[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Maastricht University Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":686},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,45,76,106,127,156,180,228,261,278,300,320,338,369,416,438,472,493,521,542,569,604,629,648,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100642703","prospective-evaluation-of-flare-detection-in-ibd-with-digital-biomarkers-bring-your-own-device-study-100642703",false,"NCT07647640","Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study","BYOD","Inclusion Criteria:\n\n* 18 years or older\n* Crohn's Disease or ulcerative colitis\n* Having a smartwatch and\u002For a smartphone\n* Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)\n\nExclusion Criteria:\n\n* No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.",[25,26,27],"Inflammatory Bowel Disease (IBD)","Ulcerative Colitis (UC)","Crohn Disease (CD)",[29,30,31],"Inflammatory Bowel Disease","Digital biomarkers","Heart rate variability","NOT_YET_RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":21},"2026-06-15",{"date":40,"type":21},"2027-10-15",{"name":42,"class":43},"Maastricht University Medical Center","OTHER",3,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100644846","effects-of-protein-type-and-mineral-form-on-amino-acid-availability-100644846","NCT07677098","Effects of Protein Type and Mineral Form on Amino Acid Availability","Effects of Protein Type and Mineral Form on Postprandial Amino Acid Availability in Healthy Young Adults: a Randomized Cross-over Study","ProMin","To be eligible to participate in this study, a participant must meet all of the following criteria:\n\n* Male or female sex\n* Aged between 18 - 35 years inclusive\n* BMI between 18 - 30 kg\u002Fm2\n* Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)\n* No physical limitations (i.e., able to perform all activities associated with daily living independently)\n\nA potential participant who meets any of the following criteria will be excluded from participation in this study:\n\n* Intolerant to milk protein and\u002For dairy-based products\n* Smoking regularly\n* Diagnosed with gastro-intestinal disorders\n* Diagnosed with metabolic disorders (e.g. diabetes)\n* Diagnosed with musculoskeletal disorders\n* Blood donation in the past 2 months\n* Females: pregnancy\n* Use of any medication known to affect protein metabolism (e.g. corticosteroids, non-steroidal anti-inflammatories or prescribed acne medications)\n* Chronic use of gastric acid suppressing drugs (e.g. proton pump inhibitors, H2-antagonists)",true,"35 Years",{"count":56,"type":21},16,"INTERVENTIONAL",[59],"NA","To compare postprandial plasma amino acid availability, expressed as incremental area under the curve (iAUC), over a 6 hour period following ingestion of 25 g of different protein isolates in healthy, young adults. The primary objective is divided into the following 2 sub-studies, each with 3 comparisons:\n\n* Sub-study 1: whey protein, calcium caseinate, sodium caseinate.\n* Sub-study 2: calcium caseinate, magnesium caseinate, potassium caseinate.",[62],"Protein Metabolism",[64,65,66,67],"Amino acid","Satiety hormone","Minerals","Protein kinetics",{"date":69,"type":36},"2026-06-30",{"date":71,"type":21},"2026-09-15",{"date":73,"type":21},"2027-07-15",{"name":42,"class":43},1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":57,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":75},"100361242","plant-stanol-esters-and-preventing-asthma-symptoms-100361242","NCT03983603","Plant Stanol Esters and Preventing Asthma Symptoms","The Effects of Long-term Daily Plant Stanol Ester Intake on Clinical Symptoms in Individuals With Allergic Asthma: an Exploratory Double-blind Randomized Controlled Trial","PLANTASTIC","Inclusion Criteria:\n\n* Diagnosed with allergic asthma (GINA step 1-4) which is in a stable phase at the moment of inclusion (defined as no changes in asthma control and lung function in (at least) the past three months)\n* Have been treated with prescribed asthma medication for at least one year\n* Aged 18-70 years old\n* BMI between 20 and 35 kg\u002Fm2\n* Willing to abstain from products containing plant sterols or stanols one month prior to the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)\n* Willing to abstain from products containing plant sterols or stanols during the study (products with a cholesterol lowering claim of Becel ProActiv, Benecol, Danacol, store brands)\n* Willing to keep the intake of fish oil supplements constant\n\nExclusion Criteria:\n\n* Currently smoking or quitted smoking in the past year, with a maximum of 10 packyears as smoking history (packyears = packs per day \\* years of smoking)\n* Allergy to an ingredient of the soft chews\n* Suffering from inflammatory diseases (for CVD, illness must be minimally 3 years ago and currently under control in order to participate in the study)\n* Fasting plasma glucose \\> 7.0 mmol\u002FL\n* Fasting serum TC \\> 8.0 mmol\u002FL\n* Having donated blood within one month prior to the start of the study, or planning to donate blood during the study\n* Pregnant women\n* Breastfeeding women","70 Years",{"count":86,"type":21},160,[59],"Plant stanols are known to lower low-density lipoprotein cholesterol. However, studies have suggested that these compounds also influence the immune system. Asthmatic responses are predominantly T helper (Th)2 cell dependent, while plant stanols were previously found to activate Th1 cells and shift the immune response away from the Th2 cell dominant asthmatic response. The question now is whether this also translates into a reduction of clinical symptoms in asthma patients.The primary objective of this study is to demonstrate clinical benefits of prolonged consumption of plant stanols (delivered via plant stanol esters) in asthma patients. The secondary objectives are to evaluate the mechanisms via which plant stanols modulate the immune system and to evaluate the effects of plant stanol ester consumption on cardiovascular (CVD) risk parameters.",[90,91],"Asthma, Allergic","Cardiovascular Diseases",[93,94,95,96],"Plant stanols","Asthma","Immune system","Metabolic health","RECRUITING","2026-06-22",{"date":100,"type":36},"2026-06-25",{"date":102,"type":36},"2019-04-29",{"date":104,"type":21},"2026-09",{"name":42,"class":43},{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":115,"studyType":22,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":4},"100642643","therapy-adjustment-and-individualized-response-with-biomarker-observation-in-real-world-heart-failure-100642643","NCT07647848","Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure","Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)","TAILOR-HF","Inclusion Criteria:\n\n1. Provide written and dated informed consent for participation prior to trial admission,\n2. Age ≥18 years, female or male\n3. A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of \\\u003C50%\n4. On treatment with oral or i.v. furosemide ≥40 mg\u002Fday or equivalent (bumetanide 1mg, torasemide 10mg)\n5. Receiving \\\u003C50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)\n6. Anticipated or planned uptitration\n\nExclusion Criteria:\n\n1. Scheduled or on renal replacement therapy,\n2. Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.\n3. Diagnosis of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, current viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis.\n4. The presence of a mechanical assist device,\n5. Scheduled for mechanical assist device or heart transplant,\n6. Current angina pectoris ≥class III,\n7. Requiring valvular surgery or revascularization in the upcoming 3 months or Coronary Artery Bypass Grafting (CABG) within the past 3 months,\n8. Anticipated need for surgery or any other cardiovascular intervention, except implantable cardioverter defibrillator and\u002For cardiac resynchronization therapy, within 4 weeks,\n9. Other non-cardiac conditions with limited life expectancy (≤ duration of the trial\u002F 1 year),\n10. Participation in another clinical trial apart from non-interventional studies.\n11. Patients with an unscheduled hospital visit or admission for reasons that are not primarily related to worsening of heart failure. Therefore, patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, may be included when the primary diagnosis for admission to hospital or outpatient clinic visit has been heart failure, rather than the concomitant condition.\n12. Women who are pregnant, breastfeeding or those considering becoming pregnant\n13. Subjects unable to provide informed consent.",{"count":20,"type":21},"6 Months","The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure.\n\nTAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.",[118,119],"Chronic Heart Failure","Acute Decompensated Heart Failure","2026-06-09",{"date":38,"type":36},{"date":123,"type":21},"2026-09-01",{"date":125,"type":21},"2028-09-01",{"name":42,"class":43},{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":135,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":57,"phases":138,"briefSummary":139,"conditions":140,"keywords":146,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":75},"100643509","autologous-fat-grafting-for-total-breast-reconstruction-in-irradiated-breast-cancer-patients-100643509","NCT07641985","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients","Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Patients","AFT-R","Inclusion Criteria:\n\n* Female, aged \\>18 years.\n* BMI between \\> 22 and \\\u003C35 kg\u002Fm2\n* History of breast cancer treated with mastectomy (minimally 3 months after mastec-tomy) and post mastectomy chest wall radiotherapy (completed ≥6 months before en-rollment).\n* May include contralateral\u002Fbilateral prophylactic mastectomy if at least one side had cancer and radiation.\n* Desires autologous breast reconstruction and accepts randomization between AFT and DIEP.\n* Medically fit for surgery (ASA I-III).\n* Sufficient donor tissue for both AFT (enough fat) and DIEP (suitable abdominal tissue and vasculature).