[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Sweden\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":723},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1406,0,25,[9,43,67,99,124,155,185,212,240,270,300,324,346,386,410,436,457,480,517,562,592,619,645,676,702],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698",false,"NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","ALL","18 Years","80 Years",{"count":22,"type":23},500,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[29],"Amyotrophic Lateral Sclerosis","RECRUITING","2026-08-24",{"date":33,"type":34},"2026-08-25","ACTUAL",{"date":36,"type":34},"2026-02-01",{"date":38,"type":23},"2029-03",{"name":40,"class":41},"Prilenia","INDUSTRY",56,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":54,"type":23},150,[26],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[58],"Diabetes Mellitus, Type 1",{"date":33,"type":34},{"date":61,"type":34},"2026-01-12",{"date":63,"type":23},"2031-07",{"name":65,"class":41},"Eli Lilly and Company",113,{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":24,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":76,"type":23},590,[78,26],"PHASE2","The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[81],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[83,84,85,86,87,88,89,90],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":33,"type":34},{"date":93,"type":34},"2026-01-02",{"date":95,"type":23},"2031-08-12",{"name":97,"class":41},"Bristol-Myers Squibb",320,{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":24,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":108,"type":23},450,[26],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[112],"Bipolar Disorder Type I With Mania",[114,115,116],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":33,"type":34},{"date":119,"type":34},"2025-07-18",{"date":121,"type":23},"2028-06-13",{"name":97,"class":41},174,{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":18,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":147,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387","NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","1 Month",{"count":133,"type":23},2000,"OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[137],"Perimembranous Ventricular Septal Defect",[139,140,141,142,143,144,145,146],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects",{"date":33,"type":34},{"date":149,"type":34},"2025-01-01",{"date":151,"type":23},"2027-06-30",{"name":153,"class":154},"Fondation Hôpital Saint-Joseph","OTHER",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":12,"sex":18,"minAge":163,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":24,"phases":167,"briefSummary":169,"conditions":170,"keywords":174,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100568620","sealion-study-on-supplemental-oxygenation-via-nasal-cannula-for-young-children-during-intubation-100568620","NCT06683599","SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation","SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula","SEALION","Inclusion Criteria:\n\n* Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.\n* Neonates and infants up to 52 weeks post-conceptual age.\n* Written informed consent provided by legal guardians prior to the intervention.\n\nExclusion Criteria:\n\n* Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.\n* Requirement for an alternative technique to direct laryngoscopy to secure the airway.\n* Specific conditions, such as congenital heart disease requiring FiO₂ \\\u003C 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.","1 Minute","52 Weeks",{"count":166,"type":23},240,[168],"NA","Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \\\u003C80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L\u002Fkg\u002Fmin) can extend safe apnea time.\n\nThis study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.",[171,172,173],"Difficult Airway","Difficult Airway Intubation","Neonate",[175,176,173],"Difficult intubation","Apneic oxygenation",{"date":33,"type":34},{"date":179,"type":34},"2024-12-10",{"date":181,"type":23},"2027-12-01",{"name":183,"class":154},"Vinícius C Quintão, MD, MSc, PhD",4,{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":24,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","6 Years",{"count":194,"type":23},134,[26],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[198],"Prader-Willi Syndrome",[200,201,202,203],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":33,"type":34},{"date":206,"type":34},"2024-05-28",{"date":208,"type":23},"2028-04",{"name":210,"class":41},"Harmony Biosciences Management, Inc.",57,{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":24,"phases":221,"briefSummary":222,"conditions":223,"keywords":226,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":239},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":220,"type":23},626,[78,26],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[224,225],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[227,228,85,225,229,230,231],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":33,"type":34},{"date":234,"type":34},"2020-12-02",{"date":236,"type":23},"2029-10-31",{"name":238,"class":41},"Mirati Therapeutics Inc.",770,{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":248,"sex":18,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":24,"phases":253,"briefSummary":254,"conditions":255,"keywords":259,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":269},"100643424","health-effects-of-ultra-processed-food-intake-100643424","NCT07634159","Health Effects of Ultra-processed Food Intake","Health Effects of Ultra-processed Food Intake: a Randomized Crossover Feeding Study","UPFront","Inclusion Criteria:\n\n* Age 20-60 years\n* Weight stable (less than 5% weight change in the past 3 months)\n* No plans to change weight\n* Willing to eat the study diet and a mixed diet\n* Habitually eats breakfast, lunch and dinner\n* Has provided informed consent to participate in the study\n\nExclusion Criteria:\n\n* Allergy or intolerance to foods included in the study. Participants with lactose intolerance treated with lactase may participate if they take enzymes.