[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Switzerland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":696},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1605,0,25,[9,55,86,115,138,167,201,236,261,283,304,325,349,372,398,420,440,471,494,521,548,590,616,643,667],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637",false,"NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[28],"Non-Small Cell Lung Cancer",[30,31,32,33,34,35,36,37,38,39,40,41],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed","RECRUITING","2026-08-24",{"date":45,"type":46},"2026-08-25","ACTUAL",{"date":48,"type":46},"2025-11-05",{"date":50,"type":21},"2030-11-15",{"name":52,"class":53},"Bristol-Myers Squibb","INDUSTRY",186,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100596975","association-of-microcirculation-vexus-score-and-femoral-vein-doppler-in-patients-on-the-icu-after-non-emergency-cardiac-surgery-100596975","NCT07052461","Association of Microcirculation, Vexus Score and Femoral Vein Doppler in Patients on the ICU After Non-emergency Cardiac Surgery","VeMic","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Elective or urgent (need for definitive procedure during hospitalisation, but not emergency intervention) cardiac surgery\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant women\n* Known severe chronic kidney disease (estimated glomerular filtration rate \\\u003C15 mL\u002Fmin per 1.73 m2 or dialysis)\n* Renal or liver transplantation\n* Any known condition interfering with Doppler evaluation of the portal system (including known or suspected cirrhosis or portal vein thrombosis or huge abdominal emphysema).\n* Inability to consent to study\n* Emergency cardiac surgery",{"count":63,"type":21},40,"OBSERVATIONAL","The aim of the VeMic study is to explore if venous congestion is linked with microcirculatory impairment in elective cardiac surgery patients in the postoperative ICU stay.",[67,68,69,70,71,72],"Microcirculatory Diffusion","Microcirculatory Convection Capacity","Venous Congestion","Postoperative Cardiac Surgery","Fluid Management","Haemodynamic Coherence",[74,75,76],"vexus score","femoral vein doppler","intensive care unit",{"date":45,"type":46},{"date":79,"type":46},"2026-04-14",{"date":81,"type":21},"2027-09-30",{"name":83,"class":84},"University Hospital, Basel, Switzerland","OTHER",1,{"id":87,"slug":88,"hasResults":12,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387","NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","1 Month",{"count":95,"type":21},2000,"The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[98],"Perimembranous Ventricular Septal Defect",[100,101,102,103,104,105,106,107],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects",{"date":45,"type":46},{"date":110,"type":46},"2025-01-01",{"date":112,"type":21},"2027-06-30",{"name":114,"class":84},"Fondation Hôpital Saint-Joseph",{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":20,"type":21},[124],"NA","A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[127,128,129],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":45,"type":46},{"date":132,"type":46},"2023-12-27",{"date":134,"type":21},"2029-08",{"name":136,"class":53},"Orchestra BioMed, Inc",130,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":146,"type":21},626,[24,25],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[150,151],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[153,154,155,151,156,157,158],"KRAS G12C","Non-small cell lung cancer","NSCLC","Adagrasib","Krazati","TPS",{"date":45,"type":46},{"date":161,"type":46},"2020-12-02",{"date":163,"type":21},"2029-10-31",{"name":165,"class":53},"Mirati Therapeutics Inc.",770,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":175,"minAge":18,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":85},"100639956","comparing-decidual-inclusion-vs-exclusion-in-uterine-suture-techniques-during-cesarean-section-to-improve-scar-thickness-and-reduce-isthmocele-risk-in-primiparous-women-100639956","NCT07608874","Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women","The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial","DISSUC","Inclusion Criteria:\n\n* Singleton, term pregnancy\n* Elective cesarean section before labor onset or membrane rupture\n* Maternal age \\>18 years\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Placenta previa\n* Maternal substance abuse or infection\n* Suspected placenta accreta\n* Diabetes\n* one or more prior cesarean section\n* Vulnerable participants (e.g., mental health conditions)\n* Emergency cesarean sections","FEMALE",{"count":177,"type":21},374,[124],"This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery.\n\nWomen having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.",[181,182],"Isthmocele","Cesarean Scar Diverticula",[184,185,186,187,188,189,190,191,192],"isthmocele","Uterine closure techniques","Decidual inclusion","Decidual sparing","Cesarean section","Scar thickness","Niche formation","Sonography","Dyspareunia","2026-08-23",{"date":45,"type":46},{"date":196,"type":46},"2026-06-17",{"date":198,"type":21},"2029-05-30",{"name":200,"class":84},"Kantonsspital Baden",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":209,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":218,"overallStatus":226,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":235},"100653021","phase-3-best-salvage-treatment-for-high-risk-relapsing-prostate-cancer-peace-9---escalate-rt-100653021","NCT07782112","Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT)","PEACE-9 - ESCALATE-RT: A Phase III Randomized Study in Patients With High-risk PSA Relapse After Local Therapy Treated With Enzalutamide Plus Androgen Deprivation Therapy and Comparing MDT ± Pelvic Radiotherapy Versus no Further Treatment","ESCALATE-RT","Inclusion Criteria:\n\n* Histologically proven initial diagnosis of adenocarcinoma of the prostate\n* Rising PSA after local therapy as defined by PSA ≥ 0.2 ng\u002FmL after RP +\u002F- adjuvant\u002Fsalvage prostate bed RT and at least 2 ng\u002FmL above nadir for primary RT, with a PSADT ≤ 9 months\n* Serum Testosterone ≥ 150 ng\u002Fdl (6.9343 nM\u002FL)\n* On PSMA PET\u002FCT restaging presence of: 1 to 5 distant metastases that are amenable to MDT ± N1 patients (no limit in the number of nodes)\n* ECOG performance status 0 - 2\n* Age \\> or =18 years\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial\n* Before patient registration\u002Frandomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* More than 5 distant PSMA positive metastases and\u002For brain or leptomeningeal metastases.