 18 years\n* Symptomatic patient referred for colonoscopy assessment\n* Able to provide oral and written informed consent\n\nExclusion criteria\n\n1. Require hospital admission for inpatient colonoscopy\n2. Previous OC with poor bowel preparation within the last 5 years\n3. Patient is unable to provide oral and written informed consent\n4. History of stenosis of the digestive tract\n5. Previous major surgery of the digestive tract with consequence of an internal derivation or a stoma\\*\n6. Patient has a pacemaker\u002Fdefibrillator\n7. Patient is pregnant or breastfeeding\n8. Known allergies to the bowel preparation regimen\n9. Have severe kidney disease\n10. Known chronic constipation\n11. Imaging examination suggestive for a colorectal tumour\n12. Anamnestic suspicion of microscopic colitis, where biopsy is needed \\*including Whipple",{"count":650,"type":22},800,[92],"The Department of Surgery at Odense University Hospital (OUH) carries out approximately 10,000 colonoscopies each year, and this number is continuously increasing. Since 2014, the screening for colorectal cancer (CRC) has resulted in a significant increase in the colonoscopy workload. Conventional colonoscopy (CC) is a hospital-based procedure that can require sedation or analgesics and is often considered uncomfortable, intimidating, or even painful. The diagnostic yield of CC can be as low as 3-5% in some patient groups, which means that an endoscopist may need to perform 20 to 30 colonoscopies to identify one case requiring treatment. Physical or cultural barriers can also deter patients from attending appointments, leading to missed cancers or precancerous lesions. To address these challenges, an alternative pathway is needed to reduce the colonoscopy burden on the healthcare system while ensuring fewer findings are missed.\n\nOne solution is to use Colon Capsule Endoscopy (CCE) as a triage tool. This procedure can be performed in outpatient healthcare centers and requires less equipment than an CC. However, CCE offers no therapeutic capability, and individuals with clinically significant findings will still require an CC. A low reinvestigation rate (\\\u003C25%-30%) is desirable for patient preference and the economy.\n\nTherefore, DanCap will introduce a new pathway that relies on CCE for routine colorectal examinations of symptomatic patients who are expected to have a low rate of positive findings and, consequently, a low reinvestigation rate, and asses the cost of this new pathway.",[654],"Colorectal Cancer",[656,657,658],"colorectal cancer","capsule endoscopy","colonoscopy","2026-03-16",{"date":661,"type":38},"2026-03-19",{"date":663,"type":38},"2024-11-27",{"date":665,"type":22},"2026-08-31",{"name":44,"class":45},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":673,"eligibilityCriteria":674,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":675,"targetDuration":677,"studyType":116,"phases":4,"briefSummary":678,"conditions":679,"keywords":682,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":690,"completionDateStruct":692,"leadSponsor":694,"locationsCount":233},"100628789","qolidia-quality-of-life-in-cancer-patients-with-diabetes-during-immunotherapy-100628789","NCT07466212","QoLIDia: Quality of Life in Cancer Patients With Diabetes During Immunotherapy","Impact of Concurrent Diabetes on Quality-of-life Changes During Immunotherapy - A Prospective Longitudinal Study","QoLIDia","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed solid malignant tumor.\n* Planned treatment with ICI monotherapy or dual-ICI combination therapy (metastatic, adjuvant, or neo-adjuvant settings).\n* Previous systemic anticancer therapy other than ICI is allowed.\n* Ability and willingness to provide written informed consent and to complete HRQoL questionnaires.\n* Sufficient Danish language proficiency to read, and complete study questionnaires.\n\nExclusion Criteria:\n\n* Previous ICI treatment within 6 months.\n* Concurrent systemic anticancer therapy other than ICI.\n* Declines or does not provide informed consent.\n* Cognitive or physical impairment preventing valid consent or completion of patient-reported outcomes.",{"count":676,"type":22},920,"6 Months","The goal of this observational study is to see how type 2 diabetes affects quality of life in cancer patients receiving immunotherapy. We want to know if patients with diabetes have a greater decline in quality of life over six months compared to those without. The main question we aim to answer is:\n\n\\- How does quality of life change over six months in patients with versus without diabetes?