\n* BMI \\\u003C18.5 or \\>35 kg\u002Fm²\n* \\>8h\u002Fweek of intense physical activity\n* Use of medications known to significantly affect appetite (e.g., oral corticosteroids, antipsychotic medications, or GLP-1 receptor agonists)\n* Use of lipid-lowering medications (e.g., statins or PCSK9 inhibitors)\n* Diagnosed diabetes or capillary blood glucose at or above 12.2 mmol\u002FL\n* Disease associated with malabsorption (e.g., inflammatory bowel disease or celiac disease)\n* Previous bariatric surgery\n* Established cardiovascular disease (heart failure, myocardial infarction, or stroke) or cancer\n* Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during the study\n* Deemed likely to have poor adherence",true,"20 Years","60 Years",{"count":252,"type":23},40,[168],"Ultra-processed food (UPF) intake has been related to negative health effects and increased energy intake in previous intervention studies. Thus, previous studies have seen weight gain from higher UPF intake which obscures the potential to see effects on cardiometabolic biomarkers, independent of weight changes. The overall aim of this project is to study the causal effects of a high UPF diet, compared to a nutrient-matched low UPF diet, on appetite and cardiometabolic health in a weight-stable context.",[256,257,258],"Cardiometabolic Risk Factors","Microbiota","Diet Interventions",[260],"Ultra-processed food","2026-08-21",{"date":31,"type":34},{"date":264,"type":34},"2026-06-25",{"date":266,"type":23},"2027-12",{"name":268,"class":154},"Göteborg University",1,{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":279,"conditions":280,"keywords":286,"overallStatus":292,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":269},"100640382","medical-team-perspectives-on-hand-and-wrist-injuries-in-elite-male-and-female-ice-hockey-players-100640382","NCT07586085","Medical Team Perspectives on Hand and Wrist Injuries in Elite Male and Female Ice Hockey Players","Medical Team Perspectives on Hand and Wrist Injuries in Elite Ice Hockey: A Cross-Sectional Survey Study in Male and Female Players","Inclusion Criteria:\n\n* Physiotherapists working with elite ice hockey teams in Sweden (SHL, HockeyAllsvenskan, SDHL)\n* Team physicians working with elite ice hockey teams in Sweden (SHL, HockeyAllsvenskan, SDHL)\n* Massage therapists and sports massage practitioners working with elite ice hockey teams in Sweden\n* Athletic trainers and performance staff involved in player health and injury management in elite ice hockey teams in Sweden\n* Currently active in a medical or performance support role within a participating elite ice hockey team during the study period\n* Able to understand and complete the questionnaire in Swedish or English Provides informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Not currently active in a medical, therapeutic, or performance support role within elite ice hockey during the study period",{"count":278,"type":23},50,"This is a cross-sectional survey study investigating how medical team staff in elite Swedish ice hockey perceive hand and wrist injuries in male and female players.\n\nHand and wrist injuries are common in ice hockey and can affect both performance and participation. While injury registries describe how often these injuries occur, less is known about how they are managed and prioritised in daily clinical practice, or whether there are differences in perception between medical teams working in male and female elite leagues.\n\nIn this study, medical team professionals working with teams in Swedish elite ice hockey (including SHL, HockeyAllsvenskan, and SDHL) will complete a structured questionnaire. This includes all relevant healthcare and medical support professionals within the teams. The survey examines perceptions of injury frequency, underreporting, functional impact, clinical management strategies, and return-to-play decision-making related to hand and wrist injuries.\n\nThe aim is to better understand how medical teams experience and manage these injuries in real-world elite sport settings, and to identify potential gaps between epidemiological data and clinical practice. The study may help inform future injury prevention strategies, improve clinical decision-making, and support the development of more standardized management approaches in elite ice hockey.\n\nNo interventions or treatments are performed in this study.",[281,282,283,284,285],"Ice Hockey","Hand","Wrist","Injuries","Medical Staff Perception",[287,288,289,290,291],"ice hockey","hand","wrist","medical staff perception","cross-sectional survey","NOT_YET_RECRUITING",{"date":31,"type":34},{"date":295,"type":23},"2026-09-01",{"date":297,"type":23},"2026-12-31",{"name":299,"class":154},"Dalarna County Council, Sweden",{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":307,"enrollmentInfo":308,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":323},"100608388","phase-3-a-trial-evaluating-brelovitug-bjt-778-vs-bulevirtide-for-the-treatment-of-chronic-hepatitis-delta-infection-azure-2-100608388","NCT07200908","A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Chronic HDV infection\n3. HDV RNA \\>500 IU\u002FmL at Screening\n4. ALT \\>ULN at Screening\n5. Willing to take or already taking HBV neucleos(t)ide therapy.