\n* Prostate recurrence (positive PSMA disease) after primary prostate irradiation\n* Prostate bed recurrence (positive PSMA disease) after salvage\u002Fadjuvant irradiation\n* Pelvic nodal recurrence (positive PSMA disease) after primary WPRT irradiation\n* Contraindications to pelvic RT and\u002For MDT\n* Prior evidence of distant metastatic disease\n* Contraindications to ADT\n* Contraindication for treatment with enzalutamide\n* Prior hormonal therapy (Neoadjuvant\u002Fadjuvant therapy to treat PCa ≤ 36 months in duration and ≥ 9 months before randomization is allowed)\n* Previous treatment with cytotoxic agent for PCa\n* Any active malignancies (i.e., progressing or requiring any treatment in the previous 36 months) other than prostate cancer (except non-muscle invasive bladder cancer; non-melanomatous skin cancer or a malignancy that is considered cured with minimal risk of recurrence","MALE",{"count":211,"type":21},140,[25],"The goal of this clinical trial is to learn if adding metastasis-directed radiotherapy with or without pelvic salvage radiotherapy, to intermittent prostate cancer drugs (intensified hormone therapy) can delay the need to restart these drugs in men with oligometastactic prostate cancer recurrence.\n\nIn practice, this study is open to men whose PSA level (a blood marker of cancer activity) is rising as defined by biochemical recurrence, and who have 1 to 5 areas of cancer spread (1 to 5 metastases defining oligometastatic status) found on a specialized scan (PSMA PET\u002FCT).\n\nSince intensified hormone therapy, including androgen deprivation therapy combined with a next-generation hormone therapy, represents the standard treatment strategy for these patients, researchers want to find out if adding radiation therapy can help patients to spend more time off cancer drugs while keeping their cancer under control.\n\nThe main questions this trial aims to answer are:\n\n* Does adding radiation therapy to each metastases with or without pelvic area, lengthen the time before participants need to restart drug treatment?\n* Does adding radiation therapy increase the number of participants whose PSA drops to a very low level (0.2 ng\u002FmL or lower)?\n* Does adding radiation therapy affect participants' quality of life?\n\nResearchers will randomly assign participants (chosen by chance) to receive either enzalutamide (next-generation hormone therapy) plus androgen-deprivation therapy (first-generation hormone therapy ) alone, or the same association of these drugs combined with radiation therapy aimed at each metastases with or without pelvic area.\n\nThis comparison will show whether adding radiation therapy helps participants reach a deeper PSA response and go longer without needing cancer drugs.\n\nParticipants will:\n\n* Take enzalutamide and androgen-deprivation therapy for 9 months\n* Have an equal chance of also receiving radiation therapy to each metastases with or without pelvic area\n* Stop drug treatment after 9 months if their PSA drops below 0.2 ng\u002FmL, a level showing the cancer is well controlled\n* Restart drug treatment if their PSA rises again during the treatment-free period\n* Have regular blood tests and clinic visits to check their PSA, testosterone, and overall health\n* Complete short quality-of-life questionnaires during the study\n* Take part in a study conducted at several hospitals in Switzerland, Belgium, and France.",[215,216,217],"Prostatic Neoplasms","Biochemical Recurrence","Oligometastatic Prostate Cancer",[219,220,221,222,223,224,225],"High-risk PSA relapse","Oligometastatic recurrence","Salvage treatment","Metastasis-directed therapy","Pelvic radiotherapy","Androgen Deprivation Therapy","Enzalutamide","NOT_YET_RECRUITING","2026-08-21",{"date":43,"type":46},{"date":230,"type":21},"2026-11",{"date":232,"type":21},"2030-07",{"name":234,"class":84},"Ente Ospedaliero Cantonale, Bellinzona",19,{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":175,"minAge":18,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":246,"conditions":247,"keywords":250,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":85},"100650064","oxytocin-in-postmenopausal-women-100650064","NCT07742124","Oxytocin in Postmenopausal Women","Circulating Oxytocin and Its Clinical Correlates in Postmenopausal Women Compared With Premenopausal Controls - The OxyMENO Study","OxyMENO","Inclusion Criteria:\n\n* Female sex at birth\n* Age ≥18 years\n\nPremenopausal group:\n\n• Premenopausal women aged 18-35 years with regular menstrual cycles (21-35 days) for ≥3 months prior to study entry\n\nPostmenopausal group:\n\n• Postmenopausal women ≥2 years of postmenopause (i.e. 3 years since last menstrual period (LMP), with menopause defined as ≥ 12 months of amenorrhea)\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Use of hormonal contraception or hormone replacement therapy within the last 3 months\n* Known endocrine disorders affecting the hypothalamic-pituitary-gonadal axis\n* Use of medications\n* Severe depression (BDI score \\> 28 points), any other severe psychiatric illness or acute medical disease\n* Inability to comply with study procedures\n* Participation in a trial with investigational drugs within the last 30 days",{"count":245,"type":21},30,"The aim of the present study is to assess whether cumulative endogenous neurophysin I secretion over one month differs between premenopausal and postmenopausal women. Using repeated measurements of neurophysin-I (NP-I, equimolar surrogate marker of oxytocin) across defined physiological time points, this study investigates oxytocin system regulation under cyclic and non-cyclic hormonal conditions.