\n* No evidence of active cancer at enrollment; remission confirmed.\n* Able to wear the EVE device (if randomized in AFT).\n* Capable of understanding study information and questionnaires (Dutch or English), willing to give informed consent, and able to comply with follow-up.\n\nExclusion Criteria:\n\n* Prior autologous breast reconstruction on the intended side. BMI \\\u003C22 or \\>35 kg\u002Fm2\n* Contraindication to DIEP flap (e.g., prior abdominoplasty or abdominal scars affecting perforators).\n* Contraindication to AFT (e.g., insufficient fat or conditions impairing fat graft viability).\n* Current chemotherapy or completed less than 4 weeks prior to enrollment.\n* Serious uncontrolled comorbidities making elective surgery unsafe (e.g., unstable heart disease, severe coagulopathy, end-stage organ failure).\n* Active smoker or not abstinent for at least 6 weeks pre-operatively.\n* Pregnant at time of enrollment.\n* In case low compliance is expected or an inability to comply with study protocol, including unwillingness to undergo either AFT or DIEP, or inability to complete follow-up (due to language, cognitive issues, or relocation plans).\n* Previous enrollment in this trial (patients can only be included once, even if later presenting for contralateral reconstruction).\n* Allergy to lidocaine or silicone","FEMALE",{"count":137,"type":21},280,[59],"The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following mastectomy. It will also evaluate patient satisfaction, quality of life, complication rates, and cost-effectiveness of both reconstruction techniques. The main questions it aims to answer are:\n\nDoes AFT result in non-inferior patient satisfaction with the reconstructed breast compared to DIEP flap reconstruction 12 months after the final operation? Does AFT result in fewer major complications and improved cost-effectiveness compared to DIEP flap reconstruction? Are quality of life outcomes and oncologic safety comparable between AFT and DIEP flap reconstruction in irradiated patients?\n\nResearchers will compare AFT to DIEP flap reconstruction to see if AFT can provide similar reconstructive outcomes with lower morbidity and fewer complications in irradiated breast cancer patients.\n\nParticipants will:\n\nUndergo breast reconstruction using either AFT or DIEP flap reconstruction Attend follow-up visits for clinical examinations, imaging, and assessment of complications Complete questionnaires about breast satisfaction, quality of life, and recovery during follow-up Be monitored for oncologic safety and reconstructive outcomes for 12 months after the final operation",[141,142,143,144,145],"Breast Cancer","Breast Reconstruction","Breast Reconstruction After Mastectomy","Breast Cancer Radiation","Lipofilling",[145,147,148],"Breast reconstruction","Irradiated patients",{"date":150,"type":36},"2026-06-11",{"date":152,"type":21},"2026-07-01",{"date":154,"type":21},"2032-07-01",{"name":42,"class":43},{"id":157,"slug":158,"hasResults":12,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":57,"phases":166,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},"100630267","phase-2-boosting-osimertinib-blood-brain-barrier-penetration-100630267","NCT07485452","Boosting Osimertinib Blood Brain Barrier Penetration","Boosting Osimertinib Blood Brain Barrier Penetration in Patients With Epidermal Growth Factor Receptor Mutated Non-small Cell Lung Cancer","OSIBBBOOST","Inclusion criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. The patient has metastatic EGFR-mutated NSCLC and is treated with osimertinib as part of regular care with CT-confirmed stable disease or better. Patients with (signs of) disease progression, are also eligible if their treating physician deems the treatment to be appropriate beyond progression and the expected osimertinib treatment duration is at least 1 month.\n2. The patient has an European Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.\n3. The patient is 18 years of age or older.\n4. The patient is able and willing to sign informed consent prior to any tests or procedures.\n5. The patient is able and willing to undergo additional blood sampling for e.g. therapeutic drug monitoring.\n6. The patient is able and willing to undergo lumbar punctions to obtain CSF.\n7. The patient must meet the criteria stated in the approved regulatory indication(s) for osimertinib where the clinical study will be performed and agree to the restrictions, monitoring, and dose-adjustment criteria stipulated in the associated product label.\n8. The patient does not harbour the ABCG2 34G\\>A single nucleotide polymorphism.\n9. The patient does not have any central nervous system (CNS) metastases.\n10. Patients with HBV are only eligible for inclusion if they meet all the following criteria:\n\n    * Demonstrated absence of HCV co-infection or history of HCV co-infection\n    * Demonstrated absence of HIV infection\n    * Participants with active HBV infection are eligible if they are:\n    * Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \\\u003C100 IU\u002FmL and transaminase levels are below ULN.\n    * Participants with a resolved or chronic HBV infection are eligible if they are:\n\n      * Negative for HBsAg and positive for hepatitis B core antibody \\[anti-HBc IgG or total anti-HBc Ab\\]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines. or\n      * Positive for HBsAg, but for \\> 6 months have had transaminases levels below ULN and HBV DNA levels below \\\u003C100 IU\u002FmL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.\n11. Patients with HIV are only eligible for inclusion if they meet all the following criteria:\n\n    * Demonstrated absence of HBV\u002F HCV co-infection\n    * Undetectable viral RNA load for 6 months\n    * CD4+ count of \\>350 cells\u002FµL\n    * No history of AIDS-defining opportunistic infection within the past 12 months\n    * Stable for at least 4 weeks on the same anti-HIV medications\n12. Patients must be willing to use protocol specified method of contraception during treatment with osimertinib and 6 weeks tafter the lost dose of osimertinib.\n\n    * Females who are not abstinent (in line with the preferred and usual lifestyle choice of the patient) and intend to be sexually active with a male partner must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n\n      * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments\n      * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution\n      * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n    * Male participants must be willing to use barrier contraception\n\nExclusion criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. The patient has an acute gout attack, and medical history of gout or xanthinuria\n2. The patient uses urate-lowering agents, azathioprine, 6-mercaptopurine, tioguanine\n3. The patient uses potent inducers of UDP-glucuronosyltransferase (UGT) enzymes, such as rifampicin and carbamazepine\n4. The patient uses prohibited co-medication: drugs that moderately or strongly inhibits or induces CYP3A4 or P-glycoprotein (P-gp)\n5. The patient has received prior treatment with intrathecal chemotherapy\n6. The patient has moderate or severe hepatic dysfunction (Child Pugh B or C)\n7. The patient has a significantly increased rate of uric acid production (such as in Lesch-Nyhan syndrome)\n8. The patient is pregnant or lactating\n9. The patient has been diagnosed with severe cardiovascular conditions (including history of myocardial infarction, stroke or instable angina pectoris, or congestive heart failure)\n10. Any of the following cardiac criteria:\n\n    * Mean resting corrected QT interval (QTc) \\> 470 msec, obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.\n    * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n    * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including: Hypokalaemia\\* ≥ CTCAE Grade 2 (\\*correction of electrolyte abnormalities should be documented prior to first dose), heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.\n11. Creatinine \\>1.5 times ULN concurrent with creatinine clearance \\\u003C50 ml\u002Fmin (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN\n12. Known galactose-intolerance, Lapp lactasedeficiency or glucose-galactose malabsorption\n13. Involvement in the planning and\u002For conduct of the study (applies to both investigator staff and\u002For staff at the study site)\n14. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment with the exception of alopecia and grade 2 prior platinum-therapy related neuropathy.\n15. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol, or active infection (e.g. patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled HBV infection.\n\n    o Screening for chronic conditions is not required.\n16. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n17. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n18. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    * Bone marrow reserve (the use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted):\n\n      * Absolute neutrophil count \\\u003C1.5 x 109\u002FL\n      * Platelet count \\\u003C100 x 109\u002FL\n      * Haemoglobin \\\u003C90 g\u002FL\n    * Hepatic function\n\n      * Alanine aminotransferase \\>2.5 times the upper limit of normal (ULN) if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases\n      * Aspartate aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases\n      * Total bilirubin \\>1.5 times ULN if no liver metastases or \\>3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases\n19. History of hypersensitivity to active or inactive excipients of osimertinib or febuxostat, or drugs with a similar chemical structure or class to osimertinib or febuxostat.\n20. Osimertinib dosage of less than 80 mg once daily.\n21. Any concurrent and\u002For other active malignancy that has required systemic treatment within 2 years of first dose of osimertinib.\n22. Major surgery within 4 weeks of the first dose of IP. Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery (VATS) are permitted.\n23. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP.\n24. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n25. Participation in another clinical study with an investigational product during the 4 weeks prior to Day 1. Patients in the follow-up period of an interventional study are permitted.\n26. If a patient uses anticoagulants and the treating physician deems it unsafe or not feasible to temporarily interrupt this medication or to bridge oral anticoagulants with parenteral anticoagulation (i.e. LMWH) at the time of the lumbar puncture procedure, the patient will be excluded.",{"count":165,"type":21},7,[167],"PHASE2","The goal of this proof-of-concept clinical study is to determine the effect of combining osimertinib with febuxostat on cerebrospinal fluid concentrations of osimertinib in patients with epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC). The main question it aims to answer is: what is the effect of combining osimertinib with the ABCG2 inhibitor febuxostat on cerebrospinal fluid to unbound plasma osimertinib concentration ratio in patients with EGFR mutated NSCLC without central nervous system (CNS) metastases and without the ABCG2 34G\\>A single nucleotide polymorphism (SNP)?",[170],"Non-Small Cell Lung Cancer","2026-06-03",{"date":173,"type":36},"2026-06-05",{"date":175,"type":21},"2026-06",{"date":177,"type":21},"2028-06",{"name":42,"class":43},2,{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":186,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":57,"phases":190,"briefSummary":191,"conditions":192,"keywords":203,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":227},"100635761","clinical-impact-of-using-improve-to-select-patients-for-carotid-revascularisation-100635761","NCT07556887","Clinical Impact of Using IMPROVE to Select Patients for Carotid Revascularisation","Clinical Impact of the Use of IMPROVE for Selection of Patients for Carotid Revascularisation: a Randomized Controlled Multicentre Non-inferiority Trial in Symptomatic Patients With 30-99% Carotid Stenosis","IMPROVE","Inclusion Criteria:\n\n* Mentally competent\n* 18 years or older\n* Recent (\\\u003C30 days) stroke (modified Rankin scale ≤3) or TIA\n* Ipsilateral 30-99% atheromatous stenosis at the carotid bifurcation assessed using non-invasive imaging according to NASCET criteria\n* Life expectancy \\>5 years\n* Patient and stenosis are suitable for carotid revascularisation\n* Patient is agreeable to randomisation and willing to accept either IMPROVE-based or CAU-based selection method for carotid revascularisation\n\nExclusion Criteria:\n\n* Cardiac source of embolism\n* Carotid stenosis caused by non-atherosclerotic disease e.g. dissection, fibromuscular disease or neck radiotherapy.\n* MRI contra-indications\n* Pregnancy",{"count":189,"type":21},613,[59],"Narrowing of the carotid artery due to atherosclerosis with an unstable plaque can cause a stroke. Patients with carotid artery disease who have had a TIA or minor stroke and are at high risk of another stroke are often treated with surgery or stenting to remove the plaque. For lower-risk patients, medication alone is the better option, as surgery also carries risks. A new decision method, based on MRI detection of unstable plaques (IMPROVE), can better assess stroke risk and help determine which patients do or do not need surgery. We are investigating whether this method is at least as effective as the standard approach, which mainly considers the degree of narrowing. We expect that this new method will help reduce strokes and lower healthcare costs.\n\nPatients will be followed for several years to compare which method is better for health and costs.",[193,194,195,196,197,198,199,200,201,202],"Carotid Artery Stenosis Symptomatic","Ischemic Cerebral Infarction","Stroke Ischemic","Atheroscleroses","Stroke (CVA) or TIA","Stroke","Intraplaque Hemorrhage","TIA (Transient Ischemic Attack)","Atherosclerosis Cerebral Infarction","Carotid Arteriosclerosis",[204,205,206,207,208,209,210,211,212,213,214,215,216,217,218],"Carotid Artery Stenosis","Transient Ischemic Attack","Ischemic Stroke","Atherosclerosis","Plaque Rupture","Revascularisation","Carotid Endarterectomy","Carotid Artery Stenting","Magnetic Resonance Imaging","Stroke Risk Prediction","Intraplaque hemorrhage","Clinical Decision Support","Randomized Controlled Mulitcentre Trial","Cost-Effectiveness Analysis","Optimal Medical Therapy","2026-05-12",{"date":221,"type":36},"2026-05-15",{"date":223,"type":36},"2026-03-31",{"date":225,"type":21},"2031-08-31",{"name":42,"class":43},10,{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":12,"sex":17,"minAge":236,"maxAge":4,"enrollmentInfo":237,"targetDuration":239,"studyType":22,"phases":4,"briefSummary":240,"conditions":241,"keywords":244,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":260},"100627863","bleeding-disorder-of-unknown-cause-in-the-netherlands-100627863","NCT07454161","Bleeding Disorder of Unknown Cause in the Netherlands","Bleeding Disorder of Unknown Cause In the Netherlands (BDUC-iN Study)","BDUC-iN","Inclusion Criteria:\n\n* Referred to a (pediatric) hemostasis specialist for evaluation of bleeding tendency.\n* Increased bleeding tendency based on: Abnormal International Society on Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH-BAT) score (≥ 5 in women age 18-30; ≥ 6 in women age 31-51, ≥ 7 in women age 52 or older; ≥4 in men and ≥ 3 in children) OR Clinical gestalt according to the investigating physician\n* Absence of diagnostic test results for a bleeding disorder in standard laboratory hemostasis tests:\n* Complete blood count: Hemoglobin \\> 6.0 mmol\u002FL; thrombocyte count \\> 100 x10\\^9\u002FL\n* Prothrombin (PT) and activated Partial Thromboplastin Time (aPTT): within local reference range, or prolonged without explanatory factor deficiency\n* Fibrinogen activity, von Willebrand Factor (VWF) antigen \\& activity, Factor VIII, IX, XI and XIII: within local reference range or abnormal but not explaining bleeding phenotype\n* Light transmission aggregometry (LTA): Not diagnostic for a platelet function\n* Kidney function: eGFR \\> 45 ml\u002Fmin\n* Liver function: ALAT, bilirubin \\\u003C 3 x upper limit of normal\n\nExclusion Criteria:\n\n* Use of medication interfering with laboratory hemostasis tests which cannot be stopped before blood withdrawal\n* Pregnancy or lactation at moment of inclusion\n* Presence of an established bleeding disorder\n* Presence of an acquired cause or another explanation for the increased bleeding tendency\n* Inability to provide informed consent","12 Years",{"count":238,"type":21},500,"10 Years","The purpose of the Bleeding Disorder of Unknown Cause in the Netherlands study (BDUC-iN) is to learn more about unexplained bleeding in individuals with a bleeding disorder of unknown cause (BDUC). The study aims to better understand why these individuals have increased bleeding and how it affects their health and daily life.\n\nThe main questions of this study are:\n\n1. What are the mechanisms underlying the bleeding tendency in BDUC?\n2. How do bleeding symptoms affect patients' daily functioning and overall health-related quality of life?\n3. How is care delivered to individuals with BDUC, and how can this be improved?\n\nParticipants with increased bleeding tendency who remain undiagnosed after standard coagulation testing and are consequently classified as having BDUC will be enrolled across the Hemophilia treatment centers in the Netherlands. Participants will undergo blood sampling for advanced hemostasis testing and genetic analysis. In addition, participants will complete validated questionnaires to assess bleeding symptoms and health-related quality of life. Participants will be followed longitudinally to evaluate how bleeding symptoms affect daily activities, medical procedures, and overall health-related quality of life.",[242,243],"Hemorrhagic Disorders","Bleeding Disorder of Unknown Cause",[245,246,247,248,249,250,251],"Bleeding disorder of unknown cause","Hemostasis","Diagnosis","Management","Pathofysiology","Quality of life","Prospective","2026-04-23",{"date":254,"type":36},"2026-04-27",{"date":256,"type":21},"2026-05-01",{"date":258,"type":21},"2039-03-01",{"name":42,"class":43},8,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":268,"targetDuration":4,"studyType":57,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":277,"locationsCount":75},"100635442","digestion-and-absorption-kinetics-of-beef-consumed-alone-or-as-part-of-a-mixed-meal-a-crossover-trial-in-young-adults-100635442","NCT07552740","Digestion and Absorption Kinetics of Beef Consumed Alone or as Part of a Mixed-Meal: a Crossover Trial in Young Adults","Meat vs Meal","Inclusion Criteria:\n\n* Aged between 18-35 years\n* BMI between 18.5-30 kg\u002Fm2\n* Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)\n* No physical limitations (i.e., able to perform all activities associated with daily living independently)\n\nExclusion Criteria:\n\n* Smoking\n* Vegan, vegetarian, or does not consume beef protein\n* Diagnosed musculoskeletal disorders\n* Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications)\n* Chronic use of gastric acid-suppressing medication or anti-coagulants\n* Unstable weight over the last three months\n* Diagnosed GI tract disorders or diseases\n* Blood donation in the past 2 months\n* Females: pregnancy",{"count":227,"type":21},[59],"The purpose of this study is to assess the digestion and absorption kinetics of beef consumed alone or as part in healthy adults. In a randomized, crossover design, 10 young, healthy adult males and females aged 18-35 years, will consume a meal consisting of 25 g protein from minced beef alone or as part of a mixed-meal during two separate experimental trials. The main study endpoint is the exogenous rate of amino acid appearance in response to the ingested beef over a 10-h period.",[62],"2026-04-22",{"date":254,"type":36},{"date":123,"type":21},{"date":276,"type":21},"2028-01-01",{"name":42,"class":43},{"id":279,"slug":280,"hasResults":12,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":57,"phases":288,"briefSummary":289,"conditions":290,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":299},"100623877","phase-2-tarlatamab-for-sclc-brain-metastases-100623877","NCT07402343","Tarlatamab for SCLC Brain Metastases","A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer","T-BRAIN","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n1. Signed and written informed consent\n2. Age 18 years or older\n3. Patients with pathology proven metastatic SCLC\n4. Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy\n5. WHO\u002FECOG PS 0-1\n6. Estimated life expectancy 12 weeks or more\n7. At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:\n\n   1. Subjects with largest measurable intracranial lesion ≥5 mm but \\\u003C10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but \\\u003C10 mm, 1.5 mm slice thickness brain MRI is required).\n   2. \"Untreated\" refers to the lesion not being previously treated with stereotactic radiosurgery\u002Ftherapy (SRS\u002FSRT) or surgery.\n   3. Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred\n8. For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent\u002Fday, dose should be noted.\n9. Adequate organ and bone marrow function, defined as:\n\n   a. Hematological function: i. Absolute neutrophil count ≥1.5 x109\u002FL ii. Platelet count ≥ 100 x109\u002FL iii. Hemoglobin ≥ 5.6 mmol\u002Fl b. Coagulation function: i. Protrombin time (PT)\u002F international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.\n\n   c. Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation \\> 30 mL\u002Fmin\u002F1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 3x ULN (or \\\u003C 5x ULN for subjects with liver metastases) ii. Total bilirubin \\\u003C 1.5x ULN (or \\\u003C 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.\n\nii. Baseline oxygen saturation \\> 90% on room air f. Cardiac function: i. Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n1. Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent\u002Fday, the patient is eligible). If in doubt, discussion with the sponsor is necessary\n2. Leptomeningeal metastases (evaluated with MRI brain)\n3. BM in eloquent area (to be discussed with neuro-oncologist)\n4. Contra-indication for MRI\n5. Prior history of severe or life-threatening events from any immune-mediated therapy\n6. Grade 2 or higher toxicity from previous systemic therapy, except for alopecia\n7. History of other malignancy within the past 2 years, with the following exceptions:\n\n   1. Malignancy treated with curative intent before enrolment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the sponsor\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   3. adequately treated cervical cancer in situ without evidence of disease\n   4. adequately treated breast ductal carcinoma in situ without evidence of disease\n   5. prostatic intraepithelial neoplasia without evidence of prostate cancer\n   6. adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ\n8. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[e.g. colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis. The following are exceptions to this criterion:\n\n   1. Subjects with vitiligo or alopecia\n   2. Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\n   3. Any chronic skin condition that does not require systemic therapy\n   4. Subjects without active disease in the last 5 years may be included but only after consultation with the sponsor\n   5. Subjects with coeliac disease controlled by diet alone\n9. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II, appendix 2), within 6 months prior to first dose of study treatment\n10. History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 6 months prior to first dose of study treatment\n11. Evidence of ILD or active, non-infectious pneumonitis\n12. History of solid organ transplant\n13. Major surgical procedures within 28 days prior to first dose of study treatment\n14. Presence of active HIV or hepatitis infection\n\n    1. HIV infection: subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of the treatment on study per local or institutional guidelines\n    2. Active hepatitis C infection (subjects with detectable hepatitis C antibody \\[HCV Ab\\] and hepatitis C virus (HCV) RNA viral load above the limit of quantification) are not allowed. Subjects with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed\n    3. Active hepatitis B infection (subjects with presence of hepatitis B surface antigen \\[HBsAg-positive\\] and hepatitis B virus (HBV) DNA viral load above the limit of quantification \\[HBV DNA positive) are not allowed. Subjects with resolved HBV infection, defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines. Subjects with inactive HBV infection inactive carrier state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with the requirement for regular monitoring for reactivation for the duration of the treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n15. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment\n\n    a. Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted during the study)\n16. Subjects with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment\n\n    a. Note: simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis, nor clinical signs of an infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n17. Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g. non-live or non-replication agent) and live viral non-replicating vaccines (e.g. Jynneos for mpox infection) within 3 days prior to first dose of study treatment\n18. Prior therapy with any selective inhibitor of the DLL3 pathway\n19. Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.\n20. Treatment in an alternative investigational trial within 28 days prior to enrollment\n21. Female subjects of childbearing potential unwilling to use protocol specified method of contraception (appendix 3) during treatment and for an additional 60 days after the last dose of tarlatamab\n22. Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab\n23. Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab\n24. Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test\n25. Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab\n26. Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab\n27. Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab\n28. Subject has known sensitivity to any of the products or components to be administered during dosing of tarlatamab.\n29. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.\n30. Subjects likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures to the best of the subject and investigators knowledge.",{"count":287,"type":21},35,[167],"A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).",[291,292],"Small Cell Lung Cancer","Brain Metastases, Adult",{"date":252,"type":36},{"date":295,"type":21},"2026-05",{"date":297,"type":21},"2030-02",{"name":42,"class":43},4,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":307,"targetDuration":4,"studyType":57,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":75},"100635695","optimal-protein-intake-to-maximize-whole-body-protein-balance-in-healthy-adults-100635695","NCT07556029","Optimal Protein Intake to Maximize Whole-Body Protein Balance in Healthy Adults","PAAKO","Inclusion Criteria:\n\n* Aged between 18-35 years\n* BMI between 18.5-30 kg\u002Fm2\n* Healthy, recreationally active (exercise at least once per two weeks and a maximum of four days per week)\n* No physical limitations (i.e., able to perform all activities associated with daily living independently)\n\nExclusion Criteria:\n\n* Smoking\n* Diagnosed musculoskeletal disorders\n* Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories, or prescribed acne medications)\n* Chronic use of gastric acid-suppressing medication or anti-coagulants\n* Unstable weight over the last three months\n* Diagnosed GI tract disorders or diseases\n* Blood donation in the past 2 months\n* Females: pregnancy",{"count":308,"type":21},12,[59],"The purpose of this study is to assess the optimal protein intake to maximize whole-body protein net balance in healthy adults. In a randomized, double-blinded, crossover design, 12 young, healthy adult males and females aged 18-35 years, will consume a test diet consisting of free amino acid mixtures based on milk protein that vary in protein content 7 separate acute metabolic trials. The main study endpoint is optimal protein intake based on the lowest protein intake that maximizes whole-body protein net balance.",[62],"2026-04-21",{"date":314,"type":36},"2026-04-29",{"date":316,"type":21},"2026-08-01",{"date":318,"type":21},"2027-04-01",{"name":42,"class":43},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":325,"eligibilityCriteria":267,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":326,"targetDuration":4,"studyType":57,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":75},"100635014","amino-acid-oxidation-of-whole-food-protein-a-dose-response-crossover-trial-in-young-adults-100635014","NCT07547176","Amino Acid Oxidation of Whole-Food Protein: a Dose-Response Crossover Trial in Young Adults","BURGER",{"count":327,"type":21},20,[59],"The purpose of this study is to assess the amino acid oxidation dose-response relationship of ingested whole-food protein in healthy adults. In a randomized, crossover design, 20 young, healthy adult males and females aged 18-35 years, will consume a dinner consisting of 0.32, 0.74, and 1.32 g protein･kg BM-1 (corresponding to 1, 2, and 4 minced beef patties, respectively) during 3 separate experimental trials.The main study endpoint is the amino acid oxidation of ingested protein over a 24-h period.",[62],"2026-04-20",{"date":252,"type":36},{"date":334,"type":36},"2025-11-01",{"date":336,"type":21},"2027-03-01",{"name":42,"class":43},{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":344,"eligibilityCriteria":345,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":348,"conditions":349,"keywords":357,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":75},"100631522","real-world-evaluation-of-the-implementation-of-lc-oct-in-daily-clinical-practice-100631522","NCT07501780","Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice","Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice: a Retrospective Observational Study","RELI","Inclusion Criteria:\n\n* Patients aged ≥18 years\n* LC-OCT performed as part of diagnostic evaluation between January 2025 and June 2025 at Mohs clinics in the Netherlands\n* Histopathological results (biopsy or excision) and\u002For 6-12 month clinical follow-up data available\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years of age\n* Cases without histopathological confirmation or available follow-up data",{"count":347,"type":21},297,"Basal cell carcinoma (BCC) is the most common skin cancer in the Netherlands, with incidence rates continuing to rise. The current diagnostic standard combines clinical evaluation and dermoscopy, while biopsy followed by histopathological examination remains the gold standard when uncertainty about the diagnosis persists. However, biopsy is invasive, time-consuming, and costly. Line-field confocal optical coherence tomography (LC-OCT) is a non-invasive imaging technique that has emerged as a promising alternative to biopsy for BCC suspected lesions.