\n\nKey Exclusion Criteria:\n\n1. Pregnant or nursing females\n2. Unwilling to comply with contraception requirements during the study\n3. Difficulty with blood collection and\u002For poor venous access for the purposes of phlebotomy\n4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).\n5. Solid organ or bone marrow transplantation\n6. Presence of other liver disease(s) (non-HBV\u002FHDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.\n\nNote - Other protocol-defined Inclusion\u002FExclusion criteria apply.","99 Years",{"count":309,"type":23},172,[26],"This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.",[313],"Chronic Hepatitis D Infection",[315],"Hepatitis Delta virus, HDV, Hepatitis D infection; Hepatitis D virus",{"date":33,"type":34},{"date":318,"type":34},"2025-08-27",{"date":320,"type":23},"2029-09-30",{"name":322,"class":41},"Mirum Pharmaceuticals, Inc.",53,{"id":325,"slug":326,"hasResults":12,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":24,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":269},"100607658","study-group-on-palliative-ercp-and-rfa-ablation-in-metastatic-and-inoperable-pancreatic-tumors-100607658","NCT07191418","Study-group on Palliative ERCP And RFA-ablation in Metastatic and Inoperable Pancreatic Tumors","Spearmint","Inclusion Criteria:\n\n* Individuals with newly diagnosed pancreatic cancer in the head of the pancreas causing compression on the bile duct.\n* Metastatic stage to the liver\n* Histologically or cytologically confirmed mPDAC.\n* Cancer burden limited to maximum 5 metastases in the liver, each of them maximum 1 cm in the larger diameter.\n* Patients must be under palliative chemotherapy treatment.\n* Cancer should be radiologically measurable (in an area not previously irradiated).\n* WHO performance status 0-2.\n* Age 18-85 years.\n\nExclusion Criteria:\n\n* Intellectual disability, unwillingness or language difficulties\n* which hinders the ability to give informed consent.\n* Ongoing extensive immunosuppression and\u002For severe leuko- or\n* thrombocytopenia.\n* Ongoing acute cholangitis.\n* Ongoing sepsis.\n* Acute kidney failure.\n* Uncompensated heart failure or unstable coronary insufficiency\n* (symptomatic\u002Funcompensated).\n* Pregnancy or breastfeeding.\n* Any metastases outside the liver.\n* Cardiac pacemakers\u002Fcardioverter defibrillators.\n* Severe coagulopathy.","85 Years",{"count":333,"type":23},178,[168],"Pancreatic ductal adenocarcinoma (PDAC) is a very aggressive cancer and may become the second leading cause of cancer death by 2030. About half of the patients are diagnosed late, when the cancer has already spread (mPDAC), and the outlook is very poor. Chemotherapy is currently the only treatment for mPDAC. It can slow the disease and slightly extend life, but usually only by a few months. There are no other treatments that clearly improve survival. Radiofrequency ablation (RFA) is a minimally invasive technique that uses high-frequency electrical energy to generate heat and destroy tumor cells. Radiofrequency energy raises the temperature of the tissue, leading to coagulative necrosis and tumor cell death. RFA is commonly used to treat certain types of cancer and pre-cancerous lesions, including liver, kidney, lung, and bone tumors. In addition to directly destroying tumor tissue, RFA may also enhance the immune system's ability to recognize and attack cancer cells by exposing tumor antigens that were previously hidden within the tumor mass. Most research on radiofrequency ablation (RFA) to date has focused on Barrett's esophagus and liver cancer. However, RFA is increasingly being explored in palliative care, where early results suggest potential benefits. Advances in miniaturized endoscopic technology have enabled the application of RFA in anatomically challenging locations, such as the bile duct. Studies, including case series and clinical trials, have demonstrated that RFA is both feasible and safe. However, its impact on overall survival remains uncertain. Many previous studies are limited by small sample sizes and heterogeneous populations, often including patients with different cancer types and disease stages, which introduces bias and limits the generalizability of findings. We have therefore designed a prospective study focusing on patients with bile duct obstruction due to pancreatic ductal adenocarcinoma (PDAC) with limited metastatic spread (oligometastatic mPDAC). This study aims to provide more robust evidence on the potential role of RFA in improving clinical outcomes in a carefully selected subset of patients with advanced PDAC.",[337],"Pancreatic Cancer Metastatic to Liver",{"date":31,"type":34},{"date":340,"type":34},"2026-04-09",{"date":342,"type":23},"2027-09",{"name":344,"class":345},"Roberto Valente","OTHER_GOV",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":385},"100593979","a-study-to-learn-about-the-study-medicine-ibuzatrelvir-in-adults-with-covid-19-who-are-severely-immunocompromised-100593979","NCT07013474","A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED","Inclusion Criteria:\n\n1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19\n2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.\n3. Severely immunocompromised due to:\n\n   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;\n   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);\n   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;\n   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.\n\nExclusion Criteria:\n\n1. Severe or critical COVID-19, or current need for supplemental oxygen.