[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amsterdam UMC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":254},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,44,76,104,131,162,184,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100590027","outcomes-following-limb-sparing-surgery-for-soft-tissue-sarcoma-100590027",false,"NCT06962072","Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma","Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection","Inclusion Criteria:\n\n* Treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010-2021.\n* Being able to visit the Amsterdam UMC, location AMC once or twice.\n* Pregnant patients must agree to be scheduled 5 months after their pregnancy ends.\n\nExclusion Criteria:\n\n* Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","OBSERVATIONAL","The goal of this study is to assess body image, health-related quality of life (QoL), and functioning (gait function, joint function, and walking ability) in patients after resection of localized soft tissue sarcoma (STS) of the extremities. A secondary objective is to assess the influence of different variables (e.g., radiotherapy, ethnicity, etc.) on body image, health-related QoL, and functioning.\n\nPatients who underwent a surgical resection at the Amsterdam UMC between 2010 and 2021 will be approached to participate in the study. Participants will complete four questionnaires and undergo a physical examination. Additionally, they will have a 3D gait analysis, a 6-minute walk test with gas analysis, and a muscle strength assessment. Furthermore, muscle volume change will be evaluated on pre- versus postoperative MRI scans.",[24],"Soft Tissue Sarcoma",[26,27,28,29,30],"Soft tissue sarcoma","Body image","Quality of life","Function","Functioning","RECRUITING","2025-12-12",{"date":34,"type":35},"2025-12-19","ACTUAL",{"date":37,"type":35},"2025-04-24",{"date":39,"type":20},"2028-01-01",{"name":41,"class":42},"Amsterdam UMC","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":55,"studyType":21,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100607372","developing-trustworthy-artificial-intelligence-ai-driven-tools-to-predict-vascular-disease-risk-and-progression-the-prospective-vascul-aid-study-100607372","NCT07187700","Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression: the Prospective VASCUL-AID Study","VASCUL-AID-PRO","Inclusion Criteria AAA:\n\n* Males\u002Ffemales between 40 and 90 years of age.\n* Males and females with AAA at inclusion, any diameter \\>3 cm (or 1.5x larger than their non-dilated part of the aorta).\n* Include: infrarenal, juxtarenal, pararenal, suprarenal abdominal aortic aneurysms.\n\nExclusion Criteria AAA:\n\nPatients with:\n\n* Insufficient schooling or sensorial deficits that interfere understanding informed consent.\n* Not able to use the VASCUL-AID mobile health app (that will be provided in Dutch, English, German, Portuguese, Serbian, Finish, Swedish languages).\n* Proven or highly suspected for infected, mycotic AAA\n* Previous AAA surgery or planned for an AAA surgery within 6 months\n* Ruptured AAA\n\nInclusion Criteria PAD:\n\n* Males\u002Ffemales between 40 and 90 years of age.\n* Patients with peripheral arterial disease stage Fontaine 2a and 2b at inclusion. Medical history (e.g. CLTI) does not matter, current disease stage is leading at inclusion.\n\nExclusion Criteria PAD:\n\nPatients with:\n\n* Insufficient schooling or sensorial deficits that interfere understanding informed consent.\n* Not able to use the VASCUL-AID mobile health app (provided in Dutch, English, German, Portuguese, Serbian, Finnish, Swedish languages).","40 Years","90 Years",{"count":54,"type":20},1100,"4 Years","Introduction:\n\nPeripheral arterial disease (PAD) and abdominal aortic aneurysm (AAA) are vascular conditions associated with significant morbidity and mortality, with 25% of AAA patients and 23% of PAD patients being at a high risk of developing cardiovascular disease. Cardiovascular risk management can reduce the risk of major adverse cardiovascular events in AAA patients from 43% to 14%. However, cardiovascular risk is not always adequately addressed in these patients. The VASCUL-AID-PRO study aims to deliver clinically relevant prediction models using artificial intelligence and machine learning of patient outcomes to enable personalized management of vascular disease.\n\nMethod:\n\nVASCUL-AID-PRO is a multi-centre international prospective cross-sectional study aiming to include 500 AAA patients and 600 PAD patients across 6 European centres. The aim is to achieve a follow-up time up to 4 years.