[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":690},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,145,0,25,[9,44,70,101,135,162,186,211,241,261,289,316,345,371,399,426,457,485,523,544,567,584,609,637,662],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100550561","phase-4-head-to-head-comparison-of-all-botulinum-neurotoxin-type-a-products-for-glabellar-rhytides-100550561",false,"NCT06448676","Head-to-Head Comparison of All Botulinum Neurotoxin Type A Products for Glabellar Rhytides","Head-to-Head Comparison of the Efficacy and Safety of All Five Commercially Available Botulinum Neurotoxin Type A Products for the Treatment of Glabellar Rhytides: A Multicenter, Double-Blind, Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 18 years or over, with moderate to severe glabellar lines\n* Willing to provide written informed consent\n* American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2\n* Negative pregnancy test\n\nExclusion Criteria:\n\n* ASA Classification 3 or over\n* History of hypersensitivity or adverse reactions to botulinum toxin or any of its components\n* Infection at the injection site\n* Previous treatment with botulinum toxin (lifetime)\n* Pregnant or breastfeeding women\n* Neuromuscular disorders or conditions that could interfere with the study assessments",true,"FEMALE","18 Years",{"count":21,"type":22},325,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Study Type: This is a multicenter, triple-blind, randomized controlled trial.\n\nPurpose: The goal of this clinical trial is to compare the effectiveness and safety of all commercially available Botulinum Neurotoxin Type A (BoNT-A) products for treating glabellar rhytides, commonly known as frown lines. This study is designed to provide comprehensive data on how these treatments compare in terms of improving frown lines and the duration of their effects.\n\nMain Questions the Study Aims to Answer:\n\nWhich BoNT-A product provides the longest lasting effect on reducing glabellar rhytides? How do these products compare in terms of safety and the occurrence of side effects?\n\nParticipant Tasks:\n\nWomen aged 18 years or older with moderate to severe glabellar lines will participate.\n\nParticipants will receive injections of a BoNT-A product into specific facial muscles.\n\nThey will need to take weekly photographs using their smartphones to document changes in their frown lines.\n\nThese photos will be securely sent to our research team for analysis. Participants will complete questionnaires at the start and end of the study to assess their satisfaction, quality of life, and any changes in their condition.\n\nComparison Group:\n\nResearchers will compare participants receiving different types of BoNT-A products to see which one is more effective at reducing frown lines and maintaining these effects over time.\n\nThe safety profiles of these products will also be compared to determine which has the fewest and least severe side effects.\n\nThis study aims to fill important gaps in our understanding of Botulinum Neurotoxin Type A treatments, guiding more effective clinical decisions and improving patient outcomes.",[28,29,30],"Wrinkle","Glabellar Frown Lines","Glabellar Furrowing","RECRUITING","2026-06-30",{"date":34,"type":35},"2026-07-02","ACTUAL",{"date":37,"type":35},"2026-02-02",{"date":39,"type":22},"2027-02-01",{"name":41,"class":42},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",3,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100555394","cognitive-behavioral-therapy-for-cancer-related-fatigue-in-patients-with-cancer-receiving-palliative-systemic-treatment-100555394","NCT06511518","Cognitive Behavioral Therapy for Cancer-related Fatigue in Patients With Cancer Receiving Palliative Systemic Treatment","Making Cognitive Behavioral Therapy for Cancer-related Fatigue Fit for Implementation in Patients With Cancer Receiving Palliative Systemic Treatment","TIRELESS","Solid (non-brain) tumor patients\n\nInclusion Criteria:\n\n* Receive systemic treatment with palliative intent for a solid (non-brain) tumor\n* Are ≥18 years old\n* Are proficient in Dutch\n* Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \\[CIS-fatigue\\] score ≥35)\n* A life expectancy of ≥6 months according to their oncologist\n* Access to a device with internet\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Dual immunotherapy\n* Have a poor performance status (Karnofsky \\\u003C70)\n* Are currently receiving treatment for a mental disorder.\n* Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself)\n* Severe cognitive deficits\n\nGlioma patients\n\nInclusion Criteria:\n\n* Histologically confirmed diffuse glioma WHO grade 2, 3, or 4\n* No oncological treatment for at least two months prior to inclusion\n* Are ≥18 years old\n* Are proficient in Dutch\n* Report severe fatigue (Checklist Individual Strength, fatigue severity subscale \\[CIS-fatigue\\] score ≥35)\n* A life expectancy of ≥3 months according to their oncologist\n* Access to a device with internet\n\nExclusion Criteria:\n\n* Signs of radiological or clinical tumor progression at the time of inclusion\n* Corticosteroid use\n* Have a poor performance status (Karnofsky \\\u003C70)\n* Are currently receiving treatment for a mental disorder\n* Treatable somatic cause that could explain the presence of severe fatigue (other than the underlying disease and the cancer treatment itself).\n* Severe cognitive deficits","ALL",{"count":54,"type":22},56,[56],"NA","Cancer-related fatigue is highly prevalent in patients receiving treatment for gliomas or palliative systemic treatment for cancer and is experienced as one of the most burdensome symptoms affecting patients' daily functioning and quality of life. From the KWF-sponsored TIRED trial, we concluded that cognitive behavioral therapy (CBT) is effective in reducing fatigue in cancer patients with severe fatigue during palliative systemic treatment and in glioma patients. However, in its current form, integration in routine medical care is difficult and scalability is a problem, as the intervention is time-intensive, requires face-to-face consults with a psychologists, and the availability of trained psychologists is limited.\n\nThe investigators expect that inter-CBT will integrate well into clinical practice and prove non-inferior in achieving a reduction in fatigue compared to face-to-face CBT as investigated in the TIRED and GRIP study. It is further expected that the interviews will provide useful information to implement this intervention.\n\nThe main aims to answer are:\n\n* To determine the non-inferiority of CBT primarily led by nurese, compared with benchmark studies in which CBT was provided by psychologists, in its effect on reduction in cancer-related fatigue\n* To adapt CBT delivery to the needs of patients treated with palliative intent and glioma (interdisciplinary web-based CBT for cancer-related fatigue.\n* To investigate its feasibility by evaluating the practical workability, acceptability, and burden for patients and health care providers.\n\nParticipants will follow the 12 weeks CBT intervention online, mainly guided by their nurse. Participants will start with a face-to-face session with the psychologists, partly together with their nurse, to start with setting their treatment goals. Then, they will work on the modules that are applicable to them. During the CBT intervention there will be a face-to-face session with their nurse to discuss the progress of their goals. Finally, all participants will complete the therapy by realizing their treatment goals. The outcomes with respect to fatigue severity and participants' goals will be discussed by the nurse with the participant in the final, face-to-face sessions. The face-to-face sessions will take 30 to max. 45 minutes, except for the first session, which will take one hour of which the nurse will be present during 15 minutes.\n\nResearchers will compare the outcomes of the study to a benchmark study where CBT was provided by psychologists in its effect on reduction in cancer-related fatigue.",[59,60],"Cancer","Palliative Treatment","2026-06-11",{"date":63,"type":35},"2026-06-15",{"date":65,"type":35},"2024-06-03",{"date":67,"type":22},"2028-02-01",{"name":41,"class":42},1,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":69},"100620581","phase-3-selective-serotonin-reuptake-inhibitors-in-post-covid-after-covid-19-100620581","NCT07359482","sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19","sElective Serotonin reuPtake inhibitoRs In posT-covid: ESPRIT","ESPRIT","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Severely fatigued (CIS fatigue score ≥ 35) at screening\n* Fatigue started\u002Fincreased significantly after Covid-19 (self-declared)\n* Fatigue symptoms must be present for at least 3 months following the acute infection.\n* Self-reported confirmation of having a SARS-CoV-2 infection by: Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical test or assessments. The above information will not be verified in medical records.\n* Command of Dutch or English language to complete questionnaires\n* Able to participate in video calling.