\n2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \\\u003C15 mL\u002Fmin)\n3. Active liver disease\n4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n8. Has received any other antiviral for the treatment of the current COVID-19 infection\n9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n11. Prior participation in this trial or any clinical trial of ibuzatrelvir.\n12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":354,"type":23},300,[26],"This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate COVID-19.",[358],"COVID-19 Infection",[360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377],"COVID-19 infection","pneumonia","respiratory tract infections","coronavirus infection","RNA virus infection","lung disease","pneumonia, viral","infections","virus","viral protease inhibitor","protease inhibitor","enzyme inhibitor","severe immunocompromise","anti-viral agents","anti-infectives","ibuzatrelvir","remdesivir","COVID-19",{"date":33,"type":34},{"date":380,"type":34},"2025-07-14",{"date":382,"type":23},"2028-02-25",{"name":384,"class":41},"Pfizer",152,{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":24,"phases":396,"briefSummary":397,"conditions":398,"keywords":400,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":402,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100592970","phase-3-a-phase-iii-study-of-azd0780-on-major-adverse-cv-events-in-patients-with-a-history-of-ascvd-events-or-at-high-risk-for-a-first-event-100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":395,"type":23},15100,[26],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[399],"Cardiovascular Disease",[401],"Atherosclerotic Cardiovascular Disease",{"date":31,"type":34},{"date":404,"type":34},"2025-06-04",{"date":406,"type":23},"2029-10-26",{"name":408,"class":41},"AstraZeneca",1452,{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":24,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":433,"locationsCount":435},"100587610","phase-3-a-study-to-assess-the-efficacy-and-safety-of-debio-4126-in-participants-with-acromegaly-previously-treated-with-somatostatin-analogs-100587610","NCT06930625","A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs","A Phase 3 Randomized 3-arm Trial (Double-blind Debio 4126, Placebo Control, and Open-label Debio 4126), to Assess the Efficacy and Safety of Debio 4126, a 12-week Octreotide Formulation, in Patients With Acromegaly Previously Treated With Somatostatin Analogs","OXTEND™-03","Inclusion criteria\n\n1. Patients ≥18 years of age\n2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.\n3. IGF-1 at screening ≤1x ULN\n4. Acromegaly diagnosis, defined as per protocol\n5. Adequate bone marrow, hepatic and renal function\n6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication\n7. Other protocol-defined criteria apply\n\nExclusion criteria\n\n1. Compression of optic chiasm causing visual defects\n2. Symptomatic cholelithiasis or bile duct dilatation\n3. Planned cholecystectomy during the trial duration\n4. Acute or chronic pancreatitis\n5. Pituitary radiotherapy\n6. Uncontrolled hypothyroidism\n7. Uncontrolled diabetes\n8. Pituitary surgery within 6 months before screening or planned on trial\n9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamine agonists within 3 months prior to screening\n10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism\n11. Other protocol-defined criteria apply",{"count":419,"type":23},119,[26],"The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.",[423],"Acromegaly",[425,426,427,428],"IGF-1","Growth hormone","Pituitary gland","Gigantism",{"date":31,"type":34},{"date":431,"type":34},"2025-11-26",{"date":38,"type":23},{"name":434,"class":41},"Debiopharm International SA",73,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":24,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":450,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":456},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":445,"type":23},700,[26],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[449],"Carcinoma, Non-Small-Cell Lung",{"date":31,"type":34},{"date":452,"type":34},"2025-03-27",{"date":454,"type":23},"2032-02",{"name":65,"class":41},369,{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":467,"conditions":468,"keywords":470,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":472,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":479},"100558951","redo-transcatheter-aortic-valve-implantation-for-the-management-of-transcatheter-aortic-valve-failure-100558951","NCT06557798","REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure","Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve","REVALVE","Inclusion Criteria:\n\n1\\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing",{"count":466,"type":23},550,"Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.\n\nThe study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).