\n\nThe primary hypothesis is that cumulative NP-I release, expressed as the area under the curve (AUC) is lower in the postmenopausal group compared to the premenopausal group.",[248,249],"Postmenopausal","Premenopausal",[251,248,249,252,253,254],"Oxytocin","Neurophysin-I","cyclic hormonal condition","menstrual cyclic phase",{"date":43,"type":46},{"date":257,"type":46},"2026-08-20",{"date":259,"type":21},"2027-09-01",{"name":83,"class":84},{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100624674","phase-1-a-study-of-bms-986528-in-participants-with-refractory-rheumatoid-arthritis-100624674","NCT07412704","A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","A Phase 1\u002F2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":270,"type":21},84,[272,24],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).",[275],"Arthritis, Rheumatoid",{"date":43,"type":46},{"date":278,"type":21},"2026-09-15",{"date":280,"type":21},"2030-09-02",{"name":52,"class":53},39,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100624093","phase-1-a-clinical-trial-of-ifinatamab-deruxtecan-in-people-with-advanced-esophageal-cancer-mk-3475-06f-100624093","NCT07405151","A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L\u002F3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)\n* Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC\n* Has measurable disease\n* If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention\n* Has clinically significant corneal disease\n* Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event\n* If infected with HIV, has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has uncontrolled or significant cardiovascular disease\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has active infection requiring systemic therapy other than those permitted.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen",{"count":291,"type":21},60,[272,24],"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.",[295],"Oesophageal Squamous Cell Carcinoma",{"date":45,"type":46},{"date":298,"type":46},"2026-03-27",{"date":300,"type":21},"2028-06-12",{"name":302,"class":53},"Merck Sharp & Dohme LLC",28,{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},"100621248","phase-2-safety-and-tolerability-of-ido-1-inhibition-in-the-prevention-of-ebv-related-pathology-in-ebv-negative-kidney-transplant-recipients-receiving-an-organ-from-ebv-positive-donors-100621248","NCT07368153","Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors","A Randomised, Controlled, Double-blind Study to Evaluate the Safety and Tolerability of IDO-1 Inhibition in the Prevention of EBV-related Pathology in EBV Negative Kidney Transplant Recipients Receiving an Organ From EBV Positive Donors.","IDEP","Inclusion Criteria:\n\n1. Willing and able to provide informed consent\n2. Male or female aged ≥18 years\n3. EBV seronegative at the time of renal transplant\n4. If women of child-bearing potential (WOCBP), participants must have a negative serum pregnancy test at screening and inclusion, and must be willing to use a highly effective method of birth control for the duration of the study. Acceptable methods of contraception:\n\n   1. Hormonal contraception associated with inhibition of ovulation\n   2. Intrauterine device (IUD)\n   3. Intrauterine hormone-releasing system (IUS)\n   4. Bilateral tubal occlusion\n   5. Vasectomised partner\n   6. Condom with spermicide\n   7. Sexual abstinence, in line with the preferred and usual lifestyle of the participant. Periodic abstinence (such as calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n5. If male, participants must be prepared to use reliable barrier method contraception and a second method such as spermicide for the duration of the study unless surgically sterile.\n\nExclusion Criteria:\n\n1. EBV seropositivity at the time of transplant\n2. Participants with any form of cancer within the last 12 months, or patients continuing to receive chemo or immunotherapy within the last 12 months.\n3. Participants with a history of PTLD\n4. Other active systemic infections requiring treatment prior to and at the time of baseline. Prophylactic agents are permitted.\n5. CYP3A4 and CYP2C28 Inhibitors and Inducers (List may be found in Appendix 1)\n6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 x ULN\n7. Any condition for which, in the opinion of the investigator, the treatment or participation in the study may pose a health risk to the participant\n8. Planned or active participation in any other study with an investigational medicinal product (IMP).\n9. Have taken an IMP within the last 3 months.\n10. Unwilling or unable to provide fully informed consent.\n11. Unwilling or unable to comply with study procedures.",{"count":313,"type":21},9,[24],"This clinical study will evaluate the safety and tolerability of an IDO-1 inhibitor in patients receiving a kidney transplant. The study includes individuals who have not previously been infected with Epstein-Barr virus (EBV) and who receive a kidney from a donor with prior EBV infection.\n\nParticipants will receive the IDO-1 inhibitor or placebo in addition to standard medical care and will be monitored for side effects and other safety-related outcomes throughout the study.",[317,318],"EBV Infections","Kidney Transplant",{"date":45,"type":46},{"date":257,"type":46},{"date":322,"type":21},"2027-02",{"name":83,"class":84},4,{"id":326,"slug":327,"hasResults":12,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":332,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":341,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":348},"100608388","phase-3-a-trial-evaluating-brelovitug-bjt-778-vs-bulevirtide-for-the-treatment-of-chronic-hepatitis-delta-infection-azure-2-100608388","NCT07200908","A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Chronic HDV infection\n3. HDV RNA \\>500 IU\u002FmL at Screening\n4. ALT \\>ULN at Screening\n5. Willing to take or already taking HBV neucleos(t)ide therapy.\n\nKey Exclusion Criteria:\n\n1. Pregnant or nursing females\n2. Unwilling to comply with contraception requirements during the study\n3. Difficulty with blood collection and\u002For poor venous access for the purposes of phlebotomy\n4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).\n5. Solid organ or bone marrow transplantation\n6. Presence of other liver disease(s) (non-HBV\u002FHDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.