\n\nThe study will include individuals aged 40-90 with either an abdominal aortic aneurysm (infrarenal, juxtarenal, pararenal, or suprarenal abdominal aortic aneurysm) or Fontaine stage 2 peripheral arterial disease.\n\nThe VASCUL-AID-PRO study will gather a variety of data from all participants, including clinical data, blood and tissue samples, cardiovascular lab values, imaging data, electrocardiograms, data from wearables and quality of life.\n\nThis data gathered will be used to further develop the multi model prediction models being developed on 5000 AAA and 6000 PAD patients included in the currently ongoing VASCUL-AID-RETRO study, with the aim of providing a clinically relevant prediction models of disease progression and other cardiovascular disease for AAA and PAD patients.\n\nFurthermore, the models developed in the VASCUL-AID studies will be internally validated using a subset of patients from the VASCUL-AID-PRO study.\n\nEthical considerations:\n\nEthical and legal considerations are paramount throughout the VASCUL-AID project. To address these concerns, an ELSI framework will be developed and integrated into all stages of the project. This framework will be continuously updated to ensure alignment with evolving ethical, legal, and social standards. This framework will specifically focus on patient safety, data handling, AI regulation and implementation, and potential biases associated with AI.",[58,59],"Abdominal Aorta Aneurism","Peripheral Arterial Disease",[61,62,63,64,65,66],"Abdominal aortic aneurysm","peripheral arterial disease","artificial intelligence","cardiovascular risk","prediction models","disease progression","NOT_YET_RECRUITING","2025-09-19",{"date":70,"type":35},"2025-09-23",{"date":72,"type":20},"2025-09",{"date":74,"type":20},"2030-12",{"name":41,"class":42},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100453156","omentum-preservation-versus-complete-omentectomy-in-gastrectomy-for-gastric-cancer-100453156","NCT05180864","Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer","OMEGA-2","Inclusion criteria\n\n* Primary resectable gastric adenocarcinoma, clinical stage T1-4aN0-3M0\n* ASA 1-3 (able to undergo surgery)\n* Scheduled for open or minimally invasive (sub)total gastrectomy with modified D2-lymphadenectomy, with or without perioperative chemotherapy\n* Age above 18\n* Able to complete questionnaires in Dutch, English or Italian\n* Written informed consent\n* Esophageal invasion \\\u003C 2 cm defined from the upper margin of the gastric rugae as determined by endoscopy\n\nExclusion Criteria:\n\n* Gastric cancer clinically staged as T1N0\n* Locally advanced gastric cancer requiring multi-visceral resection\n* Pregnancy\n* Previous malignancy (excluding non-melanoma skin cancer, pancreatic neuroendocrine tumor (pNET) \\\u003C2cm, and gastrointestinal stromal tumor (GIST) \\\u003C2cm), unless no evidence of disease and diagnosed more than three years before diagnosis of gastric cancer, or with a life expectancy of more than five years from date of inclusion\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* Previous gastric or omental surgery, with the exclusion of a gastric perforation Indication for thoracotomy\u002Fthoracoscopy",{"count":84,"type":20},654,"INTERVENTIONAL",[87],"NA","Curative therapy for gastric cancer usually consists of perioperative chemotherapy and a radical (R0) gastrectomy. A radical resection includes a modified D2 lymphadenectomy, and, generally, a complete omentectomy, to ensure the removal of omental metastatic lymph nodes and tumor deposits.\n\nThe omentum has some essential functions within the peritoneal cavity. The omentum functions as regulator of regional immune responses to prevent infections and, additionally, it prevents adhesions that can lead to small bowel obstruction. Omentectomy is associated with increased incidence of early and late postoperative complications such as abdominal abscess, ileus, and wound infections in various types of surgery.\n\nThere is little evidence regarding survival benefit of routine complete omentectomy during gastrectomy. The investigators hypothesize that omitting a complete omentectomy (and instead preserve the greater omentum distal of the gastroepiploic arcade) during gastrectomy for cancer does not negatively impact survival.