\n\nThe study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.",[469],"Aortic Valve Stenosis",[471],"Bioprosthetic Valve Failure",{"date":33,"type":34},{"date":474,"type":34},"2024-12-12",{"date":476,"type":23},"2033-03",{"name":478,"class":154},"The Leeds Teaching Hospitals NHS Trust",75,{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":516},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":488,"type":23},492,[26],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[492],"Multiple Myeloma",[494,495,496,497,498,499,500,501,502,503,504,505,506,507,508,509],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135",{"date":31,"type":34},{"date":512,"type":34},"2024-02-08",{"date":514,"type":23},"2027-12-30",{"name":384,"class":41},270,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":523,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":525,"targetDuration":4,"studyType":24,"phases":527,"briefSummary":528,"conditions":529,"keywords":531,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":555,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":561},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":526,"type":23},1264,[26],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[449,530],"Neoplasm Metastasis",[224,532,533,534,535,536,537,538,539,540,541,542,543,530,544,545,546,547,548,549,550,551,552,553,554],"KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer","Non-Small Cell Lung Cancer (NSCLC)","Antineoplastic Agents","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms","Lung Neoplasms",{"date":31,"type":34},{"date":557,"type":34},"2023-12-21",{"date":559,"type":23},"2031-01",{"name":65,"class":41},418,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":569,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":24,"phases":573,"briefSummary":574,"conditions":575,"keywords":577,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":591},"100453322","phase-3-venetoclax-in-children-with-relapsed-acute-myeloid-leukemia-aml-100453322","NCT05183035","Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)","A Randomized Phase 3 Trial of Fludarabine\u002FCytarabine\u002FGemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML","Inclusion Criteria\n\n* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101\u002FAPAL2020D. (This is only applicable for participants in USA\u002FCanada\u002FAustralia\u002FNew Zealand sites\u002FBlood Cancer United territory).\n* Participants must be \\>28 days of age and \\\u003C 22 years of age at enrollment.\n* Participants must have one of the following:\n\n  1. Children, adolescents, and young adults with AML without demonstrated FLT3\u002Finternal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3\u002FITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.\n  2. And participants must have AML which is either:\n\n     * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or\n     * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.\n* Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).\n* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:\n\n  1. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.\n  2. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  4. Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.\n  6. Radiation therapy (RT) (before start of protocol treatment):\n\n     * ≥ 14 days have elapsed for local palliative RT (small port);\n     * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis;\n     * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem Cell Infusions (before start of protocol treatment):\n\n     * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]);\n     * No evidence of active graft versus host disease (GVHD).\n  8. Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.\n  9. Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.) before start of protocol treatment.\n  10. Participants with prior exposure to venetoclax are eligible in this trial.\n* Adequate organ function:\n\n  1. Adequate Renal Function defined as:\n\n     * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml\u002Fmin\u002F1.73 m\\^2, or\n     * Normal serum creatinine based on age\u002Fsex\n  2. Adequate Liver Function defined as:\n\n     * Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n     * Alkaline phosphatase ≤ 2.5 x ULN, and\n     * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.\n  3. Cardiac performance: Minimum cardiac function defined as:\n\n     * No history of congestive heart failure in need of medical treatment\n     * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \\[SF\\] \\\u003C 25% or ejection fraction \\[EF\\] \\\u003C 40%)\n     * No signs of congestive heart failure at presentation of relapse.\n* Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation.\n\nExclusion Criteria\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.\n* Participants with Down syndrome.\n* Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).\n* Participants with isolated CNS3 disease or symptomatic CNS3 disease.\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.\n* Participants who are currently receiving an investigational drug other than those specified for this study.\n* Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection.\n* Concomitant Medications\n\n  * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment.\n  * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment.\n  * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC).\n* Pregnancy or Breast-Feeding:\n\n  * Participants who are pregnant or breast-feeding.\n  * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer.\n  * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer.\n\nAdditional criteria to receive a gemtuzumab ozogamicin infusion:\n\nGemtuzumab ozogamicin should not be given:\n\n* to participants with history of veno-occlusive disease (VOD)\u002FSinusoidal obstruction syndrome (SOS) grade 3 or 4\n* to participants with CD33 negative leukemic blasts (determined at local lab)\n\nNote that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.","29 Days","21 Years",{"count":572,"type":23},130,[26],"A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine\u002Fcytarabine\u002Fgemtuzumab ozogamicin \\[GO\\]) improves survival of children\u002Fadolescents\u002Fyoung adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.",[576],"Acute Myeloid Leukemia",[578,579,580,581,582,583],"Venetoclax","Gemtuzumab Ozogamicin","Fludarabine","Cytarabine","Relapsed refractory","Azacitidine",{"date":31,"type":34},{"date":586,"type":34},"2022-10-01",{"date":588,"type":23},"2031-04",{"name":590,"class":154},"PedAL BCU, LLC",90,{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":24,"phases":601,"briefSummary":602,"conditions":603,"keywords":606,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":611,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":618},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":600,"type":23},3500,[26],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[604,605],"Solid Tumors","Hematologic Malignancies",[607,608,609,610],"PD1","PD-1","PDL1","PD-L1",{"date":33,"type":34},{"date":613,"type":34},"2018-08-21",{"date":615,"type":23},"2043-08-04",{"name":617,"class":41},"Merck Sharp & Dohme LLC",782,{"id":620,"slug":621,"hasResults":12,"nctId":622,"briefTitle":623,"officialTitle":624,"acronym":4,"eligibilityCriteria":625,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":626,"targetDuration":4,"studyType":134,"phases":4,"briefSummary":628,"conditions":629,"keywords":631,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":642,"locationsCount":644},"100653357","a-non-interventional-study-of-participants-with-bpdcn-treated-with-chemotherapy-100653357","NCT07785180","A Non-interventional Study of Participants With BPDCN Treated With Chemotherapy","Retrospective Study of Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Treated With Chemotherapy Agents","Inclusion Criteria:\n\n* Alive, deceased, or unreachable participants (as permitted by local regulation), aged ≥18 years at the start of first-line treatment for BPDCN, and treated with chemotherapy regimens (at a minimum) as first-line treatment for BPDCN from May 2016\n* Diagnosed with BPDCN, based on clinical, laboratory, and imaging (where performed per institutional practice) assessments, with a demonstration of a specific immunophenotype (either by immunohistochemistry or flow cytometry), particularly CD4, CD56, and CD123\n* Participants (or their legally authorized representatives) who have signed the informed consent and privacy form, where required as per local regulation\n\nExclusion Criteria:\n\n* Participant has received an investigational agent as first-line therapy for BPDCN\n* Participant has received first-line therapy for BPDCN in an interventional clinical trial",{"count":627,"type":23},140,"The main goal of this study is to investigate the effectiveness and safety of chemotherapy agents in the treatment of participants with BPDCN and to provide comparator arm data to the prospective ELZONRIS registry study (STML-401-0521).",[630],"Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[632,633,634,635,636],"BPDCN","Retrospective","STML-401-0521","ELZONRIS","Chemotherapy","2026-08-20",{"date":33,"type":34},{"date":640,"type":34},"2025-10-17",{"date":266,"type":23},{"name":643,"class":41},"Stemline Therapeutics, Inc.",67,{"id":646,"slug":647,"hasResults":12,"nctId":648,"briefTitle":649,"officialTitle":650,"acronym":651,"eligibilityCriteria":652,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":653,"targetDuration":4,"studyType":24,"phases":655,"briefSummary":656,"conditions":657,"keywords":660,"overallStatus":292,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":673,"locationsCount":675},"100652841","nrp--ex-situ-hmpo2-vs-nrp-alone-in-dcd-kidney-transplantation-100652841","NCT07779187","NRP + ex Situ HMPO2 vs NRP Alone in DCD Kidney Transplantation","Oxygenated Perfusion for Enhanced Renal Function in Donation After Circulatory Death (DCD) Kidney Transplants (OxyPERF) - A National Swedish Randomized Controlled Trial","OxyPerf","Inclusion Criteria:\n\nDonor kidneys:\n\n1. All DCD donors in Sweden with consent for organ donation and where organ recovery is undertaken with NRP.\n2. Kidney deemed transplantable by donor surgeon and responsible transplant surgeon (not discarded before or during procurement)\n\nRecipients:\n\n1. All adult patients (\\>18 yrs old) eligible for renal transplantation during study duration.\n2. Recipient consented for surgery, matched to a DCD kidney.\n\nExclusion Criteria:\n\nDonor kidneys:\n\n1\\. Kidney allocated outside of Sweden according to Scandiatransplant allocation rules.\n\nRecipients:\n\n1. Paediatric patients (\\\u003C18 yrs old).\n2. Participation in other clinical drug or medical devices trials.\n3. Patient subject to combined transplant of kidney + other organ.",{"count":654,"type":23},214,[168],"The goal of this clinical trial is to learn if the combination of Normothermic Regional Perfusion (NRP) at the time of organ procurement with ex situ Hypothermic Oxygenated Perfusion (HMPO2) of kidneys recovered from donors after circulatory death (DCD) is superior to NRP alone. The researchers will learn if the combined use of these technologies provides a benefit in terms of kidney transplant outcomes. The researchers will also learn about the patient quality of life after these transplants and if the use of these technologies is cost efficient. The main questions it aims to answer are:\n\n* Does NRP +HMPO2 provides a better DCD kidney function at 1 year post-transplant compared to NRP alone.\n* Are the postoperative complications and outcomes different between the two groups?\n* Is the quality of life of recipients different between the two groups?\n* Is the use of NRP +HMPO2 a cost effective strategy? Researchers will compare NRP and HMPO2 with NRP alone to see if the combined use of the technologies provides better transplant outcomes.\n\nParticipants will:\n\n* Receive a kidney treated with one of the two strategies.