[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ziekenhuis Oost-Limburg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":467},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,42,76,104,131,159,190,224,252,275,296,320,348,372,392,418,439],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100633656","protein-provision-in-critical-illness--2-100633656",false,"NCT07529522","PRotEin Provision in Critical IllneSs -2","The Impact of Low Versus Standard Enteral Protein Provision on Health-related Quality of Life Following Intensive Care Admission: a Randomised Controlled, Multicentre, Parallel Group Trial in Mechanically Ventilated, Critically Ill Patients","PRECISe-2","Inclusion Criteria:\n\n* Adult (≥ 18 years-old) patient\n* Admission to the ICU\n* Invasive, mechanical ventilation initiated within 72 hours following ICU admission, or mechanically ventilated upon arrival to the ICU\n* Expected ICU stay on mechanical ventilation of ≥ 3 days after randomisation\n\nExclusion Criteria:\n\n* Expected contra-indication for enteral nutrition for at least one week, at the discretion of the treating physician, such as a bowel discontinuity that cannot be solved within one week\n* Moribund (expected to die within 48 hours) or withholding of treatment (DNR code 3)\n* Previous inclusion in the PRECISe-2 trial\n* Transfer from another ICU with an ICU stay longer than 3 days","ALL","18 Years",{"count":20,"type":21},1026,"ESTIMATED","INTERVENTIONAL",[24],"NA","When patients survive a life-threatening condition in the intensive care unit (ICU), they often face a prolonged recovery process marked by persistent health issues that significantly reduce their quality of life. Muscle weakness is the most defining feature of this post-intensive care syndrome. This weakness, along with the associated decline in quality of life, presents major challenges for patients, their families, and the healthcare system, including the high costs of long-term care.\n\nUntil recently, it was believed that providing additional nutrition-particularly protein-during the early phase of a critical illness could help prevent muscle loss and promote recovery. However, the recent PRECISe study showed that administering a high amount of protein (target: 2 g\u002Fkg per day) via feeding tube actually worsened outcomes: patients who received high-protein nutrition during the acute phase reported a lower quality of life over the six months following ICU admission and were discharged from the hospital later.\n\nThese findings from the PRECISe study have renewed attention on the amount of protein administered to critically ill patients. Current European ICU nutrition guidelines (1.3 g\u002Fkg per day) recommend a higher protein intake than the daily recommended amount for healthy individuals (0.8 g\u002Fkg per day). However, in critically ill patients, protein metabolism may be impaired, potentially leading to the accumulation of toxic protein breakdown products and hindering recovery, ultimately resulting in a lower quality of life.\n\nReducing protein intake below the level recommended for healthy individuals during the acute phase of a life-threatening illness-while maintaining total energy intake (calories)-may be beneficial for long-term recovery and rehabilitation.\n\nThe PRECISe-2 study investigates whether patients who receive less protein (0.6-0.8 g\u002Fkg per day) but sufficient energy during the early phase of their critical illness feel better and experience a higher quality of life in the long term compared to those who receive the standard amount of protein (1.3 g\u002Fkg per day).",[27,28],"Critical Illness","Intensive Care (ICU)","NOT_YET_RECRUITING","2026-04-20",{"date":32,"type":33},"2026-04-23","ACTUAL",{"date":35,"type":21},"2026-05",{"date":37,"type":21},"2029-07",{"name":39,"class":40},"Ziekenhuis Oost-Limburg","OTHER",15,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100622022","phase-4-the-effect-of-corticosteroids-on-quality-of-life-following-total-hip-arthroplasty-hipster-study-100622022","NCT07378215","The Effect of Corticosteroids on Quality of Life Following Total Hip Arthroplasty: HIPSTER Study","HIPSTER","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for elective total hip arthroplasty;\n* procedure under spinal anaesthesia.\n\nExclusion Criteria:\n\n* hip revision surgery (reoperation);\n* bilateral total hip arthroplasty during the same procedure;\n* known hypersensitivity to dexamethasone or other corticosteroids;\n* chronic systemic use of corticosteroids, defined as daily corticosteroid therapy for \\> 4 weeks within the last 3 months, with anticipated need for a perioperative stress dose of corticosteroids;\n* active gastric of intestinal ulcers;\n* lack of informed consent or inability to give informed consent;\n* urgent, non-elective surgery.","60 Years",{"count":51,"type":21},224,[53],"PHASE4","Total hip arthroplasty (THA) is a highly effective and commonly performed procedure for end-stage osteoarthritis. Perioperative inflammation contributes to postoperative pain, fatigue, and delayed recovery. Dexamethasone, a potent glucocorticoid with strong anti-inflammatory properties, is widely used in orthopedic surgery and incorporated into Enhanced Recovery After Surgery (ERAS) protocols for THA to reduce pain, PONV, and fatigue. While intermediate doses of dexamethasone (25 mg) are considered safe and beneficial in the short term, their long-term effects on health-related quality of life and persistent pain remain unclear.\n\nTherefore, the main objective of the HIPSTER trial is to evaluate the effect of different doses of a single intraoperative intravenous dose of dexamethasone (5 mg versus 25 mg) on health-related quality of life up to three months after surgery.",[56,57,58],"Postoperative Quality of Recovery","Health-Related Quality-of-Life","Quality of Life",[60,61,62,63,64,65],"Hip Arthroplasty","Older adult patients","Dexamethasone","Enhanced Recovery After Surgery (ERAS)","Quality of recovery","Quality of life","RECRUITING","2026-04-07",{"date":69,"type":33},"2026-04-08",{"date":71,"type":33},"2026-01-30",{"date":73,"type":21},"2027-02",{"name":39,"class":40},2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100608374","the-role-of-neuroinflammation-on-neurocognitive-outcome-in-cardiac-surgery-100608374","NCT07200726","The Role of Neuroinflammation on Neurocognitive Outcome in Cardiac Surgery","The Role of Neuroinflammation on Neurocognitive Outcome in Cardiac Surgery: INOCS Study","INOCS","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for cardiac surgery.