[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Erasmus Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":710},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,146,0,25,[9,47,80,105,118,154,181,209,232,259,288,310,340,365,392,416,449,478,508,535,566,597,619,652,682],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053232","nutritional-care-after-discharge-in-children-term-born-18years-old-100053232",false,"NCT06414200","Nutritional Care After Discharge in Children Term Born-18years Old","Nutritional Care After Hospital Discharge (NutriCAD): A Stepped Wedged Multicentre Randomized Controlled Trial in Paediatrics","NutriCAD","Inclusion Criteria:\n\n* Children term born neonates till 18 years old\n* Admitted with newly initiated nutritional support(oral and\u002For enteral nutritional support) during hospitalization\n* Nutritional Support continues at home after discharge.\n\nExclusion Criteria:\n\n* Children with existing nutritional support upon admission\n* Children in need of parenteral nutrition at discharge\n* Children with DSM-5 diagnosed feeding disorders such as anorexia\n* Absence of written informed consent","ALL","7 Days","18 Years",{"count":22,"type":23},260,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this stepped wedge cluster randomized trial is to compare nutritional care after discharge to an intervention in children term born - 18 years old discharged with newly initiated nutritional care.\n\nThe main question it aims to answer is:\n\nTo investigate whether a tailored nutritional care follow-up program in children who are being discharged from the hospital with nutritional support improves nutritional intake and status as well as feeding behavior and quality of life (QoL) in children and their parents. Furthermore, the effect on parental stress, anxiety, depression, and post-traumatic stress (PTSD) as well as QoL will be assessed with and without a tailored nutritional care follow-up program",[29],"Malnutrition, Child",[31,32,33],"Nutritional care","After discharge","Pediatric","RECRUITING","2026-07-10",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2024-04-23",{"date":42,"type":23},"2027-12-31",{"name":44,"class":45},"Erasmus Medical Center","OTHER",6,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100641411","phase-3-the-aspire-trial-achilles-tendinopathy-treated-with-corticosteroid-injections-100641411","NCT07650396","The ASPIRE Trial: AchilleS tendinoPathy Treated With cortIcosteRoid injEctions","ASPIRE","Inclusion Criteria:\n\n* Age 18-65 years\n* Clinically diagnosed midportion Achilles tendinopathy confirmed by ultrasound\n* Symptoms for at least 6 months\n* Persistent complaints despite standard care, including education, load management advice and at least 3 months of exercise therapy \u002F exercise programme\n\nExclusion Criteria:\n\n* • Clinical suspicion of insertional Achilles tendinopathy\n\n  * Clinical suspicion of Achilles tendon rupture\n  * Clinical suspicion of plantar flexor tenosynovitis\n  * Clinical suspicion of sural nerve pathology\n  * Clinical suspicion of peroneal tendon subluxation or peroneal tendinopathy\n  * Clinical suspicion of posterior ankle impingement syndrome\n  * Suspected systemic\u002Finflammatory disorder as cause of symptoms\n  * Any condition preventing participation in active exercise programme\n  * History of Achilles tendon rupture of index tendon\n  * Previous local corticosteroid injection on index Achilles tendon\n  * Previous surgery on index Achilles tendon\n  * Refusal to undergo one of the study treatments\n  * Local skin infection, suspected systemic infection with fever, or other medical condition compromising injection safety\n  * Vitamin K antagonist use with INR \\>3.0 within 3 days before injection or unknown INR\n  * Current pregnancy or breastfeeding\n  * Medication-induced tendon pathology (quinolones or statins related to symptom onset)\n  * Inability to provide informed consent\n  * Participation in another concomitant interventional programme for Achilles tendinopathy\n  * Known hypersensitivity or allergy to Depo-Medrol or Lidocaine\n  * Participants with unstable or poorly controlled diabetes mellitus may be excluded at investigator discretion for safety reasons.","65 Years",{"count":56,"type":23},276,[58],"PHASE3","Achilles tendinopathy is a common and often persistent tendon disorder associated with pain, impaired function, and reduced participation in physical activities. Standard care consists of education, load management advice, and progressive calf-strengthening exercises, yet about half of patients remain symptomatic. Corticosteroid injections are frequently used in clinical practice, but evidence on long-term efficacy and safety remains inconclusive. The ASPIRE trial is a multicentre, randomized, double-blind, placebo-controlled phase III trial evaluating whether 1-3 ultrasound-guided peritendinous corticosteroid injections added to standard care are safe and more effective than placebo injections plus standard care in adults with chronic midportion Achilles tendinopathy. The primary outcomes are change in VISA-A score over 1 year and incidence of full-thickness Achilles tendon rupture during 1-year follow-up.",[61],"Achilles Tendinopathy (AT)",[63,64,65,66,67,68,69,70],"Corticosteroid injection","Lidocaine","Placebo injection","Exercise therapy","Ultrasound-guided injection","Methylprednisolone acetate","Depo-Medrol","VISA-A","2026-06-16",{"date":73,"type":38},"2026-06-18",{"date":75,"type":38},"2026-06-03",{"date":77,"type":23},"2028-10-31",{"name":44,"class":45},1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":24,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":7},"100607397","phase-3-ctdna-based-adjuvant-chemotherapy-for-high-risk-rectal-cancer-100607397","NCT07188025","ctDNA-Based Adjuvant Chemotherapy for High-Risk Rectal Cancer","Adjuvant Chemotherapy for Prevention of Recurrence in Patients With Detectable ctDNA After Surgery in High-Risk Rectal Cancer","REACT","Inclusion Criteria\n\n* Detectable ctDNA in the postoperative blood sample\n* Age ≥ 18 years\n* WHO performance score 0-1\n* Informed consent for PLCRC with specific consent for additional blood withdrawals and offering of future experimental research\n* Informed consent for the REACT trial.\n* Histological confirmed rectal cancer; either treated with neoadjuvant (chemo)radiotherapy, and\u002For clinical\u002Fpathological T3\u002FT4 and\u002For N+ in case no neoadjuvant therapy was administered.\n* Eligible to receive treatment with combination adjuvant chemotherapy (CAPOX\u002FFOLFOX) according to the treating physician.\n* Mentally competent and able to read and understand Dutch language.\n\nExclusion Criteria:\n\n* Metastatic disease\n* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma\n* Incomplete primary tumour resection (R1 or R2 resection)\n* Contra-indication for fluoropyrimidines or oxaliplatin\n* Neoadjuvant oxaliplatin based systemic treatment, e.g. treated with the RAPIDO regimen consisting of short course radiotherapy followed by 6 cycles of CAPOX or 9 cycles of FOLFOX prior to surgery\n* Patients with a clinical complete response, who will not undergo surgery.\n* Pregnant and lactating women\n* History of psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance of the intervention group\n* Serious concomitant systemic disorders that would compromise the safety of the patient or his\u002Fher ability to complete the study, at the discretion of the investigator\n* Serious infections (uncontrolled or requiring treatment)\n* Current or recent (within 28 days prior to randomisation) treatment with another investigational drug or participation in another study interfering with the primary endpoint.",{"count":89,"type":23},103,[58],"The goal of this clinical trial is to investigate whether adjuvant chemotherapy can prevent disease recurrence in patients with high-risk rectal cancer who have detectable ctDNA after surgery.\n\nThe main research question the REACT study aims to answer is:\n\n\\- Does adjuvant chemotherapy improve disease-free survival in patients with high-risk rectal cancer with detectable ctDNA after surgery?\n\nInterventions:\n\n\\- Patients with detectable ctDNA after surgery and randomised to the experimental group will be offered adjuvant chemotherapy (4 cycles CAPOX\u002F6 cycles FOLFOX) within 12 weeks after surgery.",[93],"Rectal Cancer",[95,96],"ctDNA","Adjuvant Chemotherapy","2026-06-05",{"date":99,"type":38},"2026-06-09",{"date":101,"type":38},"2025-10-14",{"date":103,"type":23},"2035-10",{"name":44,"class":45},{"id":106,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":107,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":27,"conditions":110,"keywords":111,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":117,"locationsCount":79},"100547917","Nutritional Care After Hospital Discharge",{"count":22,"type":23},[26],[29],[31,32,33],"2026-06-02",{"date":114,"type":38},"2026-06-04",{"date":40,"type":38},{"date":42,"type":23},{"name":44,"class":45},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":126,"targetDuration":128,"studyType":129,"phases":4,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100640429","patient-ventilator-asynchrony-occurence-and-clinical-impact-in-usual-care-100640429","NCT07624786","Patient-Ventilator Asynchrony: Occurence and Clinical Impact in Usual Care","Unraveling the Clinical Impact of Patient-Ventilator Asynchrony in Usual Care","PVA-detection","Inclusion Criteria:\n\n* Age \\> 18 years old.