\n\nThis retrospective study aims to evaluate the real-world clinical performance of LC-OCT in routine dermatological practice, where it has been integrated into the diagnostic work-up for BCC-suspect lesions.",[350,351,352,353,354,355,356],"Basal Cell Carcinoma of Skin","Optical Coherence Tomography (OCT)","Neoplasms","Neoplasms, Basal Cell","Carcinoma, Basal Cell (BCC)","Real-world Study","Implementation",[358,359,360],"Line-Field Optical Coherence Tomography","Real-world evaluation","Non-melanoma skin cancer","2026-03-24",{"date":363,"type":36},"2026-03-30",{"date":365,"type":21},"2026-03-15",{"date":367,"type":21},"2027-12-01",{"name":42,"class":43},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":53,"sex":17,"minAge":377,"maxAge":378,"enrollmentInfo":379,"targetDuration":4,"studyType":57,"phases":381,"briefSummary":382,"conditions":383,"keywords":393,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":75},"100625406","long-term-effects-of-walnut-consumption-on-brain-function-100625406","NCT07422220","Long-Term Effects of Walnut Consumption on Brain Function","Long-Term Effects of Walnut Consumption on Brain Function in Men and Women With Abdominal Obesity","WalBrain","Inclusion Criteria:\n\n* Men and women, aged between 45-75 years\n* Women postmenopausal: two or more years after last menstruation\n* Waist circumference of ≥102 cm for men and ≥88 cm for women (abdominal obesity)\n* Fasting plasma glucose \\\u003C 7.0 mmol\u002FL\n* Fasting serum total cholesterol \\\u003C 8.0 mmol\u002FL\n* Fasting serum triacylglycerol \\\u003C 4.5 mmol\u002FL\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg\n* Stable body weight (weight gain or loss \\\u003C 3 kg in the past three months)\n* Willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study\n* No difficult venipuncture as evidenced during the screening visit\n\nExclusion Criteria:\n\n* Allergy or intolerance to walnuts\n* Left-handedness (effects on brain function differ between left- and right-handed adults)\n* Current smoker, or smoking cessation \\\u003C 12 months\n* Diabetic patients\n* Familial hypercholesterolemia\n* Abuse of drugs\n* More than 3 alcoholic consumptions per day\n* Use of products or dietary supplements (e.g., dietary fiber or antioxidant dietary supplements (vitamin C and E), fish or seaweed oil capsules) known to interfere with the main outcomes as judged by the principal investigators\n* Use of medication to treat blood pressure, lipid, or glucose metabolism\n* Use of an investigational product within another biomedical intervention trial within the previous 1-month\n* Severe medical conditions that might interfere with the study, such as epilepsy, asthma, kidney failure or renal insufficiency, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases, and rheumatoid arthritis\n* Active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebrovascular accident\n* Contra-indications for MRI imaging (e.g., pacemaker, surgical clips\u002Fmaterial in body, metal splinter in eye, claustrophobia)","45 Years","75 Years",{"count":380,"type":21},55,[59],"Rationale: Healthy foods, including mixed nuts, may improve brain function, which is essential for cognitive and metabolic health, and may contribute to improved food intake regulation. It is therefore important to investigate the specific effects of walnuts on cerebral blood flow responses before and after intranasal insulin administration, as well as their associated functional benefits. The investigators hypothesize that long-term walnut consumption improves vascular function and insulin-sensitivity in the brain, thereby enhancing cognitive performance and appetite control in abdominally obese men and women. Objective: The primary objectives are to investigate in abdominally obese adults the effects of 24-week walnut consumption on (regional) vascular function and insulin-sensitivity in the brain, while the investigators will also assess changes in cognitive performance and appetite-related brain reward activity (secondary objectives). Cerebral blood flow responses before (brain vascular function) and after the administration of intranasal insulin spray (brain insulin-sensitivity) will be quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL). Study design: This intervention study will have a randomized, controlled parallel design. The total study duration will be 24 weeks. Study population: Fifty-five abdominally obese men and (postmenopausal) women (aged 45-75 years) without a history of cardiovascular diseases or complaints will participate. This study population is expected to have a decreased cerebral blood flow at baseline and are also at increased risk of cognitive impairment, allowing for improvement by the intervention. Intervention: Study participants will receive daily 50 g (about 15% of energy) of raw walnuts (walnut intervention) or no walnuts (control intervention) for 24 weeks. Main study parameters\u002Fendpoints: At baseline and after 24 weeks (follow-up), participants will visit the research facilities for assessments. The primary endpoint is the difference in the cerebral blood flow response before and after intranasal insulin administration between the walnut and control intervention. Cognitive performance will be assessed, while the investigators will also focus on appetite-related brain reward activity (secondary outcomes).",[384,385,386,387,388,389,390,391,392],"Healthy","Brain Insulin Sensitivity","Cerebral Blood Flow","Brain Vascular Function","Satiety and Food Intake","Food Reward","Cognitive Performance","Abdominal Obesity","Cognitive Decline",[394,395,396,397,398,399,400,401,402,403,404,405,406,407],"Walnuts","Juglans","Brain vascular function","Brain insulin sensitivity","Satiety","Food reward mechanisms","Cognitive performance","Abdominal obesity","Cognitive decline","pCASL MRI","fMRI","CANTAB","Intranasal insulin","Food cues","2026-02-18",{"date":410,"type":36},"2026-02-19",{"date":412,"type":21},"2026-02",{"date":414,"type":21},"2027-08",{"name":42,"class":43},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":420,"acronym":4,"eligibilityCriteria":421,"healthyVolunteers":53,"sex":17,"minAge":422,"maxAge":423,"enrollmentInfo":424,"targetDuration":4,"studyType":57,"phases":426,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":75},"100623387","the-effects-of-a-4-week-supplementation-with-a-ketogenic-nutrient-mix-on-24-hour-substrate-metabolism-and-muscle-health-100623387","NCT07395973","The Effects of a 4-week Supplementation With a Ketogenic Nutrient Mix on 24-hour Substrate Metabolism and Muscle Health","Inclusion Criteria:\n\n* Aged 60-80 years\n* Body mass index (BMI) 25-35 kg\u002Fm2\n* Sedentary lifestyle (not more than 2 hours of structured physical activity per week in the past 3 months)\n* Stable dietary habits (no weight loss or gain \\> 5 kg in the past 3 months)\n* Healthy (as determined by dependent physician based on medical questionnaire)\n* Regular sleeping habits (7-9h of daily sleep)\n\nExclusion Criteria:\n\n* Type 2 diabetes\n* Participants with active congestive heart failure and\u002For severe renal and or liver insufficiency\n* Uncontrolled hypertension\n* Alcohol consumption of \\>3 servings per day for men and \\>2 servings per day for women\n* Unstable body weight (weight gain or loss \\> 5 kg in the last 3 months) or intention to lose weight\n* Participants who are on an intermittent fasting diet\n* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results\n* Significant food allergies\u002Fintolerance (seriously hampering study meals or study product)\n* Participants who do not want to be informed about unexpected medical findings\n* Blood donation during or within 2 months prior to the study\n* Disturbances in circadian rhythm determined with the follow criteria:\n* Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)\n* Heavily varying sleep-wake rhythm\n* Night shift work during last 3 months\n* Travel across \\> 1 time zone in the last 3 months\n* High daily caffeine intake \\> 400mg (more than 4 cups of coffee or energy drinks)","60 Years","80 Years",{"count":425,"type":21},14,[59],"This study will investigate the effect of providing a daily ketogenic nutritional supplement in the evening for a prolonged time (4 weeks) to induce a mild ketogenic state during the night in healthy elderly (60-80 years), overweight\u002Fobese (BMI: 25-35 kg\u002Fm2) individuals with low physical activity, on 24h rhythmicity in energy metabolism as compared to a non-ketogenic, isocaloric control.",[429],"Overweight and Obesity","2026-02-03",{"date":432,"type":36},"2026-02-09",{"date":434,"type":36},"2025-11-25",{"date":436,"type":21},"2027-10-31",{"name":42,"class":43},{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":53,"sex":17,"minAge":445,"maxAge":378,"enrollmentInfo":446,"targetDuration":4,"studyType":57,"phases":448,"briefSummary":449,"conditions":450,"keywords":454,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":179},"100587073","targeted-precision-nutrition-strategy-to-prevent-chronic-metabolic-diseases-100587073","NCT06923644","Targeted Precision Nutrition Strategy To Prevent Chronic Metabolic Diseases","PRECINUT","Inclusion Criteria:\n\n* Men and women with a BMI ≥25 to \\\u003C40 kg\u002Fm2\n* Classification possible to one of the investigational metabolic phenotypes according to the classification algorithm.