[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"France\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":669},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,7529,0,25,[9,41,80,100,127,151,181,204,225,257,277,302,327,348,377,402,429,451,477,502,529,553,575,601,629],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100641750","patient-satisfaction-safety-and-efficacy-of-endovenous-laser-treatment-for-saphenous-veins-and-varicose-veins-100641750",false,"NCT07629843","Patient Satisfaction, Safety, and Efficacy of Endovenous Laser Treatment for Saphenous Veins and Varicose Veins","Patient Satisfaction, Safety and Efficacy of Treatment for Saphenous Veins and Varicose Veins Outside the Operating Theater Under Strict Local Anesthesia With 1940nm Endovenous Laser: a Prospective Multicenter Observational Study","IPV-1940","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Endovenous Laser Ablation of a common or recurrent saphenous vein as part of routine care.\n* Clinical, Etiology, Anatomy, Pathophysiology, classification clinical stage.\n* Ability to understand the study objectives and complete questionnaires in French.\n* Patient has been informed and has verbally indicated their non-opposition to participating in the research.\n\nExclusion Criteria:\n\n* Endovenous Laser Ablation not feasible for technical reasons, particularly if the vein is too \"bent\" or there are endoluminal obstacles.\n* Episode of deep vein thrombosis less than 3 months ago or of superficial vein thrombosis less than 6 weeks ago.\n* Active cancer.\n* Geographical distance incompatible with study follow-up, according to the investigator's judgment.\n* Patients currently participating or having participated in research within the previous 3 months.\n* Persons covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponds to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).","ALL","18 Years",{"count":21,"type":22},155,"ESTIMATED","1 Year","OBSERVATIONAL","The purpose of this study is to evaluate the post-operative patient satisfaction on the treatment of saphenous veins and varicose veins outside the operating theater under strict local anesthesia with a 1940 nm laser via the Venous Treatment Satisfaction Questionnaire early.",[27],"Saphenous Vein Injury","NOT_YET_RECRUITING","2026-08-24",{"date":31,"type":32},"2026-08-25","ACTUAL",{"date":34,"type":22},"2026-09",{"date":36,"type":22},"2028-06",{"name":38,"class":39},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":71,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823","NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.",{"count":49,"type":22},260,"INTERVENTIONAL",[52],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[55],"Solid Tumors",[57,58,59,60,61,62,63,64,65,66,67,68,69],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","RECRUITING",{"date":31,"type":32},{"date":73,"type":32},"2026-07-27",{"date":75,"type":22},"2032-05-20",{"name":77,"class":78},"Bristol-Myers Squibb","INDUSTRY",57,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":50,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":97,"leadSponsor":99,"locationsCount":40},"100626606","study-comparing-neoadjuvant-versus-adjuvant-stereotactic-radiotherapy-of-brain-metastases-100626606","NCT07437820","Study Comparing Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy of Brain Metastases","Prospective, Randomized, Multicenter Study Comparing the Efficacy and Tolerance of Neoadjuvant Versus Adjuvant Stereotactic Radiotherapy in the Management of Brain Metastases","NeoSRS","Inclusion Criteria:\n\n* Patients aged 18 years and older;\n* Patients with 1 to 12 brain metastases on preoperative MRI, at least one of which (contrast enhancement of at least 1 cm) is accessible for the most complete possible resection (target lesion);\n* Patients with a Karnofsky performance score of ≥ 70;\n* Patients able to perform neurocognitive tests without assistance;\n* Patients who understand the study and agree to attend all visits;\n* Patients who have signed a written informed consent form;\n* Affiliation with a social security system.\n\nExclusion Criteria:\n\n* Patient who has already been treated with surgery, radiosurgery, and\u002For radiotherapy for the target brain metastasis;\n* Medical contraindication to MRI;\n* Patient with an estimated life expectancy of ≤ 3 months;\n* Patients participating in another clinical trial, or who are in the exclusion period of another clinical trial;\n* Patients unable to complete a self-administered questionnaire;\n* Patients from a vulnerable population.",{"count":89,"type":22},68,[91],"NA","The purpose of this study is to evaluate the local control rate on the target lesion at 6, 12, and 24 months after treatment with neoadjuvant stereotactic radiotherapy (SRS NEO group) compared to standard care, adjuvant stereotactic radiotherapy (POST OP SRS group).",[94],"Brain Metastases, Adult",{"date":31,"type":32},{"date":34,"type":22},{"date":98,"type":22},"2030-06-30",{"name":38,"class":39},{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":50,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100624292","shockfast-intravascular-lithotripsy-device-for-treatment-of-calcified-coronary-lesions-100624292","NCT07407738","ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions","ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions, a Prospective, Randomised, International Trial: ShockFast IVL Trial","IVL","Inclusion Criteria:\n\n1. Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing\n\n   Angiographic criteria:\n2. Native de novo coronary lesions\n3. Vessel diameter between 2.5mm - 4.0mm\n4. Lesion Length: ≤40mm\n5. Severe Calcification:\n\n   1. Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other\n   2. Presence of severe calcified protruding noduli\n6. No flow disturbances at baseline (Thrombolysis in Myocardial Infarction \\[TIMI\\] 3 flow at baseline)\n7. Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia\n\n   OCT Criteria:\n8. Total calcium arc \\> 180° or\n9. Presence of a protruding calcified noduli\n\nExclusion Criteria:\n\n1. Ejection fraction less than 25%\n2. Lesion located in Left Main (LM) coronary artery\n3. Calcifications located mostly \\> 0.5 mm from the vessel lumen.\n4. Severe renal Impairment; Serum Creatinine \\> 220 μmol or currently undergoing hemodialysis\n5. Severe lesion tortuosity where OCT is judged impossible to cross.\n6. Inability to tolerate dual antiplatelet therapy for 6 months or longer\n7. Inability to obtain inform consent or deemed poorly compliant by the investigator\n8. Presence of permanent pacemaker\n9. Angiographic evidence of thrombus in the target vessel\n10. Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX)\n11. Target lesion is a chronic total occlusion (CTO)\n12. Presence of aneurysm within 10mm proximal or distal to the target lesion",{"count":109,"type":22},120,[91],"Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed. This is a minimally invasive procedure used to treat narrowed or blocked coronary arteries. Sometimes a stent is placed to keep the artery open. If the lesions in the coronary artery are calcified, this may cause difficulties for successful stent placement. The calcified plaques can be fractured via intravascular lithotripsy (IVL) with devices like ShockWave IVL and ShockFast IVL. The aim of this study is to compare the this relatively new ShockFast IVl with the more widely used ShockWave IVL.",[113,114],"Coronary Arterial Disease","Calcified Coronary Artery Disease",[116,117,118,106],"Shockwave Intravascular Lithotripsy","Shockfast Intravascular Lithotripsy","Coronary Calcified Lesion",{"date":31,"type":32},{"date":121,"type":32},"2026-02-16",{"date":123,"type":22},"2027-03-01",{"name":125,"class":78},"Shunmei Medical",13,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":50,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":137,"type":22},500,[139],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[142],"Amyotrophic Lateral Sclerosis",{"date":31,"type":32},{"date":145,"type":32},"2026-02-01",{"date":147,"type":22},"2029-03",{"name":149,"class":78},"Prilenia",56,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":50,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":173,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":180},"100610417","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-belantamab-mafodotin-in-combination-with-standard-of-care-in-participants-with-relapsed-refractory-multiple-myeloma-rrmm-100610417","NCT07227311","A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Standard of Care in Participants With Relapsed-Refractory Multiple Myeloma (RRMM)","A Phase 2, Multicenter, Open Label, Non-randomized Study to Evaluate the Efficacy and Safety of Extended Dosing of Belantamab Mafodotin in Different Combinations With Standard of Care Regimens in Participants With Relapsed-refractory Multiple Myeloma (DREAMM-15)","Inclusion Criteria:\n\n• Participants are eligible to be included in the study only if all of the following criteria apply:\n\nApplicable to All Arms - BPd, BVd, BKd:\n\n* Male or female, 18 years or older (at the time consent is obtained).\n* Have a confirmed diagnosis of Multiple Myeloma (MM) as defined by the International Myeloma Working Group (IMWG) criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status of zero to 2.\n* Have been previously treated with at least 1, but no more than 2, prior lines of MM therapy and must have documented disease progression during or after their most recent therapy.\n* Must have at least 1 aspect of measurable disease, defined as one the following:\n\n  1. Urine M-protein excretion ≥200 mg\u002F24 h, or\n  2. Serum M-protein concentration ≥0.5 g\u002FdL (≥5.0 g\u002FL), or\n  3. Free Light Chain (FLC) assay: involved FLC level ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum free light chain ratio (\\\u003C0.26 or \\>1.65) only if patient has no measurable urine or serum M spike.\n* Patients with a history of Autologous Stem Cell Transplant (ASCT) are eligible for study participation provided the following eligibility criteria are met:\n\n  1. ASCT was \\>100 days prior to the first dose of study medication,\n  2. No active bacterial, viral, or fungal infection(s) present.