\n* Recordings available of ventilator waveforms synchronized with the patient's electronic health record during invasive mechanical ventilation.\n* Duration of mechanical ventilation of at least 24 hours.\n\nExclusion Criteria:\n\n* (Previous) registered objection of patient and\u002For relatives to re-use clinical data for research purposes\n* No consent for re-use of data for research",{"count":127,"type":23},110,"3 Months","OBSERVATIONAL","The goal of this observational study is to unravel the occurence, impact and relations of Patient-Ventilator Aynchrony (PVA) in mechanically ventilated patients. The main questions it aims to answer are:\n\n* How often does PVA occur?\n* What are relations between clinical characteristics and PVA occurence?\n* What are relations between PVA occurence and patient outcomes?\n\nAll questions will be assessed using data collected during the whole course of mechanical ventilation. Mechanically ventilated patients' medical data will be re-used. PVAs will be automatically classified on ventilator waveform data, using validated Deep Breath software.",[132,133],"Mechanical Ventilation","Patient-Ventilator Asynchrony",[135,136,137,138,139,140,141,142,143,144],"asynchrony","Patient-ventilator asynchrony","dyssynchrony","Patient-ventilator interaction","mechanical ventilation","AI","algorithm","classification algorithm","ICU","Artificial intelligence","NOT_YET_RECRUITING","2026-05-29",{"date":75,"type":38},{"date":149,"type":23},"2026-06",{"date":151,"type":23},"2027-02",{"name":44,"class":45},3,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":153},"100603205","phase-2-interact-stomach-ii-100603205","NCT07133490","INTERACT Stomach-II","Intraperitoneal Irinotecan Combined With Systemic Therapy for Patients With Gastric Peritoneal Metastases: A Phase II, Multicenter Study","Inclusion Criteria:\n\n* Histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma\n* Pathologically and clinically confirmed diagnosis of macroscopic peritoneal metastases (defined as PCI score ≥ 1)\n* WHO-performance score of 0 to 1 with a life expectancy greater than or equal to three months\n* Aged 18 years or older\n* Written informed consent according to the ICH-GCP and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Distant metastases other than peritoneal metastases or metastatic lymph nodes\n* Prior palliative systemic therapy for gastric cancer\n* Prior (neo)-adjuvant systemic therapy for gastric cancer within the six months before enrolment in this study\n* Severe symptomatic ascites requiring monthly recurrent therapeutic paracentesis\n* Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency\n* Any contra-indication for the (planned) systemic chemotherapy (e.g. active infection, serious concomitant disease, severe allergy, persistent neurologic toxicity after (neo-)adjuvant oxaliplatin based systemic therapy), as determined by the treating medical oncologist\n* Inadequate organ functions (defined as a hemoglobin \\\u003C5.0 mmol\u002Fl, an absolute neutrophil count \\\u003C1.5 x 109\u002Fl, platelet count \\\u003C100 x 109\u002Fl, creatinine clearance \\\u003C30 ml\u002Fmin, bilirubin \\>2x ULN and liver transaminases \\>2.5x ULN)\n* Pregnant or lactating women\n* Concomitant participation in any clinical study that could modify the outcomes relevant to this study\n* Absence of assurance of compliance with the protocol",{"count":162,"type":23},55,[164],"PHASE2","This is a phase II study conducted in three hospitals in the Netherlands (Erasmus MC in Rotterdam, Catharina Hospital in Eindhoven, and the Netherlands Cancer Institute in Amsterdam). A total of 55 patients will take part. The aim is to test whether a new combination treatment is feasible for patients with gastric peritoneal metastases (PM). The treatment includes chemotherapy (intraperitoneal irinotecan and standard systemic therapy such as CAPOX or FOLFOX), and may also include nivolumab or trastuzumab, depending on biomarker results.",[167],"Peritoneal Metastases From Gastric Cancer",[169,170,171,172],"Gastric cancer","Peritoneal metastases","Intraperitoneal chemotherapy","Irinotecan","2026-05-28",{"date":175,"type":38},"2026-06-01",{"date":177,"type":38},"2025-10-01",{"date":179,"type":23},"2028-07-01",{"name":44,"class":45},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":24,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},"100583985","implementation-of-home-monitoring-in-patients-with-pulmonary-fibrosis-100583985","NCT06883448","Implementation of Home Monitoring in Patients With Pulmonary Fibrosis","The SUITS Study: Implementation of Home Monitoring in Patients With Pulmonary Fibrosis","SUITS","Inclusion Criteria:\n\n* A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS\u002FERS\u002FJRS\u002FALAT guidelines;\n* Adults (=\u002F\\>18 years).\n\nExclusion Criteria:\n\n* Patients who are not able to speak, read and\u002For write in Dutch;\n* Patients with no access to the internet;\n* Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;\n* Patients who are or have been using a home monitoring program for PF.",{"count":190,"type":23},220,[26],"The objective of this study is to evaluate the impact of structurally replacing half of the outpatient clinic visits for patients with pulmonary fibrosis by home monitoring and video consultations on patient self-management and health(care) outcomes.",[194,195],"Pulmonary Fibrosis","Interstitial Lung Disease (ILD)",[197,198,199],"eHealth","Hybrid care","Self-management","2026-05-22",{"date":202,"type":38},"2026-05-27",{"date":204,"type":38},"2024-10-02",{"date":206,"type":23},"2027-09-01",{"name":44,"class":45},11,{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":24,"phases":218,"briefSummary":219,"conditions":220,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":231,"locationsCount":79},"100638079","evaluation-of-an-instructional-video-about-medication-management-during-admission-and-medication-adherence-for-kidney-transplantation-and-in-the-outpatient-clinic-in-a-dutch-university-hospital-100638079","NCT07592624","Evaluation of an Instructional Video About Medication Management During Admission and Medication Adherence for Kidney Transplantation and in the Outpatient Clinic in a Dutch University Hospital.","MediT","Inclusion Criteria:\n\n* The patient is able to take the medication independently or with the help of someone else (professionals not included).\n* After admission, the patient is discharged to their own home or home of friend\u002Frelative.\n* The patient had a follow up at the outpatient clinic in the Erasmus Medical Center for at least one year after transplantation.\n* The patient is able to read the medication list or an illiteracy-friendly medication list.\n\nExclusion Criteria:\n\n* Patients under 18 years of age\n* Patients who got discharged with a medication dispenser\n* Refusal to participate in the study.\n* Cognitive impairments that hinder participation.\n* Patients and\u002For family who can not understand (language barrier) the instructional video.",{"count":217,"type":23},308,[26],"The goal of this RCT is to evaluate the effect of the instructional video on improving patient compliance and reducing medication errors. The study will include adult kidney transplant recipients (18 years or older) at Erasmus MC who have undergone a kidney transplantation starting January 2026.\n\nThe main questions it aims to answer:\n\nThe primary aim of this study is to assess whether our developed video instruction, compared with the traditional verbal instruction, both of which are given shortly before training during admission, reduces the number of medication errors in kidney transplant patients.\n\nThe study will also examine the correlation between patient characteristics (such as age, comorbidities, and language proficiency) and medication errors. Additionally, patient-reported medication errors will be measured through a questionnaire completed during follow-up visits at the outpatient clinic, which is part of standard care.