[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Belgium\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":640},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1991,0,25,[9,48,85,106,129,150,173,197,218,245,264,286,318,339,364,389,414,440,472,500,521,541,564,596,617],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053420","to-assess-the-correlation-of-high-resolution-specimen-pet-ct-imaging-using-the-xeos-aura-10-pet-ct-with-the-histopathology-results-and-long-term-outcome-of-patients-undergoing-resective-cancer-surgery-100053420",false,"NCT06970275","To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.","PETRiS","Inclusion Criteria :\n\nAll patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.\n\nPatients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.\n\nExclusion Criteria:\n\n* Under the age of 18 years at the time of resective surgery.\n* Women who are pregnant or breastfeeding.","ALL","18 Years",{"count":21,"type":22},850,"ESTIMATED","OBSERVATIONAL","This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.",[26,27,28,29],"Prostate Cancers","Breast Cancer","Head and Neck Cancer","Cancer",[31,32,33,34],"PET-CT","Registry","Imaging","cancer","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-11-19",{"date":43,"type":22},"2031-01-15",{"name":45,"class":46},"XEOS Medical","INDUSTRY",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100053387","phase-3-a-study-evaluating-the-efficacy-and-safety-of-pegozafermin-in-participants-with-mash-and-fibrosis-enlighten-fibrosis-100053387","NCT06318169","A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 80 years (inclusive) at time of signing the informed consent form (ICF)\n* Biopsy-confirmed MASH with fibrosis stage F2 or F3\n* Body mass index (BMI) at screening ≥25.0 kilograms (kg)\u002Fmeters squared (m\\^2) (≥23 kg\u002Fm\\^2 for Asian participants).\n\nKey Exclusion Criteria:\n\n* Chronic liver diseases other than MASH\n* Evidence of cirrhosis on screening liver biopsy\n* Have type 1 diabetes or poorly controlled type 2 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL)\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) or pioglitazone must be on stable dose for at least 6 months prior to Screening\n\nOther inclusion and exclusion criteria may apply.","80 Years",{"count":57,"type":22},1350,"INTERVENTIONAL",[60],"PHASE3","The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.",[63],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Fibrosis",[65,66,67,68,69,70,71,72,73,74,75,76],"Liver Diseases","Fatty Liver","Digestive System Diseases","Metabolic diseases","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Steatohepatitis","Metabolic dysfunction-associated steatotic liver disease","MASLD","Nonalcoholic fatty liver disease","NAFLD","Fibrosis",{"date":38,"type":39},{"date":79,"type":39},"2024-03-13",{"date":81,"type":22},"2029-02",{"name":83,"class":46},"89bio, Inc.",361,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100054277","deep-brain-stimulation-dbs-retrospective-outcomes-study-100054277","NCT03664609","Deep Brain Stimulation (DBS) Retrospective Outcomes Study","Inclusion Criteria:\n\n* Must be previously treated with or eligible for implantation with a deep brain stimulation system\n\nExclusion Criteria:\n\n* No Exclusion Criteria",{"count":92,"type":22},5000,"The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.",[95,96,97],"Parkinson Disease","Essential Tremor","Dystonia",{"date":38,"type":39},{"date":100,"type":39},"2019-03-12",{"date":102,"type":22},"2028-12",{"name":104,"class":46},"Boston Scientific Corporation",19,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":58,"phases":116,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100054056","phase-2-podomount-basket-a-study-to-test-whether-bi-764198-helps-adults-and-adolescents-with-different-types-of-kidney-disease-100054056","NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","12 Years",{"count":115,"type":22},132,[117],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[120],"Proteinuric Kidney Diseases",{"date":38,"type":39},{"date":123,"type":39},"2026-03-23",{"date":125,"type":22},"2028-02-17",{"name":127,"class":46},"Boehringer Ingelheim",161,{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":58,"phases":138,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100054317","phase-3-dareon-nec-1-a-study-in-people-with-advanced-extrapulmonary-neuroendocrine-cancer-epnec-to-compare-obrixtamig-plus-carboplatin-and-etoposide-treatment-with-standard-chemotherapy-100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.",{"count":137,"type":22},390,[60],"This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[141],"Extrapulmonary Neuroendocrine Cancer (epNEC)","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":145,"type":22},"2026-07-07",{"date":147,"type":22},"2031-03-11",{"name":127,"class":46},165,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":58,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100054199","a-study-of-varipulse-catheter-and-trupulse-generator-with-varipulse-pro-software-in-participants-with-paf-or-psaf-100054199","NCT07429214","A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF","Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software","VP-CONFIRM","Inclusion criteria:\n\n* Diagnosed with symptomatic persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)\n* Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation\n* Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD\n* Age 18-75 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Continuous AF greater than (\\>) 12 months (1-Year) (Longstanding Persistent AF)\n* Previous surgical or catheter ablation for atrial fibrillation\n* Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention \\[PCI\\])\n* Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure\n* Any carotid stenting or endarterectomy\n* Presence of left atrium (LA) thrombus\n* Severe dilatation of the LA (left atrial diameter \\[LAD\\] \\>50 millimeters \\[mm\\] antero-posterior diameter in case of transthoracic echocardiography \\[TTE\\])\n* Severely compromised left ventricular ejection fraction (LVEF less than \\[\\\u003C\\] 40 percent \\[%\\])\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)\n* Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 6 months \\[180 days prior to consent date\\])\n* Rheumatic Heart Disease\n* Uncontrolled heart failure or New York heart association (NYHA) function class III or IV\n* Severe mitral regurgitation\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Unstable angina pectoris within the past 6 months prior to consent date\n* Acute illness or active systemic infection or sepsis\n* Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity \\[Body Mass Index \\>40 kilogram per meter square {kg\u002Fm\\^2}\\], renal insufficiency (with an estimated creatinine clearance \\\u003C 30 milliliters per minute {mL\u002Fmin}\u002F1.73 m\\^2)\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation\n* Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter\n* Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease \\[COPD\\]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms\n* Significant congenital anomaly or medical problems that in the opinion of the investigator would preclude enrollment in this study\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Current enrollment in an investigational study evaluating another device, biologic, or drug\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being\n* Life expectancy less than 12 months\n* Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter\u002Fdefibrillators (ICDs),etc. (at principal investigator \\[PI\\] discretion)\n* Presence of iron-containing metal fragments in the body\n* Unresolved pre-existing neurological deficit","75 Years",{"count":160,"type":22},50,[162],"NA","The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).",[165],"Atrial Fibrillation",{"date":38,"type":39},{"date":123,"type":39},{"date":169,"type":22},"2026-12-30",{"name":171,"class":46},"Biosense Webster, Inc.",10,{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":58,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100053315","phase-3-long-term-follow-up-of-participants-treated-with-galapagos-chimeric-antigen-receptor-car-t-cell-therapies-100053315","NCT06652633","Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies","A Long-term Follow-up Study for Patients Treated With Galapagos CAR T-cell Therapies","Hesperia","Inclusion Criteria:\n\n* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.\n\nExclusion Criteria:\n\n* There are no exclusion criteria for this study",{"count":182,"type":22},546,[60],"This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.\n\nPer Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events (AEs) and the long-term benefit\u002Frisk profile and to monitor for replication-competent lentivirus (RCL) and CAR-T cell persistence.",[186],"Hematological Malignancies",[188],"CAR T-cell therapy",{"date":38,"type":39},{"date":191,"type":39},"2024-09-09",{"date":193,"type":22},"2039-07",{"name":195,"class":46},"Lakefront Biotherapeutics NV",11,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":58,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":217},"100053501","phase-2-a-clinical-study-of-zilovertamab-vedotin-mk-2140-plus-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-polatuzumab-vedotin-plus-r-chp-in-people-with-diffuse-large-b-cell-lymphoma-dlbcl-mk-2140-011waveline-011-100053501","NCT06890884","A Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011\u002FwaveLINE-011)","A Randomized, Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) Plus R-CHP Versus Polatuzumab Vedotin Plus R-CHP in Treatment-naïve Participants With GCB Subtype of Diffuse Large B-cell Lymphoma (DLBCL)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed diagnosis of germinal center B-cell (GCB) subtype of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues.\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.\n* Has received no prior treatment for their DLBCL.\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of transformation of indolent disease to DLBCL.\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma.\n* Has Ann Arbor Stage I DLBCL.\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.\n* Has clinically significant pericardial or pleural effusion.\n* Has ongoing Grade \\>1 peripheral neuropathy.\n* Has a demyelinating form of Charcot-Marie-Tooth disease.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has ongoing corticosteroid therapy.\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years.\n* Known active central nervous system (CNS) lymphoma.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has active infection requiring systemic therapy.\n* Has active HBV (defined as HBsAg positive and detectable HBV deoxyribonucleic acid (DNA)) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.\n* Has history of stem cell\u002Fsolid organ transplant.",{"count":205,"type":22},594,[117],"Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing.\n\nThe goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.",[209],"Lymphoma, Large B-Cell, Diffuse",{"date":38,"type":39},{"date":212,"type":39},"2025-04-11",{"date":214,"type":22},"2032-12-16",{"name":216,"class":46},"Merck Sharp & Dohme LLC",136,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":58,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":237,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100054198","phase-3-a-study-to-access-intravenous-iv-telisotuzumab-adizutecan-in-combination-with-iv-bevacizumab-compared-to-standard-of-care-iv-bevacizumabin-combination-with-oral-trifluridine-and-tipiracil-in-adult-participants-with-refractory-metastatic-colorectal-cancer-100054198","NCT07525206","A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer","An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)\u002F Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.\n* Life expectancy \\>= 12 weeks per investigator assessment\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.\n* History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine\u002Ftipiracil.\n* History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.",{"count":227,"type":22},700,[60],"Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.\n\nIn this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine\u002Ftipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[231],"Colorectal Cancer",[231,233,234,235,236],"Telisotuzumab Adizutecan","Bevacizumab","Trifluridine and Tipiracil","AndroMETa-CRC-560",{"date":38,"type":39},{"date":239,"type":39},"2026-05-22",{"date":241,"type":22},"2030-03",{"name":243,"class":46},"AbbVie",16,{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":257,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},"100054181","patient-retrospective-outcomes-pro-100054181","NCT01550575","Patient Retrospective Outcomes (PRO)","PRO","Key Inclusion Criteria:\n\n* Previously treated with or eligible for use with Boston Scientific Systems\n* 18 years of age or older at the start of Baseline",{"count":253,"type":22},15000,"This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.",[256],"Chronic Pain",{"date":38,"type":39},{"date":259,"type":39},"2012-04-03",{"date":261,"type":22},"2030-12",{"name":104,"class":46},144,{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":58,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":278,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100053627","phase-3-a-study-to-test-the-efficacy-and-safety-of-riliprubart-against-the-usual-treatment-of-intravenous-immunoglobulin-ivig-in-people-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100053627","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":273,"type":22},160,[60],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[277],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":38,"type":39},{"date":280,"type":39},"2024-08-21",{"date":282,"type":22},"2029-01-12",{"name":284,"class":46},"Sanofi",129,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":58,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":310,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":317},"100053442","phase-3-a-study-to-evaluate-mezigdomide-bortezomib-and-dexamethasone-mezivd-versus-pomalidomide-bortezomib-and-dexamethasone-pvd-in-participants-with-relapsed-or-refractory-multiple-myeloma-rrmm-100053442","NCT05519085","A Study to Evaluate Mezigdomide, Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)","A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib and Dexamethasone (MEZIVd) Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM): SUCCESSOR-1","SUCCESSOR-1","Inclusion Criteria\n\n\\- Participant has documented diagnosis of MM and measurable disease, defined as any of the following:.