\n\nNote - Other protocol-defined Inclusion\u002FExclusion criteria apply.","99 Years",{"count":334,"type":21},172,[25],"This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.",[338],"Chronic Hepatitis D Infection",[340],"Hepatitis Delta virus, HDV, Hepatitis D infection; Hepatitis D virus",{"date":45,"type":46},{"date":343,"type":46},"2025-08-27",{"date":345,"type":21},"2029-09-30",{"name":347,"class":53},"Mirum Pharmaceuticals, Inc.",53,{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":356,"sex":17,"minAge":357,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":360,"briefSummary":361,"conditions":362,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":371},"100596349","a-clinical-study-of-mk-8527-to-prevent-human-immunodeficiency-virus-type-1-hiv-1-mk-8527-011-100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study",true,"16 Years",{"count":359,"type":21},4390,[25],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[363,364],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis",{"date":43,"type":46},{"date":367,"type":46},"2025-07-31",{"date":369,"type":21},"2027-07-22",{"name":302,"class":53},81,{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes","75 Years",{"count":382,"type":21},645,[24],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[386,387,388,389],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":45,"type":46},{"date":392,"type":46},"2025-05-27",{"date":394,"type":21},"2028-03",{"name":396,"class":53},"Spyre Therapeutics, Inc.",267,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":419},"100584534","phase-3-study-of-olomorasib-ly3537982-in-combination-with-standard-of-care-in-participants-with-resected-or-unresectable-kras-g12c-mutant-non-small-cell-lung-cancer-100584534","NCT06890598","Study of Olomorasib (LY3537982) in Combination With Standard of Care in Participants With Resected or Unresectable KRAS G12C-mutant Non-Small Cell Lung Cancer","A Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02","SUNRAY-02","Inclusion Criteria:\n\n* Histological or cytological confirmation of NSCLC.\n\n  * Part A\n\n    1. Clinical Stage II-IIIB (N0, N1, N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.\n    2. Pathologic Stage II-IIIB (N0, N1, N2) NSCLC treated with initial upfront resection.\n  * Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n* Must have an ECOG performance status of 0 or 1.\n* Able to swallow oral medication.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have known, actionable changes in the EGFR or ALK genes.\n* Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.\n* Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.\n* Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.",{"count":407,"type":21},700,[25],"The main purpose of this study is to assess if olomorasib in combination with pembrolizumab is more effective than the pembrolizumab and placebo combination in part A in participants with resected KRAS G12C-mutant NSCLC and to assess if olomorasib in combination with durvalumab is more effective than the durvalumab and placebo combination in part B in participants with unresectable KRAS G12C-mutant non-small cell lung cancer. The study may last up to 3 years for each participant.",[411],"Carcinoma, Non-Small-Cell Lung",{"date":43,"type":46},{"date":414,"type":46},"2025-03-27",{"date":416,"type":21},"2032-02",{"name":418,"class":53},"Eli Lilly and Company",369,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100576040","phase-1-substudy-06e-umbrella-study-of-combination-therapies-in-esophageal-cancer-mk-3475-06ekeymaker-u06-100576040","NCT06780111","Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E\u002FKEYMAKER-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable\u002FMetastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E","Inclusion Criteria\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.\n* Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee\u002Fradiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n* Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible.\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Has adequate organ function.\n\nExclusion Criteria\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.\n* Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.\n* Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.\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* Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec.\n* Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Has peripheral neuropathy ≥ Grade 2.\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has had a history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out.\n* Has active infection requiring systemic therapy.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.",{"count":428,"type":21},298,[272,24],"Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.\n\nAvailable treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.\n\nResearchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.",[432],"Esophageal Squamous Cell Carcinoma",{"date":45,"type":46},{"date":435,"type":46},"2025-07-30",{"date":437,"type":21},"2032-01-04",{"name":302,"class":53},45,{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":446,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":22,"phases":450,"briefSummary":451,"conditions":452,"keywords":455,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":470},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","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":21},450,[25],"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",[155,456,457,458,459,460,461,462],"Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":45,"type":46},{"date":465,"type":46},"2025-07-17",{"date":467,"type":21},"2029-12",{"name":469,"class":53},"Nuvalent Inc.",158,{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":477,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":486,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":493},"100558951","redo-transcatheter-aortic-valve-implantation-for-the-management-of-transcatheter-aortic-valve-failure-100558951","NCT06557798","REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure","Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve","REVALVE","Inclusion Criteria:\n\n1\\. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention\n\nExclusion Criteria:\n\n1. Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation\n2. Active endocarditis\n3. Untreated acute valve thrombosis\n4. Life-expectancy less than 1 year\n5. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable\n6. Pregnant or nursing",{"count":480,"type":21},550,"Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and\u002For leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.