\n\nThe instructional video will be evaluated by a short questionnaire.",[221,222,223,224],"Kidney Transplant","Adult","Medication Adherence","Instruction Videos","2026-05-11",{"date":227,"type":38},"2026-05-18",{"date":229,"type":23},"2026-07-01",{"date":42,"type":23},{"name":44,"class":45},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":24,"phases":242,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":256,"leadSponsor":258,"locationsCount":79},"100637722","sweet--sour-dietary-acid-load-in-type-2-diabetes-and-kidney-disease-across-sex-and-ethnic-groups-100637722","NCT07587918","Sweet & Sour: Dietary Acid Load in Type 2 Diabetes and Kidney Disease Across Sex and Ethnic Groups","Sweet & Sour: Exploring Dietary Acid Load in Type 2 Diabetes & Kidney Disease Across Sex and Ethnicity","Sweet & Sour","Inclusion Criteria:\n\n* Age \\>18 years\n* Presence of T2D and CKD stage G1-3a with albuminuria (\\>10mg\u002Fmmol)\n* BMI≥ 25kg\u002Fm2 - Use of metformin on a stable dose (i.e. no changes in the last three months)\n* Adequate knowledge of the Dutch language to comprehend the provided study information\n* If incretin therapy is used, then subject must have used that for a minimum of 6 months before starting with the trial\n* Use of ACE inhibitors or angiotensin II receptor blokkers\n* Of white European Dutch or South-Asian Surinamese descent\n\nExclusion Criteria:\n\n* Use of insulin\n* serum bicarbonate \\\u003C 20 mmol\u002FL\n* Use of antibiotics 3 months before inclusion\n* Vegetarian diet - Presence of inflammatory bowel disease or other chronic inflammatory disease\n* Alcohol consumption of more than 14 units per week in women, or more than 21 units per week in men\n* Active malignancy - bariatric or other weight loss surgery in the history\n* patients diagnosed with eating disorders (such as bulimia nervosa, anorexia nervosa or binge-eating disorder)\n* HbA1c \\>9% (75mmol\u002Fmol) at screening\n* Unmotivated or not able to adhere to a specific diet\n* The subject is already currently involved in a clinical trial",{"count":241,"type":23},80,[26],"Chronic kidney disease (CKD) is a common condition and a major global cause of illness and mortality. The most common cause of kidney damage is diabetes, a condition that disrupts metabolism, leading to increased risk of damage to the kidneys and blood vessels. There is evidence suggesting that a diet with high acid load - consisting of acid-forming foods such as meat, cheese, and grain products - may contribute to this damage. People with such a diet often have poorer blood sugar control and more kidney damage. However, it is not yet well understood whether reducing dietary acid load can improve kidney function and diabetes management. Additionally, the role of ethnicity and sex in this process remains insufficiently explored.\n\nThe goal of this clinical trial is to understand how diet affects kidney function and blood sugar regulation in individuals with diabetes type 2 and chronic kidney disease, as well as to explore the role of sex and ethnicity in these effects. The main questions it aims to answer are:\n\nDoes a diet with lower acid load (e.g. less meat, cheese, and grain products) improve kidney function and blood sugar regulation in people with diabetes type 2 and chronic kidney disease?\n\nDoes the effect of diet on kidney function and blood sugar differ between ethnic groups, specifically between White-Dutch and South-Asian Surinamese descent people?\n\nParticipants will:\n\n* be randomly assigned to follow either a high- or low-acid load diet for 8 weeks;\n* Visit the study center four times (including screening)\n* Complete food diaries three times per week and keep in regular contact with a dietitian;\n* Collect 2x24-hour urine samples and morning feces at each visit ;\n* Undergo blood sampling and an oral glucose tolerance test (OGTT).\n* Spend a total of 8 hours at the study center (2 visits of 3 hours for OGTT and body composition tests, and 2 visits of 1 hour for additional assessments);\n* Have up to 200 ml of blood collected during the study.",[245,246],"Type 2 Diabetes","Chronic Kidney Disease",[248,249,250,238,251],"sex differences","Ethnic","acid lowering diet","kidney health","2026-05-07",{"date":254,"type":38},"2026-05-14",{"date":175,"type":23},{"date":257,"type":23},"2028-06-01",{"name":44,"class":45},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":79},"100573662","implementation-of-a-home-based-computerized-cognitive-rehabilitation-program-for-patients-with-abi-100573662","NCT06749197","Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI","Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With Acquired Brain Injury","CoRe@Home","Inclusion Criteria:\n\n* diagnosed with acquired brain injury\n* receiving outpatient rehabilitation\n* sufficient command of Dutch or English language\n* internet access\n\nExclusion Criteria:\n\n* incapacitated patients like patients diagnosed with dementia",{"count":268,"type":23},30,[26],"Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and\u002For subjective cognitive complaints, especially in the domains of attention and working memory. Cognitive deficits are associated with anxiety and depression and may affect social participation and health-related quality of life (HR-QoL). Approximately 25% of the patients with ABI will be referred to an in- and\u002For outpatient rehabilitation center for multidisciplinary therapy to optimize recovery. Multiple studies suggest that supervised computerized cognitive training (CCT) may enhance cognitive functioning in patients with ABI. Recently, the CCT program RehaCom was introduced as an online version which is suitable for home training. In this study the feasibility and outcomes of implementing home-based CCT into a blended care pathway will be investigated in patients receiving outpatient rehabilitation therapy after ABI.\n\nObjective: The aim of this study is to assess the feasibility and to evaluate the effect of blending a home-based CCT program (RehaCom) in standard care on cognitive functioning in patients after ABI.\n\nThe secondary aim is to evaluate the effect of this CCT program on subjective cognitive complaints, self-efficacy, psychological outcome measures and HR-QoL.\n\nStudy design: Randomized cross-over trial comparing a 5-week blended care pathway to 5 weeks of standard care within 30 patients with ABI.\n\nStudy population: Adults with ABI receiving outpatient rehabilitation therapy.\n\nIntervention: A blended care pathway including 1 cognitive strategy training session of 1 hour per week in the outpatient rehabilitation center in combination with home-based CCT in 4 sessions of 30 minutes per week, during 5 weeks. The standard care pathway includes 2 cognitive training sessions of 1 hour per week in the outpatient rehabilitation center during 5 weeks.\n\nMain study parameters\u002Fendpoints: Cognitive functioning (attention and working memory), self-efficacy, psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed at baseline (T0), after 6 weeks (T1) and after 12 weeks (T2).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: In the blended care pathway patients will be instructed to follow a home-based CCT program. Training at home requires a time investment from patients but will also reduce the number of visits to the rehabilitation center. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment instead of traveling to the rehabilitation center for scheduled cognitive training. Increasing patients' responsibility in their recovery process may improve their self-efficacy and HRQoL.\n\nCompletion of online questionnaires also requires a certain time investment from patients and might lead to temporary fatigue. Patients may take a break at any moment and continue completing the questionnaires at a later time. By a maximum duration of 45 to 60 minutes per measurement we aim to minimize the burden for patients. There are no risks associated with participation.",[272],"Acquired Brain Injury (Including Stroke)",[274,275,276,277,278,279],"cognition","cognitive impairment","attention deficit","memory disorder","computerized cognitive training","home-based training","2026-04-30",{"date":282,"type":38},"2026-05-01",{"date":284,"type":38},"2025-03-20",{"date":286,"type":23},"2026-12-31",{"name":44,"class":45},{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":24,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":79},"100623859","cbct-guided-markerless-sbrt-for-renal-cell-cancer-100623859","NCT07402109","CBCT Guided Markerless SBRT for Renal Cell Cancer","Organ Sparing Marker-less CBCT-guided Stereotactic Adaptive Radiotherapy for Primary Non-metastasized Renal Tumors","CT-STARRS","Inclusion Criteria:\n\n* Patients with histologically proven non-metastastic RCC or high suspicion of RCC based on imaging without histological evidence\n* No metastatic lesions\n* Patients must be 18 years or older\n* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician.\n\nWritten informed consent\n\nExclusion Criteria:\n\n* Previous high-dose radiotherapy in the region of the kidney",{"count":297,"type":23},40,[26],"This study aims to improve the treatment of kidney tumors using radiotherapy, by investigating whether kidney cancer can be more effectively irradiated with the help of new imaging techniques",[301],"Renal Cell Carcinoma (RCC)","2026-04-03",{"date":304,"type":38},"2026-04-08",{"date":306,"type":38},"2026-04-01",{"date":308,"type":23},"2030-01-01",{"name":44,"class":45},{"id":311,"slug":312,"hasResults":12,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":317,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":24,"phases":320,"briefSummary":321,"conditions":322,"keywords":327,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":337,"leadSponsor":339,"locationsCount":79},"100632391","prevention-of-noise-induced-hearing-loss-in-primary-education-100632391","NCT07513077","Prevention of Noise-Induced Hearing Loss in Primary Education","Effectiveness of an Educational Program in Primary Schools to Prevent Noise-induced Hearing Loss","Inclusion Criteria:\n\nFor schools: None.\n\nFor children:\n\n* Dutch primary school children in group 7 (corresponding to Year 6 in the UK).\n* Informed consent from legally authorized parent(s) or guardian(s).\n\nParents:\n\n• Child is participating.\n\nExclusion Criteria:\n\nFor schools:\n\n• HoorToren package has been taught at group 6 in the previous school year.\n\nFor children:\n\n* Children without informed consent from legally authorized parent(s) or guardian(s).\n* Children who cannot read and write Dutch.\n\nFor parents:\n\n• Parents who cannot read and write Dutch",true,{"count":319,"type":23},600,[26],"The goal of this randomized controlled trial is to evaluate the effectiveness of the educational program the HoorToren in promoting recreational safe listening behavior among Dutch primary school children in group 7 (aged 10-11 years) and thereby contribute to preventing noise-induced hearing loss. The main objectives are:\n\n* To evaluate the HoorToren's effects on promoting the child's safe listening behavior when using headphones or earbuds. Both safe listening and its psychological determinants will be measured.\n* To evaluate the HoorToren's effects on parents' perception of their child's safe listening behaviors. The effects on parental behavior promoting or facilitating their child's safe listening behavior, including its psychological determinants, will also be evaluated.\n\nResearchers will compare children who receive lessons from the HoorToren educational program, and their parents (intervention group) with children and their parents who do not receive the lessons (control group) to evaluate the effectiveness of the HoorToren. Outcomes will be assessed using newly developed and validated self-report questionnaires for both children and their parents. Additionally, the child's listening behavior will be measured via a smartphone application installed on the child's phone. Measurements will take place at four time points during the school year.",[323,324,325,326],"Effectiveness of Application Education Intervention","Noise Induced Hearing Loss","Behavior Change Interventions","Primary School Children",[328,329,330,331,332],"Noise-induced hearing loss","Prevention","Primary school","Randomized controlled trial","Effectiveness","2026-03-30",{"date":335,"type":38},"2026-04-06",{"date":333,"type":38},{"date":338,"type":23},"2027-08",{"name":44,"class":45},{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":354,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":153},"100554901","optimizing-cardiac-rehabilitation-by-refining-sleep-and-stress-100554901","NCT06505109","OPTImizing CArdiac REhabilitation by REfining Sleep and STress","OPTICARE-RESST","Inclusion Criteria:\n\n* Participate in CR at one of the study centres for any cardiac diagnosis or reason as stated in the Dutch guidelines\n* Age at or above 18 years\n* Proficient in the Dutch language\n* Experiencing sleep and\u002For stress problems as indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI score \\>5) or Perceived Stress Scale-10 (PSS-10 score \\>13)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric, cognitive or physical comorbidity that would impede CR participation\n* Active treatment for sleep disorders, stress, or other forms of (behavioural) therapy at the start of the study or expected to start within the first 6 months of the study, that could interfere with the RESST intervention. Note: Participants with previously diagnosed sleep disorders are eligible if they still experience sleep or stress problems, unless they fall under the above criteria. Participants who received a prior treatment that is still ongoing but has resulted in a stable sleep and stress condition in the 3 months before the cardiovascular event (e.g., Continuous Positive Airway Pressure (CPAP)) are eligible.",{"count":348,"type":23},200,[26],"The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.",[352,353],"Cardiovascular Diseases","Cardiac Rehabilitation",[352,353,355,356],"Sleep","Stress","2026-03-11",{"date":359,"type":38},"2026-03-13",{"date":361,"type":38},"2024-08-28",{"date":363,"type":23},"2027-01",{"name":44,"class":45},{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":373,"minAge":20,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":375,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":79},"100626465","clinical-feasibility-of-the-architect-applicator-in-cervical-cancer-brachytherapy-100626465","NCT07435987","Clinical Feasibility of the ARCHITECT Applicator in Cervical Cancer Brachytherapy","Clinical Feasibility of the ARCHITECT Applicator in High-dose-rate Cervical Cancer Brachytherapy","ARCHITECT","Inclusion Criteria:\n\n* Locally advanced cervical cancer (FIGO 2018 stage 1B3-IVA) with indication for primary radiotherapy including brachytherapy\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable to give informed consent;\n* Tumour extension in the lower 2\u002F3rd of the vagina;\n* Requiring a Geneva tandem with ovoids' size 13 mm in the first application for brachytherapy;\n* Known nylon allergy.","FEMALE",{"count":7,"type":23},[26],"This prospective, non-randomised, single centre, phase I trial assesses the clinical feasibility of the use of the patient-tailored ARCHITECT applicator in locally advanced cervical cancer brachytherapy.",[378,379],"Locally Advanced Cervical Cancer","Uterine Carcinoma",[381,382,383],"Brachytherapy","Patient-tailored applicator","3D-printed applicator","2026-02-20",{"date":386,"type":38},"2026-02-27",{"date":388,"type":23},"2026-05",{"date":390,"type":23},"2027-12",{"name":44,"class":45},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":317,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":413,"leadSponsor":415,"locationsCount":4},"100625741","evaluating-the-usability-of-new-dialysis-bags-100625741","NCT07426575","Evaluating the Usability of New Dialysis Bags","Evaluating the Usability of New Dialysis Bags for Continuous Renal Replacement Therapy: A Survey Among ICU Nurses","Inclusion Criteria:\n\n* Nurse working in an adult intensive care unit (ICU)\n* Competent in performing continuous renal replacement therapy (CRRT)\n\nExclusion Criteria:\n\n* Nurses with less than 6 months of experience in administering CRRT, to ensure sufficient experience for a valid head-to-head comparison with the older dialysis bags.\n* Nurses who are not directly involved in the handling or replacement of dialysis bags during CRRT procedures.",{"count":400,"type":23},126,"Objective: To compare the usability, efficiency, and ergonomics of new dialysis bags with current bags from the nursing perspective in ICU settings.\n\nStudy Type: Prospective, single-center observational study.\n\nMethods: ICU nurses (126 total) will complete two surveys (pre- and post-implementation) evaluating both dialysis bags.",[403],"Renal Replacement Therapies",[405,406,407,408],"acute kidney disease","Renal replacement therapy","Evalatuion study","ICU nurses","2026-02-15",{"date":411,"type":38},"2026-02-23",{"date":409,"type":23},{"date":414,"type":23},"2027-06-15",{"name":44,"class":45},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":422,"eligibilityCriteria":423,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":24,"phases":426,"briefSummary":427,"conditions":428,"keywords":434,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":79},"100588092","virtual-ward-for-early-discharge-in-patients-receiving-inpatient-care-100588092","NCT06936891","Virtual Ward for Early Discharge in Patients Receiving Inpatient Care","Virtual Ward for Early Discharge in Patients Receiving Inpatient Care: A Prospective Feasibility Study on Home Monitoring for the Early Discharge of Eligible Hospitalized Patients in an Outpatient Setting","VIP care","Inclusion Criteria:\n\n* Adult patients (≥18 years old).