\n\ni) M-protein ≥ 0.5 grams per deciliter (g\u002FdL) by serum protein electrophoresis (sPEP) or.\n\nii) M-protein ≥ 200 milligrams (mg) per 24-hour urine collection by urine protein electrophoresis (uPEP).\n\niii) For participants without measurable disease in sPEP or uPEP: serum free light chain (sFLC) levels \\> 100 mg\u002FL (10 mg\u002FdL) involved light chain and an abnormal kappa\u002Flambda FLC ratio.\n\n* Participants received 1 to 3 prior lines of antimyeloma therapy.\n* Participants achieved minimal response \\[MR\\] or better to at least 1 prior antimyeloma therapy.\n\nExclusion Criteria\n\n\\- Participant has had progression during treatment or within 60 days of the last dose of a proteasome inhibitor, except as noted below:.\n\ni) Subjects who progressed while being treated with, or within 60 days of last dose of bortezomib maintenance given once every 2 weeks (or less frequently) are not excluded.\n\nii) Participants who progressed while being treated with ixazomib monotherapy maintenance ≥ 6 months prior to the time of starting study treatment are not excluded.\n\n* For participants with prior treatment of a bortezomib containing regimen, the best response achieved was not a minimal response (MR) or better, or participant discontinued bortezomib due to toxicity.\n* Participant has had prior treatment with mezigdomide or pomalidomide.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":295,"type":22},810,[60],"The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.",[299],"Relapsed or Refractory Multiple Myeloma",[301,302,303,304,305,306,307,308,309],"Multiple myeloma","RRMM","MeziVd","PVd","CC92480","pomalidomide","bortezomib","dexamethasone","mezigdomide",{"date":38,"type":39},{"date":312,"type":39},"2022-09-20",{"date":314,"type":22},"2033-11-30",{"name":316,"class":46},"Celgene",266,{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":326,"targetDuration":4,"studyType":58,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":338},"100053951","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-dnth103-in-adults-with-chronic-inflammatory-demyelinating-polyneuropathy-captivate-100053951","NCT06858579","A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)","CAPTIVATE","Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out.\n2. Weight range between 40 kilograms (kg) and 120 kg.\n3. Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.\n4. CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.\n5. Must be neurologically stable.\n6. Must have an INCAT score between 2 and 9 inclusive.\n7. Must fulfill one of the following treatment conditions for CIDP:\n\n   1. Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \\[IVIg\\] or subcutaneous immunoglobulin \\[SCIg\\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.\n   2. Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.\n   3. Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and\u002For oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.\n   4. Treatment naïve with no history of prior treatment for CIDP.\n8. Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.\n9. Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.\n10. Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.\n\nExclusion Criteria:\n\n1. Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.\n2. Known evidence of central demyelination or known history of myelopathy.\n3. History or presence of significant medical\u002Fsurgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety\u002Fefficacy or study procedures.\n4. Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.\n5. Known complement deficiency or history of positive titer for anti-C1 antibodies.\n6. Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).\n7. Participants with an autoimmune disease affecting joints, muscle or nervous system.\n8. Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.\n9. Prior history of N. meningitidis infection.\n10. History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.\n11. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.",{"count":327,"type":22},256,[60],"The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).",[277],{"date":38,"type":39},{"date":333,"type":39},"2025-02-10",{"date":335,"type":22},"2030-12-31",{"name":337,"class":46},"Dianthus Therapeutics",180,{"id":340,"slug":341,"hasResults":12,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":347,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":58,"phases":350,"briefSummary":351,"conditions":352,"keywords":354,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":363},"100053966","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-multiple-treatment-combinations-with-intravenous-mirvetuximab-soravtansine-in-adult-participants-with-ovarian-cancer-100053966","NCT07059845","A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","FLORENZA","Inclusion Criteria:\n\nSubstudy 1\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\n  2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.