\n\nOMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Adult patients (\\>18 years) with primary resectable gastric cancer, clinical stage T2-4a N0-3 M0 or cT1N+ scheduled for open or minimally invasive (sub)total gastrectomy are included. The primary study objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of three-year overall survival.",[90],"Stomach Neoplasm",[92,93,94],"Gastrectomy","Omentectomy","Survival","2025-08-28",{"date":97,"type":35},"2025-09-04",{"date":99,"type":35},"2024-03-01",{"date":101,"type":20},"2031-01-01",{"name":41,"class":42},16,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":85,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100568338","study-with-a-newly-optical-coherence-tomography-probe-for-optimizing-bladder-cancer-diagnosis-and-treatment-100568338","NCT06679920","Study With a Newly Optical Coherence Tomography Probe for Optimizing Bladder Cancer Diagnosis and Treatment","IDEAL Phase II Study of a Newly Designed Optical Coherence Tomography Probe During Transurethral Resection for Optimizing Bladder Cancer Diagnosis and Treatment","BLOCT","Inclusion Criteria:\n\n* Age \\> 18 years.\n* Have at least 1 suspected bladder tumour seen at cystoscopy.\n* Have a bladder that is accessible for cystoscopy.\n* Be in a physical condition to undergo a TURBT.\n* Eligible patients must be fully informed about the study and written signed informed consent must be obtained prior to any study related investigation\u002Fintervention.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* The only tumour site is at the bladder neck.\n* The tumour(s) is larger than 2 centimetres in diameter.\n* \\>5 tumours present.\n* Solely a suspected flat lesion present.",{"count":113,"type":20},15,[87],"The goal of this clinical trial is to see if a new designed optical coherence tomography catheter can be used in bladder cancer in patients undergoing a transurethral resection of a bladder tumour. The main question it aims to answer is:\n\n\\- Is the optical coherence tomography catheter feasible in capturing images of bladder tumours and normal bladder wall during a transurethral resection of a bladder tumour?\n\nParticipants will undergo measurements with a new optical coherence tomography device during the transurethral resection of their bladder tumour(s).",[117],"Bladder Cancer",[119,120,121],"OCT","Optical Coherence Tomography","Bladder cancer","2024-12-04",{"date":124,"type":35},"2024-12-06",{"date":126,"type":20},"2024-12",{"date":128,"type":20},"2025-04",{"name":41,"class":42},2,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":85,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100302859","prospective-endoscopic-follow-up-of-patients-with-submucosal-and-high-risk-mucosal-esophageal-adenocarcinoma-100302859","NCT03222635","Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma","Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.","PREFER","Inclusion Criteria:\n\n* Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Prior history of high-risk mucosal or ≥T1sm.\n* Synchronous esophageal squamous cell carcinoma.\n* Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.\n* Tumor-positive deep resection margin (R1) in ER specimen.\n* Patients unable to give signed informed consent.",{"count":140,"type":20},225,[87],"Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).",[144,145,146],"Submucosal Esophageal Adenocarcinoma","Barrett Esophagus","High-risk Mucosal Esophageal Adenocarcinoma",[148,149,150,151,152],"Barrett's esophagus","Submucosal esophageal adenocarcinoma","Endoscopic treatment","Endoscopic follow-up","High-risk mucosal esophageal adenocarcinoma","2024-07-23",{"date":155,"type":35},"2024-07-24",{"date":157,"type":35},"2017-07-25",{"date":159,"type":20},"2028-07-25",{"name":41,"class":42},20,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":85,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":43},"100546805","non-invasive-brain-stimulation-for-the-treatment-of-mild-cognitive-impairment-in-parkinsons-disease-100546805","NCT06399731","Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease","NEuroStimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease: an Acceptability Cross-over Study","NESCIO-PD","Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson's disease, diagnosed by a neurologist;\n* Mild to moderate disease stage (Hoehn \\& Yahr disease stage \\\u003C 4);\n* Movement Disorders Society level I criteria for PD-MCI (Litvan et al., 2012):\n\n  * Montreal Cognitive Assessment score range \\[21-25\\] (Dalrymple-Alford et al., 2010), or\n  * performance 1-2 SD below appropriate norms on at least 2 neuropsychological tests, or\n  * classification of PD-MCI based on recent (\\\u003C 6 months previous to participation) neuropsychological assessment taken elsewhere (report will be requested);- In