\n* Currently hospitalized and eligible for early discharge according to clinical judgment.\n* Ability to provide written informed consent.\n* Access to a smartphone or tablet with internet connection.\n* Patient is capable of using the Digizorg app or has support from a caregiver who can assist.\n* Suitable home situation for Virtual Ward care (e.g., safe environment, necessary utilities available).\n* Enrollment in one of the predefined Virtual Ward care pathways\n\nExclusion Criteria:\n\n* Patients requiring continuous hospital-based monitoring or interventions that cannot be safely delivered at home.\n* Patients who are hemodynamically unstable or require oxygen therapy \\>5 liters\u002Fminute at the time of discharge.\n* Patients unable or unwilling to comply with home monitoring procedures.\n* Patients with significant cognitive impairment without adequate caregiver support.\n* Patients with a life expectancy less than 30 days, as assessed by the treating physician.\n* Patients participating in another interventional clinical trial that could interfere with the Virtual Ward protocol.\n* Any other condition that, in the opinion of the treating physician, would make participation unsafe or infeasible.",{"count":425,"type":23},306,[26],"This study evaluates the feasibility of providing hospital-level care at home for eligible patients through a Virtual Ward. Patients are discharged early from the hospital and monitored remotely using digital vital sign monitoring and anamnesis questionnaires. The primary aim is to determine if at least 30% of eligible patients can be safely and successfully transferred to the Virtual Ward under current Dutch healthcare conditions.",[429,430,431,432,433],"Early Discharge","Telemedicine","Virtual Clinic","Hospital at Home","Feasibility Studies",[435,436,437,438,439,440,441],"early discharge","telemedicine","virtual ward","virtual clinic","hospital at home","feasability","telemonitoring",{"date":443,"type":38},"2026-02-17",{"date":445,"type":38},"2025-04-16",{"date":447,"type":23},"2028-12-31",{"name":44,"class":45},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":24,"phases":458,"briefSummary":459,"conditions":460,"keywords":463,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":475,"leadSponsor":477,"locationsCount":79},"100624179","clinical-evaluation-of-ai-decision-support-for-early-rehabilitation-after-surgery-100624179","NCT07406269","Clinical Evaluation of AI Decision Support for Early Rehabilitation After Surgery","Evaluation of Clinical Effectiveness and Implementation of an Artificial Intelligence Based Decision Support Tool That Guides Early Rehabilitation After Gastrointestinal and Oncology Surgery","DESIRE","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing gastrointestinal or oncological surgery\n* Postoperatively admitted to the surgical ward\n* Expected to remain admitted for at least 2 days after surgery\n\nExclusion Criteria:\n\n* Admitted to the intensive care unit (ICU) at the time of prediction on postoperative day 2\n* Inability to provide informed consent in Dutch or English",{"count":89,"type":23},[26],"After gastrointestinal or oncology surgery, it can be difficult to determine when a patient is ready to safely begin early rehabilitation or move toward discharge. Delays may prolong hospital stay, while premature decisions may increase risks.\n\nThis study evaluates an artificial intelligence (AI)-based decision support tool that analyzes routinely collected hospital data to identify patients who are likely ready for early rehabilitation and discharge planning after surgery. The tool provides a simple yes\u002Fno output to support clinicians in their decision-making.\n\nThe AI tool does not replace clinical judgment. Treating physicians remain fully responsible for all care decisions.\n\nThe purpose of this study is to examine how well this tool performs in clinical practice and how it can be safely and effectively implemented to support postoperative care.",[461,462],"Oncologic Surgery","Gastrointestinal Cancers",[464,465,466,467,468,469,470],"Artificial Intelligence","Clinical Decision Support System","Postoperative Care","Early Rehabilitation","Gastrointestinal Surgery","Oncological Surgery","Predictive Modeling","2026-02-06",{"date":473,"type":38},"2026-02-12",{"date":175,"type":23},{"date":476,"type":23},"2027-07-01",{"name":44,"class":45},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":485,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":488,"conditions":489,"keywords":496,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":79},"100600426","point-of-care-fibrinogen-measurement-in-trauma-patients-in-the-emergency-department-100600426","NCT07097337","Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department","POCFIB","Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the exclusion criteria detailed below.\n\nInclusion criteria\n\nTo be eligible to participate in this study, a subject must meet the following criteria:\n\n* The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury\n* The participant is deemed by the attending clinician to have on-going active hemorrhage\n* The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated\n\nExclusion criteria\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n* The participant has been transferred from another hospital\n* The trauma team leader deems the injuries incompatible with life","16 Years",{"count":487,"type":23},150,"Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC). This is a condition where the blood doesn't clot properly, making bleeding worse. The reasons behind TIC are complicated and not fully understood.\n\nOne important substance involved is fibrinogen, a protein that helps blood clot. Low levels of fibrinogen are often the first sign of TIC and tend to be linked with how bad the injury is. Because of this, doctors have been giving trauma patients extra fibrinogen early on, hoping it will help them survive.\n\nHowever, a recent large study (called CRYOSTAT-2) showed that giving high doses of fibrinogen to all trauma patients didn't actually help reduce deaths. This suggests that not everyone needs it-only patients with very low fibrinogen levels (below 1.5 grams per liter) should get it.\n\nThe problem is: it currently takes 30 to 45 minutes to get fibrinogen test results. In emergency situations, that's too slow. So doctors have been guessing who needs it, which might not always be the best approach.\n\nWhat This Study Aims to Do This new study wants to see if a faster, bedside test-called a point-of-care (POC) fibrinogen test-can be used in the Emergency Department (ED) during trauma resuscitations.\n\nMain Goals:\n\nFeasibility: Can the test be done quickly and easily during emergency care?\n\nUsefulness: If the fast test had been available, would doctors have made different decisions-like giving or not giving fibrinogen? And would that have changed outcomes for the patients?\n\nStudy Details Feasibility Study: To see if the test is practical during trauma care.\n\nRetrospective Cohort Study: To look back at patients and see if early test results could have changed decisions or outcomes.\n\nWho's In the Study? Adults over 16 who arrive at the ED with serious trauma and for whom the hospital's Massive Transfusion Protocol was activated (meaning they had major bleeding).\n\nThey must have received at least one unit of blood.\n\nHow the Study Will Work The Test: A small amount of blood (0.15 ml) will be taken from blood that's already being drawn for routine care-so no extra blood draws are needed.\n\nThe POC test (called qLabs Fib) will be done at the same time as standard lab tests.\n\nImportant Note: Doctors won't make decisions based on this fast test for now. It's just being tested for feasibility.\n\nNurses will note how long the test takes and if they had any trouble using it.\n\nLater, researchers will look back at the data to see:\n\n* What the fibrinogen levels were.\n* Whether the fast results could have helped guide better treatment.\n* If outcomes like how much blood was given or survival were affected.\n\nWhy It Matters If the fast test works well, it could lead to\n\n* Faster, more accurate treatment in trauma cases.\n* Less unnecessary use of fibrinogen, saving resources and avoiding possible side effects.\n* Better outcomes for patients by tailoring treatment to their actual needs.",[490,491,492,493,494,495],"Trauma Induced Coagulopathy","Trauma Coagulopathy","Fibrinogen Deficiency","Fibrinogen; Deficiency, Acquired","Massive Transfusion Protocol","Massive Hemorrhage",[497,498,499,500],"point of care fibrinogen","trauma induced coagulopathy","fibrinogen suppletion","fibrinogen",{"date":502,"type":38},"2026-02-10",{"date":504,"type":38},"2025-11-01",{"date":506,"type":23},"2027-03-01",{"name":44,"class":45},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":516,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":518,"conditions":519,"keywords":521,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":79},"100622405","prediction-models-for-ldlt-outcomes-100622405","NCT07383194","Prediction Models for LDLT Outcomes","A Clinically Applicable Prediction Model for Living Donor Liver Transplantation Outcomes Using the International LDLT Registry","PREDICTLDLT","Inclusion Criteria:\n\n\\- All LDLT donor-recipient pairs registered in the International LDLT Registry from September 1, 2023 to present.