\n* All prior treatment-related toxicities (defined by National Cancer Institute-Common Terminology Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0) must be ≤Grade 1 at the time of enrollment, except for alopecia.\n* Adequate organ system functions as defined by the laboratory assessments.\n* Contraceptive requirements for men and women per local regulations; strict pregnancy prevention for women of childbearing potential (WOCBP), including negative pregnancy tests and use of highly effective contraception.\n* Male participants must refrain from sperm donation and must use a condom plus an additional highly effective method of contraception if sexually active with a woman of childbearing potential.\n\nSpecific Inclusion Criteria for BPd arm:\n\n• Prior treatment must include a lenalidomide-containing regimen, with lenalidomide administered for at least 2 consecutive cycles.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nApplicable for all (BPd, BVd, BKd):\n\n* Active plasma cell leukemia at Screening.\n* Symptomatic amyloidosis, including active Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma proliferative disorder, and Skin changes (POEMS).\n* Previous or concurrent invasive malignancy other than MM, except:\n\n  1. The disease must be considered medically stable for at least 2 years; or\n  2. The patient must not be receiving active therapy, other than hormonal therapy for this disease.\n* Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n* Plasmapheresis within 7 days prior to the first dose of study intervention.\n* Patients after prior allogeneic stem cell transplant\n* Any major surgery within 4 weeks prior to start of treatment, except for bone stabilizing surgery.\n* Evidence of active mucosal or internal bleeding.\n* Intolerance or contraindications to anti-viral prophylaxis.\n* Current corneal epithelial disease except for mild punctate keratopathy.\n* Systemic anti-myeloma therapy (including chemotherapy and systemic steroids); prior treatment with an anti-MM monoclonal antibody drug within 30 days of receiving the first dose of study intervention.\n* Presence of active renal condition (infection, requirement for dialysis, or any other condition that could affect participant's safety). Patients with isolated proteinuria resulting from MM are eligible, provided they fulfill certain criteria\n* Received prior B-cell maturation antigen (BCMA)-targeted therapy.\n* Contact lenses are prohibited while receiving belantamab mafodotin treatment. Use may be restarted after a qualified eye care specialist confirms there are no other contraindications. Bandage contact lenses are permitted during study treatment as directed by the treating eye care specialist.\n* HIV infection unless well-controlled, no recent AIDS-defining infections, and adequate CD4+ count.\n* Significant liver dysfunction (ALT \\>2.5x ULN, bilirubin \\>1.5x ULN, cirrhosis, unstable liver\u002Fbiliary disease).\n* Positive hepatitis B or C markers unless criteria for resolved infection are met.\n* Evidence of cardiovascular risk including any of the following: untreated arrhythmias, recent MI\u002FACS\u002Fangioplasty\u002Fbypass, NYHA III\u002FIV heart failure, uncontrolled hypertension, QTc prolongation.\n\nSpecific Exclusion Criteria for BPd Arm:\n\n* Received prior treatment with or intolerant to pomalidomide.\n* Active or history of venous and arterial thromboembolism within the past 3 months.\n\nSpecific Exclusion Criteria for BVd Arm:\n\n* Intolerant to bortezomib or refractory to bortezomib (defined as progressive disease during treatment with a bortezomib-containing regimen of 1.3 mg\u002Fm² twice weekly or within 60 days of completing that treatment).\n* Ongoing Grade 2 or higher peripheral neuropathy or neuropathic pain.\n\nSpecific Exclusion Criteria for BKd Arm:\n\n* Intolerant to carfilzomib or refractory to carfilzomib (defined as progressive disease during treatment with a carfilzomib-containing regimen or within 60 days of completing that treatment).\n* Known history of allergy to captisol (i.e., cyclodextrin derivatives) used to solubilize carfilzomib.\n* Left ventricular ejection fraction \\\u003C40% as assessed by transthoracic echocardiogram.\n* Pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to enrolment.\n* Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n* Known pulmonary hypertension.",{"count":159,"type":22},200,[52],"This study is for adults with multiple myeloma (a type of blood cancer) that has come back after being treated earlier or isn't responding to the current treatment.