\n\nSubstudy 2\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nSubstudy 3\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nExclusion Criteria:\n\nSubstudy 1\n\n* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.\n* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.\n* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).\n\nSubstudy 2\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.\n\nSubstudy 3\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.","FEMALE",{"count":349,"type":22},400,[117],"Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.\n\nMirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.\n\nParticipants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[353],"Ovarian Cancer",[353,355,234,356],"Mirvetuximab Soravtansine","Carboplatin",{"date":38,"type":39},{"date":359,"type":39},"2025-11-13",{"date":361,"type":22},"2029-01",{"name":243,"class":46},77,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":158,"enrollmentInfo":371,"targetDuration":4,"studyType":58,"phases":373,"briefSummary":374,"conditions":375,"keywords":377,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},"100053409","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-pegozafermin-in-participants-with-compensated-cirrhosis-due-to-mash-100053409","NCT06419374","A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH","A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ENLIGHTEN-Cirrhosis)","Key Inclusion Criteria:\n\n* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).\n* Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors.\n* Biopsy-confirmed fibrosis stage F4 MASH (NASH Clinical Research Network (CRN) system) with compensated cirrhosis.\n* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \\\u003C50.0 kilograms (kg)\u002Fmeters squared (m\\^2).\n\nKey Exclusion Criteria:\n\n* Liver disorder other than MASH.\n* History or evidence of hepatic decompensation.\n* History or evidence of hepatocellular carcinoma.\n* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.\n* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U\u002FL).\n* Participants taking vitamin E (\\>400 international units \\[IU\\]\u002Fday) must be on stable dose for at least 6 months prior to screening.\n\nOther protocol-defined inclusion and exclusion criteria may apply.",{"count":372,"type":22},762,[60],"The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \\[previously known as nonalcoholic steatohepatitis, NASH\\]).",[376],"Metabolic Dysfunction-Associated Steatohepatitis (MASH) \u002F Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis",[378,66,67,68,69,70,379,380,72,73,74,75,76,381],"Liver disease","Nonalcoholic steatohepatitis","NASH","Cirrhosis",{"date":38,"type":39},{"date":384,"type":39},"2024-05-24",{"date":386,"type":22},"2031-08",{"name":83,"class":46},317,{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":58,"phases":398,"briefSummary":399,"conditions":400,"keywords":404,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":244},"100053980","comprehensive-left-atrial-appendage-occlusion-with-rhythm-restoration-100053980","NCT07523620","Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration","CLEAR","Inclusion Criteria:\n\n* Subject must provide written informed consent prior to any clinical investigation-related procedure.\n* 18 years of age or older, or the age of legal consent\n* CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men\n* Able to stop anticoagulation by 90 days post index procedure\n* Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT\n* Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF\n* Documented symptomatic PAF or PersAF. Documentation requirements are as follows:\n\nParoxysmal:\n\n* Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND\n* One electrocardiographically documented PAF episode within 12 months prior to enrollment.\n\nPersistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by\n\n* Physician's note, AND either\n* 24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR\n* Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:\n\n  * That are taken at least 7 days apart but less than 12 months apart\n  * If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent\u002Fenrollment\n  * The most recent electrocardiogram must be within 180 days of enrollment.\n\nNOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.