case of (dopaminergic) medication use, participants are on stable medication for at least one month before participation and expect to remain on stable medication during the study\n\nExclusion Criteria:\n\n* Indication for dementia based on the SAGE (cut-off ≤ 14; Scharre et al., 2010);\n* Severe depressive disorder (Beck Depression Inventory - Ib score \\> 18);\n* Psychotic disorder (except for benign hallucinations with insight), screened with the Scale for Assessment of Positive Symptoms for Parkinson's disease;\n* Indication of alcohol or drug abuse;\n* Contra-indication for rTMS according to Magstim Rapid2 Manual; rTMS should not be:\n\n  * used on or in the vicinity of patients or users with cardiac demand pacemakers, implanted medication pumps, cochlear devices, implanted defibrillators and\u002For implanted neurostimulators\n  * used on or in the vicinity of patients with implanted metal objects• used on patients where the skin in the area to be contacted is broken\n  * used on those with large ischaemic scars\n  * used on pregnant women\n  * used on infants under the age of 2 years\n  * used on epileptic individuals\n  * used on those with a family history of convulsions\n  * used on individuals with brain lesions that could affect seizure threshold\n  * used on individuals suffering from multiple sclerosis\n  * used on individuals taking tricyclic antidepressants, neuroleptic agents or any other drug that could lower seizure threshold,\n  * used on individuals suffering from sleep deprivation during rTMS procedures\n  * used on individuals with a heavy consumption of alcohol or those using epileptogenic drugs\n  * used on individuals with severe heart disease or with increased intracranial pressure be used on those who have uncontrolled migraines\n* Contra-indication for tDCS according to Neuroelectrics Starstim Manual; tDCS should not be used in case of:\n\n  * Patients with a history of seizures;\n  * Patients with unexplained episodes of loss of consciousness, since such condition could be related with brain alterations or epilepsy;\n  * Patients with unstable or non-controlled neuropsychiatric illness;\n  * Patients having implanted brain medical devices;\n  * Patients with implanted pacemakers;\n  * Patients having any electrically, magnetically or mechanically activated implant;\n  * Patients having cardiac, neural or medication implants;\n  * Patients having vascular clips or any other electrically sensitive support system in the brain;\n  * Patients with serious brain injury;\n  * Patients showing damage of skin at sites of stimulation (the device can only be used in healthy skin without wounds, otherwise the resistance to current can be altered);\n  * Patients suffering from skin problems, such as dermatitis, psoriasis or eczema;\n  * Patients suffering from severe or frequent headaches;\n  * Patients with any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia;\n  * Pregnant women (women of childbearing age should undertake a pregnancy test to confirm eligibility before treatment).\n* Contra-indication for MR imaging:\n\n  * metal in the body (pacemaker, port-a-cath, prosthesis, (cochlear) implant)\n  * previous brain surgery\n  * head trauma that resulted in unconsciousness for at least 1 hour\n  * clips\n  * (old metal containing) tattoo\n  * irremovable piercings\n  * irremovable metal braces\n  * pregnancy\n  * claustrophobia other problems lying still for 45 minutes\n  * metal in the teeth\n  * neurostimulator (including deep brain stimulation)\n* Space-occupying lesion on MRI.",{"count":161,"type":20},[87],"This cross-over pilot study aims to study the acceptability of two methods of non-invasive brain stimulation for the treatment of Parkinson's disease mild cognitive impairment (PD-MCI) - repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) targeted at the left dorsolateral prefrontal cortex (DLPFC). Twenty participants will undergo both interventions in a cross-over design. They sequentially undergo four consecutive phases (4 weeks each), 1) no-intervention baseline, 2) rTMS ór tDCS, 3) no-intervention, 4) second intervention. The primary outcome measure will be acceptability of the interventions, and secondary outcomes include feasibility, cognitive function, neuropsychiatric symptoms, motor function. We will use MRI to explore personalized targeting.",[174,175],"Parkinson Disease","Mild Cognitive Impairment","2024-07-12",{"date":178,"type":35},"2024-07-16",{"date":180,"type":35},"2024-05-31",{"date":182,"type":20},"2026-05-01",{"name":41,"class":42},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":4},"100554015","atrial-fibrillation-ablation-and-autonomic-modulation-via-thoracoscopic-surgery-10-year-follow-up-100554015","NCT06493591","Atrial