\n\nExclusion Criteria:\n\n* dementia, as diagnosed by a specialist, since this would make detection of PNCD impossible;\n* urgent, not elective surgery.",{"count":85,"type":21},80,"OBSERVATIONAL","RATIONALE: Postoperative cognitive changes are common after cardiac surgery and can be categorised into three main types: postoperative delirium (POD), delayed neurocognitive recovery (DNCR) and postoperative neurocognitive disorder (PNCD). DNCR is diagnosed until postoperative day 30 and PNCD is diagnosed at least 30 days after the operation. Both conditions can be mild or major, and can affect the quality of life of these patients.\n\nThe incidence of PNCD in cardiac surgery is around 40%. Despite this high incidence, screening for PNCD is absent in current postoperative care since the diagnosis of PNCD is difficult and very time intensive. Furthermore, the underlying pathogenesis is incompletely understood.\n\nThe identification of a biomarker and\u002For validated short diagnostic instrument would be of paramount importance to easily identify patients at risk, or to diagnose patients with PNCD in order to identify therapeutical pathways for this disease.\n\nOBJECTIVES: The main objective of this prospective clinical trial is to evaluate the performance of the short NPA and\u002For biochemical markers for the diagnosis of DNCR and PNCD in cardiac surgery patients aged 60 years or older.\n\nSTUDY DESIGN: Single-centre interventional observational study\n\nSTUDY INTERVENTIONS: Patients will undergo a neurophysiological assessment (NPA) pre-operatively and at two timepoints post-operatively, namely 6 (+\u002F-1) days and 40 (+\u002F- 10) days after surgery. During the stay at the intensive care unit, they will be screened daily for delirium, using the CAM-ICU and 3D-CAM.\n\nTo evaluate whether the development of DNCR or POD has an important effect on quality of recovery , the quality of recovery scale 15 (QOR-15), muscle strength (handgrip strength) and the Chalder fatigue score will be scored post-operative (postop day 1, 3 and 5). To evaluate whether PNCD has an effect on quality of live the EQ5D5L score will be measured at 40 (+\u002F- 10) days after surgery, compared to preoperative values.\n\nOn several time points, blood samples will be drawn to measure markers of neuroinflammation. The time points will be preoperatively, at the moment of arrival on ICU, postoperative day 1, 2 and 3, if still on ICU. Two repeat blood sample will be taken at the moment of NPA performed after 6 (+\u002F- 1) days and 40 (+\u002F- 10) days after surgery, if the patient is willing (not obligatory).\n\nSTUDY POPULATION:\n\nPatients aged 60 years or older who are scheduled for cardiac surgery.\n\nInclusion criteria:\n\n* aged 60 years or older;\n* scheduled for cardiac surgery.\n\nExclusion criteria:\n\n* dementia, as diagnosed by a neurologist;\n* urgent, not elective surgery.\n\nMAIN STUDY ENDPOINTS:\n\nPrimary outcome PNCD defined as a decline of \\> 1 SD on \\> 2 tests in one or more cognitive domains or a decline of \\> 1 SD on total cognitive domain score.\n\nSecondary outcomes Postoperative delirium - CAM-ICU will be evaluated twice daily (morning and evening) on every day when the patient is awake (not intubated) on the ICU. This is standard of care and is part of the routine clinical care in the hospital. Furthermore, once daily a 3D-CAM will be performed on day 1, 3 and 5.\n\nQuality of recovery\n\n* QOR-15, a validated measurement of quality of recovery in the short term postoperative recovery, will be evaluated pre-operatively and postoperatively day 1, 3 and 5.\n* EQ5D5L, a validated measurement of quality of recovery in the long term postoperative recovery, will be evaluated preoperatively and at the moment of the third NPA measurement.\n* Postoperative muscle function (upper extremity, by hand grip strength) on day 1, 3 and 5 after surgery and at the moment of the second and third NPA measurement (being day 6 (+\u002F-1) and day 40 (+\u002F-10) postoperatively), as compared to preoperative values.\n* Chalder Fatigue questionnaire on day 1, 3 and day 5 and on the second and third NPA measurement, as compared to preoperative.\n\nBiochemical analysis\n\n\\- Blood samples will be drawn for analysis before induction of anaesthesia (preoperatively), at the end of the operation (immediately postoperatively on arrival in ICU), on day 1, 2 and 3 postoperatively (if still at the ICU) and at the time of the postoperative follow-up visits with the NPA testing (day 6 (+\u002F-1) and day 40 (+\u002F-10) days post-surgery).\n\nAt each time point, markers of neuroinflammation and -degeneration will be determined.\n\nTertiary outcomes\n\n* Length of CPB\n* Duration of mechanical ventilation\n* Administered anaesthetic drugs during surgery\n* Transfusion need\n* Length of ICU stay (days)\n* Length of in-hospital stay (days)\n* Readmission to ICU or hospital within 28 days after surgery\n* Cardiovascular outcome: atrial fibrillation, , thrombo-embolic events, myocardial injury, myocardial infarction, cardiac arrest, cardiac death\n* Pulmonary outcome: postoperative pulmonary complications, postoperative pneumonia, postoperative respiratory failure\n* Postoperative infection within 28 days after surgery",[89,90,91,92,93,94,95,96],"Postoperative Neurocognitive Dysfunction","Postoperative Neurocognitive Disorder","Cardiac Surgery","Major Surgery Under General Anesthesia","Major Surgery in Adult Patients","Postoperative Fatigue","Elderly Patients","Quality of Recovery",{"date":69,"type":33},{"date":99,"type":33},"2025-10-21",{"date":101,"type":21},"2026-10",{"name":39,"class":40},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":103},"100553011","phase-4-the-effect-of-nocturnal-dexmedetomidine-on-postoperative-sleep-quality-and-fatigue-after-major-surgery-in-elderly-patients-dexsleep-study-100553011","NCT06480539","The Effect of Nocturnal Dexmedetomidine on Postoperative Sleep Quality and Fatigue After Major Surgery in Elderly Patients: DEXSLEEP Study","DEXSLEEP","Inclusion Criteria:\n\n* aged 60 years or older;\n* scheduled for thoracoscopic lung surgery.