\n* Willing and able to provide informed consent\n* Allowing the trial team to exchange medical information that is relevant for the participants' safety and trial assessments with their GP and pharmacy.\n\nExclusion Criteria:\n\n* Use of medication with interaction with fluvoxamine that cannot be discontinued\n* Hospitalized in the acute phase of Covid-19\n* Psychiatric\u002Fsomatic disorders that could explain the severity of fatigue\n* Neurodegenerative disorders (i.e. M Parkinson, Multiple sclerosis, M Alzheimer)\n* Suicidality (current or recent) (according to WHO suicide screener)\n* Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months\n* Pregnancy (a positive urine or serum pregnancy test) or unwilling to use standard contraception\n* Brugada- or Long QT interval syndrome\n* epilepsy, porphyria, history of severe liver impairment\n* known allergies to fluvoxamine or placebo\u002Fexcipients\n* known current alcohol or drug use problems.\n* Bleeding disorders and past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders\n* claustrophobia (optional MRI substudy)\n* having metal implants (optional MRI substudy)\n* inability to lay still for 45 minutes (optional MRI substudy)\n* Neurotrauma\u002F large stroke or brain abnormalities interfering with image analyses (optional MRI substudy)\n* Inability to come to the Amsterdam UMC (optional MRI substudy).","70 Years",{"count":80,"type":22},160,[82],"PHASE3","Fatigue, cognitive problems, post-exertional malaise (PEM) and postural orthostatic tachycardia syndrome (POTS) are common and debilitating symptoms after COVID-19. The pathophysiology of post-COVID is not well understood and there is no established biomedical treatment. Treatment options for post-COVID are thus much needed.\n\nA promising candidate intervention is fluvoxamine, a selective serotonin reuptake inhibitor (SSRI), that may reduce post-COVID symptoms because of its regulatory effect on the (neuro) immune system, the hypothalamic-pituitary-adrenal (HPA) axis and the tryptophan system. The investigators will randomize 160 participants to either fluvoxamine or placebo for 12 weeks.\n\nThe investigators will use advanced functional neuroimaging techniques during cognitive challenge (optional substudy) and plasma biomarkers (inflammatory markers, cortisol, serotonin, IDO-2 activity), to facilitate identifying potential mechanistic pathways of post -COVID treatment.",[85,86,87],"Post-COVID","POST-Covid 19","Post-COVID Conditions",[89,90,91,92],"post-COVID","fluvoxamine","fatigue","biomarkers","2026-06-08",{"date":95,"type":35},"2026-06-09",{"date":97,"type":35},"2026-06-04",{"date":99,"type":22},"2028-05-01",{"name":41,"class":42},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":23,"phases":110,"briefSummary":111,"conditions":112,"keywords":117,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":69},"100643406","3d-hand-orthosis-trial-100643406","NCT07633821","3D Hand Orthosis Trial","Cost-effectiveness of 3D-printed Hand Orthoses for Activities of Daily Living in Chronic Hand Conditions","Inclusion Criteria:\n\n* Diagnosed with a chronic, stable hand condition due to a neurological disorder, musculoskeletal disorder, neuromuscular disease or injury;\n* Minimum age of 18 years;\n* Indicated for a first or repeat prescription of a circular thumb, wrist or wrist-thumb orthosis for permanent use for improving ADL performance.\n\nExclusion Criteria:\n\n* Indicated for an orthosis for a non-functional hand;\n* Insufficient mastery of the Dutch language.",{"count":109,"type":22},100,[56],"In people with chronic hand conditions, hand orthoses are frequently prescribed to improve performance in activities of daily living (ADL). Conventional hand orthoses are custom-made on a plaster cast of the hand, a process that is time-consuming and labor-intensive. It has been demonstrated that the production time of manufacturing hand orthoses can be reduced by using 3-dimensional scanning and printing (i.e. 3D-printed hand orthosis), offering a promising cost-effective alternative to conventional hand orthoses. The current study builds on a previously conducted feasibility study, which demonstrated comparable effects of 3D-printed and conventional hand orthoses on ADL performance, hand function, and quality of life in people with chronic hand conditions. User satisfaction and production time favored the 3D-printed orthoses. However, to date only small and self-controlled studies have investigated the effects of 3D-printed versus conventional hand orthoses for permanent use on ADL performance and orthosis satisfaction in chronic hand conditions. Evidence from randomized controlled trials and data on the cost-effectiveness are lacking. The aims of this study are:\n\n1. To determine whether treatment with 3D-printed hand orthoses is non-inferior compared to treatment with conventional hand orthoses in terms of ADL performance, hand function, pain, quality of life and functional status in individuals with chronic hand conditions.\n2. To assess whether treatment with 3D-printed hand orthoses results in greater patient satisfaction compared to treatment with conventional hand orthoses.\n3. To assess the cost-effectiveness of treatment with 3D-printed hand orthoses compared to treatment with conventional hand orthoses.",[113,114,115,116],"Hand Injuries and Disorders","Neurological Conditions","Neuromuscular Diseases (NMD)","Musculoskeletal Conditions (e.g., Tendinitis, Capsulitis)",[118,119,120,121,122,123,124,125,126],"Orthotic Devices","Cost-Effectiveness Analysis","Hand","Printing, Three-Dimensional","Activities of Daily Living","Rehabilitation","Quality of Life","Non-Inferiority Trial","Patient Satisfaction","NOT_YET_RECRUITING","2026-06-05",{"date":93,"type":35},{"date":131,"type":22},"2026-06",{"date":133,"type":22},"2030-09",{"name":41,"class":42},{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100643088","phase-2-hypofractionated-definitive-chemoradiotherapy-for-oesophageal-cancer-100643088","NCT07632079","Hypofractionated Definitive Chemoradiotherapy for Oesophageal Cancer","HYpofractionated Definitive chemoRadiotherapy for Oesophageal Cancer (HYROC): a Multicenter Phase II Feasibility Study","HYROC","Inclusion Criteria:\n\n* Age ≥18 years.\n* Histologically confirmed oesophageal or GOJ carcinoma (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, large cell carcinoma or undifferentiated carcinoma).\n* An oesophageal tumour location can involve the proximal, middle and\u002For distal third of the oesophagus.\n* If the tumour extends below the GOJ into the cardia, the bulk of the tumour must involve the oesophagus or GOJ (i.e. Siewert type I or II). The tumour should not extend more than 5 cm into the stomach.\n* Clinical stage cT1N1-3M0 or cT2-4aN0-3M0, using the Tumour-Node-Metastasis classification system (TNM, 8th edition), deemed suitable for definitive CRT with curative intent.\n* No evidence of distant metastases (M0), as confirmed by standard staging procedures including Fluorine-18 Fluorodeoxyglucose (18F-FDG) PET\u002FCT.\n* World Health Organization (WHO) performance status 0-2.\n* Adequate hematologic, renal, and hepatic function:\n\n  * Platelet count ≥100 × 10⁹\u002FL\n  * Absolute neutrophil count ≥1.5 × 10⁹\u002FL\n  * Glomerular filtration rate ≥50 mL\u002Fmin\n  * Total bilirubin ≤1.5 × upper normal limit\n* Written informed consent obtained before any study-specific procedures.\n* Able to comply with study procedures and scheduled follow-up.\n\nExclusion Criteria:\n\n* High grade dysplasia without histological evidence of invasive carcinoma.\n* Presence of distant metastases (M1).\n* Patients with pathological lymph nodes at both supraclavicular and celiac trunk level.\n* Prior thoracic or upper abdominal radiotherapy that would preclude safe delivery of the planned radiotherapy dose.\n* Prior chemotherapy for oesophageal or gastric cancer.\n* Presence of an oesophageal stent.\n* Active uncontrolled infection.\n* Clinically significant comorbidities that would preclude safe administration of CRT (e.g. severe pulmonary, cardiac, or hepatic impairment).\n* Pregnancy or breastfeeding.\n* Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients.\n* History of malignancies, with the exception of basal cell carcinoma of the skin, ductal carcinoma in situ of breast, cervical intraepithelial neoplasia of uterine cervix, or other malignancies that do not interfere with the prognosis of oesophageal cancer.",{"count":144,"type":22},60,[146],"PHASE2","The goal of this clinical trial is to learn if hypofractionation of definitive chemoradiotherapy can treat patients with locally advanced esophageal cancer. The main question it aims to answer is if this treatment is feasible and safe. We also want to investigate the toxicity, in particular the radiation-induced lymphopenia.