\n\nThe main goal is to find out if the study drug, belantamab mafodotin, given less often (on an extended schedule) with other cancer medicines, can still treat the cancer effectively while causing fewer side effects, especially those affecting the eyes. The study will also look at how well the treatment works overall and how safe it is when administered to the participants.",[163],"Multiple Myeloma",[165,166,167,168,169,170,171,172],"Relapsed-Refractory Multiple Myeloma","DREAMM-15","Belantamab Mafodotin","Blenrep","Pomalidomide","Bortezomib","Carfilzomib","Dexamethasone",{"date":31,"type":32},{"date":175,"type":32},"2026-04-15",{"date":177,"type":22},"2030-08-30",{"name":179,"class":78},"GlaxoSmithKline",59,{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":23,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":50,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":203},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","35 Years",{"count":191,"type":22},150,[139],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[195],"Diabetes Mellitus, Type 1",{"date":31,"type":32},{"date":198,"type":32},"2026-01-12",{"date":200,"type":22},"2031-07",{"name":202,"class":78},"Eli Lilly and Company",113,{"id":205,"slug":206,"hasResults":12,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":50,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":40},"100609125","therapeutic-benefits-of-a-motor-imaging-protocol-following-anterior-cruciate-ligament-reconstruction-surgery-100609125","NCT07210489","Therapeutic Benefits of a Motor Imaging Protocol Following Anterior Cruciate Ligament Reconstruction Surgery","Therapeutic Benefits of a Motor Imaging Protocol After Anterior Cruciate Ligament Reconstruction Surgery: Study of Lower Limb Symmetry During Various Functional Tests","IMAGERIEMOTR","Inclusion Criteria:\n\n* Patients aged 18 to 45;\n* Individuals who have undergone anterior cruciate ligament reconstruction for the first time on the operated leg;\n* All types of surgery (harvesting of the new gracilis or patellar tendon) within 3 months prior to inclusion;\n* Patients able to understand and read French;\n* Affiliation with a social insurance plan;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Recurrence or rupture of the contralateral anterior cruciate ligament;\n* Osteotomy;\n* Cognitive disorders observed by the investigator;\n* Vestibular disorders known to the patient or observed by the investigator;\n* Post-surgical complications (infection, early graft rupture);\n* Patient participating in another interventional clinical trial, or in a period of exclusion from another interventional study;\n* Patient under guardianship or conservatorship;\n* Pregnant or breastfeeding women.","45 Years",{"count":214,"type":22},70,[91],"The purpose of this study is to compare changes in lower limb symmetry during functional and strength tests, before and after the motor imagery program, in patients who received the 3-week motor imagery program starting 3 months post-surgery versus patients who did not receive the motor imagery program.",[218],"Anterior Cruciate Ligament Tear",{"date":31,"type":32},{"date":221,"type":22},"2026-10",{"date":223,"type":22},"2028-03",{"name":38,"class":39},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":50,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":250,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":256},"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","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.",{"count":137,"type":22},[52,139],"A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[236],"Non-Small Cell Lung Cancer",[238,239,240,241,242,243,244,245,246,247,248,249],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed",{"date":31,"type":32},{"date":252,"type":32},"2025-11-05",{"date":254,"type":22},"2030-11-15",{"name":77,"class":78},186,{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":50,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":276,"locationsCount":40},"100598834","phase-3-efficacy-and-safety-of-intravenous-lidocaine-versus-placebo-in-patients-receiving-morphine-rachi-analgesia-100598834","NCT07076641","Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Morphine-rachi Analgesia","Phase III, Randomized, Double-blind Study to Assess the Efficacy and Safety of Intravenous Lidocaine Versus Placebo in Patients Receiving Analgesic Morphine Rachi Anesthesia for Major Digestive or Abdominal Surgery by Laparotomy.","LIDORACHI","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Major digestive or abdominal surgery (pancreatic, hepatic, colorectal, gynecological, esophageal, gastric, duodenal, small intestine...);\n* Scheduled surgery;\n* Laparotomy;\n* Patient in agreement with morphine rachi anesthesia;\n* Social security affiliation;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Contraindication to non-steroidal anti-inflammatory drugs: history of gastro duodenal ulcer, renal failure from stage 3 A or higher;\n* History of bradycardia and\u002For known conduction disorder (atrioventricular block) \u002F Pacemaker ;\n* Unstable coronary ;\n* Myocardial infarction \\\u003C6 months;\n* Severe cardiocirculatory insufficiency;\n* Severe hepatic insufficiency;\n* Allergy to morphine ;\n* Allergy to lidocaine;\n* Rhythm disorders at risk of sudden death (e.g. Brugada syndrome);\n* Flecaine as usual treatment;\n* Chronic pain with level II or III analgesics;\n* Gabapentinoids: pregabalin (Lyrica), gabapentin;\n* Drug