\n\nExclusion Criteria:\n\n* lack of informed consent or inability to give informed consent;\n* ≥ 2nd-degree atrioventricular block without pacemaker;\n* uncontrolled hypotension (blood pressure \\&lt; 90\u002F60 mmHg);\n* known hypersensitivity to dexmedetomidine or to any of the excipients;\n* acute cerebrovascular conditions;\n* urgent, not elective surgery.",{"count":112,"type":21},102,[53],"In the aftermath of major surgery, many patients suffer from pain, fatigue, reduced general well-being, and cognitive dysfunction. Another common concern after major surgery is sleep impairment and there is little known about its effect on postoperative morbidity, especially postoperative fatigue and muscle function.\n\nDexmedetomidine has been shown to possibly improve postoperative sleep quality in critically ill patients. However, whether the administration of dexmedetomidine translates into reduced postoperative fatigue and\u002For weakness and improved enhanced recovery after surgery by improving sleep, is currently unknown.\n\nThe DEXSLEEP study will evaluate the effect of nocturnal administration of dexmedetomidine, as compared to placebo (i.e. no dexmedetomidine), on postoperative quality of recovery, postoperative fatigue and muscle weakness.",[94,116,117],"Postoperative Sleep Disturbances","Surgical Stress Response",[119,63,120,64,121,122,123,124],"Major surgery","Elderly patients","Postoperative fatigue","Postoperative muscle weakness","Postoperative sleep disturbances","Dexmedetomidine",{"date":69,"type":33},{"date":127,"type":33},"2024-06-06",{"date":129,"type":21},"2026-04",{"name":39,"class":40},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":103},"100632453","phase-4-the-assessment-of-partial-guideline-directed-medical-therapy-down-titration-in-heart-failure-in-remission-100632453","NCT07513883","The Assessment of Partial Guideline-Directed Medical Therapy Down Titration in Heart Failure in Remission.","A Prospective, Randomized, Controlled Clinical Pilot Trial Investigating the Partial Down-titration of Guideline-directed Medical Therapy in Patients With Heart Failure in Remission.","TAPERED-HF","Inclusion Criteria:\n\n* Signed and dated written informed consent prior to randomization\n* Age ≥ 18 years\n* Prior diagnosis of heart failure with reduced ejection fraction (left ventricular ejection fraction \\\u003C 40%)\n* Heart failure remission (defined as a quantified improvement in LVEF to ≥50% or described as a \"normalized\" or \"recovered\" LVEF on echocardiography or cardiac MRI at least 6 months prior; a normal LVESVi and LVEF during screening; no residual functional limitations caused by heart failure; a NT-proBNP \\\u003C 250 pg\u002FmL during screening)\n* Treatment with at least three heart failure therapies (ACE inhibitors, angiotensin-receptor blockers, angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, or sodium-glucose cotransporter-2 inhibitors), consistent with international heart failure guidelines, at maximally tolerated dose and stable for at least 6 months before screening.\n\nExclusion Criteria:\n\n* Severe kidney disease: chronic kidney disease with significant albuminuria, defined as an eGFR (creatinine or cystatin C-based using the 2021 CKD-EPI formula) \\\u003C 60 mL\u002Fmin\u002F1,73m2 and a urine-albumine creatinine ratio ≥ 200 mg\u002Fg, or requiring dialysis, or a history of kidney transplantation.\n* Recent major cardiovascular events, including acute coronary syndromes, coronary artery bypass surgery, stroke, or TIA, in the 90 days before screening.\n* Uncontrolled hypertension, defined as a systolic blood pressure above 160 mmHg and\u002For a diastolic blood pressure above 100 mmHg despite three antihypertensive agents, assessed during a 24-hour blood pressure measurement during screening.\n* Atrial fibrillation or atrial flutter with a resting heart rate \\> 110 beats per minute during screening\n* Suboptimal biventricular pacing in those treated with cardiac synchronization therapy, defined as a biventricular pacing percentage under 98% during screening.\n* Any concomitant current or future class I indication for the use SGLT2i beside heart failure: diabetes mellitus type II with ASCVD, or at least two major risk factors (i.e., obesity, hypertension, smoking, dyslipidemia or albuminuria) during screening.\n* Any sustained ventricular arrhythmias in the six months before screening.\n* Any untreated valvular heart disease of moderate or greater severity during screening.\n* Presence of any other disease with a life expectancy of less than two years.\n* Pregnant or lactating women.",{"count":140,"type":21},100,[53],"Heart failure (HF) is a chronic condition that is characterized by a weakened and enlarged heart. It typically causes symptoms such as breathlessness and swelling of the legs, and it is a serious illness that shortens life expectancy. In recent years, new medicines have been developed that can improve heart function and help patients with HF live longer. HF patients with reduced heart function typically are recommended to take four different medicines for the rest of their lives. Some patients respond so well to treatment that their heart function and symptoms appear to recover; this is called HF in remission. While the four standard medicines have proven to increase lifespan in patients with heart failure with reduced heart function, it is not known whether they all need to be continued lifelong after recovery of the heart. Current guidelines recommend treating patients lifelong, yet this is based on limited scientific evidence. Lifelong therapy comes with disadvantages: it carries considerable costs for patients and health care systems, causes potential side effects, and makes it harder for patients to keep up with all their other medications. This study will test whether carefully reducing certain HF medicines is safe compared to continuing them. Patients with heart failure in remission will be randomly assigned to either: (1) continue all standard therapies, or (2) gradually reduce medicines to just two per day under close medical supervision. Patients will followed for two years to see whether their heart function remains stable. This will be measured by looking at echograms of the heart (echocardiograms), blood tests, and whether patients experience serious events such as hospitalizations or death. This study will investigate whether