\n\nNormally, definitive chemoradiotherapy for patients with locally advanced esophageal cancer consist of 28 fractions of 1.8 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 5.5 weeks. In this study, participants will receive 20 fractions of 2.4 Gy with concurrent 6 cycles of carboplatin and paclitaxel in 4 weeks. The follow-up will be conform standard-of-care.",[149],"Locally Advanced Esophageal or GE Junction Cancer",[151,152,153],"Definitive chemoradiotherapy","Hypofractionation","Locally advanced esophageal or GE junction cancer","2026-06-02",{"date":93,"type":35},{"date":157,"type":35},"2026-04-28",{"date":159,"type":22},"2028-07",{"name":41,"class":42},7,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100477083","personalized-mechanical-ventilation-guided-by-ultrasound-in-patients-with-acute-respiratory-distress-syndrome-100477083","NCT05492344","Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome","Inclusion Criteria:\n\n* Admitted to a participating ICU,\n* invasively ventilated and\n* fulfil the Berlin criteria for moderate or severe ARDS.\n\nExclusion Criteria:\n\n* Age under 18,\n* participation in other interventional studies with conflicting endpoints,\n* conditions in which LUS is not feasible or possible (e.g. subcutaneous emphysema, morbid obesity or wounds),\n* mechanical ventilation for longer than 7 consecutive days in the past 30 days,\n* history of ARDS in the previous month,\n* body-mass index higher than 40 kg\u002Fm²,\n* intracranial hypertension,\n* broncho-pleural fistula,\n* chronic respiratory diseases requiring long-term oxygen therapy or respiratory support,\n* pulmonary fibrosis with a vital capacity \\\u003C 50% (severe or very severe),\n* previously randomized in the PEGASUS study\n* ECMO\n* patients who receive invasive ventilation in home setting due to a neurological disease\n* pregnant patients\n* patients who are moribund or facing end of life and\n* no informed consent.","100 Years",{"count":170,"type":22},538,[56],"Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.",[174,175,176],"ARDS, Human","Lung Ultrasound","Mechanical Ventilation","2026-05-22",{"date":179,"type":35},"2026-05-27",{"date":181,"type":35},"2022-08-09",{"date":183,"type":22},"2027-11-01",{"name":41,"class":42},10,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":23,"phases":196,"briefSummary":197,"conditions":198,"keywords":200,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":69},"100481236","endobiliary-radiofrequency-ablation-for-malignant-biliary-obstruction-due-to-perihilar-cholangiocarcinoma-100481236","NCT05546372","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma","Endobiliary Radiofrequency Ablation for Malignant Biliary Obstruction Due to Perihilar Cholangiocarcinoma: a Randomized Controlled Trial","RACCOON","Inclusion Criteria:\n\n* 18 years or older.\n* Capable of providing written and oral informed consent.\n* Histological or cytological proof of perihilar CCA (adenocarcinoma).\n* Perihilar biliary obstruction with an indication for drainage with uSEMS.\\*\n* Advanced (no candidate for surgical resection) due to metastases, vascular or lymph node (N2) involvement on imaging or during staging laparoscopy according to multidisciplinary team (MDT).\n\n  * Only patients with pCCA are eligible however in case of reasonable doubt between intrahepatic CCA with a perihilar biliary obstruction or massforming pCCA, patients can be included.\n\nExclusion Criteria:\n\n* Patients who potentially qualify for curative resection of pCCA.\n* pCCA eligible for liver transplantation.\n* Life-expectancy less than 3 months.\n* ERCP and PTC technically not feasible.\n* Uncontrolled coagulopathy (PTT \\>1,5x prolonged or thrombocytes below 40\\*10E9\u002FL).\n* Ongoing cholangitis or liver abscess. Patients are required to be off antibiotic treatment for cholangitis and\u002For liver abscess at least 7 days.\n* Any condition that is unstable or that could jeopardize the safety of the subject and their compliance in the study.\n* Patients who are pregnant or breastfeeding.",{"count":195,"type":22},122,[56],"A multicentre, parallel group, open label, randomized controlled trial comparing endobiliary RFA prior to metal stent placement with stent placement only in patients with inoperable perihilar cholangiocarcinoma.",[199],"Perihilar Cholangiocarcinoma",[201,202],"Endobiliary radiofrequency ablation","Stent patency","2026-05-21",{"date":205,"type":35},"2026-05-26",{"date":207,"type":35},"2022-10-22",{"date":209,"type":22},"2027-06-30",{"name":41,"class":42},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":23,"phases":221,"briefSummary":222,"conditions":223,"keywords":227,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":69},"100639491","splintless-versus-conventional-maxillomandibular-advancement-surgery-for-obstructive-sleep-apnea-100639491","NCT07598461","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea","Splintless Versus Conventional Maxillomandibular Advancement Surgery for Obstructive Sleep Apnea: a Randomized Controlled Trial","SvCMAS","Inclusion Criteria:\n\nFor OSA patients:\n\n* Adults aged 18 years or older;\n* Moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15 events\u002Fhour) as determined by an overnight polysomnography (PSG) preoperatively;\n* Continunous positive airway pressure failure or intolerance;\n* General good health for surgery;\n* MMA surgery indicated for OSA treatment.\n\nFor bedpartners of patients:\n\n• Sharing a bed ⩾2 nights\u002Fweek with patient.\n\nExclusion Criteria:\n\nFor OSA patients:\n\n* Other adjunctive procedures indicated at the time of MMA (e.g., multi-piece Le Fort I osteotomy, temporomandibular joint reconstruction);\n* Previous history of orthognathic surgery;\n* Cleft palate and syndromic patients;\n* Refusal to participate.\n\nFor bedpartners of patients:\n\n• Refusal to participate.",{"count":220,"type":22},66,[56],"The goal of this clinical trial is to find out whether using a splintless surgical approach improves the accuracy of maxillomandibular advancement (MMA) surgery for treating obstructive sleep apnea (OSA) in adults. The study will also look at the safety, functional outcomes, and cost-effectiveness of the splintless approach. The main questions it aims to answer are:\n\nDoes the splintless approach lead to more accurate surgical movements of the jaws compared to the conventional splint-based method? What are the safety profile, functional outcomes, and cost-effectiveness of the splintless approach?\n\nResearchers will compare splintless MMA to conventional MMA.\n\nPatients will:\n\nUndergo MMA surgery using either the splintless or splint-based method; Attend regular follow-up visits as part of routine care; Complete questionnaires and undergo assessments at various time points; Receive one additional CT scan (24 months after surgery) and one overnight sleep study (60 months after surgery).\n\nBedpartners of patients will:\n\nComplete questionnaires at various time points.\n\nThis trial will help determine whether the splintless approach is a better, safer, and more effective alternative for treating OSA with MMA surgery.",[224,225,226],"Sleep Apnea Syndrome (OSAS)","Orthognathic Surgical Procedures","Sleep Apnea - Obstructive",[228,229,230,231,232],"OSA","Maxilomandibular advancement surgery","MMA","Patient-specific implants","Splintless orthognathic","2026-05-13",{"date":235,"type":35},"2026-05-20",{"date":237,"type":22},"2026-12-01",{"date":239,"type":22},"2033-02-28",{"name":41,"class":42},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":250,"conditions":251,"keywords":254,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":258,"leadSponsor":260,"locationsCount":69},"100637904","natural-history-of-central-and-mixed-sleep-apneas-followed-by-maxillomandibular-advancement-for-obstructive-sleep-apnea-100637904","NCT07596719","Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea","CMAI","Inclusion Criteria:\n\n* Adults aged 18 years or older;\n* Mild to severe OSA as determined by a polysomnography (PSG) preoperatively;\n* Completion of MMA for OSA treatment;\n* Subjects with preoperative and postoperative PSG;\n* Patients who are present with MMA treatment-related central apneas postoperatively\n\nExclusion Criteria:\n\n* Patients who underwent other adjunctive procedures at the time of MMA (e.g., multi-piece Le Fort osteotomy, TMJ reconstruction);\n* Previous history of orthognathic surgery;\n* Cleft palate and syndromic patients.",{"count":144,"type":22},"OBSERVATIONAL","The goal of this observational prospective cohort study is to learn about the natural course of central and mixed sleep apneas that develop after maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA) in adult patients.\n\nThe main question it aims to answer is:\n\nDo central and mixed apneas resolve, partially resolve, or persist in the long term after MMA?\n\nParticipants will:\n\nUndergo a first postoperative polysomnography (PSG) at 3-6 months after MMA (part of standard care).\n\nBe invited into the study if central\u002Fmixed apneas are detected (CMAI% \\>25%). Undergo a second PSG at least 12 months after MMA (extra study procedure)",[224,252,253,225],"Central Sleep Apnea","Maxillomandibular Advancement Surgery",[228,230,252],{"date":256,"type":35},"2026-05-19",{"date":237,"type":22},{"date":259,"type":22},"2027-12-31",{"name":41,"class":42},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":23,"phases":270,"briefSummary":271,"conditions":272,"keywords":274,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":288},"100640840","effect-of-4-weeks-of-oral-probiotic-desulfovibrio-piger-supplementation-on-immunological-and-metabolic-parameters-in-individuals-with-longstanding-type-1-diabetes-100640840","NCT07585994","Effect of 4 Weeks of Oral Probiotic Desulfovibrio Piger Supplementation on Immunological and Metabolic Parameters in Individuals With Longstanding Type 1 Diabetes","PROSPER","Inclusion Criteria:\n\n* Males or females, age \\>18 years\n* A diagnosis of type 1 diabetes, with duration of more than 5 years, with minimally one of antiGAD65, IA2, ZnT8 autoantibodies present assessed at diagnosis or routine visits at Diabeter Centrum.