addiction and substitute drugs;\n* Epileptic disorders ;\n* Myasthenia gravis;\n* Creatinine clearance below 10 mL\u002Fmin;\n* Hypokalemia, hypoxia or acid-base disorders;\n* Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;\n* Inability to understand study information (due to linguistic, psychological, cognitive or literacy problems);\n* Women who are or may become pregnant\\* (of childbearing age, without effective contraception) or who are breast-feeding;\n* Patient deprived of liberty, under guardianship or unable to give consent.",{"count":266,"type":22},76,[139],"The purpose of this study is to evaluate the superiority of IV lidocaine combined with morphine spinal anesthesia versus placebo combined with morphine spinal anesthesia, in reducing postoperative morphine consumption at 48 hours, in patients undergoing major digestive or abdominal surgery by laparotomy.",[270,271],"Digestive System Disease","Surgery",{"date":31,"type":32},{"date":34,"type":22},{"date":275,"type":22},"2027-07-30",{"name":38,"class":39},{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":50,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":286,"type":22},590,[52,139],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[290],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[59,292,65,57,58,293,294,68],"Lung cancer","MRTX1719","First-line",{"date":31,"type":32},{"date":297,"type":32},"2026-01-02",{"date":299,"type":22},"2031-08-12",{"name":77,"class":78},320,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":309,"enrollmentInfo":310,"targetDuration":4,"studyType":50,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100587506","phase-3-a-study-to-assess-the-long-term-safety-of-karxt-for-the-treatment-of-manic-episodes-in-bipolar-i-disorder-balsam-3-100587506","NCT06929273","A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":311,"type":22},450,[139],"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.",[315],"Bipolar Disorder Type I With Mania",[317,318,319],"Bipolar-I disorder","Mania","Bipolar-I disorder with Mania",{"date":31,"type":32},{"date":322,"type":32},"2025-07-18",{"date":324,"type":22},"2028-06-13",{"name":77,"class":78},174,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":340,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":347},"100581902","rebecca-real-world-early-breast-cancer-management-100581902","NCT06856343","REBECCA Real-world Early BrEast CanCer mAnagement","REBECCA Real-world Early BrEast CanCer mAnagement REBECCA. a French National Multicentric Real-world Study of Early Breast Cancer Patients","REBECCA","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years\n* Patient diagnosed with HER2-negative eBC\n* Patient about to be initiated with adjuvant Olaparib at their physician's discretion\n* Patient has been informed and does not object to participation in the study.\n\nExclusion Criteria:\n\n* Patient not consenting to participate.\n* Patients included in the Early Access Program",{"count":336,"type":22},126,"This is a French observational, national, multicenter prospective cohort study of patients with HER2-negative eBC treated with olaparib at their physician's discretion.",[339],"Breast Cancer",{"date":31,"type":32},{"date":342,"type":32},"2024-12-30",{"date":344,"type":22},"2028-01-31",{"name":346,"class":78},"AstraZeneca",58,{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":18,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"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":357,"type":22},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).",[360],"Perimembranous Ventricular Septal Defect",[362,363,364,365,366,367,368,369],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects",{"date":31,"type":32},{"date":372,"type":32},"2025-01-01",{"date":374,"type":22},"2027-06-30",{"name":376,"class":39},"Fondation Hôpital Saint-Joseph",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":383,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":50,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":386,"type":22},390,[52],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[390],"Metastatic Colorectal Cancer",[390,392,393],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":31,"type":32},{"date":396,"type":32},"2025-04-24",{"date":398,"type":22},"2028-04",{"name":400,"class":78},"AbbVie",65,{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":18,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":50,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":428},"100571581","phase-3-corticosteroids-before-extubation-in-pediatric-intensive-care-unit-100571581","NCT06722118","Corticosteroids Before Extubation in Pediatric Intensive Care Unit","Corticoïdes Avant Extubation en réanimation pédiatrique : étude Multicentrique, Prospective, randomisée, Contre Placebo","COBEX-PED","Inclusion Criteria:\n\n* Patients intubated with an endotracheal tube with or without a cuff,\n* Aged from 2 days post-term to 6 years,\n* On mechanical ventilation for at least 36 hours,\n\nAnd meeting the following extubation criteria:\n\n* Extubation planned by the medical team\n* Fraction of inspired oxygen (FiO2) ≤ 45%,\n* Oxygen saturation measured by pulse oximeter ≥ 95% or appropriate according to the pathology,\n* Positive end-expiratory pressure (PEEP) ≤ 8 cmH2O,\n* Peak inspiratory pressure ≤ 22 cmH2O or presence of cough.