\n\nWhen the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.\n\nThe main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.\n\nThe study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).\n\nThe study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.",[483],"Aortic Valve Stenosis",[485],"Bioprosthetic Valve Failure",{"date":45,"type":46},{"date":488,"type":46},"2024-12-12",{"date":490,"type":21},"2033-03",{"name":492,"class":84},"The Leeds Teaching Hospitals NHS Trust",75,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":22,"phases":503,"briefSummary":504,"conditions":505,"keywords":510,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":520},"100552196","phase-1-substudy-06c-a-study-of-investigational-agents-with-pembrolizumab-mk-3475-and-chemotherapy-in-participants-with-first-line-locally-advanced-unresectablemetastatic-gastroesophageal-adenocarcinoma-mk-3475-06ckeymaker-u06-100552196","NCT06469944","Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable\u002FMetastatic Gastroesophageal Adenocarcinoma (MK-3475-06C\u002FKEYMAKER-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable\u002FMetastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically and\u002For cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma\n* Is not expected to require tumor resection during the treatment course\n* Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines\n* Core\u002Fexcisional biopsy of a tumor lesion not previously irradiated has been provided\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline\n* Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible\n* Has adequate organ function\n* Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator\u002Fradiology assessment and verified by blinded independent central review (BICR)\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention\n* Has a life expectancy of at least 6 months\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation\u002Frandomization\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has squamous cell or undifferentiated gastroesophageal cancer.\n* Has had previous therapy for locally advanced unresectable or metastatic gastric\u002Fgastroesophageal junction (GEJ)\u002Fesophageal adenocarcinoma\n* Has experienced weight loss \\>20% over 3 months before the first dose of study intervention\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has Grade ≥2 peripheral neuropathy\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention\n* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment\n* Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents\n* Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and\u002For a topoisomerase I inhibitor-based chemotherapy\n* Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention\n* Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has received a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening\n* Has an active infection requiring systemic therapy\n* Has concurrent active hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus \\[HCV\\] Ab positive and detectable HCV ribonucleic acid \\[RNA\\] infection or a known history of hepatitis B and\u002For C infection\n* Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study\n* Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication\n* Has poorly controlled diarrhea\n* Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention\n* Has history of allogeneic tissue\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":502,"type":21},160,[272,24],"This is a phase 1\u002F2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.\n\nThis substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.",[506,507,508,509],"Gastroesophageal Junction","Gastroesophageal Adenocarcinoma","Esophageal Neoplasms","Esophageal Cancer",[511,512,513],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":45,"type":46},{"date":516,"type":46},"2024-09-20",{"date":518,"type":21},"2029-09-12",{"name":302,"class":53},51,{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":380,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100526296","phase-2-a-study-to-determine-if-bhv-7000-is-effective-and-safe-in-adults-with-refractory-focal-onset-epilepsy-100526296","NCT06132893","A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy","A Phase 2\u002F3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy","RISE 2","Key Inclusion Criteria:\n\n1. Male and Female participants 18 to 75 years of age at time of consent.\n2. Diagnosis of Focal Onset Epilepsy at least 1 year prior to screening visit defined by 2017 International League Against Epilepsy (ILAE) Classification and based on requirements of Epilepsy Adjudication criteria.\n\n   a. Focal seizures i. Focal aware seizures with clinically observable signs and\u002For symptoms ii. Focal impaired awareness seizures iii. Focal to bilateral tonic-clonic seizures\n3. Subject meets the 2009 ILAE definition of drug resistant epilepsy, failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication (ASM) schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom.\n4. Ability to keep accurate seizure diaries\n5. Current treatment with at least 1 and up to 3 ASMs and 4 epilepsy treatments in total\n\nKey Exclusion Criteria:\n\n1. History of status epilepticus (convulsive status epilepticus for \\> 5 minutes or focal status epilepticus with impaired consciousness for \\> 10 minutes) within the last 6 months prior to screening visit that is not consistent with the subject's habitual seizure.\n2. History of repetitive\u002Fcluster seizures (where individual seizures cannot be counted) within the last 6 months prior to screening visit and during observation phase.\n3. Resection neurosurgery for seizures \\\u003C4 months prior to the screening visit.\n4. Radiosurgery performed \\\u003C2 years prior to the screening visit.\n5. Subjects with only focal aware nonmotor seizures which involve subjective sensory or psychic phenomena only, without impairment of consciousness or awareness (formally called simple partial seizures), with or without ictal EEG correlation with clinical symptoms.\n6. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and\u002For confound the interpretation of safety or efficacy data from the study, as judged by the Investigator",{"count":530,"type":21},390,[24,25],"The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.",[534],"Focal Epilepsy",[534,536,537,538,539],"Epilepsy","Seizure","Refractory Epilepsy","Partial Epilepsy",{"date":43,"type":46},{"date":542,"type":46},"2024-03-14",{"date":544,"type":21},"2026-12",{"name":546,"class":53},"Biohaven Therapeutics Ltd.",124,{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":589},"100525272","phase-3-a-study-of-first-line-olomorasib-ly3537982-and-pembrolizumab-with-or-without-chemotherapy-in-patients-with-advanced-kras-g12c-mutant-non-small-cell-lung-cancer-100525272","NCT06119581","A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer","SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression","SUNRAY-01","Inclusion Criteria:\n\n* Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.\n* Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).\n* Must have disease with evidence of KRAS G12C mutation.\n* Must have known programmed death-ligand 1 (PD-L1) expression\n\n  * Part A: Greater than or equal to (≥)50 percent (%).\n  * Part B: 0% to 100%.\n  * Part C: \\\u003C50%.\n* Must have measurable disease per RECIST v1.1.\n* Must have an ECOG performance status of 0 or 1.\n* Estimated life expectancy ≥12 weeks.\n* Ability to swallow capsules.\n* Must have adequate laboratory parameters.\n* Contraceptive use should be consistent with local regulations for those participating in clinical studies.\n* Women of childbearing potential must\n\n  * Have a negative pregnancy test.\n  * Not be breastfeeding during treatment\n\nExclusion Criteria:\n\n* Have a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1\u002F2\u002F3.\n* Have had any of the following prior to randomization:\n\n  \\-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.\n\n  \\--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:\n* Have known active central nervous system metastases and\u002For carcinomatous meningitis.\n\nExclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)\n\n* Have predominantly squamous cell histology for NSCLC\n* Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed\n* Is unable or unwilling to take folic acid or vitamin B12 supplementation.",{"count":557,"type":21},1264,[25],"The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.",[411,561],"Neoplasm Metastasis",[150,563,564,565,566,567,568,569,570,571,572,573,574,561,28,575,35,576,577,578,579,580,581,582,34],"KRAS G12 Lung Cancer","Advanced Lung Cancer","Metastatic Lung Cancer","KRAS G12C inhibitor","KRAS G12C Positive","KRAS Mutation","KRAS G12 Mutation","Lung Cancer Mutation","Olomorasib","Lung Diseases","Neoplastic Processes","Pathologic Processes","Non-Small Cell Lung Cancer (NSCLC)","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Respiratory Tract Diseases","Carcinoma, Bronchogenic","Bronchial Neoplasms",{"date":43,"type":46},{"date":585,"type":46},"2023-12-21",{"date":587,"type":21},"2031-01",{"name":418,"class":53},418,{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":599,"briefSummary":600,"conditions":601,"keywords":604,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":615},"100498096","phase-1-a-study-of-debio-0123-in-combination-with-temozolomide-in-adult-participants-with-recurrent-or-progressive-glioblastoma-and-of-debio-0123-in-combination-with-temozolomide-and-radiotherapy-in-adult-participants-with-newly-diagnosed-glioblastoma-100498096","NCT05765812","A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","A Phase 1\u002F2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","Screening Inclusion Criteria for Phase 1 and Phase 2:\n\n* Signed written informed consent approved before undertaking any study-specific procedures.\n* Age ≥18 years of age.\n* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.\n* Adequate bone marrow, hepatic, and renal function.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Willing to practice highly effective methods of contraception.\n* Life expectancy of at least 3 months in the best judgment of the Investigator.\n* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n\nAdditional specific inclusion criteria for Phase 1 and Phase 2:\n\n• A maximum of 1 \\[for Phase 1 (Dose Expansion) and phase 2\\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).\n\nNote: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \\[GLIADEL®\\]) for first recurrence is allowed.\n\n* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.\n* KPS ≥60.\n\nAdditional specific inclusion criteria for Phase 1 Arm A:\n\n* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):\n* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).\n* Astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific inclusion criteria for Phase 1 Arm B and C:\n\n* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.\n* KPS ≥70.\n\nAdditional specific inclusion criteria for Phase 1 dose expansion and Phase 2:\n\n• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021\n\nAdditional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific exclusion criteria for Phase 1 and Phase 2\n\n* Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.\n* Any anticancer treatment, monoclonal antibodies\u002Fbiologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.\n* Hypersensitivity to Debio 0123, TMZ, dacarbazine, or any of the excipients found in the formulation for Debio 0123 or TMZ.\n* Prior exposure to any WEE1 inhibitor.\n* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell\u002Fsquamous cell skin cancer) that have been treated with curative intent.\n* Left ventricular ejection fraction (LVEF) below 55%.\n\nAdditional specific exclusion criteria for Phase 1 Arm B and C:\n\n* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.\n* Prior therapy that would result in an overlap of the radiation fields.\n\nAdditional specific exclusion criteria for Phase 1 dose expansion and Phase 2\n\n• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.\n\n\\[Note: Other inclusion\u002Fexclusion criteria mentioned in the protocol may apply.\\]",{"count":598,"type":21},116,[272,24],"The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.\n\nThe primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development.