\n* Evidence of remaining residual beta cell function with detectable UCPCR (more than 0.01 nmol\u002Fmmol C-peptide\u002Fcreatinine ratio) and or fasting plasma C-peptide more than 0.2 mmol\u002FL.\n* BMI 18-30 kg\u002Fm2\n\nExclusion Criteria:\n\n* Use of antibiotics or proton-pump inhibitors within the last three months before screening or during study period\n* Use of other probiotic supplementation within the last month before screening or during study period\n* A history of cholecystectomy\n* Overt untreated gastrointestinal disease, inflammatory bowel disease or abnormal bowel habits\n* Absence of a large bowel (ie colostomy)\n* Evidence for comprised immunity (HIV infection, chemotherapy, other autoimmune diseases, systemic anti-inflammatory therapy)\n* History of cardiovascular disaeses (CVD) events\n* Hepatic enzymes\\>2.5 higher than the upper limit of normal range, determined during MARVEL visits\u002Froutine visits\n* Kidney failure (eGFR \\\u003C15ml.min\u002F1.73m2), dialysis, kidney transplantation,\n* Inability or unwillingness to donate feces or urine.\n* Smoking or illicit drug use (e.g. MDMA\u002Famphetamine\u002Fcocaine\u002Fheroin\u002FGHB) in the past three months or use during the study period.\n* Alcohol abuse (equal or above 21 units per week)\n* Inability or unwillingness to provide informed consent.",{"count":269,"type":22},20,[56],"The goal is to establish the effect of oral probiotic Desulfovibrio piger (D. piger) supplementation on immunological and metabolic parameters in individuals with longstanding type 1 diabetes with residual beta cell function. The investigators will perform a double-blind, randomized, placebo-controlled trial in 2x10 participants to measure effects of D. piger on parameters of systemic and intestinal inflammation and residual beta cell function.",[273],"Type 1 Diabetes Mellitus",[275,276,277,278,279],"type 1 diabetes mellitus","gut microbiome","probiotics","immunological parameters","residual beta cell function","2026-05-10",{"date":282,"type":35},"2026-05-14",{"date":284,"type":22},"2026-05",{"date":286,"type":22},"2028-05",{"name":41,"class":42},2,{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":288},"100592962","phase-2-timing-of-minimally-invasive-local-treatment-after-first-line-systemic-therapy-in-oligometastatic-esophageal-or-gastric-adenocarcinoma-100592962","NCT07000253","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma","Timing of Minimally Invasive Local Treatment After First-Line Systemic Therapy in Oligometastatic Esophageal or Gastric Adenocarcinoma: A Randomized Prospective Clinical Study (OMEC-5)","OMEC-5","Inclusion Criteria:\n\n* Age ≥18 years\n* Ability to provide written informed consent\n* Histologically confirmed esophageal, gastric or gastroesophageal junction tumor with oligometastatic (M1) disease defined according to the OMEC consensus statement:\n\n  * One organ with ≤3 metastases or 1 involved extra-regional lymph node station (based on the TNM 8 classification)\n  * ≤3 unilobar liver metastases or ≤2 bilobar liver metastases\n  * ≤ 3 unilateral lung metastases\n  * Unilateral adrenal gland involvement\n  * Metastasis confined to 1 bone structure or 1 soft tissue compartment\n* Synchronous oligometastatic disease with a resectable primary tumor or metachronous oligometastatic disease (in the event of a locoregional recurrence this should be resectable)\n* Metastases should be deemed amenable by the international multidisciplinary expert team for radical local treatment\n* WHO performance status 0-2\n* Indication for checkpoint inhibition and\u002For targeted therapy\n\n  * PD-L1 with a CPS of 1 or higher as per local clinical practice for immunotherapy use\n  * HER2 overexpression as per local clinical practice for trastuzumab use\n  * Claudin 18.2 overexpression as per local clinical practice for zolbetuximab use.\n  * Any other biomarker that allows targeted therapy in first line approved by EMA\n* No prior systemic therapy for metastatic disease\n* CT-scan ≤8 weeks prior to inclusion\n* Ability to undergo local treatment and start systemic treatment beyond 18 weeks of total systemic treatment.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma\n* Brain metastases\n* Peritoneal or pleural carcinomatosis\n* Patients with MSI dMMR\n* Uncontrolled immunodeficiency (e.g. AIDS)\n* Peripheral neuropathy \\>CTCAE grade 1, precluding start of full dose oxaliplatin treatment\n* Both organ metastasis and extra-regional lymph node metastasis\n* Conditions precluding local treatment or systemic therapy for oligometastatic disease:\n\n  * Serious medical comorbidities precluding local treatment (e.g., interstitial lung disease in patients with pulmonary metastasis)\n  * Clinical or radiological evidence of spinal cord compression or epidural tumor within 2 mm of the spinal cord\n  * Simultaneous other malignancy or previous other malignancy with a disease-free period of \\\u003C5 years, except adequately treated non-melanoma skin cancer or in-situ cancers\n  * Uncontrolled (bacterial) infections\n  * Significant concomitant diseases preventing the safe administration of study drugs or likely to interfere with study assessments\n  * Uncontrolled angina pectoris, cardiac failure or clinically significant arrhythmias\n  * Continuous use of immunosuppressive agents equivalent to \\>10 mg daily prednisone\n  * Concurrent use of the antiviral agent sorivudine or chemically related analogues, such as brivudine\n  * Pregnancy or breast feeding\n  * Patients (M\u002FF) with reproductive potential not implementing adequate contraceptive measures",{"count":298,"type":22},290,[146,82],"Purpose of the Study:\n\nThis clinical study investigates whether a shorter or longer duration of systemic therapy before local treatment (surgery or radiation) results in better disease control in patients with esophageal or gastric cancer with a limited number of metastases, also known as oligometastases.\n\nBackground:\n\nIn about 25% of patients with advanced esophageal or gastric cancer, the disease spreads to only a few sites (oligometastatic disease). Prior studies suggest that local treatment after systemic therapy may extend survival in this subgroup. However, it is unclear how long systemic therapy should last before initiating local treatment. The OMEC-5 study aims to clarify this and identify potential biomarkers for treatment response.\n\nStudy Design:\n\nInitiated by Amsterdam UMC and UMCU and conducted in multiple hospitals across Europe.\n\nTotal of 414 patients to be enrolled.\n\nDuration: \\~53 months (35 months enrollment + 18 months follow-up).\n\nApproved by the medical ethics committee at Amsterdam UMC.\n\nProcedure:\n\nEligibility screening: Includes physical exam, blood tests (incl. circulating tumor cells), medical history review, and confirmation of oligometastases by an expert panel.\n\nInitial treatment: All participants receive 4 months of standard systemic therapy (chemotherapy + immunotherapy and\u002For targeted therapy depending on tumor markers like HER2 or Claudin 18.2).\n\nResponse assessment (Review 1): Imaging and\u002For laparoscopic examination.\n\nIf oligometastases persist and tumors have not progressed, participants are randomized into two groups:\n\nGroup A (longer systemic therapy): 4 more months of systemic therapy, then local treatment if disease is stable, followed by 4 months of immunotherapy ± targeted therapy.\n\nGroup B (shorter systemic therapy): Immediate local treatment followed by 4 months of systemic therapy, then reassessment and potentially 4 months of immunotherapy ± targeted therapy.\n\nFollow-up: Regular scans and quality-of-life questionnaires (5 times), and periodic blood sampling (4 times).\n\nTreatments Involved:\n\nChemotherapy: CapOx or FOLFOX\n\nImmunotherapy: nivolumab or pembrolizumab\n\nTargeted therapy: trastuzumab (HER2-positive) or zolbetuximab (Claudin 18.2-positive)\n\nPotential Benefits and Risks:\n\nPatients may benefit from better disease control and a personalized treatment strategy.\n\nKnown side effects relate to the standard treatments used (chemo, immuno, targeted therapies), and no extra medical risk is expected beyond routine care.\n\nPossible inconveniences include blood draws, scans, minor surgery (laparoscopy), and time investment.\n\nData and Sample Handling:\n\nPersonal data and tumor\u002Fblood samples are coded and securely stored.\n\nData may be used for future cancer research if the patient consents.\n\nParticipants can withdraw at any time.\n\nConfidentiality and Privacy:\n\nPatient data are kept confidential, and participants have rights to access or delete their data. Privacy measures comply with GDPR and Dutch law.