\n* Visit the clinic as per usual clinical practice for checkups and tests\n* Report on their quality of life pre and post transplant\n* Undergo a kidney biopsy at one year to forecast long term transplant function",[658,659],"Kidney Transplant","DCD Kidney",[661,662,663,664,665,666,667],"DCD kidneys","Normothermic Regional Perfusion (NRP)","Hypothermic oxygenated perfusion","Patient reported outcomes","Kidney transplants","Randomised Control Trial","Health economic analysis",{"date":261,"type":34},{"date":670,"type":23},"2027-01-01",{"date":672,"type":23},"2030-12-31",{"name":674,"class":154},"Karolinska University Hospital",3,{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":24,"phases":686,"briefSummary":687,"conditions":688,"keywords":691,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":694,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":699,"locationsCount":701},"100639449","phase-3-a-study-to-compare-elritercept-to-placebo-in-adults-with-myelofibrosis-and-anemia-who-are-taking-ruxolitinib-100639449","NCT07623161","A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib","A Phase 3, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK-226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy","ELRISE MF","Inclusion Criteria:\n\n1. Aged ≥18 years at the time of signing the informed consent form (ICF).\n2. Able to understand the purpose and risks of the trial and voluntarily sign an ICF.\n3. Diagnosed with primary myelofibrosis (PMF), post-essential thrombocythemia (post-ET MF) or post-polycythemia vera (post-PV MF) according to the 2022 WHO criteria (WHO Classification of Tumours Editorial Board 2024), confirmed by local pathology report.\n4. Transfusion status as assessed in the 12 weeks immediately preceding randomization classified as Transfusion Dependent: 3 to 8 RBC units over 12 weeks.\n5. Receiving ruxolitinib (as approved in the country of the trial site) as the standard of care treatment for MF for at least 12 consecutive weeks, and on a stable daily dose for at least the 8 weeks immediately preceding the date of randomization.\n6. Eastern Cooperative Oncology Group score less than or equal to (≤) 2.\n\nExclusion Criteria:\n\n1. Prior treatment with luspatercept, sotatercept, or other transforming growth factor beta inhibitors or activin receptor ligand traps.\n2. Systemic treatment within 28 days before randomization with any of the following:\n\n   1. Androgens (including danazol). Participants on stable androgen dosing for hypogonadism for ≥8 weeks are allowed.\n   2. erythropoiesis-stimulating agents.\n   3. granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor.\n   4. High dose corticosteroids. Participants on stable chronic steroid doses of prednisone ≤10 mg\u002Fday or corticosteroid equivalent for ≥4 weeks are allowed. Other treatments for autoimmune diseases may be allowed upon medical monitor review.\n   5. Hydroxyurea.\n   6. Immunomodulatory drugs (for example, thalidomide, pomalidomide, or lenalidomide).\n   7. Interferon.\n   8. Thrombopoietin receptor agonists.\n   9. Any investigational drug, including antihemojuvelin antibody. If the half-life of the investigational product is known, the exclusionary period prior to randomization is equal to 5 half-lives of the investigational product or 28 days, whichever is longer.\n3. Initiation of new iron chelation therapy or dose adjustments to existing iron chelation therapy ≤8 weeks prior to randomization. Participants on stable doses of iron chelation therapy for ≥8 weeks are allowed.\n4. Clinically significant anemia that is due to causes other than MF or Janus kinase (JAK) inhibitor therapy (for example, thalassemia, iron deficiency, vitamin B12 and\u002For folate deficiencies, autoimmune or hemolytic anemia, infections, or any active clinically significant bleeding or sequestration).\n5. Receipt of RBC transfusion for any reason(s) other than underlying MF within 12 weeks before randomization.\n6. Life expectancy \\\u003C12 months per investigator's judgment.\n7. Clinically significant cardiovascular disease, defined as:\n\n   1. New York Heart Association heart disease Class III or IV;\n   2. Fridericia corrected QT interval \\>500 millisecond (ms) during screening;\n   3. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before screening.\n8. Uncontrolled hypertension, defined as repeated elevations of systolic blood pressure of ≥160 millimetres of mercury (mmHg) and\u002For diastolic blood pressure ≥100 mmHg despite adequate treatment.\n9. Medical history of thromboembolic events within 6 months before screening, including history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis. Participants with prior superficial thrombophlebitis are allowed.\n10. Prior history of malignancies, other than MF. Participants who are free of other malignant disease for ≥2 years and have completed treatment, including maintenance, are allowed. Participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n    1. Basal or squamous cell carcinoma of the skin;\n    2. Carcinoma in situ of the cervix;\n    3. Carcinoma in situ of the breast; and\u002For\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the Tumour, Node, and Metastasis (TNM) staging system);\n    5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n11. History of solid organ or bone marrow transplantation.\n12. Active infection requiring intravenous antibiotics within 28 days or oral antibiotics within 7 days before randomization. Prophylactic antibiotics and\u002For antifungals for neutropenia are allowed.\n13. Known positivity for Human Immunodeficiency Virus (HIV), active hepatitis B virus (HBV), or active hepatitis C virus (HCV). Participants without known history of HIV, HBV, and\u002For HCV do not require further testing, unless testing is mandated per local guidelines.