partial therapy discontinuation is safe and feasible.",[144],"Heart Failure",[146,147,148,149,150,151],"Heart failure in remission","Heart failure improvement","Guideline-recommended medical therapy","Heart failure recovery","Therapy withdrawal","Heart failure treatment","2026-04-01",{"date":67,"type":33},{"date":155,"type":33},"2026-03-16",{"date":157,"type":21},"2028-12",{"name":39,"class":40},{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":175,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":103},"100530348","the-effects-of-various-concentrations-of-ropivacaine-on-the-onset-and-duration-of-ankle-blocks-100530348","NCT06185608","The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ankle Blocks","The Effects of Various Concentrations of Ropivacaine on the Onset and Duration of Ultrasound-guided Ankle Blocks in Patients Undergoing Hallux Valgus Repair Surgery - a Randomized, Double-blinded, Parallel-group Interventional Study","ROADS","Inclusion Criteria:\n\n* Provide signed and dated informed consent\n* Age 18 up to and including 75 years, scheduled for elective forefoot surgery for hallux valgus repair, with or without one or more of the following: minor toe procedures, osteotomies, arthrodesis or toe extensor\u002Fflexor procedures, under unilateral ankle block at ZOL Genk\n* ASA physical I-II-III\n* Able to ambulate (ability to walk independently, with or without assistive devices)\n* Able to learn and perform study sensory and motor assessment by exhibiting sensitivity to pinprick, cold, and light touch (tested beforehand with pinprick\u002Fcold\u002F light touch sensation test) as the patient will have to perform these sensory and motor assessments by him\u002Fherself at home at postoperative day 0 to 2\n\nExclusion Criteria:\n\n* Language barrier\n* Preexisting lower extremity neuropathy\n* Contraindications to ankle block (local infection, edema, burn, soft tissue trauma, or distorted anatomy with scarring in the area of block placement)\n* Contraindications for use of NSAIDs\n* Allergy to local anesthetics\n* Uncontrolled anxiety, psychiatric or neurological disorder that might interfere with study assessment\n* Weight below 50 kg based on a maximum dose of 3 mg\u002Fkg ropivacaine and a maximum dose of 150 mg ropivacaine.\n* Preoperative use of opioids or gabapentin less than 3 days before surgery\n* Contraindications for use of paracetamol\n* Contraindications for use of tramadol","75 Years",{"count":169,"type":21},174,[24],"Peripheral nerve blocks are essential in ensuring effective regional anesthesia and postoperative analgesia in forefoot surgery for hallux valgus repair, with or without minor concomitant toe procedures. Many factors influence the onset and duration of peripheral nerve blocks. In the advent of ultrasound-guided nerve blocks, the accuracy in administering LA has significantly improved, potentially reducing the required dosage, which is also associated with less risk for toxicity. However, the effect of the concentration of LA on the onset time and duration of ultrasound-guided ankle blocks for forefoot surgery has not yet been studied. This poses a clinically relevant dilemma regarding the necessity of administering lower or higher concentrations of ropivacaine to achieve a clinically relevant faster onset time and longer duration of an ankle block.",[173,174],"Hallux Valgus","Anesthesia",[176,177,178,179,180,181],"Ropivacaine","Peripheral Nerve Block","Locoregional anesthesia","Onset","Duration","Sensory block","2026-03-19",{"date":184,"type":33},"2026-03-24",{"date":186,"type":33},"2025-05-22",{"date":188,"type":21},"2027-10-01",{"name":39,"class":40},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":198,"sex":199,"minAge":18,"maxAge":4,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":203,"conditions":204,"keywords":211,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100513529","synbiotics-in-patients-at-risk-for-preterm-birth-100513529","NCT05966649","Synbiotics in Patients at RIsk fOr Preterm Birth","Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal","PRIORI","Inclusion Criteria:\n\n1. Signed written informed consent must be obtained before any study assessment is performed;\n2. 18 years of age or older;\n3. Singleton pregnancy;\n4. Pregnancy consultation between 8 and 10 weeks gestation.\n5. At least one of the following risk factors for spontaneous preterm birth:\n\n   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency\n   * PPROM ≤36 weeks in previous pregnancy\n   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.\n\nExclusion Criteria:\n\n1. Patients who are already using pro-, pre- or synbiotics and not willing to stop\n2. Multiple pregnancy\n3. Need for primary (type 1) cerclage\n4. Inflammatory bowel disease\n5. Known congenital uterine anomaly\n6. History of LLETZ conization",true,"FEMALE",{"count":201,"type":21},402,[24],"Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.\n\nPrevious preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.\n\nInfections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).\n\nSynbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.",[205,206,207,208,209,210],"Preterm Spontaneous Labor With Preterm Delivery","Preterm Birth","Microbial Colonization","Microbiome Dysbiosis","Vaginal Microbiome","Synbiotics",[212,213,214,210],"Preterm birth","Vaginal microbiome","Probiotics","2026-02-23",{"date":217,"type":33},"2026-02-27",{"date":219,"type":33},"2023-03-16",{"date":221,"type":21},"2029-06",{"name":39,"class":40},9,{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":22,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":103},"100620673","comparing-the-garmin-venu-3--garmin-venu-4-for-non-invasive-vital-sign-monitoring-to-a-hospital-grade-monitor-100620673","NCT07360678","Comparing the Garmin Venu 3 \u002F Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor","GARMIN","Inclusion Criteria:\n\n* Provide signed and dated informed consent\n* Adults older than 18 years of age\n* Speak and understand the Dutch language\n* Hospitalized for at least another 24 hours\n\nExclusion Criteria:\n\n* Life expectancy is less than 30 days\n* Patient is isolated due to infection control",{"count":232,"type":21},30,[24],"This clinical trial evaluates the accuracy of the Garmin Venu 3 \u002F Garmin Venu 4 smartwatch in measuring vital signs (heart rate, respiratory