\n\nCompensation and Insurance:\n\nParticipation is voluntary, with no financial compensation. Standard treatment costs are covered by healthcare insurance. No extra insurance is required, as the treatment aligns with standard care practices.",[302,303,304,305,306,307],"Esophageal Cancer","Gastric (Stomach) Cancer","Gastric Adenocarcinoma","Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma","Esophageal Carcinoma","Gastric (Cardia, Body) Cancer","2026-05-03",{"date":310,"type":35},"2026-05-07",{"date":312,"type":35},"2026-04-29",{"date":314,"type":22},"2034-01",{"name":41,"class":42},{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":330,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":344},"100526705","the-effect-of-exercise-and-diet-on-quality-of-life-in-patients-with-incurable-cancer-of-esophagus-and-stomach-radices-100526705","NCT06138223","The Effect of exeRcise And Diet on Quality of Life in Patients With Incurable Cancer of Esophagus and Stomach (RADICES)","RADICES","Inclusion Criteria:\n\n* Incurable adenocarcinoma of the esophagus or stomach\n* Recurrence after treatment with curative intent or irresectable\u002Fmetastatic disease at primary diagnosis. Inclusion can take place regardless of the plan or the actual initiation of multi-line systemic treatment. (i.e. patients that have already started with anticancer therapy are eligible for inclusion too)\\*\n* Able and willing to perform the exercise and nutritional program and wear the activity tracker.\n* Able and willing to fill out the POCOP\u002FRADICES questionnaires.\n* Life expectancy \\> 12 weeks.\n* Age ≥ 18 years.\n\nExclusion Criteria:\n\n* Unstable bone metastases inducing skeletal fragility as determined by the treating clinician.\n* Untreated symptomatic known brain metastasis.\n* Serious active infection.\n* Too physically active (i.e. \\>210 minutes\u002Fweek of moderate-to-vigorous intentional exercise) or engaging in intense exercise training comparable to the RADICES exercise program.\n* Severe neurologic or cardiac impairment according to the American College of Sports Medicine criteria.\n* Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise.\n* Uncontrolled severe pain.\n* Any other contraindications for exercise as determined by the treating physician.\n* Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician.\n* Pregnancy.\n\n  * Note:\n\nAfter one year of recruitment we broadened our inclusion criteria from GAC patients receiving beyond first-line palliative treatment or best supportive care to any patient with recurrence\u002Fprogression of GAC after curative treatment or irresectable\u002Fmetastatic disease at diagnosis, regardless of timing or type of palliative treatment and number of lines received. This was done to increase generalizability and offer the intervention earlier in the palliative phase to enhance its benefits. We acknowledge this results in a more heterogeneous group, but we believe also a more representative group.\n\nThe inclusion criterium before broadening was:\n\nProgressive disease after first-line palliative systemic treatment OR within 6 months after completion of curative treatment (i.e. within six months after neoadjuvant chemoradiation, adjuvant nivolumab, or definitive chemoradiation for esophageal adenocarcinoma or within six months after adjuvant 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) for gastric\u002Fesophageal cancer or neoadjuvant FLOT if no adjuvant FLOT was given, or after progression during participation in the LyRICX study). Patients on capecitabine monotherapy who are eligible for oxaliplatin reintroduction can be included, too.",{"count":324,"type":22},196,[56],"The survival of patients with incurable gastroesophageal cancer can extend over a year with anticancer therapy. However, the number of patients with deteriorating quality of life in this patient group steadily decreases over time during the treatment. Potentially reversible causes related to deterioration of quality of life are diminished muscle mass, physical capacity and nutritional status. Therefore, interventions that can target these in order to maintain or improve quality of life are urgently needed.\n\nHowever, it is yet unknown whether improvement of physical capacity and nutritional status improves quality of life in patients with incurable gastroesophageal adenocarcinoma after failure of first-line treatment. Since these patients are in a precarious situation, the benefits and harms of a combined exercise and nutritional intervention should be carefully evaluated.Therefore this study investigates the effect of a combined exercise and nutrition intervention compared to usual care on quality of life in incurable GAC patients after progression upon first-line treatment.\n\nA total of 196 patients with metastasized gastroesophageal cancer will be recruited and randomly allocated 1:1 to standard care or standard care plus a combined exercise and nutritional intervention.",[328,329],"GastroEsophageal Cancer","Incurable Disease",[331,332,333,334,335,336,337],"gastroesophageal cancer","GAC","Palliative","exercise intervention","nutritional intervention","Quality of life","QOL",{"date":310,"type":35},{"date":340,"type":35},"2024-01-01",{"date":342,"type":22},"2028-09-30",{"name":41,"class":42},22,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":52,"minAge":4,"maxAge":19,"enrollmentInfo":353,"targetDuration":355,"studyType":249,"phases":4,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":69},"100634416","searching-patterns-in-the-robustness-of-immunological-fviii-tolerance-100634416","NCT07539402","Searching Patterns In the Robustness of Immunological FVIII Tolerance","Searching Patterns In the Robustness of Immunological FVIII Tolerance (SPIRIT)","SPIRIT","Inclusion Criteria:\n\n* Congenital hemophilia A of all severities\n* Using NFT for prophylaxis\n* Aged under 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Acquired hemophilia A\n* Any other bleeding disorder",{"count":354,"type":22},500,"5 Years","Children with hemophilia A lack clotting factor VIII (FVIII) due to a genetic mutation. It is well known that administration of FVIII concentrate leads to immunological tolerance for the FVIII protein in the majority of children. In 30% of these children tolerance is not achieved leading to the development of anti-FVIII antibodies (i.e. inhibitors). Our knowledge on the underlying immunological mechanisms leading to tolerance is limited. Recently, Non-Factor Therapy (NFT) has become available for prevention of bleeding in patients with hemophilia, i.e. prophylaxis. Currently, many children with severe hemophilia A use NFT as the subcutaneous administration of NFT is very convenient. In children on NFT prophylaxis, intravenous FVIII concentrate is exclusively used on-demand for treatment of bleeding. As NFT is very effective in the prevention of bleeds, patients may not be exposed to the deficient FVIII protein for periods up to a year or longer. It is currently not known how robust immunological tolerance is in the absence of exposure to a deficient antigen. The infrequent exposure to FVIII, enabled by NFT, provides an opportunity to study the immunological tolerance mechanisms for FVIII in children with hemophilia A.\n\nThe aim of SPIRIT is to investigate the mechanisms of the immunological tolerance to FVIII in patients with hemophilia A aged younger than 18 years using NFT for prophylaxis.\n\nIn this observational cohort study, children (aged \\\u003C18 years) with congenital hemophilia A, who are treated with non-factor therapy as prophylaxis, will be longitudinally followed. Participants will have blood drawn anually, during the regular clinic visits, and additionally following FVIII exposure. Feces samples will be collected and analyzed in children aged \\\u003C12 years, following the same scheme as blood sampling.\n\nThe main study endpoint are the immunological mechanisms underlying tolerance to FVIII, including presence, titers, subtypes and affinities of FVIII-specific (non-)neutralizing antibodies, FVIII-specific T and B cell responses and the role of gut microbiota.",[358,359],"Hemophilia A","Hemophilia A, Congenital",[358,361,362],"Factor VIII","Tolerance","2026-04-16",{"date":365,"type":35},"2026-04-20",{"date":367,"type":22},"2026-05-01",{"date":369,"type":22},"2029-03",{"name":41,"class":42},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":69},"100634090","phase-2-hyperbaric-oxygen-therapy-as-adjunctive-treatment-for-fracture-related-infection-100634090","NCT07535164","Hyperbaric Oxygen Therapy as Adjunctive Treatment for Fracture-Related Infection","Supplementary Oxygen Therapy After Limb Debridement and Reconstruction Surgery in Infected Extremity Fractures (SOLDIER): a Pilot, Non-blinded, Randomized Controlled Trial","SOLDIER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed or highly suspected post-traumatic FRI of the lower limb, for which surgical intervention will be conducted\n\nExclusion Criteria:\n\n* Patients with a known contraindication for HBOT: untreated pneumothorax; epilepsy; middle ear or thorax surgery in the previous 12 months; inability to equalize the ears; COPD grade 4 or other severe air trapping lung disease; presence of a device that is not known to be compatible with HBOT; severe claustrophobia; pregnancy; BMI ≥ 35; obstructive sleep apnoea syndrome or obesity hypoventilation syndrome with a chronic increased PaCO2 \\> 6.4 kPa\n* Patients with an early (i.e. diagnosed \\\u003C6 weeks post initial trauma) FRI, which is treated by DAIR-procedure (Debridement, Antibiotics, Implant Retention) without soft tissue reconstruction\n* Patients with an active isolation precautions protocol which is incompatible with treatment in a hyperbaric chamber (i.e. with multiple patients in the chamber at the same time)\n* Inability to understand Dutch or English",{"count":380,"type":22},50,[146],"A fracture-related infection (FRI) is a difficult to treat condition in which a bone fracture and surrounding tissues are infected. This results in impaired healing and ongoing symptoms such as pain, wound leakage and swelling, which affects patients' functioning and quality of life. Despite adequate treatment in the form of extensive surgical debridement and long-term antibiotics, it is hard to obtain infection eradication.