\n* Weight stability for at least 3 months (+\u002F- 3 kg)\n\nExclusion Criteria:\n\nDiseases\n\n* (Pre-)diagnosis of type 1 or type 2 diabetes mellitus (i.e., FPG ≥ 7,0 mmol\u002FL) and HbA1c ≥ 6,5% (48 mmol\u002Fmol)\n* Renal or hepatic malfunctioning (pre-diagnosis or determined based on ALAT and creatinine values)\n* Gastrointestinal diseases or abdominal surgery (allowed i.e.:\n\nappendectomy, cholecystectomy)\n\n* Food allergies, intolerances (including gluten\u002Flactose intolerance) and\u002For eating disorders interfering with the study\n* Cardiovascular diseases (e.g., heart failure) or cancer (e.g., noninvasive skin cancer allowed)\n* High systolic blood pressure (untreated \\>160\u002F100 mmHg, drug-regulated \\>140\u002F90 mmHg)\n* Diseases affecting glucose and\u002For lipid metabolism (e.g., pheochromocytoma, Cushing's syndrome, acromegaly)\n* Diseases with a life expectation shorter than 5 years\n* Major mental disorders\n* Drug treated thyroid diseases (well substituted hypothyroidism is allowed inclusion)\n* Other physical\u002Fmental conditions that may interfere with study outcomes\n\nMedication\n\n* Medication known to interfere with study outcomes (e.g., PPAR-α or PPAR-γ agonists (fibrates), sulfonylureas, biguanides, α-glucosidaseinhibitors, thiazolidinediones, repaglinide, nateglinide, insulin, and chronic use of NSAIDs)\n* Use of certain anticoagulants other than acetylsalicylic acid\n* Use of antidepressants (stable use ≥ 3 months prior to and during study allowed)\n* Use of statins (stable use ≥ 3 months prior to and during study allowed)\n* Chronic corticosteroids treatment (\\>7 consecutive days of treatment)\n* Use of antibiotics within 3 months prior to the study\n\nLifestyle\n\n* Participation in regular sports activities (moderate-to-vigorous physical exercise \\>4 hours per week)\n* Having a restricted dietary pattern interfering with the study diets (e.g., vegetarian, vegan, Atkins diet and\u002For other special diets)\n* Plans to lose or gain more than 5% body weight\n* Abuse of alcohol (alcohol consumption \\>14 units\u002Fweek) and\u002For drugs (cannabis included)\n* Not willing to limit alcohol consumption to 7 drinks per week\n* Regular smoking (including use of e-cigarettes and vapes)\n* Use of strong vitamins or other dietary supplements (e.g., pre- or probiotics) expected to interfere with the study outcomes\n\nOther\n\n* Metabotype classification is not possible\n* Pregnant or lactating women, or women who are planning to become pregnant\n* Inability to comply with the study diet\n* Blood donation within the last 3 months\n* Participation in possibly interfering studies within the last 3 months\n* Inability to understand study information and\u002For communicate with staff\n* Unwillingness to be randomised or sign informed consent\n* Unwillingness to save data for 15 years\n* Deemed unsuitable for participation in the trial, for any reason, as judged by the research physician or principal investigator","40 Years",{"count":447,"type":21},240,[59],"Nutrition is very important to keep blood sugar levels balanced. If blood sugar levels are too high, it can lead to diseases such as cardiovascular disease and type 2 diabetes (T2DM). Therefore, adjusting what one eats, also called a diet or nutritional intervention, can help prevent these diseases. However, not everyone responds the same to a diet. In about 30% of people, a diet does not work as hoped. This can be due to various reasons, such as a person's metabolism, genetic predisposition, the composition of the food one eats, or the bacteria in the intestines. Everyday things like sleep, stress, and movement also play a role. The investigators used a computer model to classify people with overweight and obesity into groups based on these factors. The investigators call such a group a 'Metabolic Phenotype', or in short 'Metabotype'. Based on the Metabotype, a personalised diet was developed (personalised nutrition intervention) that may better suit each person's unique situation.\n\nThe investigators hypothesize that a precision nutrition intervention, tailored to Metabotypes identified through unsupervised clustering (using the aforementioned computer model) of predefined, accurate features related to cardiometabolic health-specifically, tissue-specific glucose and lipid metabolism and detailed body composition-will enhance blood glucose homeostasis, reduce cardiometabolic risk, and improve adherence to the intervention and mental well-being, compared to population-based dietary guidelines. The present project will contribute to targeted and efficient precision-based dietary strategies for individuals at increased risk of T2DM.",[451,452,453],"Obesity and Overweight","Pre-diabetic","Type 2 Diabetes Mellitus (T2DM)",[455,456,457,458,459,460,461,462,463],"Dietary intervention trial","Precision nutrition","Tissue-specific insulin resistance","Body composition","Metabotyping","Glucose homeostasis","Cardiometabolic health","Insulin resistance","Metabolic phenotype","2026-01-15",{"date":466,"type":36},"2026-01-20",{"date":468,"type":36},"2025-04-23",{"date":470,"type":21},"2027-04",{"name":42,"class":43},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":480,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":57,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":75},"100547348","the-impact-of-physical-activity-versus-dietary-energy-restriction-on-tumour-and-muscle-protein-synthesis-in-prostate-cancer-patients-100547348","NCT06406803","The Impact of Physical Activity Versus Dietary Energy Restriction on Tumour and Muscle Protein Synthesis in Prostate Cancer Patients","The Impact of Physical Activity Versus Dietary Energy Restriction on Prostate Tumour and Muscle Tissue Protein Synthesis in Vivo in Prostate Cancer Patients","DIRECT","Inclusion Criteria:\n\n* Diagnosed with prostate cancer (Stages I-III)\n* Scheduled to undergo a prostatectomy\n* BMI between 18.5-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Receiving pre-operative chemo, hormonal, radio therapy\n* Physically unable to perform the exercise program\n* Performing \\>300 min of moderate-vigorous physical activity per week (e.g., running, road cycling, swimming).","MALE",{"count":482,"type":21},45,[59],"Background: Prostate cancer is the second most common cancer and the fifth leading cause of death in men worldwide. Tumour growth is attributed to disproportionately greater protein synthesis rates relative to protein breakdown rates. Tumour protein synthesis is modulated by several factors, including energy availability, blood flow, and hormone concentrations (e.g., IGF-1). Lifestyle modifications are rapidly becoming recognized as important adjunct therapeutic approaches to slow cancer development and enhance treatment efficacy. Dietary energy restriction is a 30-50% reduction in food intake, which induces an energy deficit and has been shown to attenuate tumour growth in rodent models. Muscle mass often declines during cancer treatment and negatively impacts treatment success rates and recovery. One drawback to dietary energy restriction is that it may accelerate declines in skeletal muscle mass and strength in cancer patients. Exercise also induces an energy deficit by increasing energy expenditure. In addition, exercise alters blood flow and releases circulating molecules, which appear to lower tumour protein synthesis rates. Exercise increases muscle protein synthesis rates, which would provide further benefits to cancer patients by helping to maintain skeletal muscle mass. Despite their promising therapeutic properties, the clinical efficacy of dietary energy restriction and exercise has not been directly determined in vivo in cancer patients.\n\nHypothesis and Objectives: The objective of this study is to compare the impact of dietary energy restriction versus (isocaloric) daily exercise on muscle, prostate, and prostate tumour protein synthesis rates over a 7-day period in vivo in prostate cancer patients.\n\nIt is hypothesized that 1) dietary energy restriction will lower both prostate tumour and muscle tissue protein synthesis rates and that 2) daily exercise will lower prostate tumour protein synthesis rates but increase muscle protein synthesis rates in prostate cancer patients.\n\nSetting and Methods: Forty-five prostate cancer patients scheduled to undergo radical prostatectomy will be randomly assigned to one of three groups. The first group will undergo 7 days of dietary energy restriction (40% less food intake). The second group will perform 7 days of daily exercise and mild dietary energy restriction resulting in a total energy deficit of 40%. The third group will follow their regular diet and physical activity (control group). The research team will provide all aspects of the intervention (standardized meals, personalized exercise supervision). Patients will ingest deuterium-labelled water (2H2O) throughout the intervention period. After 7 days, patients will undergo a radical prostatectomy, during which tumour tissue, skeletal muscle tissue, and blood will be collected. Deuterium (2H-alanine) incorporation into the tissue samples will be measured to assess prostate tumour and skeletal muscle tissue protein synthesis rates.",[486],"Cancer of Prostate",{"date":488,"type":36},"2026-01-16",{"date":490,"type":36},"2024-10-12",{"date":412,"type":21},{"name":42,"class":43},{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":4,"eligibilityCriteria":499,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":500,"targetDuration":4,"studyType":57,"phases":502,"briefSummary":503,"conditions":504,"keywords":510,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":44},"100522417","the-n-lva-study-rct-comparing-lva-vs-sham-surgery-in-cancer-related-lymphedema-100522417","NCT06082349","The N-LVA Study: RCT Comparing LVA vs. Sham Surgery in Cancer-related Lymphedema","Effectiveness and Cost-effectiveness of Lymphaticovenous Anastomosis for Cancer Patients Who Suffer From Chronic Peripheral Lymphedema: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Treated for cancer and underwent treatment of either axillary or inguinal lymph nodes or radiotherapy;\n* Early stage lymphedema (ISL I-II) in the upper or lower extremity, and diagnosed by lymphoscintigraphy for the lower extremity;\n* Unilateral lymphedema;\n* Viable lymphatic vessels as determined by indocyanine green (ICG)Lymphography (stage II-III);\n* Refractory lymphedema that underwent at least three months of conservative treatment;\n* Informed consent.