\n\nExclusion Criteria:\n\n* Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure\n* Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)\n* Patients with heart prosthetic valves\n* Patient implanted with an inferior vena cava filter\n* Patients with left ventricular ejection fraction ≤30%\n* Patients with NYHA Class IV heart failure\n* Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)\n* Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure\n* Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)\n* Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)\n* Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure\n* Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation\n* Patients with a stent, constriction, or stenosis in a pulmonary vein\n* Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL\u002Fbeat, regurgitant fraction ≥ 50%, and\u002For effective regurgitant orifice area ≥ 0.40cm2)\n* Patients with severe renal failure (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2) or on chronic dialysis\n* Patients with severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)",{"count":397,"type":22},240,[162],"The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.",[401,402,403],"Atrial Fibrillation (AF)","Paroxysmal AF","Persistent Atrial Fibrillation",[405,165,406,403],"Left Atrial Appendage","Paroxysmal Atrial Fibrillation",{"date":38,"type":39},{"date":409,"type":39},"2026-03-31",{"date":411,"type":22},"2028-02-28",{"name":413,"class":46},"Abbott Medical Devices",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":12,"sex":18,"minAge":113,"maxAge":422,"enrollmentInfo":423,"targetDuration":4,"studyType":58,"phases":425,"briefSummary":426,"conditions":427,"keywords":429,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100054201","phase-3-a-study-to-evaluate-the-safety-and-effectiveness-of-upadacitinib-tablets-in-adult-and-adolescent-participants-with-severe-alopecia-areata-100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","63 Years",{"count":424,"type":22},1500,[60],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[428],"Alopecia Areata",[428,430,431,432],"Upadacitinib","Rinvoq","ABT-494",{"date":38,"type":39},{"date":435,"type":39},"2023-10-11",{"date":437,"type":22},"2030-04",{"name":243,"class":46},281,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":58,"phases":450,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100053250","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100053250","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":449,"type":22},450,[60],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[453,454],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[456,457,458,459,460,461,462,463],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":38,"type":39},{"date":466,"type":39},"2025-07-17",{"date":468,"type":22},"2029-12",{"name":470,"class":46},"Nuvalent Inc.",156,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":480,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":499},"100054300","spontaneous-eye-blinking-in-disorders-of-consciousness-100054300","NCT06323031","Spontaneous Eye Blinking in Disorders of Consciousness","Spontaneous Eye Blinking as a Diagnostic and Prognostic Marker in Patients With Disorders of Consciousness After Severe Acquired Brain Injury","Blink-DoC","Inclusion Criteria:\n\n* clinical diagnosis of DoC (UWS, MCS minus, MCS plus) following repeated clinical evaluation (at least four CRS-R in a week)\n* age ≥ 18 years\n* time post-onset ≤6 months\n* Previous sABI of any etiology (traumatic, vascular, anoxic, mixed, etc.)\n* Negative anamnesis for neurological or psychiatric disorders.\n\nExclusion Criteria:\n\n* unstable clinical conditions (e.g. respiratory failure, fever, status epilepticus, etc.);\n* ophthalmic diseases, or clinically detected peripheral damage in eyelid motility (e.g. orbital fracture);\n* intake of sedative drugs in the preceding 24 hours;\n* additional brain event following admission (e.g., stroke).",true,{"count":482,"type":22},70,"Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and\u002For sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).\n\nThis is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months.",[485],"Disorders of Consciousness",[485,487,488,489,490],"blinking","diagnosis","prognosis","rehabilitation",{"date":38,"type":39},{"date":493,"type":39},"2025-05-08",{"date":495,"type":22},"2026-12-31",{"name":497,"class":498},"Fondazione Don Carlo Gnocchi ETS","OTHER",8,{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":508,"conditions":509,"keywords":510,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":520},"100053391","met-non-small-cell-cancer-registry-moment-100053391","NCT05376891","Met Non Small Cell Cancer Registry (MOMENT)","Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)","Inclusion Criteria:\n\n* Participants who signed ICF\n* Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)\n* Participants who are starting or are already being treated with systemic therapy\n\nExclusion Criteria:\n\n* Participants who are enrolled in a clinical trial",{"count":227,"type":22},"The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.