\n\nThis pilot, non-blinded, randomized controlled trial (RCT) will assess the feasibility of a subsequent, larger RCT, in which hyperbaric oxygen therapy (HBOT) will be investigated as potential treatment modality for FRI in adjunction to standard care. HBOT induces an increased oxygen tension in the body and thereby inhibits inflammation and the growth of several bacteria. Furthermore, it stimulates bone and blood vessel formation. Therefore, HBOT might be of added value in the treatment of FRI. Data on process-related outcomes, patient-reported outcome measures, and clinical parameters are obtained during this pilot study to determine whether a subsequent study investigating the efficacy of HBOT is viable.",[384,385],"Fracture Related Infection","Hyperbaric Oxygenation",[387,388,389,390,391],"Hyperbaric oxygen therapy","Fracture-related infection","Lower extremity","Feasibility studies","Randomized controlled trial","2026-04-09",{"date":363,"type":35},{"date":395,"type":22},"2026-08",{"date":397,"type":22},"2028-08",{"name":41,"class":42},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":69},"100452204","phase-4-clinical-outcome-and-cost-effectiveness-of-reduced-noradrenaline-by-using-a-lower-blood-pressure-target-in-patients-with-cardiogenic-shock-from-acute-myocardial-infarction-100452204","NCT05168462","Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction","NORSHOCK","Inclusion criteria:\n\n1. Acute myocardial infarction, STEMI or NSTEMI\n2. Early revascularization by PCI\n3. Cardiogenic shock, characterized by:\n\nI. a. Systolic blood pressure (SBP) ≤ 90 mmHg for \\> 30 minutes, OR b. Use of drugs to maintain SBP \\> 90 mmHg at randomization.\n\nII. Clinical signs of impaired organ perfusion with at least one of the following criteria:\n\n1. Altered mental status\n2. Cold, clammy skin and extremities\n3. Oliguria with urine output \\\u003C 30ml\u002Fhour\n4. Serum lactate \\> 2.0 mmol\u002FL\n\nIII. Clinical signs of pulmonary congestion\n\nExclusion Criteria:\n\n1. Resuscitation \\> 30 minutes\n2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)\n3. Onset of shock \\> 12 hours\n4. Imminent need for mechanical circulatory support (i.e. ECPR)\n5. Women \\\u003C45 years",{"count":407,"type":22},776,[25],"Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes.\n\nObjective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy.\n\nStudy design: Open label, randomized controlled multicenter trial\n\nStudy population: Adults patients with CS due to AMI\n\nIntervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg).\n\nMain study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.",[411,412],"Cardiogenic Shock","Myocardial Infarction",[414,415,416,417],"Noradrenaline","Blood pressure target","Cardiogenic shock","Myocardial infarction","2026-03-24",{"date":420,"type":35},"2026-03-27",{"date":422,"type":35},"2022-10-01",{"date":424,"type":22},"2028-04-01",{"name":41,"class":42},{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":430,"acronym":431,"eligibilityCriteria":432,"healthyVolunteers":17,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":249,"phases":4,"briefSummary":436,"conditions":437,"keywords":442,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":454,"leadSponsor":456,"locationsCount":69},"100616085","velopharyngeal-insufficiency-after-maxillomandibular-advancement-osteotomy-in-obstructive-sleep-apnea-patients-100616085","NCT07301021","Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients","VPIMMA","Inclusion Criteria:\n\n* Age \\> 18 years\n* Mild to severe OSA\n* Indication for MMA for OSA treatment\n\nExclusion Criteria:\n\n* patients who underwent other adjunctive procedures at the time of MMA (e.g., multipiece le Fort osteotomy, TMJ reconstruction\n* Previous history of orthognathic surgery\n* Previous history of orthognathic surgery\n* Previous history of oropharyngeal surgery (UPPP or multi-level surgery)\n* Cleft palate and syndromic patients\n* Neuromusculair diseases which causes VPI, dysphagia or dysarthria\n* Incapacity",{"count":434,"type":22},28,"2 Years","The aim of this study is to gain insight into the development of velopharyngeal insufficiency (VPI) in patients who have undergone maxillomandibular advancement osteotomy (MMA) as a treatment for obstructive sleep apnea syndrome (OSAS). A speech therapist evaluates nasality, speech, and swallowing before and after the surgery.",[438,439,440,441],"Velopharyngeal Insufficiency","Swallowing","Nasality","Speech",[443,444,445,446,447,448,449],"maxillomandibular advancement","obstructive sleep apnea","velopharyngeal insufficiency","speech therapy","swallowing","nasality","speech","2026-03-18",{"date":452,"type":35},"2026-03-20",{"date":367,"type":22},{"date":455,"type":22},"2027-12-01",{"name":41,"class":42},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":69},"100628272","assesment-of-the-clinical-benefit-of-provocation-on-tilt-table-in-syncope-patients-tiltsync-trial-100628272","NCT07459478","Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial","Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial","TiltSYNC","Inclusion Criteria:\n\n* All patients \\>18 years of age with certain\u002Fhighly likely vasovagal syncope after the guideline based syncope evaluation\n\nExclusion Criteria:\n\n* Those aged \\\u003C18 years\n* Any patient diagnosed with another form of reflex syncope other than vasovagal syn-cope\n* Contraindication for tilt table testing at the discretion of the responsible physician\n* Those with a learning disability\n* Those presenting with pre-syncope and not with complete loss of consciousness\n* Those who are unwilling to provide informed consent\n* Those already diagnosed prior to evaluation who are referred for specific treatment op-tions",{"count":466,"type":22},238,[56],"multicenter prospective randomized controlled comparison of biofeedback with tilt table testing (investigational management strategy) vs biofeedback without tilt table testing (reference management strategy) in patients with certain\u002Fhighly likely vasovagal syncope",[470],"Vasovagal Syncope (VVS)",[472,473,474,475,476],"Suspected vasovagal syncope","Tilt table testing","Syncope","Therapeutic","Biofeedback","2026-03-09",{"date":479,"type":35},"2026-03-11",{"date":481,"type":35},"2025-10-30",{"date":483,"type":22},"2028-03-01",{"name":41,"class":42},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":17,"sex":18,"minAge":493,"maxAge":494,"enrollmentInfo":495,"targetDuration":4,"studyType":23,"phases":497,"briefSummary":498,"conditions":499,"keywords":512,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":69},"100628155","effectiveness-of-an-mhealth-innovation-on-the-impact-of-menstrual-complaints-in-adolescents-100628155","NCT07457957","Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents","The Effectiveness of an mHealth Innovation on the Impact of Menstrual Complaints in Adolescents - A Randomised Controlled Trial","MGA","Inclusion Criteria:\n\n* Dutch, English, Turkish or Moroccan-Arabic speaking\n* Post menarche\n* Access to a smartphone or tablet with iOS or Android operating system\n\nExclusion Criteria:\n\n* Amenorrhea\n* Pregnancy\n* No menstrual bleeding or withdrawel bleeding in the 3 months prior to inclusion.\n* Previously or currently under treatment by a health care provider for menstrual complaints","12 Years","21 Years",{"count":496,"type":22},874,[56],"The aim of this study is to improve menstrual health-related quality of life in adolescents by using a mobile menstrual health tracker. We will perform a randomized controlled trial to evaluate the (cost)-effectiveness of this mHealth intervention.",[500,501,502,503,504,505,506,507,508,509,510,511],"Dysmenorrhea","Heavy Menstrual Bleeding","Menstrual Cramps","Menstrual Bleeding, Heavy","Menstrual Discomfort","Menstrual Cycle Abnormal","Menstrual Disorder","Menstrual Health","Mobile Application","mHealth","Menstrual Health Intervention","Adolescent",[513,509,514,511,515],"randomized clinical trial","Menstrual health","Menstrual Tracker App","2026-03-04",{"date":477,"type":35},{"date":519,"type":22},"2026-02-16",{"date":521,"type":22},"2029-05-31",{"name":41,"class":42},{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":531,"targetDuration":533,"studyType":249,"phases":4,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":69},"100552383","in-hospital-24-hour-observation-of-syncope-patients-100552383","NCT06472375","In Hospital 24 Hour Observation of Syncope Patients","Multicenter Randomized Clinical Trial to Assess the Clinical Benefit of 24-hour in Hospital Observation of Syncope Patients Admitted to the Cardiac Emergency Room","RISC","Inclusion Criteria:\n\nAll patients that are assessed as low- and intermediate risk syncope, are eligible for inclusion in this trial.