Fibrillation Ablation and Autonomic Modulation Via Thoracoscopic Surgery, 10 Year Follow up.","AFACT-10","Inclusion Criteria:\n\n* AFACT Trial participant\n\nExclusion Criteria:\n\n* Refusal to be contacted for future studies during or since the AFACT trial.",{"count":192,"type":20},200,"This observational study investigates the long-term outcomes of patients ten years after their participation in a previous study on the surgical treatment of atrial fibrillation (AF). Participants were part of a the AFACT study a decade ago that explored whether damaging nerves around the heart could reduce AF. Participants were randomized to standard thoracoscopic AF ablation (MiniMaze) with or without Ganglion Plexus (GP) ablation. This new study aims to assess and compare the long-term effects of these treatments. We are specifically interested which treatment leads to more freedom from AF.\n\nKey questions include:\n\nHow many patients are free from AF ten years after treatment without using antiarrhythmic drugs? What are the complications from both treatments?\n\nParticipants will undergo the following assessments:\n\n* Clinical assessment at the outpatient clinic.\n* ECG and 24-hour Holter ECG\n* Echocarddiogram and laboratory assessment.\n* SF-36 Quality of life questionnaire.",[195],"Atrial Fibrillation",[195,197,198,199,200],"Thoracoscopy","Ganglia, autonomic","Ganglion Plexus","Ablation","2024-07-11",{"date":176,"type":35},{"date":204,"type":20},"2024-09-01",{"date":206,"type":20},"2025-08-01",{"name":41,"class":42},{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":216,"minAge":17,"maxAge":217,"enrollmentInfo":218,"targetDuration":4,"studyType":85,"phases":220,"briefSummary":222,"conditions":223,"keywords":233,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":4},"100550855","phase-3-preeclampsia-intervention-netherlands-100550855","NCT06452498","Preeclampsia Intervention Netherlands","Metformin for the Prolongation of Pregnancy in Preterm Preeclampsia","PI-NL","Inclusion Criteria\n\nAll of the following:\n\n* Aged 18 years or older\n* Singleton pregnancy\n* Gestational age between 23+0 and 31+6 weeks\n* A diagnosis of preterm preeclampsia, defined according to modified International Society for the Study of Hypertension in Pregnancy (ISSHP) classification, including only those who have proteinuria (≥300 mg of protein in a 24-hour urine specimen or a protein-creatinine-ratio \\>50 in a single urine sample)\n* Estimated fetal weight \\>400 grams\n* No clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise.\n* Ability to understand English or Dutch\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria\n\nAny of the following:\n\n* Current use of metformin or a clinical indication for the use of metformin\n* A decision for immediate delivery (including cases where corticosteroids are administered with planned delivery directly after completion of treatment) or termination of pregnancy (e.g., due to disease severity in the patient combined with a dismal prognosis for the fetus), as made by the treating multidisciplinary team and the parent(s)\n* Contraindication(s) for the use of metformin (e.g., severe renal insufficiency, acute metabolic acidosis, severe liver insufficiency)\n* Use of drugs that might interact with metformin\n* Suspicion of a major fetal anomaly and\u002For chromosomal abnormality\n* Unable or unwilling to (completely) understand or provide informed consent, due to language, culture, or other barriers","FEMALE","50 Years",{"count":219,"type":20},180,[221],"PHASE3","The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development.\n\nMetformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.",[224,225,226,227,228,229,230,231,232],"Pre-Eclampsia Onset Less Than 37 Weeks","Pre-Eclampsia","Pre-Eclampsia; Complicating Pregnancy","Pre-Eclampsia as Antepartum Condition","Pre-eclampsia or Eclampsia With Pre-existing Hypertension","Pre-Eclampsia; Affecting Fetus","HELLP Syndrome Complicating Pregnancy","HELLP Syndrome","HELLP",[234,235,236,237,238,239,240,241,242,231,243,244,245],"Preterm Preeclampsia","Metformin","RCT","Placebo","Gestational Prolongation","Treatment","Pregnancy","Multicenter","Preterm","Hypertensive disorders of pregnancy","Preeclampsia","Randomized controlled trial","2024-06-05",{"date":248,"type":35},"2024-06-11",{"date":250,"type":20},"2024-08",{"date":252,"type":20},"2028-07",{"name":41,"class":42},""]