rate, SpO₂) compared to the clinically validated Philips IntelliVue X2. The study aims to determine whether the consumer-grade smartwatch can provide reliable data for remote patient monitoring, early hospital discharge, and chronic disease management, offering a more accessible and affordable alternative to MDR-certified devices.",[236],"Validation of Vital Signs Measured by a Consumer-grade Smartwatch",[238,239,240,241,242,243],"Vital signs","Garmin","Accuracy","Heart rate","Respiratory rate","Peripheral Oxygen Saturation (SpO2)","2026-02-20",{"date":246,"type":33},"2026-02-24",{"date":248,"type":33},"2025-10-12",{"date":250,"type":21},"2026-06",{"name":39,"class":40},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":274},"100620590","phase-4-the-impact-of-iv-iron-on-exercise-capacity-and-quality-of-life-in-pulmonary-hypertension-100620590","NCT07359599","The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension","A Randomized, Double-blind, Placebo-controlled, Multicentre Trial, Assessing the Impact of Ferric Carboxymaltose on Exercise Capacity and Functional Status in Pulmonary Hypertension","IRON-PH","Inclusion Criteria:\n\n* ≥18 years of age\n* WHO functional class II - IV\n* Iron deficiency defined as TSAT \\\u003C21% (no more than ≥3 months old at randomization)\n* PH defined by echocardiography and\u002For right heart catheterization (RHC) according to the following WHO groups:\n\n  * Group 1 PH:\n\n    * Patients with a diagnosis of idiopathic PAH, hereditary PAH, drug induced PAH or PAH and associated with CTD or CHD (historical RHC available) on stable and optimized doses of PAH targeted therapies for at least 4 weeks before randomization.\n    * Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.\n  * Group 2 PH and baseline LVEF \\> 50% on imaging modality within last 6 months before randomization and on stable doses of loop diuretics and HFpEF therapies for 4 weeks. Group 2 PH can be included based on echocardiography or RHC.:\n\n    * Echocardiography (\\\u003C6mo before randomization):\n\n      * Presence of LVH or LA-enlargement\n      * E\u002Fe' \\>15 (at rest or exercise)\n      * TRVmax \\>2.8 m\u002Fs (at rest) or mPAP\u002FCO\\>3 mHg\u002FL\u002Fmin (exercise) or echocardiographic evidence of high or intermediate probability for PH as per 2022 ESC PH guidelines.\n    * RHC (\\\u003C6mo before randomization)\n\n      * mPAP \\> 20 mmHg\n      * PCWP \\> 15 mmHg at rest or PCWP\u002FCO-slope \\> 2mmHg\u002FL\u002Fmin or exercise PCWP\\>25mmHg, or PCWP 13-15 mmHg with elevation ≥18mmHg after 500 cc Fluid Challenge\n  * Group 4 PH:\n\n    * Inoperable CTEPH\n    * Persistent\u002Frecurrent CTEPH (\\> 1 year after endarterectomy or \\> 6 months after balloon pulmonary angioplasty) ineligible for balloon pulmonary angioplasty.\n    * Echocardiographic evidence of a high or intermediate probability for PH as per 2022 ESC PH guidelines.\n\nExclusion Criteria:\n\n* Screening haemoglobin \\\u003C 8 g\u002Fdl or \\>15 g\u002Fdl\n* Ferritin \\> 700 ng\u002FmL\n* Known hypersensitivity reaction to any component of FCM\n* Group 1 PH associated with veno-occlusive diseases.\n* Primary diagnosis of group 3 PH\n* Primary diagnosis of group 5 PH\n* Treatment with oral or other IV iron therapies at screening.\n* Current or planned mechanical circulatory support or lung\u002Fheart transplantation.\n* Any planned surgery or procedure leading to expected significant blood loss (defined as more than 250 ml = equal to 125mg of iron).\n* Haemodialysis or peritoneal dialysis (current or planned within the next 24 weeks).\n* Inability to return for follow up visits within the necessary windows\n* Concurrently in a study with another investigational product.\n* Uncorrected moderate to severe aortic stenosis (AVA \\\u003C1.5cm² and mean gradient \\>20 mmHg) or severe valvular regurgitation (except tricuspid regurgitation)\n* Impression by investigator that patient cannot perform a 6MWT\n* Active infection as judged by the investigator.\n* Pregnancy or desire to become pregnant during the study duration.",{"count":261,"type":21},306,[53],"Pulmonary hypertension (PH) is a condition characterized by elevated blood pressure in the pulmonary arteries. This leads to symptoms such as shortness of breath and a significantly reduced exercise capacity, resulting in a very poor quality of life. Currently, treatment options for PH are limited.\n\nMore than 60% of patients with PH develop iron deficiency. Studies have shown that this deficiency is associated with more severe symptoms, reduced exercise capacity, and even lower quality of life. Oral iron supplements are often ineffective in these patients due to impaired absorption in the intestines, caused by chronic low-grade inflammation-a common feature in PH.\n\nIntravenous iron administration can rapidly correct the deficiency, but it remains unclear whether this also leads to clinical improvements such as enhanced exercise capacity, reduced shortness of breath, and improved quality of life. Moreover, the cost-effectiveness of this treatment is still unknown. The IRON-PH study aims to answer these questions.\n\nAs part of the IRON-PH study, 306 patients with pulmonary hypertension will be enrolled. Each patient will be randomized to receive either intravenous iron (ferric carboxymaltose) or intravenous placebo (NaCl 0.9%).",[265,266],"Pulmonary Hypertension","Iron Deficiency","2026-01-28",{"date":71,"type":33},{"date":270,"type":33},"2026-01-27",{"date":272,"type":21},"2028-10",{"name":39,"class":40},7,{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":198,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":103},"100614587","test-retest-reliability-of-cardiopulmonary-exercise-testing-with-echocardiography-100614587","NCT07281534","Test-Retest Reliability of Cardiopulmonary Exercise Testing With Echocardiography","Analysing the Test-Retest Reliability of Cardiopulmonary Exercise Testing With Echocardiography","REPEATCPETecho","Inclusion Criteria:\n\n* Capable of performing a maximal exercise test.\n* Provide signed and dated informed consent.