\n\nThe initial syncope evaluation includes:\n\n1. Complete and thorough history taking of the syncope event and past medical history\n2. Physical examination including supine and standing BP measurement and\n3. 12 lead ECG.\n\nExclusion Criteria:\n\nA potential patient who meets any of the following criteria will be excluded from participation in this study:\n\n1. Those aged \\\u003C18 years\n2. Those in whom syncope \u002F transient loss of consciousness co-exist with trauma or other serious condition identified in the CER (massive bleeding, pulmonary embolus) or any high-risk features upon assessment with guideline based SA\n3. Those with any other conditions then syncope \u002F transient loss of consciousness for which admission is required (including social indication for admission, etc.)\n4. Contraindication for early discharge as the discretion of the responsible physician\n5. Those with a learning disability\n6. Those presenting with pre-syncope\n7. Those who are unwilling to provide informed consent (those will be asked to be enrolled for the SYNCOPE R.I.S.C-registry)",{"count":532,"type":22},640,"1 Month","Syncope is very common and has a broad differential diagnosis. Guidelines on syncope recommend to apply guideline based syncope algorithm (SA) to identify low- \u002F intermediate risk syncope patients and recommend to discharge these patients. The time window when to discharge these patients is not defined in the guidelines. In current medical practice low- \u002F intermediate risk syncope patients are either immediately discharged or discharged after 24-hour observation with telemetry (TM). There seems to be an equipoise for both treatment strategies in current medical practice for these low risk syncope patients. A randomized controlled trial to compare discharge after 24 hour observation including TM with immediate discharge has never been done on the Cardiac Emergency Room (CER).",[474],"2026-02-23",{"date":538,"type":35},"2026-02-24",{"date":540,"type":35},"2023-11-17",{"date":542,"type":22},"2026-08-01",{"name":41,"class":42},{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":355,"studyType":249,"phases":4,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":288},"100414544","a-personalized-surveillance-and-intervention-protocol-for-duodenal-and-gastric-polyposis-in-patients-with-familial-adenomatous-polyposis-100414544","NCT04677998","A Personalized Surveillance and Intervention Protocol for Duodenal and Gastric Polyposis in Patients With Familial Adenomatous Polyposis","Inclusion Criteria:\n\n* Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and\u002For clinical diagnosis (\\>100 colorectal adenomas in combination with a positive family history of FAP)\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Endoscopic removal of all polyps with an indication for removal not possible\u002Ffeasible\n* Gastric or duodenal cancer at baseline endoscopy\n* Need for surgery",{"count":551,"type":22},1000,"The purpose of this study is to determine the efficacy and safety of a personalized surveillance and intervention protocol for duodenal and gastric polyposis in patients with familial adenomatous polyposis (FAP)",[554],"Familial Adenomatous Polyposis",[556,557,558,559],"Endoscopic surveillance","Endoscopic interventions","Personalized care","Gastrointestinal neoplasia","2026-02-20",{"date":536,"type":35},{"date":563,"type":35},"2020-11-24",{"date":565,"type":22},"2027-11",{"name":41,"class":42},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":573,"targetDuration":355,"studyType":249,"phases":4,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":578,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":288},"100414545","a-personalized-surveillance-and-intervention-protocol-for-patients-with-familial-adenomatous-polyposis-that-have-undergone-proctocolectomy-100414545","NCT04678011","A Personalized Surveillance and Intervention Protocol for Patients With Familial Adenomatous Polyposis That Have Undergone (Procto)Colectomy","Inclusion Criteria:\n\n* Diagnosis of FAP, at least one of following: genetic diagnosis (proven APC germline mutation) and\u002For clinical diagnosis (\\>100 colorectal adenomas in combination with a positive family history of FAP)\n* Have undergone prophylactic (procto)colectomy with IRA\u002FISA or IPAA\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Not able to remove all polyps with an indication for removal during (multiple) clearing endoscopies\n* Cancer at baseline endoscopy\n* Need for surgery",{"count":551,"type":22},"The purpose of this study is to determine the efficacy and safety of a personalised surveillance and intervention protocol for patients with familial adenomatous polyposis (FAP) that have undergone (procto)colectomy.",[554],[556,557,577,559],"Personalised care",{"date":536,"type":35},{"date":580,"type":35},"2021-11-24",{"date":582,"type":22},"2026-11",{"name":41,"class":42},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":590,"eligibilityCriteria":591,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":592,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":593,"conditions":594,"keywords":596,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":69},"100513967","effect-of-left-ventricle-diastolic-dysfunction-on-outcomes-in-female-cardiac-surgery-patients-100513967","NCT05972356","Effect of Left Ventricle Diastolic Dysfunction on Outcomes in Female Cardiac Surgery Patients","The Effect of Left Ventricular DIastolic Dysfunction on Short Term Cardiac Surgery Outcomes in Female Cardiac patieNts","EDISON","Inclusion Criteria:\n\n* All patients \\>18 years, who undergo cardiac surgery from 1 January 2023 till 31 December 2026 in the Amsterdam UMC\n\nExclusion Criteria:\n\n* Patients who object to the re-use of their care data",{"count":551,"type":22},"The aim of this study is to evaluate the differences between males and females with LVDD, undergoing cardiac surgery. The investigators will look at perioperative factors such as body weight, body surface area, previous medical history, cardiac function measured by amongst others, transoesophageal echocardiography and haemodynamic parameters, transfusion, coagulation, cardiopulmonary bypass (CPB) related factors, inotropic requirements, risk, and outcome scores as well as complications, morbidity and mortality at 30 days. The investigators will evaluate these variables in an observational setting, with the goal of improving outcome in females after cardiac surgery in the future.",[595],"Left Sided Heart Failure",[597,598,599,600],"sex-differences","left ventricular diastolic dysfunction","cardiac surgery","outcomes","2026-02-12",{"date":603,"type":35},"2026-02-17",{"date":605,"type":35},"2025-09-01",{"date":607,"type":22},"2027-09-01",{"name":41,"class":42},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":617,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":624,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":635,"locationsCount":636},"100585951","adaptive-vs-continuous-subthalamic-nucleus-deep-brain-stimulation-in-parkinsons-disease-100585951","NCT06909045","Adaptive vs. Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease","Randomized Controlled Trial Comparing Adaptive Versus Continuous Subthalamic Nucleus Deep Brain Stimulation in Parkinson's Disease","CLOSE-PD","Inclusion Criteria:\n\n* Diagnosis of idiopathic PD based on the UK Brain Bank criteria (Hughes et al. 1992);\n* Age older than 18 years;\n* Previous implantation of Medtronic PerceptTM PC\u002FRC DBS electrodes bilateral targeting the STN;\n* Optimal contact point compatible with aDBS in at least one STN;\n* Reliable beta peak in at least one STN;\n* Able to provide informed consent and comply with the study protocol;\n* Understand the Dutch language.\n\nExclusion Criteria:\n\n* Legally incompetent adults;\n* Patients with ongoing participation in other clinical trials involving neurological interventions;\n* Inability to recognize the difference between the motor ON or OFF state;\n* Mild cognitive impairment or dementia;\n* Pregnancy.",{"count":618,"type":22},130,[56],"The objective of the CLOSE-PD study is to compare the efficacy of adaptive deep brain stimulation (aDBS) with continue deep brain stimulation (cDBS) in patients with Parkinson's disease. The main question it aims to answer is:\n\n\\- whether the change in daily mean ON time without troublesome dyskinesia in aDBS is greater than cDBS over a six-month follow-up period?\n\nResearchers will compare aDBS to regular continue deep brain stimulation (cDBS).