\n\nExclusion Criteria:\n\n* History of lymphatic reconstruction in the past 10 years;\n* Late-stage lymphedema of the extremity (ISL classification ≥ II lymphedema) with evident fat deposition and\u002For fibrosis;\n* Patients with active distant metastases, treated with palliative intent;\n* Patients with the active treatment of primary cancer, i.e. surgery, radiotherapy, and\u002For chemotherapy. Note: patients receiving adjuvant targeted and\u002For endocrine treatment are eligible;\n* Edema due to venous insufficiency, evaluated by venous duplex ultrasound of the deep and superficial venous system;\n* Active infection in the lymphedematous extremity;\n* Bilateral lymphedema;\n* Lymphedema present in genital or breast area only;\n* Primary lymphedema;\n* Non-viable lymphatic system as determined by ICG Lymphography (stages IV and V).",{"count":501,"type":21},110,[59],"The goal of this randomized controlled trial is to compare the effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) with sham surgery for patients suffering from unilateral cancer-related lymphedema in either the upper or lower extremity. It aims to answer whether LVA is more effective than sham surgery in terms of improvement in Lymph-ICF score.\n\nA total of 110 participants will be allocated randomly into two groups at a 1:1 ratio. The first group will receive lymphaticovenous anastomosis (LVA), while the second group will undergo sham surgery.",[505,506,507,508,509],"Lymphedema, Secondary","Lymphedema of Upper Limb","Lymphedema, Lower Limb","Lymphedema Arm","Lymphedema of Leg",[511,512,513,514],"Lymphaticovenous anastomosis","Sham surgery","Microsurgery","LVA",{"date":488,"type":36},{"date":517,"type":36},"2023-12-18",{"date":519,"type":21},"2029-03-01",{"name":42,"class":43},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":53,"sex":17,"minAge":445,"maxAge":378,"enrollmentInfo":528,"targetDuration":4,"studyType":57,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":541,"locationsCount":75},"100620260","high-dairy-food-patterns-and-gut-brain-axis-100620260","NCT07355309","High-Dairy Food Patterns and Gut-Brain Axis","Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity","Inclusion Criteria:\n\n* Men and postmenopausal women (≥ 2 years since last menstruation);\n* Aged between 40-75 years;\n* BMI between 25-35 kg\u002Fm2 (overweight or obese);\n* Low-to-moderate habitual dairy consumption (≤ 3 servings\u002Fday);\n* Fasting serum total cholesterol \\\u003C 8.0 mmol\u002FL;\n* Fasting serum triacylglycerol \\\u003C 4.5 mmol\u002FL;\n* Fasting plasma glucose \\\u003C 7.0 mmol\u002FL;\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg;\n* Stable body weight (weight gain or loss \\\u003C 3 kg in the past three months).\n\nExclusion Criteria:\n\n* Left-handedness;\n* Milk protein allergy or lactose intolerance;\n* Current smoker, or smoking cessation \\\u003C 12 months;\n* Familial hypercholesterolemia;\n* Abuse of drugs;\n* Alcoholic intake \\>3 standard drinks\u002Fday;\n* Use of medications, food products or dietary supplements affecting glucose, lipid, or blood pressure regulation, gut microbiota or mental or neurological function, judged by the principal investigator;\n* Use of antibiotics within the previous month;\n* Use of other biomedical investigational products within the previous month;\n* Participation in another clinical trial within the past month;\n* Severe medical conditions including type 2 diabetes, epilepsy, asthma, kidney failure, COPD, inflammatory bowel disease, autoimmune diseases, or rheumatoid arthritis;\n* History of cardiovascular events (e.g., heart attack, stroke) or active cardiovascular disease;\n* Contra-indications for MRI imaging (e.g. pacemaker, metal implants, claustrophobia);\n* Willing to donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion;\n* Difficult to venipuncture as evidenced during the screening visit.",{"count":529,"type":21},40,[59],"Disturbances in brain insulin sensitivity are associated not only with obesity and type 2 diabetes, but also with brain aging and cognitive decline. Longitudinal studies suggest that dietary patterns, particularly those high in dairy intake, may impact brain function via the gut-brain axis. Indeed, dairy foods are known to modulate gut microbiota and may, through this pathway, not only improve brain insulin sensitivity and cognitive performance, but also mental health and appetite regulation. However, underlying mechanisms remain largely unexplored. The primary objective of this study is to evaluate, in older adults with overweight or obesity, the effects of a high-dairy food pattern (4-5 daily servings of (butter)milk, cheese, yogurt, or cottage cheese) compared to a low-dairy food pattern (≤1 serving daily) on (regional) brain vascular function and insulin sensitivity. These outcomes will be quantified using the non-invasive MRI perfusion technique Arterial Spin Labeling (ASL), which assesses cerebral blood flow (CBF) in response to intranasal insulin, a validated physiological marker of brain insulin sensitivity. Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). Exploratory analyses include conventional cardiometabolic risk markers (blood pressure, lipid and glucose metabolism), and perceivable (consumer) benefits.",[385,387,386,390,533,534],"Appetite Control","Gut Microbiota","2026-01-12",{"date":537,"type":36},"2026-01-21",{"date":539,"type":21},"2025-12-22",{"date":318,"type":21},{"name":42,"class":43},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":550,"targetDuration":4,"studyType":57,"phases":552,"briefSummary":553,"conditions":554,"keywords":557,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":568,"locationsCount":75},"100569895","frequency-of-interrupting-sitting-and-cognitive-function-100569895","NCT06700187","Frequency of Interrupting Sitting and Cognitive Function","Effects of Sitting Interruption Frequency on Cognitive Function and Glucose Metabolism: A Randomized, Controlled Cross-over Study Involving Young Sedentary Adults","FISCF","Inclusion Criteria:\n\n* Men and women aged 18-35 years;\n* BMI between 18.5-24.9 kg\u002Fm2;\n* SB, i.e. sitting for an average of at least 9 hours per day;\n* Physically inactive, i.e. engaging in exercise for less than 2 to 3 times per week;\n* Stable body weight (weight gain or loss \\\u003C 3 kg in the past three months);\n* Willingness to engage in four 6-hour laboratory visits;\n* No difficult cannulation.\n\nExclusion Criteria:\n\n* Not sedentary, i.e. sitting for less than an average of 9 hours per day;\n* Physically active, i.e. engaging in exercise for more than 3 times a week;\n* Abuse of drugs;\n* Use medication to treat BP, lipid, or glucose metabolism;\n* Pregnant females.",{"count":551,"type":21},33,[59],"Rationale: Sedentary behavior (SB) has been associated with impaired cognitive function in elderly, and negatively impacts glucose metabolism. Interrupting sitting with physical activity (PA) bouts may exert beneficial effects on cognitive function via an improved glucose metabolism. Nevertheless, the impact of breaking up prolonged sitting with various frequencies of PA bouts remains unexplored in young sedentary adults. Moreover, we hypothesize that the pattern of the breaks modifies the effects. Thus, randomized controlled trials (RCTs) are highly needed to investigate the effects of interrupting sitting with different frequencies of PA on cognitive function and glucose metabolism. We now hypothesize that interrupting sitting with different frequencies of walking breaks differentially affects cognitive function and glucose metabolism.\n\nObjective: The aim is to investigate the effects of breaking up sitting with different frequencies of PA bouts on cognitive function and glucose metabolism in young sedentary adults.\n\nStudy design: A randomised, controlled cross-over study will be performed, consisting of four interventions in a counterbalanced order: uninterrupted prolonged sitting, short breaks, moderate breaks, and long breaks.\n\nIntervention: Participants will complete four conditions in a randomized, counterbalanced order: sitting (uninterrupted prolonged sitting without any interruptions), short breaks (walk 1 minute every 10 minutes), moderate breaks (walk 3 minutes every 30 minutes), and long breaks (walk 27 minutes during the intervention). Each condition lasts 4.5 hours.",[555,556],"Sedentary Behaviors","Breaking Prolonged Sitting With Physical Activity",[558,559,560,561],"Sedentary behavior","sitting interruptions","cognition","glucose metabolism",{"date":563,"type":36},"2026-01-14",{"date":565,"type":36},"2024-10-03",{"date":567,"type":21},"2026-03-27",{"name":42,"class":43},{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":575,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":57,"phases":579,"briefSummary":580,"conditions":581,"keywords":586,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":601,"leadSponsor":603,"locationsCount":299},"100615035","optimal-cerebral-perfusion-pressure-guided-therapy-assessment-of-target-effectiveness---ii-100615035","NCT07287358","Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II","CPPopt Guided Therapy: Assessment of Target Effectiveness - II","Cogitate II","Inclusion Criteria:\n\n* Adult (\\>18 years old)\n* Severe TBI requiring ICP-directed therapy for at least 24 hrs on the assessment of the recruiting intensive care team and\u002For attending neurosurgeon\n* Start randomization within 24 hrs after ICU admission.