\n\nThe Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.",[602,603],"Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Astrocytoma, Grade III",[605,606,607],"WEE1 inhibitor","Glioblastoma, IDH-wildtype, Grade 4, World Health Organization (WHO) 2021","Astrocytoma, IDH-mutant, Grade 3, WHO 2021",{"date":43,"type":46},{"date":610,"type":46},"2023-05-15",{"date":612,"type":21},"2028-09",{"name":614,"class":53},"Debiopharm International SA",16,{"id":617,"slug":618,"hasResults":12,"nctId":619,"briefTitle":620,"officialTitle":620,"acronym":621,"eligibilityCriteria":622,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":623,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":626,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":636,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":7},"100467937","phase-3-hydrochlorothiazide-to-protect-polycystic-kidney-disease-patients-and-improve-their-quality-of-life-100467937","NCT05373264","HYDROchlorothiazide to PROTECT Polycystic Kidney Disease Patients and Improve Their Quality of Life","HYDRO-PROTECT","Inclusion Criteria:\n\n* ADPKD diagnosis (modified Ravine criteria)\n* ≥18 years old\n* eGFR \\> 25 mL\u002Fmin\u002F1.73m2\n* On stable treatment with the highest tolerated dose of V2RA for a minimum of 3 months\n\nExclusion Criteria:\n\n* Known intolerance to hydrochlorothiazide\n* Use of any diuretic\n* Orthostatic hypotension complaints or blood pressure \\\u003C105\u002F65mmHg during screening visit\n* Uncontrolled hypertension (blood pressure \\>160\u002F100mmHg)\n* Hypokalemia (\\\u003C3.5 mmol\u002FL)\n* History of active gout on maintenance preventive treatment for gout (allopurinol, desuric and\u002For colchicine), defined as ≥2 episodes during the last year\n* History of skin cancer (basal cell, squamous cell and melanoma)","80 Years",{"count":625,"type":21},300,[25],"Autosomal dominant polycystic kidney disease (ADPKD) is characterized by progressive formation of renal cysts which ultimately lead to a loss of renal function.\n\nTolvaptan (a V2R antagonist) is currently the only effective treatment for preserving renal function in ADPKD. However, side-effects such as polyuria limit its tolerability and thereby the therapeutic potential. This study will test whether co-administration with hydochlorothiazide can improve V2RA efficacy (slowing kidney function decline) and tolerability (quality of life) in ADPKD. Approximately 300 patients will be enrolled.",[629],"ADPKD",[629,631,632,633,634,635],"Tolvaptan","Hydrochlorothiazide","Quality of Life","Side effects","Polyuria",{"date":45,"type":46},{"date":638,"type":46},"2024-07-31",{"date":640,"type":21},"2031-07",{"name":642,"class":84},"University Medical Center Groningen",{"id":644,"slug":645,"hasResults":12,"nctId":646,"briefTitle":647,"officialTitle":648,"acronym":4,"eligibilityCriteria":649,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":22,"phases":652,"briefSummary":653,"conditions":654,"keywords":655,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":666},"100463825","phase-1-a-study-to-evaluate-investigational-agents-with-or-without-pembrolizumab-mk-3475-in-participants-with-advanced-esophageal-cancer-previously-exposed-to-programmed-cell-death-1-protein-pd-1-programmed-cell-death-ligand-1-pd-l1-treatment-mk-3475-06b-100463825","NCT05319730","A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)\u002F Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and\u002For Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1\u002FPD-L1 Treatment (KEYMAKER-U06): Substudy 06B","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)\n* Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)\u002Fprogrammed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy\n* Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice\n* Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible\n\nExclusion Criteria:\n\n* Direct invasion into adjacent organs such as the aorta or trachea\n* Has experienced weight loss \\>10% over approximately 2 months prior to first dose of study therapy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* History of allogenic tissue\u002Fsolid organ transplant\n* Clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation\u002Frandomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation\u002Frandomization",{"count":651,"type":21},230,[272,24],"This is a Phase 1\u002F2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and\u002For chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1\u002FPD-L1 based treatment.",[432],[656,657,658,659],"Esophageal cancer","Programmed Cell Death 1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)",{"date":45,"type":46},{"date":662,"type":46},"2023-05-16",{"date":664,"type":21},"2029-04-10",{"name":302,"class":53},59,{"id":668,"slug":669,"hasResults":12,"nctId":670,"briefTitle":671,"officialTitle":672,"acronym":4,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":674,"maxAge":675,"enrollmentInfo":676,"targetDuration":4,"studyType":22,"phases":677,"briefSummary":678,"conditions":679,"keywords":681,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":688,"startDateStruct":689,"completionDateStruct":691,"leadSponsor":693,"locationsCount":695},"100453322","phase-3-venetoclax-in-children-with-relapsed-acute-myeloid-leukemia-aml-100453322","NCT05183035","Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)","A Randomized Phase 3 Trial of Fludarabine\u002FCytarabine\u002FGemtuzumab Ozogamicin With or Without Venetoclax in Children With Relapsed AML","Inclusion Criteria\n\n* Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101\u002FAPAL2020D. (This is only applicable for participants in USA\u002FCanada\u002FAustralia\u002FNew Zealand sites\u002FBlood Cancer United territory).\n* Participants must be \\>28 days of age and \\\u003C 22 years of age at enrollment.\n* Participants must have one of the following:\n\n  1. Children, adolescents, and young adults with AML without demonstrated FLT3\u002Finternal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3\u002FITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.\n  2. And participants must have AML which is either:\n\n     * Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or\n     * Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.\n* Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).\n* Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:\n\n  1. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.\n  2. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and\u002For hydrocortisone.\n  3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.