\n\nExclusion Criteria:\n\n\\- Unstable symptoms, whereby therapy cannot be delayed for a week.",{"count":232,"type":21},[24],"CPETecho is progressively employed in diagnostic settings for pathophysiological detection, offering comprehensive assessment of both pulmonary and cardiac functions. This technique evolves from its invasive counterpart, where a diagnostic catheter is employed for hemodynamic monitoring, by substituting the invasive component with non-invasive echocardiography. Nevertheless, data on the test-retest reliability of CPETecho remain sparse, a factor critical in differentiating between measurement effects and actual therapeutic impacts.",[287],"Dyspnea; Cardiac","2025-12-12",{"date":290,"type":33},"2025-12-15",{"date":292,"type":33},"2025-11-01",{"date":294,"type":21},"2026-06-01",{"name":39,"class":40},{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":103},"100550306","prevalence-of-nafld-in-t1dm-patients-100550306","NCT06445361","Prevalence of NAFLD in T1DM Patients","The Prevalence of Non-Alcoholic Fatty Liver Disease in Type 1 Diabetes Mellitus Patients Followed at Ziekenhuis Oost-Limburg, Genk, Belgium","PAD1ZOL","Inclusion Criteria:\n\n* T1DM\n* ≥ 18 years of age\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Excessive alcohol use\n* Exclusion of other causes of liver disease and secondary causes of liver steatosis",{"count":305,"type":21},138,[24],"To determine the prevalence of NAFLD in T1DM patients.",[309,310,311],"NAFLD","Type 1 Diabetes","Fatty Liver, Nonalcoholic","2025-07-22",{"date":314,"type":33},"2025-07-28",{"date":316,"type":33},"2023-07-01",{"date":318,"type":21},"2026-07-01",{"name":39,"class":40},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":199,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":329,"conditions":330,"keywords":336,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":347,"locationsCount":103},"100592489","imaging-comparison-for-the-preoperative-planning-and-diagnosis-of-die-a-multicenter-retrospective-study-100592489","NCT06994091","Imaging Comparison for the Preoperative Planning and Diagnosis of DIE: a Multicenter Retrospective Study.","The Added Value of (Standard) Magnetic Resonance Imaging Compared to Transvaginal Ultrasound for the Preoperative Planning and Diagnosis of Deep Infiltrating Endometriosis: a Multicenter Retrospective Study.","Inclusion Criteria:\n\n* All patients who underwent preoperative imaging at AZ Sint-Jan AV and Ziekenhuis Oost-Limburg (ZOL) between October 2021 and December 2024, TVS with or without complementary MR followed by therapeutic surgery as part of DIE.\n\nExclusion Criteria:\n\n* Performing imaging, TVS with or without additional MR, by an operator without specific experience in the field.\n* Lack of a TVS report diagnosing DIE.\n* Preoperative diagnosis of only superficial endometriosis and\u002For endometriomas without DIE.\n* Performance of surgery by a surgeon without specific experience in the field.\n* Lack of a surgical report that correctly describes all DIE lesions.",{"count":328,"type":21},200,"Several centers in Belgium use both transvaginal ultrasound (TVS) and magnetic resonance imaging (MRI) for the preoperative diagnosis of deep infiltrating endometriosis (DIE), while other centers rely almost exclusively on TVS. From the perspective of both the patient and the endometriosis care team, it is not primarily important that every individual lesion is mapped perfectly preoperatively, but rather that all lesions impacting clinical management and surgical planning are accurately detected. This is particularly crucial when a multidisciplinary approach is required, involving a urologist for bladder lesions and\u002For an abdominal surgeon for invasive rectosigmoid lesions. Moreover, providing the patient with thorough preoperative counseling is essential, and this is, of course, determined by the preoperative findings and the type of planned surgical procedure.\n\nIn this study, we first assess the diagnostic performance of TVS in the preoperative diagnosis of DIE. As a secondary objective, we evaluate the added value of MRI compared to TVS for preoperative surgical planning in patients who also underwent an MRI examination.",[331,332,333,334,335],"Deep Endometriosis","Surgery","Transvaginal Ultrasound","MRI","Preoperative Planning",[337,338,339,334,340],"deep endometriosis","surgery","tranvaginal ultrasound","preoperative planning","2025-05-20",{"date":343,"type":33},"2025-05-29",{"date":345,"type":21},"2025-06-01",{"date":288,"type":21},{"name":39,"class":40},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":354,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":371,"locationsCount":4},"100578375","a-study-comparing-two-mandibular-advancement-devices-in-the-treatment-of-sleep-apnea-100578375","NCT06810479","A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea","A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea","MRA OSA","In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Provide signed and dated informed consent\n* Males or females aged 18 and above\n* Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous surgery on the upper airways\n* Prior treatment of OSA (CPAP or MRA)\n* Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders\n* Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)\n* Presence of temporomandibular joint dysfunction",{"count":357,"type":21},20,[24],"The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.\n\nPatiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.",[361],"Apnea, Obstructive",[363,364,365],"sleep apnea","MRA","mandibular repositioning appliance","2025-03-20",{"date":368,"type":33},"2025-03-21",{"date":366,"type":21},{"date":152,"type":21},{"name":39,"class":40},{"id":373,"slug":374,"hasResults":11,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100569469","better-in-better-out-cystectomy-100569469","NCT06694649","Better in Better Out Cystectomy.","Effectiveness of Prehabilitation in Patients Undergoing Radical Cystectomy: a Retrospective Analysis","BIBOCYS-1","Inclusion Criteria:\n\n* Histologically confirmed primary bladder cancer (cTa-4N0-3M0) who underwent RARC.\n\nExclusion Criteria:\n\n* Patients who needed a semi-urgent cystectomy.\n* Patients with severe cognitive or psychiatric impairment.\n* Patients with a contraindication to perform physical exercise training or a cardiopulmonary exercise test (CPET).