\n\nParticipants will:\n\n* be set up to cDBS during the first programming visit (visit 2);\n* be randomized 1:1 to aDBS or cDBS two weeks after visit 2;\n* follow-up will be at three and six months after visit 2;\n* complete PD Home diary at baseline, two weeks, three months and at six months after visit 2.",[622,623],"Deep Brain Stimulation","Parkinson Disease",[625,626,627,628],"adaptive DBS","continue DBS","aDBS","cDBS","2026-01-28",{"date":631,"type":35},"2026-01-29",{"date":633,"type":35},"2026-01-27",{"date":39,"type":22},{"name":41,"class":42},4,{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":249,"phases":4,"briefSummary":647,"conditions":648,"keywords":652,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":288},"100614135","timing-and-dose-of-fluid-deresuscitation-in-critically-ill-patients-100614135","NCT07275658","Timing and Dose of Fluid Deresuscitation in Critically Ill Patients","Timing and Dose of Fluid Deresuscitation in Critically Ill Patients: a Prospective Observational Multicenter Study","TIDE","Inclusion Criteria:\n\n* Admission to one of the participating ICUs;\n* Clinical indication for deresuscitation using diuretics or ultrafiltration as set by the treating physician; first attempt during the ICU stay.\n\nExclusion Criteria:\n\n* Age below 18 years old;\n* Major cardiac shunts;\n* Moderate to severe aortic regurgitation;\n* Morbid Obesisty (BMI \\>40);\n* POCUS impossible or unreliable (i.e. pre-existing interstitial lung disease);\n* PLR or modified form of PLR impossible (i.e. ECMO);\n* Transfer from another ICU;\n* Previous inclusion in this study;\n* Patients who are moribund or facing the end of life;\n* Opt out.",{"count":646,"type":22},150,"Fluid deresuscitation is an important intervention in the Intensive Care Unit (ICU). This study aims to find (1) determinants of successful deresuscitation, (2) the optimal rate (dose) of deresuscitation based on these determinants, and (3) differences in metabolic profiles for a more personalized approach of deresuscitation.\n\nThis study is a multicenter, prospective, observational cohort study in critically ill patients. This study will include ICU patients who have a clinical indication for deresuscitation as set by the treating physician. Clinical, ultrasound and laboratory values will be collected and used for analysis.",[649,650,651],"Fluid Overload","Critical Care, Intensive Care","Deresuscitation",[653],"ultrasound, RRT, furosemide","2026-01-19",{"date":656,"type":35},"2026-01-21",{"date":658,"type":35},"2025-10-15",{"date":660,"type":22},"2027-02-28",{"name":41,"class":42},{"id":663,"slug":664,"hasResults":12,"nctId":665,"briefTitle":666,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":52,"minAge":19,"maxAge":670,"enrollmentInfo":671,"targetDuration":4,"studyType":23,"phases":673,"briefSummary":674,"conditions":675,"keywords":677,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":69},"100523196","trial-to-evaluate-efficacysafety-of-revita-dmr-treatment-paradigm-1-and-retreatment-in-type-2-diabetes-patients-100523196","NCT06092476","Trial to Evaluate Efficacy+Safety of Revita DMR Treatment Paradigm 1 and Retreatment in Type 2 Diabetes Patients","A Randomized Double-blind Sham-controlled Trial to Evaluate Efficacy+Safety of Revita Duodenal Mucosal Resurfacing (DMR) Treatment Paradigm+Retreatment in Patients With Type 2 Diabetes Using Non-insulin Glucose Lowering Medications (REMIND)","REMIND","Inclusion Criteria:\n\n1. Diagnosed with Type 2 Diabetes.\n2. Age ≥ 18 to ≤ 75 years.\n3. Insulin naïve patients who are on stable dose (maximally approved or tolerated dose) of 2 or more glucose lowering drugs, including metformin, sulphonylurea (SU), (sodium-glucose cotransporter-2) inhibitors (SGLT-2i), Glucagon-like peptide-1 receptor agonists (GLP-1RA) or dipeptidyl peptidase 4 inhibitor (DPP-4i) and\u002For, thiazolidinedionderivaten (TZD) for at least 12 weeks.\n4. BMI ≥ 24 and ≤ 40 kg\u002Fm2\n5. HbA1c of ≥ 54 mmol\u002Fmol (7.5%) and ≤ 86 mmol\u002Fmol (10.0%).\n6. Signed and dated written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.\n\nExclusion Criteria:\n\n1. Uncontrolled hyperglycemia with a glucose level \\>270 mg\u002Fdl (\\>15.0 mmol\u002FL) after an overnight 8-hour fasting at the end of run-in and confirmed by a second measurement on the consecutive day.\n2. Subjects who are using insuline.\n3. Known case of absolute insulin deficiency as indicated by a fasting plasma C-peptide value of \\\u003C0.6 ng\u002Fml (\\\u003C0,2 nmol\u002FL).\n4. Diagnosis of autoimmune diabetes\u002FType 1 diabetes mellitus, monogenic (neonatal or maturity onset diabetes of the young (MODY)) diabetes or Type 1 diabetes in adults\u002Flatent autoimmune diabetes of adults (LADA).\n5. History of more than 1 severe hypoglycemia episode or unawareness within past 6 months in which third party assistance was needed.\n6. Clinically significant valvular heart disease or severe aortic stenosis.\n7. Acute coronary syndrome (non-ST wave elevated myocardial infarction (STEMI), STEMI and unstable angina pectoris), stroke or transient ischemic attack within the past 3 months.\n8. Indication of acute liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN).\n9. Presence of acute or chronic active hepatitis B or C (except if hepatitis C is cured) or cirrhosis; or hepatic decompensation during the last 6 months; or alcoholic or autoimmune chronic hepatitis.\n10. Impaired renal function, defined as estimated Glomerular Filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m2 or end stage renal failure or on dialysis.\n11. Diagnosed with esophageal motility disorder or Glomerular Filtration rate (GERD) gr 3 or diagnosed during screening endoscopy.\n12. Known history of a structural or functional disorder of the stomach, e.g. active gastric ulcer, chronic gastritis, gastric varices, hiatal hernia, stomach cancer or any other disorder of the stomach.\n13. Previous GI surgery that could affect the ability to treat the duodenum such as patients who have had a Billroth 2, Roux-and-Y gastric bypass, gastric sleeve or other similar procedures.\n14. Known intestinal autoimmune disease, including Celiac disease, or pre-existing symptoms of lupus erythematosus, scleroderma, or other autoimmune connective tissue disorder, which affects the small intestine.\n15. Patients with active helicobacter pylori infection. Patients may be enrolled if they had history of h-pylori infection and were successfully treated.\n16. History of active malignancy or partial remission from clinically significant malignancy within the past 5 years. With the exception of basal or squamous cell skin cancer or carcinoma in situ or those received curative treatment and in complete remission for 5 years or if subject confirmed as cancer free.\n17. Blood dyscrasias or any disorders causing hemolysis or unstable Red Blood Cells (sickle cell trait is allowed).\n18. Known case of severe peripheral vascular disease.\n19. Clinically active systemic infection.\n20. Known immunocompromised status, including individuals who have undergone organ transplantation, chemotherapy, or radiotherapy within the past 12 months, clinically significant leukopenia or positive for the human immunodeficiency virus (HIV), on potential immunosuppressants.\n21. Current treatment with systemic steroids or change in dosage of thyroid hormones within 6 weeks prior to consent or any other uncontrolled endocrine disorder.\n22. Use of anticoagulation therapy (such as warfarin, coumadin, Novel Oral AntiCoagulants (NOAC) or anti-platelet agents (such as thienopyridine) which cannot be discontinued for 5-7 days or 2 drug half-lives before the procedure; Acetylsalicylic acid does not need to be discontinued.\n23. Actively participating in weight loss program or using medications for weight loss 3 months prior to randomization.\n24. General contraindications to deep or conscious sedation or general anesthesia or high risk (e.g., American Society of Anesthesiologists Classification (ASA) 4 or higher) or contraindications to upper GI Endoscopy.\n25. Nursing or Pregnant women or women of child bearing potential who are unwilling to practice acceptable method of birth control.\n26. History of alcohol, legal or illegal drug and substance abuse.\n27. Intake of an investigational drug in another trial within 30 days prior to consent or active participation in another clinical trial of an investigational drug or device.\n28. Any other clinical or mental condition which would jeopardize subject's safety or makes subject a poor candidate for clinical trial participation.","75 Years",{"count":672,"type":22},18,[56],"The objective of this study is to evaluate feasibility, safety, and efficacy of endoscopic DMR Treatment Paradigm 1 (compared to sham) and to evaluate feasibility, safety, and efficacy of re-treatment with DMR at 24 weeks (compared to baseline and a single DMR procedure) in patients with type 2 diabetes with non-insulin glucose lowering medications.",[676],"Diabetes Mellitus, Type 2",[678,679,680,681],"Type 2 Diabetes","Duodenal ablation","Endoscopy","Duodenal Mucosal Resurfacing","2026-01-15",{"date":684,"type":35},"2026-01-16",{"date":686,"type":35},"2024-08-09",{"date":688,"type":22},"2027-07-01",{"name":41,"class":42},""]