\n\nExclusion Criteria:\n\n* Two stage LDLT\n* Dual grafts LDLT",{"count":517,"type":23},3000,"Rationale:\n\nLiving donor liver transplantation (LDLT) has emerged as an important option for patients with end-stage liver disease. To facilitate international and meaningful comparisons, our institution participates in the International LDLT Registry. Several models to predict outcomes post-LDLT have been developed to council and justify the major surgery that the living liver donors undergo. However, most proposed models are at high risk of bias and demonstrate suboptimal discriminative ability.\n\nThis study aims to externally validate the most promising prediction models and subsequently, develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nObjective(s):\n\nThe main objective of this study is to develop a new, clinically applicable prediction model for LDLT outcomes, using the International LDLT Registry.\n\nThe secondary objective is to externally validate the most promising existing prediction models for LDLT outcomes, using the International LDLT Registry.\n\nStudy type:\n\nThis is an observational, multicenter cohort study using prospectively collected data from the International LDLT Registry. Registry data will be analyzed retrospectively for the purposes of external model validation and prediction model development.\n\nStudy population:\n\nThe study population consists of living liver donors and their corresponding recipients recorded in the International LDLT registry.\n\nMethods:\n\nFor external validation, parameters will be entered in the existing prediction models resulting in the predicted risks. Model discrimination will be measured using the area under the curve (AUC) and by the discrimination slope. The DeLong test will be used to test for difference between the AUC of the different prediction models. Calibration will be evaluated by comparing the observed with the predicted rate of events and graphically represented by calibration plots.\n\nFor the development of a new prediction model, the outcome of interest is early graft failure, defined as graft loss within 90 days after transplantation. A multivariable logistic regression model will be developed to estimate the individual risk of early graft failure. Internal validation will be performed using bootstrapping, and model performance will be assessed in terms of discrimination and calibration. Model performance will also be tested in subgroups.",[520],"Living Donor Liver Transplantation",[522,523,524,525,526],"Liver Transplantation","Living Donor","Graft Survival","Mortality","Prediction Algorithms","2026-02-02",{"date":529,"type":38},"2026-02-03",{"date":531,"type":23},"2026-03-10",{"date":533,"type":23},"2027-07-02",{"name":44,"class":45},{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":18,"minAge":20,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":24,"phases":544,"briefSummary":546,"conditions":547,"keywords":550,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100622515","phase-1-combining-latency-reversing-agents-to-address-the-hiv-reservoir-100622515","NCT07384624","Combining Latency Reversing Agents to Address the HIV Reservoir","Curing HIV: Proof of Concept Randomized Clinical Trial With Pyrimethamine, Lenalidomide, TOpiramate","PLUTO","Inclusion Criteria:\n\n* Documented HIV-1 infection, confirmed by 4th generation ELISA, Western Blot or PCR.\n* Age ≥ 18 years old.\n* Confirmed HIV1, subtype A, B, C or D.\n* Uninterrupted ART therapy for a minimum 6 months. .\n* Plasma HIV RNA \\\u003C≤50 copies\u002Fml prior to inclusion at two consecutive measurements at least three months apart.\n* No disclosed missed ART on more than 2 days per month.\n* Current blood CD4+T-cell count of ≥200 cells\u002Fmm3\n* No clinical signs of cellular immunodeficiency or AIDS.\n* Pre-ART plasma HIV RNA ≥1000 copies\u002FmL.\n* Able to understand provided information and to give informed consent.\n\nExclusion Criteria:\n\n* Prior exposure to any of the studied LRAs in the previous 90 days\n* HIV-2 (double)infection\n* Co-infection with hepatitis B, unless resolved HBV (anti-HBc positive, anti-HBs positive and HBsAg negative) OR HBsAg positive and on continuous HBV-active antiviral therapy for ≥24 weeks prior to dosing, and HBV DNA undetectable or ≤ 200 IU\u002FmL on two measurements (screening and within 4 weeks prior to enrolment), and no history of advanced fibrosis\u002Fcirrhosis (stage F2 and higher)\n* Co-infection with hepatitis C, measured by the presence of hepatitis C virus RNA in blood.\n* Co-medication with clinically significant interactions with LRA\n* mRNA vaccine or adjuvant vaccine (e.g. Shingrix) in the previous 8 weeks.\n* Megaloblastic anaemia due to folate deficiency and untreated haemolysis of any cause\n* Active malignancy during the past year with the exception of basal carcinoma of the skin, stage 0 cervical carcinoma, Kaposi's sarcoma treated with ART alone or other indolent malignancies.\n* History of suicide attempt or suicidal ideation.\n* History of ophthalmological medical problems leading to glaucoma or visual field disturbances (e.g. macula oedema). Refraction abnormalities that can be corrected by lenses are acceptable.\n* History of any medical condition with a causal relationship with hyperammonemia.\n* History of epileptic seizures in the previous year.\n* Registered allergies for any of the investigational medical products\n* Sexually active participants who do not fit any of the following:\n\n  a) Female subject of childbearing potential willing to comply with pregnancy tests before start and four weeks after end of treatment and willing to use of double contraceptive measures during and until 1 week after administration of study medication. Non-childbearing is defined by one of the following criteria: amenorrhoea for ≥ 1 year, premature ovarian failure, assigned male at birth, or having undergone bilateral salpingo-oophorectomy, or hysterectomy. b) Sexually active male PLWH who have sex with female partners of childbearing potential and willing to abstain from sex or willing to use condom protection during and until 1 week after administration of study medication.\n\n  c) Sexually active male PLWH who have sex with postmenopausal female partners and willing to abstain from sex or willing to use condom protection or with a postmenopausal female partner on pre-exposure prophylaxis during and until 1 week after administration of study medication.\n\n  d) Male PLWH who have sex with male partners and willing to abstain from sex or willing to use a condom protection during and until 1 week after administration of study medication.\n\n  e) Male PLWH who have sex with male partners on preexposure prophylaxis during and until 1 week after administration of study medication.\n* Any lab abnormalities at screening as listed below:\n\n  1. Moderate kidney impairment, defined as eGFR \\\u003C50 mL\u002Fmin. In PLWH on dolutegravir- or bictegravir-based ART regimens, cystatin C-based eGFR can be used, since possible drug interference with tubular creatinine excretion which leads to eGFR underestimation.\n  2. Moderate hepatic impairment, defined as bilirubin \\> 3 x upper limit of normal (ULN) or ALT \\> 3x ULN\n  3. Inadequate blood counts, defined as: haemoglobin \\\u003C6.5 mmol\u002FL (males) or \\\u003C6.0 mmol\u002FL (females), Absolute neutrophil count \\\u003C1000 cells\u002Fmm3, thrombocytes \\\u003C100 x109\u002FL, international standardized ratio \\>1.6, activated partial thromboplastin time \\>40 seconds,",{"count":268,"type":23},[545,164],"PHASE1","The PLUTO trial aims to contribute to the worldwide search for a functional cure of HIV. One the strategies (\"shock and kill' strategy) aims to reverse the HIV-reservoir from latency by increasing cell-associated HIV-RNA, which will lead to increased antigen presentation, trigger immune recognition, and facilitate the elimination of reservoir cells. Participants of the trial are adults with HIV with undetectable viral load that are able to give informed consent to participate in the trial, in total 30 patients will be recruited. The investigational medical compounds in this trial are topiramate, lenalidomide and pyrimethamine, which will be combined. These are all licensed drugs for other conditions.