\n14. Body mass index ≥40 kilograms per square meter (kg\u002Fm\\^2).\n15. Major surgery within 28 days before randomization.\n16. History of allergy\u002Fanaphylaxis to recombinant proteins, investigational product, or excipients (refer to the current elritercept investigator's brochure for a list of excipients), or ruxolitinib.\n17. Any of the following local laboratory abnormalities:\n\n    1. Absolute neutrophil count \\\u003C500\u002Fmicroliter (μL) (0.5×109\u002F liter (L)).\n    2. Platelet count \\\u003C50,000\u002FμL (50×109\u002FL) or \\>1,000,000\u002FμL (1000×109\u002FL).\n    3. Blasts \\>5% as assessed in peripheral blood at screening or ≥10% in any historical bone marrow assessments. Participants with isolated transient elevations of peripheral blood blasts may be eligible after discussion between the investigator and medical monitor to confirm the blast count is not indicative of disease progression.\n    4. Serum aspartate aminotransferase or alanine aminotransferase ≥3× the upper limit of normal (ULN).\n    5. Total bilirubin ≥2×ULN. Participants with known history of Gilbert syndrome with unconjugated bilirubin less than (\\\u003C) 3×ULN are allowed. Higher levels if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis) may be allowed upon medical monitor review.\n    6. Estimated glomerular filtration rate \\\u003C30 milliliters per minute per 1.73 square meters (mL\u002Fmin\u002F1.73 m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration equation.\n    7. Ferritin ≤50 micrograms per liter (μg\u002FL).\n    8. Folate ≤2.0 nanograms per milliliter (ng\u002FmL).\n    9. Vitamin B12 ≤200 picograms per milliliter (pg\u002FmL).\n18. Ongoing participation in another interventional clinical trial.\n19. Participant is unwilling or, in the opinion of the investigator, the participant is unable to comply with the requirements of the protocol.\n20. Is a person of childbearing potential but does not agree to use at least 1 form of highly effective contraception from the time of signing the ICF until at least 60 days after the last dose of elritercept or placebo.\n21. Participants of male birth who are fertile and who have partners of childbearing potential, who do not agree to use acceptable barrier contraception, that is, a male condom, during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n22. If applicable, participant with a positive serum pregnancy test during the screening period or known to be pregnant or a lactating participant who does not agree to forego breastfeeding during the entire treatment period until at least 60 days after the last dose of elritercept or placebo.\n23. For participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults.",{"count":685,"type":23},324,[26],"The main aim of this study is to find out how well elritercept works to improve anemia in participants with myelofibrosis (MF) who are taking ruxolitinib when compared to placebo.\n\nOther aims are to learn how elritercept improves anemia compared to placebo; to learn if elritercept reduces tiredness, improves symptoms related to MF, and helps participants do physical activities more easily. The study also aims to find out how elritercept affects the bone marrow, the spleen, and whether participants develop antibodies to the study drug.\n\nThe study will also check how safe elritercept is compared to placebo, and if elritercept stays safe over a long period of time. Participants will receive study treatment for at least 9 months (36 weeks). After this period, participants who received placebo will have the option to switch to elritercept.",[689,690],"Myelofibrosis","Anemia",[692,693],"TAK-226","Drug therapy",{"date":31,"type":34},{"date":696,"type":23},"2026-09-02",{"date":698,"type":23},"2034-03-30",{"name":700,"class":41},"Takeda",195,{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":707,"acronym":4,"eligibilityCriteria":708,"healthyVolunteers":12,"sex":18,"minAge":709,"maxAge":4,"enrollmentInfo":710,"targetDuration":4,"studyType":24,"phases":712,"briefSummary":713,"conditions":714,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":716,"startDateStruct":717,"completionDateStruct":719,"leadSponsor":721,"locationsCount":722},"100636783","phase-2-a-clinical-trial-of-mk-1045-in-people-with-b-cell-acute-lymphoblastic-leukemia-mk-1045-005-100636783","NCT07570173","A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)","A Phase 2\u002F3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n* Has a confirmed diagnosis of relapsed\u002Frefractory (R\u002FR) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow\n* Has CD19+ disease, confirmed by local flow cytometry and\u002For immunohistochemistry testing at the time of enrollment\n* Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment\n* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Has Burkitt's leukemia\n* History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic\u002Fischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis\n* Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded\n* History of serious cardiovascular and cerebrovascular diseases.\n* HIV-infection with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Isolated extramedullary disease (EMD)\n* Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement\n* Active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications","12 Years",{"count":711,"type":23},340,[78,26],"Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R\u002FR B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.",[715],"B-cell Acute Lymphoblastic Leukemia",{"date":31,"type":34},{"date":718,"type":34},"2026-05-18",{"date":720,"type":23},"2033-10-18",{"name":617,"class":41},19,""]