\n* Metastatic or non-primary disease.",{"count":140,"type":21},"The current gold standard for non-metastatic muscle-invasive bladder cancer or treatment-refractory high-risk non-muscle-invasive bladder cancer is radical cystectomy (RC). This procedure is associated with high rates of perioperative complications (30-65%) and mortality (1.5-10%). Patients who require radical cystectomy often present with multiple co-morbidities, a certain degree of frailty, functional deficits, and a high level of past or current tobacco use. According to the \"better in, better out\" principle, it is likely that by improving the physical, nutritional and psychological status, a reduction in morbidity and mortality will be observed.\n\nThe literature suggests that multimodal prehabilitation may reduce complications and improve functional recovery after major cancer surgery. Therefore, the prehabilitation programme used in this study includes exercise training, dietary advice, psychological support and smoking cessation advice. Prehabilitation has been offered to a selection of patients with increased risk for postoperative complications since 01\u002F05\u002F2023.\n\nAt ZOL Genk, patients receive preparation for RC in one of three ways, depending on a balancing exercise that considers the patient's complexity and frailty, functionality, mobility and other factors. Patient preference and place of residence are also taken into account in determining the most appropriate preparation pathway. 1. The patient is solely encouraged to increase his fitness level by means of independent aerobic exercise. 2. The patient receives a prescription for primary care physiotherapy in his own area. 3. The patient undergoes our full internal prehabilitation program. The primary objective of this study is to compare these three different groups in terms of mortality, ICU length of stay, length of hospital stay, complication rate, type of complications and readmission rate. Finally, patient adherence will be examined.",[383],"Bladder Cancer","2024-11-18",{"date":386,"type":33},"2024-11-19",{"date":388,"type":21},"2024-11",{"date":390,"type":21},"2024-12",{"name":39,"class":40},{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":406,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":103},"100539832","does-vessel-sparing-surgery-in-anterior-approach-total-hip-arthroplasty-change-clinical-outcome-100539832","NCT06308965","Does Vessel-sparing Surgery in Anterior Approach Total Hip Arthroplasty Change Clinical Outcome?","USP","Inclusion criteria To be eligible to participate in this study, a subject must meet all criteria below;\n\n* Scheduled for THA by Dr. Frans-Jozef Vandeputte or Professor Dr. Kristoff Corten\n* Provide signed and dated informed consent\n* Males or females age \\> 18 years\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Neurological problems with sensorial and\u002For motoric disturbances (Multiple Sclerosis, Parkinson's disease, hemiplegia, …)\n* Previous surgery of the ipsilateral hip\n* Ipsilateral neck of femur fracture\n* Previous contralateral THA\n* Significant hip deformity: Crowe type 3 and 4 dysplasia, Leg-Calvé-Perthes\n* Avascular necrosis of the femoral head\n* Participating in another study that may interfere with participation in this study",{"count":400,"type":21},300,[24],"During direct anterior approach (DAA) for total hip arthroplasty (THA), ligation of the lateral femoral circumflex artery and vessel is always conducted. However, this standardized procedure may jeopardize blood muscle perfusion and cause tenderness in the tensor fascia lata muscle. The investigators want to investigate whether blood vessel-sparing surgery is feasible, reproducible, and would alter outcomes following DAA THA.\n\nThe surgical technique of the vessel-sparing procedure will be described and investigated in a prospective blinded RCT. The investigators hypothesize that the vessel-sparing technique is feasible in 60% of the patients. If these vessels were not sacrificed, the investigators expect the incidence of TFL tendinopathy to be lower.",[404,405],"Tensor Fasciae Latae Syndrome","Arthroplasty Complications",[407,408,409],"Total Hip Arthroplasty","Ultra Sparing Procedure","Direct Anterior Approach","2024-11-12",{"date":412,"type":33},"2024-11-15",{"date":414,"type":33},"2024-06-11",{"date":416,"type":21},"2027-03",{"name":39,"class":40},{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":425,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":427,"conditions":428,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":103},"100514102","coagulation-disorders-in-ischaemic-and-haemorrhagic-stroke-100514102","NCT05974111","COAgulation Disorders in Ischaemic and Haemorrhagic Stroke","COADIHS","Inclusion Criteria:\n\nPresenting at the hospital with ischaemic stroke, haemorrhagic stroke, aneurysmal subarachnoid haemorrhage or any other type of non-traumatic, intracranial bleeding\n\nIn patients with minor ischemic stroke (NIHSS \\\u003C= 4) only baseline lab sampling will be performed (T0 and T0B).\n\nExclusion Criteria:\n\n* Refusal of participation by patient or legal representative\n* Traumatic intracranial (subdural, subarachnoid, epidural haematoma) bleeding\n* Patients receiving treatment with interference on coagulation (pro \u002F anti) before first sampling: in this group of patients the coagulation assessment at presentation will be excluded, further lab sampling is performed according to protocol.\n* Patients categorized as having stroke mimic will be excluded from analysis afterwards",{"count":426,"type":21},350,"In this study the investigators will assess both procoagulant and anticoagulant pathways using thrombin generation and platelet function tests; as well as neuronal ischemia using cell free DNA in all patients presenting with ischaemic and haemorrhagic stroke (including aneurysmal subarachnoid haemorraghe). Also the cross-talk between inflammation and thrombosis, so-called thrombo-inflammation is further investigated. As such the investigators aim to characterise the patient's coagulation profile before administration of any treatment. By assessing these pathways the investigators strive to detect specific markers to predict vital and functional outcome at 3 months in these patients. Finally the investigators may provide new pathophysiological insights in the course of disease following these events that can possibly improve future therapeutic strategies.",[429,430,431],"Ischemic Stroke","Haemorrhagic Stroke","Aneurysmal Subarachnoid Hemorrhage",{"date":433,"type":33},"2024-11-14",{"date":435,"type":33},"2023-05-02",{"date":437,"type":21},"2025-08-31",{"name":39,"class":40},{"id":440,"slug":441,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":455,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":41},"100470572","comparison-of-conventional-and-cooled-radiofrequency-of-the-genicular-nerves-in-patients-with-chronic-knee-pain-100470572","NCT05407610","Comparison of Conventional and Cooled Radiofrequency of the Genicular Nerves in Patients With Chronic Knee Pain","Comparison of Conventional and Cooled Radiofrequency Treatment of the Genicular Nerves Versus Sham Procedure for Patients With Chronic Knee Pain: a Multicentre, Double Blind, Randomised Controlled Trial","COGENIUS","Inclusion Criteria:\n\n* Signed written informed consent must be obtained before any study assessment is performed.