\n\nExclusion Criteria:\n\n* Known pregnancy\n* Moribund at presentation (e.g. bilaterally absent pupillary responses)\n* Patients with a primary decompressive craniectomy\n* Failure to get final written informed consent",{"count":578,"type":21},60,[59],"After severe traumatic brain injury, adequate blood flow to the brain is essential for recovery. This depends on arterial blood pressure, yet intensive care units apply fixed targets to all patients - treating every brain and patient the same. This study aims to change that. With new technology, 'optimal' blood pressure can be determined for each individual brain and treatment can be tailored accordingly. This personalized approach to neurocritical care has never been tested in a randomized controlled study before. If effective in showing reduced brain damage biomarkers, it will fundamentally transform brain injury treatment and dramatically improve recovery outcomes for patients worldwide.",[582,583,584,585],"Traumatic Brain Injury","Severe Traumatic Brain Injury","Intracranial Pressure","Cerebral Perfusion Pressure",[587,588,589,590,591,592,593,594,595,596],"CPPopt","optimal cerebral perfusion pressure","pressure reactivity index","PRx","Intracranial pressure","cerebral perfusion pressure","traumatic brain injury","severe traumatic brain injury","cogitate","cogitate-II","2025-12-31",{"date":599,"type":36},"2026-01-06",{"date":256,"type":21},{"date":602,"type":21},"2028-05-15",{"name":42,"class":43},{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":612,"targetDuration":4,"studyType":57,"phases":613,"briefSummary":614,"conditions":615,"keywords":617,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":75},"100614532","nutritional-and-physical-intervention-during-bed-rest-100614532","NCT07280819","Nutritional and Physical Intervention During Bed Rest","The Impact of Protein Source and Neuromuscular Electrical Stimulation on Muscle Protein Synthesis During Bed Rest","Bed-Plant","Inclusion Criteria:\n\n* Healthy (assessed based on routine medical questionnaire)\n* Male and female sexes\n* Aged between 18 and 35 years inclusive\n* BMI between 18.5 and 30.0 kg\u002Fm²\n\nExclusion Criteria:\n\n* Vegan diet\n* Allergies or intolerance to cow's milk products, fish, soy, and\u002For pea protein\n* Galactosemia\n* Smoking on a weekly basis (i.e., every week)\n* Diagnosed diabetes mellitus\n* Chronic corticosteroid use\n* Severe kidney and\u002For liver failure\n* Dialysis\n* Bleeding disorders, including anticoagulant and antiplatelet therapy\n* Currently pregnant",{"count":327,"type":21},[59],"Hospitalization often involves long periods of bed rest and reduced nutritional intake, which can lead to skeletal muscle loss and anabolic resistance. These effects slow recovery and increase the risk of complications, long-term disability and healthcare costs. Animal-based proteins are effective at stimulating muscle protein synthesis (MPS) because they contain all essential amino acids and have high bioavailability, but they are less sustainable. Plant-based proteins are more environmentally friendly but may be less effective for MPS due to lower essential amino acid content and lower digestibility. Combining different plant proteins may improve their quality, yet their impact during bed rest is still unclear. Neuromuscular electrical stimulation (NMES) may help counteract anabolic resistance by mimicking exercise, but its long-term effects in bedridden individuals are not well studied.\n\nThis prospective, randomized, controlled trial aims to assess the effects of a nutritional intervention (plant-dominant versus dairy-based protein) and a physical stimulus (NMES versus non-NMES) on MPS during 4 days of bed rest in healthy young adults.",[616],"Muscle Protein Synthetic Response to Protein",[618,619,620],"muscle biopsy","tracer methodology","NMES","2025-12-10",{"date":623,"type":36},"2025-12-12",{"date":625,"type":21},"2026-01",{"date":627,"type":21},"2029-01",{"name":42,"class":43},{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":57,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":647,"locationsCount":75},"100612650","measuring-total-energy-expenditure-in-critically-ill-patients-using-the-doubly-labelled-water-method-100612650","NCT07256340","Measuring Total Energy Expenditure in Critically Ill Patients Using the Doubly Labelled Water Method","IC-TEE","Inclusion Criteria:\n\n* Admitted to the ICU of Jessa Hospital\n* Male and female sexes\n* Age: \\> 18 years old\n* Expected ICU stay of 5 days or more\n\nExclusion Criteria:\n\n* Dialysis",{"count":637,"type":21},50,[59],"Critically ill patients, such as those with trauma or sepsis, experience high rates of malnutrition (up to 75%). Malnutrition worsens outcomes by increasing infection rates, hospital stays, mortality, and healthcare costs. Adequate nutrition is therefore crucial in the ICU. To ensure appropriate nutrition, accurate determination of total energy expenditure (TEE) is essential. In practice, predictive equations are often used, but these can misestimate TEE in ICU patients due to complex metabolic changes. Indirect calorimetry is recommended but limited by technical constraints. Consequently, the doubly labeled water (DLW) method, though expensive, offers a precise and non-invasive way to measure TEE over time.\n\nThis study applies the DLW method in ICU patients to improve energy assessment and guide personalized nutrition strategies that support recovery and outcomes.",[641],"Critical Illness","2025-12-03",{"date":621,"type":36},{"date":645,"type":36},"2025-12-01",{"date":104,"type":21},{"name":42,"class":43},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":654,"eligibilityCriteria":655,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":57,"phases":658,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":75},"100570976","enhanced-protein-intake-to-support-muscle-protein-synthesis-in-icu-100570976","NCT06714240","Enhanced Protein Intake to Support Muscle Protein Synthesis in ICU","Increased Protein Amount as a Nutritional Strategy to Enhance Muscle Protein Synthesis in ICU Patients","IPA-IC","Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Suitability for enteral nutrition (i.e., no GI failure, absence of complete intestinal obstruction, no major intra-abdominal sepsis)\n* Expected mechanical ventilation of minimal three days\n* Expected ICU stay of at least seven days\n\nExclusion Criteria:\n\n* BMI ≥ 40 kg\u002Fm²\n* Spinal cord injury\n* Chronic corticosteroid use before hospital admission\n* severe allergies or intolerances (e.g., to cow's milk protein, fish, soy, pea protein or galactosemia)\n* Severe kidney and\u002For liver failure\n* Requirements for dialysis\n* Bleeding disorders, including anticoagulant and antiplatelet therapy",{"count":657,"type":21},26,[59],"Rationale - Critically ill patients often experience severe skeletal muscle wasting due to an imbalance between muscle protein synthesis (MPS) and degradation, contributing to long-term impairments such as ICU-acquired weakness (ICU-AW) and post-intensive care syndrome (PICS). Effective interventions to mitigate muscle wasting remain a critical unmet need. Protein intake has been identified as a potential modulator of MPS, but anabolic resistance and conflicting evidence regarding optimal protein intake necessitate further investigation.\n\nObjective\u002FHypothesis - This study aims to evaluate the effect of a normal (target: 0.8 g protein\u002Fkg\u002Fday) versus elevated (target: 1.3 g protein\u002Fkg\u002Fday) protein intake on MPS rates over four days in critically ill patients.\n\nPopulation - 26 critically ill patients who are suitable for enteral nutrition, mechanically ventilated (min 3 days), and stay at the ICU for at least 7 days will be included.\n\nMethod: Patients are randomly assigned to two groups (normal or higher protein intake). Muscle biopsies and blood samples will be collected to assess muscle protein synthesis rates.",[641,616],{"date":621,"type":36},{"date":663,"type":36},"2025-09-01",{"date":665,"type":21},"2028-09",{"name":42,"class":43},{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":53,"sex":17,"minAge":18,"maxAge":445,"enrollmentInfo":673,"targetDuration":4,"studyType":57,"phases":675,"briefSummary":676,"conditions":677,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":679,"lastUpdatePostDateStruct":680,"startDateStruct":682,"completionDateStruct":683,"leadSponsor":685,"locationsCount":75},"100611793","protein-intake-distribution-to-support-muscle-anabolism-in-healthy-young-adults-100611793","NCT07245199","Protein Intake Distribution to Support Muscle Anabolism in Healthy Young Adults","Inclusion Criteria:\n\n* Aged between 18-40 years\n* Healthy\n* 18.5 ≤ BMI 30 ≤ kg・m-2\n\nExclusion Criteria:\n\n* Smoking\n* Sports\u002Fexercise \\>4 sessions\u002Fweek or a structured resistance or endurance training schedule\n* Lactose intolerant or allergies to milk protein\n* A history of neuromuscular problems\n* Use of anticoagulation medication\n* Individuals on any medications known to affect protein metabolism (i.e. , non-steroidal anti-inflammatories, or prescription acne medications).\n* Strict vegetarian\n* Injury or condition that would limit the participant from performing the resistance exercise.\n* Pregnancy\n* Hormone replacement therapy\n* Blood donation within the past 2 months",{"count":674,"type":21},36,[59],"The purpose of the study is to evaluate whether the distribution pattern of daily protein intake affects how much muscle protein can be built in the muscle after resistance exercise and at rest.",[678],"No Condition, Healthy Individuals","2025-11-20",{"date":681,"type":36},"2025-11-24",{"date":625,"type":21},{"date":684,"type":21},"2027-01-01",{"name":42,"class":43},""]