\n\nParticipants will complete quality-of-life surveys at the start, then at 3 and 6 months. This will help us see if diabetes adds extra challenges during cancer treatment",[680,681],"Cancer","Type 2 Diabetes",[683,680,684,458,685,686],"Type 2 diabetes","Immunotherapy","Patient-reported outcomes","Real-world study","2026-03-11",{"date":689,"type":38},"2026-03-12",{"date":691,"type":22},"2026-03-10",{"date":693,"type":22},"2027-10-01",{"name":44,"class":45},{"id":696,"slug":697,"hasResults":12,"nctId":698,"briefTitle":699,"officialTitle":700,"acronym":701,"eligibilityCriteria":702,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":703,"targetDuration":4,"studyType":23,"phases":705,"briefSummary":706,"conditions":707,"keywords":710,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":714,"lastUpdatePostDateStruct":715,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":722},"100583563","fdg-petct-vs-ct-for-monitoring-metastatic-breast-cancer-100583563","NCT06877949","FDG-PET\u002FCT vs. CT for Monitoring Metastatic Breast Cancer","FDG-PET\u002FCT Versus Conventional CT for Response Monitoring in Metastatic Breast Cancer: A Multicenter Randomized Clinical Trial (MONITOR-RCT)","MONITOR-RCT","Inclusion Criteria:\n\n1. Women and men aged ≥18 years\n2. Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.\n3. Considered eligible for first-line systemic treatment\n4. Considered eligible for continuous treatment monitoring by scans.\n5. Signed informed consent\n6. Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.\n\nIn case of patients for whom it is necessary to start first-line systemic treatment while still waiting for the evaluation of the biopsy, it is allowed to include the patients, as long as the other criteria are fulfilled and the biopsy is made or planned. In case verification by biopsy fails, the patients will leave the trial (cf. 4c). We expect that up to 3% of the patients included will start first-line systemic treatment prior to evaluation of the biopsy\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Ongoing oncological treatment for another cancer\n3. Exclusively brain metastasis\n4. Allergy to FDG",{"count":704,"type":22},420,[92],"Several studies have shown improved sensitivity of FDG-PET\u002FCT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. For response monitoring, we expect FDG-PET\u002FCT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies.\n\nCurrent knowledge about the potential benefit of FDG-PET\u002FCT for response monitoring of patients with metastatic breast cancer comes from observational studies. Consequently, current evidence is only hypothesis-generating and prospective, randomized trials such as the MONITOR-RCT are needed to corroborate these findings.\n\nThe MONITOR-RCT clinical trial aims to investigate whether monitoring with FDG-PET\u002FCT can improve survival in patients diagnosed with metastatic breast cancer. It is a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET\u002FCT with a standard monitoring strategy based on CT.\n\nParticipating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medical treatment and subsequent regular response monitoring. A total of 420 patients will be included in the study, with recruitment taking place across 11 participating hospital sites in Denmark, Germany, and Italy.\n\nThe main questions it aims to answer are:\n\n* Can monitoring with FDG-PET\u002FCT compared to conventional CT prolong the overall survival of MBC patients?\n* Is this-as expected-due to earlier detection of disease progression and earlier initiation of second-line therapies?\n* Is this accompanied by less need for additional diagnostics, less need for hospitalization, and improved quality of life?\n\nParticipants will:\n\n* Undergo FDG-PET\u002FCT scans at scheduled intervals to monitor disease progression.\n* Be given standard treatments as part of oncological care, which is informed by the FDG-PET\u002FCT scans\n* Fill out questionnaires about their quality of life at various time points throughout the study.\n\nObjectives are:\n\nPrimary: To demonstrate superiority in overall survival of response monitoring with FDG-PET\u002FCT in patients with metastatic breast cancer over response monitoring based on CT. Appropriately adapted PERCIST criteria for FDG-PET\u002FCT and the RECIST1.1 criteria for CT will be used.\n\nSecondary: To demonstrate superiority in quality of life and exposure to oncologic treatment with FDG-PET\u002FCT and to investigate the cost-effectiveness.",[708,709],"Metastatic Breast Cancer","Response Monitoring",[708,709,711,712,713],"FDG-PET\u002FCT","Survival","Progression","2026-02-19",{"date":716,"type":38},"2026-02-20",{"date":718,"type":38},"2025-04-02",{"date":720,"type":22},"2029-04",{"name":44,"class":45},11,""]