\n\nThe study consists of two phases. In phase I participants will receive a single dose of the IMPs, as combination therapy. Sampling will be performed before, during and after medical treatment to evaluate latency reversal and safety endpoints. In phase II, participants will receive the combination of IMPs which is the most potent and within safety limits selected from phase I during a four-week treatment. Sampling will take place on a weekly basis to assess latency reversal, reservoir reduction and safety.\n\nParticipants will be recruited from the Erasmus MC, Amsterdam university Medical Center, Radboud University Medical Center and the University Medical Center Utrecht.",[548,549],"HIV (Human Immunodeficiency Virus)","HIV -1 Infection",[551,552,553,554,555,556,557],"HIV","HIV reservoir","Latency Reversing Agent","HIV cure","Topiramate","Pyrimethamine","Lenalidomide","2026-01-29",{"date":529,"type":38},{"date":561,"type":23},"2026-04",{"date":563,"type":23},"2028-07",{"name":44,"class":45},4,{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":18,"minAge":574,"maxAge":575,"enrollmentInfo":576,"targetDuration":4,"studyType":24,"phases":578,"briefSummary":580,"conditions":581,"keywords":588,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":594,"leadSponsor":596,"locationsCount":79},"100622279","phase-4-cyclosporine-or-methotrexate-for-pediatric-alopecia-areata-routine-clinical-care-effectiveness-study-100622279","NCT07381556","Cyclosporine Or Methotrexate for Pediatric Alopecia Areata: Routine Clinical Care Effectiveness Study","The Effectiveness of Cyclosporine Versus Methotrexate in the Treatment of Pediatric Alopecia Areata in Routine Clinical Care: a Patient Preference Trial","COMPARE","Inclusion criteria\n\nIn order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n* Age 2-17 years\n* Clinical diagnosis of AA by a certified dermatologist\n* Willingness of participant (in case 12-17 years) and parents to provide informed consent for participation in the study.\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n* Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.\n* Patients who are ineligible for the CsA arm (due to contraindications), are automatically included in the MTX arm.\n* Contra-indications CsA:\n\nImpaired kidney function. Poorly controlled hypertension Active infections. Presence of a malignancy. Nephrotic syndrome combined with poorly controlled hypertension, infection or malignancy.\n\nKidney disorders, except in cases of nephrotic syndrome with mild to moderate renal impairment.\n\n* Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the CsA arm.\n* Contraindications MTX:\n\nConception (both male and female) and lactation Severe kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse Bone marrow hypoplasia, immunodeficiency Anemia, leukopenia, or thrombocytopenia Poor nutritional status (low albumin) Hypersensitivity or allergy to MTX Lung toxicity due to MTX or significant reduction in lung function.","2 Years","17 Years",{"count":577,"type":23},50,[579],"PHASE4","Rationale: Since the introduction of Janus kinase (JAK) inhibitors, there has been a significant advancement in the treatment of pediatric alopecia areata. Eligibility for this treatment, in the Netherlands, requires prior failure of systemic therapies such as cyclosporin or methotrexate. However, the choice between methotrexate and cyclosporin as first-line systemic treatment is not supported by robust comparative studies.\n\nTherefore, the investigators conduct a patient preference trial with a long-term follow-up provided in the Pediatric Systemic Alopecia Areata Registry (STA2R-Pediatric). This study will evaluate the effectiveness of Cyclosporin (CsA) and Methotrexate (MTX) in children and adolescents with moderate-to-severe AA.\n\nObjective(s): To investigate the effectiveness of CsA and MTX in the treatment of children and adolescents with alopecia areata in routine clinical care.\n\nStudy type: This is a prospective, patient preference clinical trial with a duration up to 36 weeks in accordance with the routine clinical care guidelines.\n\nStudy population: This study will include children and adolescents (2-17 years old) diagnosed with AA who start first-line systemic treatment.\n\nMethods: Patients and their parents will choose between CsA and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. The participants will not be randomized. The primary endpoint is the measurement of the Severity of Alopecia Tool (SALT) at 9-months with a secondary endpoint at 24 weeks. SALT scores will be measured by a blinded assessor. The (Children) - Dermatology Life Quality Index ((C)-DLQI) questionnaire will be conducted at each visit (0, 3, 6, 9 months), allowing evaluation of the impact on patients' quality of life.",[582,583,584,585,586,587],"Alopecia Areata(AA)","Alopecia Areata (AA)","Alopecia Totalis\u002FUniversalis","Alopecia Universalis (AU)","Alopecia Totalis (AT)","Alopecia Areata (& Ophiasis)",[33,589,590],"Alopecia areata","systemic treatment alopecia areata","2026-01-26",{"date":527,"type":38},{"date":504,"type":38},{"date":595,"type":23},"2027-11-01",{"name":44,"class":45},{"id":598,"slug":599,"hasResults":12,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":604,"targetDuration":4,"studyType":129,"phases":4,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":79},"100621608","camk2-related-synapthopathies-natural-history-study-100621608","NCT07372833","CAMK2-related Synapthopathies Natural History Study","Natural History Data of International Subjects With an ULTRA-Rare Neuro Developmental Disorder as Part of the ENCORE Expert Clinics, Specifically CAMK2A, CAMK2B, CAMK2D, and CAMK2G.","Inclusion Criteria:\n\n* Subject with a (likely) pathogenic variation in one of the CAMK2 genes\n* Consent for anonymous registration in an (inter)national database\n\nExclusion Criteria:\n\n\\- Subjects with a Variant of Unknown Significance (VUS); in those cases functional analysis should be performed first.",{"count":487,"type":23},"The key endpoint for this prospective cohort study is:\n\nMapping of the disease course of all known patients (both children and adults, international) with a CAMK2 mutation, for which ENCORE has founded an expert clinic, and therefore has a substantial and active neuroscientific research arm combined with tertiary academic clinical care delivery for those living in the Netherlands.\n\nSuch robust clinical maps can subsequently be used for genotype-phenotype correlations and, identify clinically relevant outcome measures for prognostication, improvement of care delivery \\& future clinical trials. Additionally, it will most likely generate new research questions for basic scientists who are trying to unravel the specific mechanisms of disease pathophysiology.",[607,608],"CAMK2","Calcium\u002FCalmodulin-dependent Protein Kinase 2",[607,610],"Calcium\u002Fcalmodulin-dependent protein kinase 2","2026-01-23",{"date":613,"type":38},"2026-01-28",{"date":615,"type":38},"2021-02-09",{"date":617,"type":23},"2040-01-01",{"name":44,"class":45},{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":623,"acronym":624,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":626,"maxAge":627,"enrollmentInfo":628,"targetDuration":4,"studyType":24,"phases":630,"briefSummary":631,"conditions":632,"keywords":637,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":651},"100575392","high-intensity-interval-training-in-patients-with-a-right-ventricle-to-pulmonary-artery-conduit-100575392","NCT06771687","High Intensity Interval Training in Patients With a Right Ventricle to Pulmonary Artery Conduit","Right HIIT","Inclusion Criteria:\n\n1. Congenital absence of an unobstructed connection between the right ventricle and pulmonary artery, requiring surgical implantation of a right ventricle to pulmonary artery conduit, including patients with:\n\n   1. Truncus arteriosus\n   2. Pulmonary atresia with ventricular septum defect\n   3. Severe tetralogy of Fallot\n   4. Other forms of pulmonary atresia with biventricular correction\n2. Age 12 to 45 years.\n3. Current follow-up in Academic Center for Congenital Heart Disease (ACAHA; Erasmus MC Rotterdam and Radboudumc Nijmegen).\n4. Signed informed consent.\n\nExclusion Criteria:\n\n1. Ventricular arrhythmias and\u002For channelopathy.\n2. Implantable cardioverter defibrillator implantation due to inherited arrhythmia syndromes.\n3. Left ventricular ejection fraction and\u002For right ventricular ejection fraction less than 30 percent.\n4. Elite athletes (i.e. national team, Olympians, professional athletes, exercising equal to or more than 10 h\u002Fweek, according to definition in 2020 European Society of Cardiology Guidelines for Sports Cardiology and Exercise in Patients with Cardiovascular Disease).\n5. Cardiovascular lesions requiring intervention (according to international guidelines).\n6. Cardiovascular intervention (surgery or catheterization) less than 6 months ago.