\n  4. Interleukins, Interferons and Cytokines (other than Hematopoietic Growth Factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than Hematopoietic Growth Factors) before start of protocol treatment.\n  5. Hematopoietic growth factors: ≥ 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥7 days for short-acting growth factor before start of protocol treatment.\n  6. Radiation therapy (RT) (before start of protocol treatment):\n\n     * ≥ 14 days have elapsed for local palliative RT (small port);\n     * ≥ 84 days must have elapsed if prior craniospinal RT or if ≥ 50% radiation of pelvis;\n     * ≥ 42 days must have elapsed if other substantial bone marrow (BM) radiation.\n  7. Stem Cell Infusions (before start of protocol treatment):\n\n     * ≥ 84 days since allogeneic (non-autologous) bone marrow or stem cell transplant (with or without total body irradiation \\[TBI\\]) or boost infusion (any stem cell product; not including donor lymphocyte infusion \\[DLI\\]);\n     * No evidence of active graft versus host disease (GVHD).\n  8. Participants who are receiving cyclosporine, tacrolimus or other agents to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial. Participants must be off medications to treat or prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant for at least 14 days prior to enrollment.\n  9. Cellular Therapy: ≥ 42 days after the completion of donor lymphocyte infusion (DLI) or any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.) before start of protocol treatment.\n  10. Participants with prior exposure to venetoclax are eligible in this trial.\n* Adequate organ function:\n\n  1. Adequate Renal Function defined as:\n\n     * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60ml\u002Fmin\u002F1.73 m\\^2, or\n     * Normal serum creatinine based on age\u002Fsex\n  2. Adequate Liver Function defined as:\n\n     * Direct bilirubin \\\u003C 1.5 x upper limit of normal (ULN), and\n     * Alkaline phosphatase ≤ 2.5 x ULN, and\n     * Serum glutamic pyruvic transaminase (SGPT) alanine aminotransferase (ALT) ≤ 2.5 x ULN. If higher transaminases outside these ranges (up to 5x ULN) are due to a radiographically identifiable leukemia infiltrate, the participant will remain eligible. Transaminase elevation up to 5x ULN is also allowed in case of steatosis on echography.\n  3. Cardiac performance: Minimum cardiac function defined as:\n\n     * No history of congestive heart failure in need of medical treatment\n     * No pre-treatment diminished left ventricular function on echocardiography (shortening fraction \\[SF\\] \\\u003C 25% or ejection fraction \\[EF\\] \\\u003C 40%)\n     * No signs of congestive heart failure at presentation of relapse.\n* Participant, parent or guardian must sign and date informed consent and pediatric assent (when required), prior to the initiation of screening or study specific procedures, according to local law and legislation.\n\nExclusion Criteria\n\n* Participants who in the opinion of the investigator may not be able to comply with the study requirements of the study, are not eligible.\n* Participants with Down syndrome.\n* Participants with Acute promyelocytic leukemia (APL) or Juvenile myelomonocytic leukemia (JMML).\n* Participants with isolated CNS3 disease or symptomatic CNS3 disease.\n* Participants with malabsorption syndrome or any other condition that precludes enteral administration of venetoclax.\n* Participants who are currently receiving an investigational drug other than those specified for this study.\n* Participants with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known congenital bone marrow failure syndrome.\n* Participants with known prior allergy to any of the medications used in protocol therapy.\n* Participants with documented active, uncontrolled infection at the time of study entry.\n* Known hepatitis C virus (HCV), hepatitis B virus (HBV) (known positive hepatitis B virus (HBV) surface antigen (HBsAg) results), or human immunodeficiency virus (HIV) infection.\n* Concomitant Medications\n\n  * Participants who have received strong and moderate CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of study treatment.\n  * Participants who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit within 3 days of the start of study treatment.\n  * Participants who have hypersensitivity to the active substance or to any of the excipients listed in summary of product characteristics (SPC).\n* Pregnancy or Breast-Feeding:\n\n  * Participants who are pregnant or breast-feeding.\n  * Participants of reproductive potential may not participate unless they have agreed to use a highly effective contraceptive method per Clinical Trial Facilitation Group (CTFG) guidelines for the duration of study therapy and at least 30 days after last dose of venetoclax, or 7 months after gemtuzumab ozogamicin treatment, or for 6 months after the completion of all study therapy, whichever is longer.\n  * Male participants must use a condom during intercourse and agree not to father a child or donate sperm during therapy and for the duration of study therapy and at least 30 days after last dose of venetoclax or 4 months after last dose of gemtuzumab ozogamicin, 6 months from the last dose of cytarabine, or 90-days after last exposure to any other chemotherapy, whichever is longer.\n\nAdditional criteria to receive a gemtuzumab ozogamicin infusion:\n\nGemtuzumab ozogamicin should not be given:\n\n* to participants with history of veno-occlusive disease (VOD)\u002FSinusoidal obstruction syndrome (SOS) grade 3 or 4\n* to participants with CD33 negative leukemic blasts (determined at local lab)\n\nNote that these participants are eligible for the study but will not be treated with gemtuzumab ozogamicin.","29 Days","21 Years",{"count":137,"type":21},[25],"A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine\u002Fcytarabine\u002Fgemtuzumab ozogamicin \\[GO\\]) improves survival of children\u002Fadolescents\u002Fyoung adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.",[680],"Acute Myeloid Leukemia",[682,683,684,685,686,687],"Venetoclax","Gemtuzumab Ozogamicin","Fludarabine","Cytarabine","Relapsed refractory","Azacitidine",{"date":43,"type":46},{"date":690,"type":46},"2022-10-01",{"date":692,"type":21},"2031-04",{"name":694,"class":84},"PedAL BCU, LLC",90,""]