\n\nThe registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.",[29],[511,512],"Disease Registry","METex14 Skipping Alterations",{"date":38,"type":39},{"date":515,"type":39},"2022-10-04",{"date":517,"type":22},"2028-04-28",{"name":519,"class":46},"EMD Serono Research & Development Institute, Inc.",66,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":58,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":317},"100054283","phase-3-a-study-to-evaluate-zilovertamab-vedotin-mk-2140-combination-with-rituximab-plus-cyclophosphamide-doxorubicin-and-prednisone-r-chp-versus-rituximab-plus-cyclophosphamide-doxorubicin-vincristine-and-prednisone-r-chop-in-participants-with-previously-untreated-dlbcl-mk-2140-010-100054283","NCT06717347","A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident\u002Fstroke (\\\u003C6 months prior to enrollment), myocardial infarction (\\\u003C6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue\u002Fsolid organ transplant",{"count":529,"type":22},1046,[60],"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.",[533],"Diffuse Large B-Cell Lymphoma",[209],{"date":38,"type":39},{"date":537,"type":39},"2025-01-27",{"date":539,"type":22},"2032-03-29",{"name":216,"class":46},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":58,"phases":551,"briefSummary":553,"conditions":554,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":563},"100053298","phase-1-a-study-evaluating-the-safety-activity-and-pharmacokinetics-of-divarasib-as-a-single-agent-or-in-combination-with-other-anti-cancer-therapies-in-participants-with-previously-untreated-advanced-or-metastatic-non-small-cell-lung-cancer-with-a-kras-g12c-mutation-100053298","NCT05789082","A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","A Phase Ib\u002FII, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","KRAScendo 170","Inclusion Criteria:\n\n* Confirmation of Biomarker eligibility\n* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy\n* No prior systemic treatment for advanced unresectable or metastatic NSCLC\n* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.\n\nExclusion Criteria:\n\n* Known concomitant second oncogenic driver with available targeted treatment\n* Squamous cell histology NSCLC\n* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)\n* Prior treatment with a KRAS G12C inhibitor\n* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment\n* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia\n* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids\n* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.\n* Participants with brain metastases for whom complete surgical resections is clinically appropriate",{"count":550,"type":22},320,[552,117],"PHASE1","The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).",[555],"Non-Small Cell Lung Cancer",{"date":38,"type":39},{"date":558,"type":39},"2023-06-20",{"date":560,"type":22},"2032-01-29",{"name":562,"class":46},"Hoffmann-La Roche",71,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":570,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":58,"phases":574,"briefSummary":575,"conditions":576,"keywords":580,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":588,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100054235","phase-3-zilebesiran-in-patients-with-hypertension-not-adequately-controlled-and-with-either-established-cardiovascular-disease-or-high-risk-for-cardiovascular-disease-100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":573,"type":22},11000,[60],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[577,578,579],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[581,582,583,584,585,586,587],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":38,"type":39},{"date":590,"type":39},"2025-09-22",{"date":592,"type":22},"2030-09-30",{"name":594,"class":46},"Alnylam Pharmaceuticals",995,{"id":597,"slug":598,"hasResults":12,"nctId":599,"briefTitle":600,"officialTitle":601,"acronym":4,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":18,"minAge":603,"maxAge":55,"enrollmentInfo":604,"targetDuration":4,"studyType":58,"phases":606,"briefSummary":607,"conditions":608,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":616},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years",{"count":605,"type":22},1200,[60],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[609],"Crohn's Disease",{"date":38,"type":39},{"date":612,"type":39},"2024-06-05",{"date":614,"type":22},"2029-11-12",{"name":216,"class":46},499,{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":18,"minAge":624,"maxAge":625,"enrollmentInfo":626,"targetDuration":4,"studyType":58,"phases":628,"briefSummary":629,"conditions":630,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":639},"100053407","phase-2-efficacy-safety-and-pharmacokinetics-of-vericiguat-in-pediatric-participants-with-heart-failure-due-to-left-ventricular-systolic-dysfunction-mk-1242-036-100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":627,"type":22},342,[117,60],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[631,632],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":38,"type":39},{"date":635,"type":39},"2023-05-31",{"date":637,"type":22},"2032-04-15",{"name":216,"class":46},107,""]