\n7. Cardiovascular medication changes less than 3 months ago.\n8. Hospitalization for treatment of cardiovascular events less than 6 months ago.\n9. Comorbidities or developmental delay impeding exercise training (e.g. neuromuscular disease, symptomatic myocardial ischemia, syndromic diagnoses such as trisomy 21).\n10. Inability to provide informed consent.","12 Years","45 Years",{"count":629,"type":23},38,[26],"The goal of this clinical trial is to learn if a specific type of exercise training (high intensity interval training) can improve exercise capacity in people with a congenital heart defect that required the creation of a new connection between the right ventricle and pulmonary artery. This includes people with a truncus arteriosus, pulmonary atresia with a ventricular septal defect or severe tetralogy of Fallot. This study focuses on people aged 12 to 45 years. The main questions it aims to answer are:\n\n* Can a 12-week home-based high intensity interval exercise training program increase the exercise capacity?\n* Can factors that predict whether or not the exercise training program can increase the exercise capacity in specific people be identified?\n\nResearchers will compare the results from the intervention group to the control group. Participants will be assigned to one of these two groups at inclusion. The control group will also receive the intervention, after the control period.\n\nParticipants will:\n\n* Participate in a 12-week home-based exercise training program (3x30 minutes a week, digitally supervised);\n* Attend 2 or 3 study visits (which partially is standard care) (2 visits for the intervention group, 3 visits for the control group);\n* Each study visit includes: echocardiography, magnetic resonance imaging (MRI) of the heart, cardiopulmonary exercise testing (CPET), blood and feces sampling, and questionnaires on quality of life and physical activity.",[633,634,635,636],"Congenital Heart Disease","Truncus Arteriosus","Pulmonary Atresia","Tetralogy of Fallot",[638,639,635,636,640,641,642],"Heart Defects, Congenital","Truncus Arteriosus, Persistent","Physical Conditioning, Human","High-Intensity Interval Training","Exercise Test","2026-01-19",{"date":645,"type":38},"2026-01-21",{"date":647,"type":38},"2025-01-16",{"date":649,"type":23},"2028-10",{"name":44,"class":45},2,{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":658,"eligibilityCriteria":659,"healthyVolunteers":12,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":660,"targetDuration":4,"studyType":24,"phases":662,"briefSummary":663,"conditions":664,"keywords":668,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":675,"lastUpdatePostDateStruct":676,"startDateStruct":678,"completionDateStruct":680,"leadSponsor":681,"locationsCount":79},"100621443","phase-4-iron-infusion-in-patients-undergoing-transcatheter-aortic-valve-implantation-100621443","NCT07370688","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation","Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation: Study Protocol of the Randomized Controlled IRON-TAVI Trial","IRON TAVI","Inclusion Criteria:\n\n* Patient age ≥ 65 years\n* Patients with severe AS and ID undergoing successful TAVI\n* ID defined as Ferritin \\\u003C 100 ug\u002FL and\u002For Transferrin saturation \\\u003C 20%\n* Ability to perform assessment of QoL (questionnaire assessment) and EC (6-MWT)\n* Signed Informed Consent\n\nExclusion Criteria:\n\n* Contra-indication for TAVI\n* Ferritin \\> 400 ug\u002FL\n* Hemoglobin \\\u003C5.6 mmol\u002FL or \\\u003C9 g\u002FdL\n* Hemoglobin \\>8.7 mmol\u002FL or \\>14 g\u002FdL in men and \\>8.1 mmol\u002FL or \\>13 g\u002FdL in women\n* Anaemia due to known reasons other than ID and\u002For anticipated non-response to iron-supplementation (e.g. hemogobinopathy, bone marow disease, active cancer, unresolved active bleeding)\n* Chronic liver disease (including active hepatitis) and\u002For screening alanine transaminase or aspartate transaminase above three times the upper limit of the normal range.\n* Renal dialysis (previous, current, or planned within the next 6 months) or MDRD\u002FCKD-EPI estimated glomerular filtration rate \\\u003C15 mL\u002Fmin.\n* History of iron overload\n* History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 3 months and\u002For such therapy planned within next 6 months\n* Clinically apparent infection requiring antibiotic treatment\n* Known hypersensitivity to iFCM or to any of its excipients\n* Pregnancy\n* Study subject participation in another TAVI related clinical study in which the primary endpoint includes mortality, hospitalization for heart failure and\u002For quality of life assessment.",{"count":661,"type":23},402,[579],"The aim of the open-label, randomized controlled superiority IRON TAVI trial is to investigate whether intravenous iron therapy (ferric carboxymaltose) improves Health-Related Quality of Life (HRQOL) in patients with severe aortic stenosis (AS) and iron deficiency (ID), undergoing transcatheter aortic valve implantation (TAVI).\n\nThe main questions it aims to answer are:\n\n1. Does intravenous iron therapy improve HRQOL after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n2. Can intravenous iron therapy enhance exercise capacity, as measured by the 6-minute walk test, after TAVI in patients with severe AS and ID compared to no intravenous iron therapy (standard of care)?\n\nThe intervention group (receiving iron therapy after TAVI) will be compared to the control group (receiving no iron therapy after TAVI (standard of care)).\n\nParticipants will:\n\n* Provide written informed consent\n* Be randomly assigned to one of two groups:\n\n  1. Intervention group: receiving intravenous iron therapy after TAVI (1-3 administrations in the course of 12 weeks)\n  2. Control group: receiving standard of care (= no iron therapy)\n* Complete assessments of HRQOL and the 6-minute walk test at baseline and week 24 after TAVI.\n* During follow-up visits, other clinical parameters will be collected (i.e. laboratory status, mortality status, adverse clinical events)",[665,666,667,352],"Aortic Valve Stenosis","Iron Deficiency","TAVI(Transcatheter Aortic Valve Implantation)",[669,670,671,665,672,673,674,666,352],"Health-related Quality of Life","Six-Minute Walk Test","Randomized Controlled Trial","Intravenous Iron Therapy","Kansas City Cardiomyopathy Questionnaire","Functional Recovery","2026-01-18",{"date":677,"type":38},"2026-01-27",{"date":679,"type":38},"2024-08-12",{"date":563,"type":23},{"name":44,"class":45},{"id":683,"slug":684,"hasResults":12,"nctId":685,"briefTitle":686,"officialTitle":687,"acronym":688,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":18,"minAge":690,"maxAge":691,"enrollmentInfo":692,"targetDuration":4,"studyType":24,"phases":694,"briefSummary":695,"conditions":696,"keywords":698,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":706,"completionDateStruct":708,"leadSponsor":709,"locationsCount":153},"100593362","accuracy-and-sustainability-of-scale-eye-evaluation-for-measuring-reliable-polyp-size-100593362","NCT07005453","Accuracy and Sustainability of SCALE-EYE Evaluation for Measuring Reliable Polyp Size","Diagnostic Performance and Sustainability of Using SCALE-EYE During Real-Time Colonoscopy","ASSEMBLE","Inclusion Criteria:\n\n* Participants aged 55-80\n* Scheduled for fecal immunochemical test (FIT) screening or surveillance colonoscopy\n* Polyps of all forms ≤25 mm as assessed by the endoscopist\n\nExclusion Criteria:\n\n* No detected colorectal polyps or only diminutive (≤5 mm) hyperplastic rectal polyps are present\n* Inadequate bowel preparation (Boston Bowel Preparation Score (BBPS) \\\u003C2 per segment)\n* Intraprocedural complications, not caused by the study device\n* Known or suspected inflammatory bowel disease (IBD)\n* Polyposis syndromes (e.g. serrated polyposis, familial adenomatous polyposis)\n* Ileoanal pouch and anastomosis\n* History of radiation or chemotherapy for colorectal lesions\n* Scheduled for therapeutic procedure (for example intervention to stop a lower gastro-intestinal bleeding, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD))\n* Pregnancy\n* No Informed consent (IC) possible","55 Years","80 Years",{"count":693,"type":23},241,[26],"A multicenter, randomized, parallel group, endoscopist blinded study to assess the diagnostic performance and sustainability of SCALE-EYE in a screening and surveillance colonoscopy population.\n\nSustainability will be evaluated in terms of the reduction in colonoscopies, associated waste and carbon footprint.",[697],"Colorectal Polyps",[699,700,701,702],"virtual scale endoscopy","biopsy forceps","optical assessment","colorectal cancer","2026-01-12",{"date":705,"type":38},"2026-01-13",{"date":707,"type":38},"2025-09-23",{"date":306,"type":23},{"name":44,"class":45},""]