\n* Adult patients (Age ≥ 18 years old).\n* Chronic anterior knee pain (\\> 12 months) that is moderate to severe (defined as NRS \\> 4 on most or all days for the index knee either constantly or with motion at time of screening and, an average NRS score reported in the patient diary \\>4 at the end of the run-in period).\n* Unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.\n* Only for patients with Osteoarthritis (OA): Radiologic confirmation of knee osteoarthritis of grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the screening for the index knee according the Kellgren Lawrence criteria diagnosed by an independent radiologist with experience in musculoskeletal imaging on radiography (Rx) or magnetic resonance imaging (MRI). If imaging will need to be performed at screening it is recommended to perform an MRI instead of Rx. Imaging with MRI will enable the independent radiologist to perform a better estimation of the grade of OA.\n* Only for patients with Persistent Post-Surgical Pain (PPSP) after Total Knee Arthroplasty (TKA): Patients with PPSP\\* after TKA need to have had a negative orthopaedic work-up\n\nExclusion Criteria:\n\n* Local or systemic infection (bacteraemia).\n* Evidence of inflammatory arthritis or an inflammatory systemic disease responsible for knee pain.\n* Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, ...) in the index knee during the 3 months prior to procedure.\n* Pregnant, nursing or planning to become pregnant before the study intervention. Participants who become pregnant after the study intervention during the follow-up period will not be excluded.\n* Chronic widespread pain.\n* Patients with unstable psychosocial disorder.\n* Allergies to products used during the procedure (lidocaine, propofol, chlorhexidine).\n* Uncontrolled coagulopathy defined as supratherapeutic dose of anticoagulation medication.\n* Uncontrolled immune suppression.\n* Participating in another clinical trial\u002Finvestigation within 30 days prior to signing informed consent.\n* Patient is currently implanted with a neurostimulator.\n* Current radicular pain in index leg.\n* Previous conventional or cooled radiofrequency of the index knee.\n* Patients with bilateral knee pain defined as chronic knee pain (\\> 12 months) in both knees that is moderate to severe (defined as a numeric rating scale (NRS) \\> 4 on most or all days either constantly or with motion) and that is unresponsive (meaning insufficient pain reduction or intolerance) to conventional treatments ongoing for at least 12 months prior to inclusion. Conventional treatments must include all of the following: active physiotherapy, pharmacological treatment of pain and intra-articular corticosteroid infiltration.\n* Patients who have a planned TKA in the near future defined as patients who already have agreed on a date for the TKA procedure.\n* Patients who are unwilling or mentally incapable to complete the study questionnaires.",{"count":448,"type":21},400,[24],"Chronic knee pain remains a disabling disease despite current treatment strategies. There is an increase in the prevalence of osteoarthritis (OA) of the knee in the general population, presently affecting approximately 450,000 individuals in Belgium. A total knee replacement is a viable alternative for severe knee OA that does not respond to conservative therapy. Unfortunately, up to 53% of patients who undergo a total knee replacement develop persistent post-surgical pain (PPSP). There is currently no effective therapy for PPSP.\n\nA radiofrequency (RF) treatment applies high frequency current on the nerve responsible for pain conduction, resulting in an interruption of the transmission of pain. This can be applied to the nerves innervating the knee joint - the superolateral, superomedial and inferomedial genicular nerves - and could be an alternative, minimally invasive treatment for patients with knee OA who fail conservative treatments and for patients with PPSP. Data from the recent literature indicates that this treatment leads to a reduction of pain intensity and could result in an improvement of knee function, of the psychological state of the individual, and finally in an increase in health-related quality of life. Furthermore, RF of the genicular nerves could help avoid or delay a total knee replacement therefore potentially contributing to cost reduction. Both cooled and conventional RF treatments are reported in the literature to improve pain. The use of water to cool the RF electrodes results in an increased lesion size by removing heat from adjacent tissue, allowing power delivery to be increased. As a consequence, cooled RF could result in a higher chance of success and longer duration of effect. Until now, the studies performed on cooled RF are industry initiated and a direct comparison between conventional, cooled and a sham procedure is lacking.\n\nThe aim of the COGENIUS trial is to investigate the effect of the two types of RF treatment on individuals experiencing chronic knee pain that is resistant to conservative treatments. For this purpose, the efficacy and cost-effectiveness of cooled and conventional RF will be compared to a sham procedure in patients suffering from knee OA and PPSP after total knee replacement.",[452,453,454],"Knee Osteoarthritis","Persistent Postsurgical Pain","Chronic Knee Pain",[456,453,457,458],"Osteoarthritis","Knee","Radiofrequency ablation","2023-05-22",{"date":461,"type":33},"2023-05-24",{"date":463,"type":33},"2022-07-07",{"date":465,"type":21},"2026-09-01",{"name":39,"class":40},""]