\n* Affiliated with a social security system,\n* Collection of informed consent from the parental authority, by both parents or the legal guardian(s).\n\nExclusion Criteria:\n\n* Refusal of consent by at least one parent or by the legal guardian(s),\n* Patient with a contraindication to IV-DXM:\n\n  * Uncontrolled local or general infection,\n  * Active viral infections (hepatitis, herpes, chickenpox, shingles),\n  * Live vaccines,\n  * Severe coagulation disorders,\n  * Ongoing gastrointestinal bleeding,\n  * Known hypersensitivity to IV-DXM or one of its excipients.\n* Patient participating in another interventional study involving human subjects or being in the exclusion period following a previous study involving human subjects, if applicable,\n* Patient receiving State Medical Aid,\n* Patient on long-term NIV,\n* Known upper airway pathology (UAP) before intubation or at the time of extubation,\n* History of UAP surgery within the month preceding inclusion,\n* Any situation deemed incompatible with the child's participation in the trial at the discretion of the investigating physician,\n* Decision to limit or stop therapeutic interventions.\n* Premature patients aged less than 40 weeks of gestation\n* Newborns aged less than 2 days after post-term birth","2 Days","6 Years",{"count":413,"type":22},348,[139],"Fifty to 60% of children admitted to a pediatric intensive care unit (PICU) are placed under invasive mechanical ventilation (MV) at least once during their stay. After extubation, about 30% of these patients will experience respiratory distress due to upper airway obstruction (RDUAO), and about one-third of these cases will require re-intubation. Treating this RDUAO extends the length of stay in the PICU.\n\nPre-extubation corticosteroid therapy has been validated in adults as a preventive treatment for the occurrence of RDUAO. However, the lack of robust data in pediatrics has not allowed for a consensus on the benefit of its use in children on MV in the PICU.\n\nThe investigators propose to conduct a randomized, multicenter, double-blind, placebo-controlled study evaluating the effect of intravenous dexamethasone (IV-DXM) before extubation on the incidence of RDUAO in children.",[417],"Intensive Care Pediatric",[419,420],"Corticosteroids","Intensive Care Pediatrics",{"date":31,"type":32},{"date":423,"type":32},"2025-10-28",{"date":425,"type":22},"2028-11",{"name":427,"class":39},"Assistance Publique - Hôpitaux de Paris",15,{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":50,"phases":438,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":450},"100563701","phase-1-a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-gdc-7035-as-a-single-agent-and-in-combination-in-patients-with-advanced-solid-tumors-100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":437,"type":22},410,[439],"PHASE1","This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[442],"Solid Tumor",{"date":31,"type":32},{"date":445,"type":32},"2024-11-14",{"date":447,"type":22},"2028-05-31",{"name":449,"class":78},"Genentech, Inc.",42,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":18,"minAge":459,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":476},"100560673","performance-and-safety-assessment-of-the-mechanical-decongestant-seawater-spray-enriched-with-essential-oils-from-laboratoires-gilbert-in-patient-with-acute-rhinitis-associated-with-nasal-obstruction-100560673","NCT06580210","Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction","Prospective Multicenter Clinical Investigation to Evaluate the Performance and the Safety of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert (DEMECA)","DEMECA","Inclusion Criteria:\n\n* 1\\. Patient ≥ 12 years,\n* 2\\. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,\n* 3\\. a. Informed adult patient who has given written consent prior to any study specific procedure,\n* b. Informed minor patients who has given assent and whose legal guardians have given written consent prior to any study specific procedure,\n* 4\\. Patient able to meet the study requirements (questionnaire completion),\n* 5\\. Patient affiliated to a social security scheme.\n\nExclusion Criteria:\n\n* 1\\. Patient who does not want to participate to the clinical investigation,\n* 2\\. Hypersensitivity to seawater and\u002For known allergies to any of the ingredients of the spray,\n* 3\\. A child with a history of febrile convulsions,\n* 4\\. Diseases leading to respiratory insufficiency,\n* 5\\. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,\n* 6\\. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,\n* 7\\. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,\n* 8\\. Patient under guardianship, curatorship of safeguard of justice.","12 Years",{"count":461,"type":22},114,"The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.",[464,465,466,467,468],"Acute Rhinitis","Nasal Obstruction","Rhinosinusitis","Rhinopharyngitis","Allergic Rhinitis",{"date":31,"type":32},{"date":471,"type":32},"2024-10-22",{"date":473,"type":22},"2026-12-07",{"name":475,"class":78},"Laboratoires Gilbert",3,{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":40},"100558210","aqualisqol-of-cll-patients-treated-with-acalabrutinib-in-france-retrospective-study-based-on-data-from-platon-database-100558210","NCT06548152","AQUALIS:QoL of CLL Patients Treated With Acalabrutinib in France, Retrospective Study Based on Data From PLATON Database","AQUALIS: Quality of Life of Patients With Chronic Lymphocytic Leukemia Treated With Acalabrutinib in France: a Retrospective Observational Study Based on Data Extracted From the PLATON Database","AQUALIS","Inclusion criteria:\n\nThe following patients will be eligible for inclusion in the AQUALIS study :\n\n* Patient enrolled in the PLATON database\n* Patient ≥18 years old\n* Treatment naïve CLL patient treated with acalabrutinib in a real life setting. Treatment pattern is Acala mono or Acala + Obinutuzumab\n* Patient who do not object to his health data collected in PLATON study being re-use for analysis\u002Fresearch purpose\n* Patients who started Acala but discontinued before 12 months are also included.\n\nExclusion criteria:\n\n* Pregnant women\n* Patients under protection of justice\n* Patients over the age of 18 and unable to express their non-opposition\n* Patients with prior CLL treatments",{"count":109,"type":22},"QoL is often not assessed in real-world studies; hence, there is limited understanding about the real-world QoL of patients diagnosed with CLL. Besides, studies evaluating QoL have largely focused on comparing treated and untreated populations. In particular, QoL of patients treated with acalabrutinib has not been evaluated in a real-life setting.\n\nThe aim of this study is to describe the QoL of CLL patients treated with acalabrutinib between the treatment initiation and twelve months after, in a real-life setting.",[488],"Chronic Lymphocytic Leukemia",[490,491,492,493,494,495],"Chronic Lymphocytic Leukemia (LLC)","Quality of life","Acalabrutinib","France","Retrospective observational study","PLATON database",{"date":31,"type":32},{"date":498,"type":32},"2025-04-28",{"date":500,"type":22},"2026-12-31",{"name":346,"class":78},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":510,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":50,"phases":514,"briefSummary":515,"conditions":516,"keywords":519,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":528},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":513,"type":22},975,[139],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[517,518],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[520],"GA secondary to AMD",{"date":31,"type":32},{"date":523,"type":32},"2024-10-30",{"date":525,"type":22},"2033-04-09",{"name":527,"class":78},"Regeneron Pharmaceuticals",224,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":411,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":50,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":547,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":551,"locationsCount":79},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening",{"count":537,"type":22},134,[139],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[541],"Prader-Willi Syndrome",[543,544,545,546],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":31,"type":32},{"date":549,"type":32},"2024-05-28",{"date":398,"type":22},{"name":552,"class":78},"Harmony Biosciences Management, Inc.",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":50,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":574},"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":137,"type":22},[91],"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.",[564,565,566],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":31,"type":32},{"date":569,"type":32},"2023-12-27",{"date":571,"type":22},"2029-08",{"name":573,"class":78},"Orchestra BioMed, Inc",130,{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":585,"conditions":586,"keywords":589,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100492944","coroflex-isar-neo-pmcf-study-100492944","NCT05698732","Coroflex® ISAR NEO PMCF Study","Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study","rEPIC07","Inclusion Criteria:\n\nCoroflex® ISAR NEO is intended to be used for\n\n* Patients must be at least 18 years of age AND\n* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his\u002F her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND\n* Patients with Novo lesion length 2-4 mm AND\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients with express refusal by the patient to participate in the study.\n* Patients pregnant women and lactating women.\n* Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).\n* Patients in whom anti-platelet and\u002For anti-coagulation therapy is contraindicated\n* Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation\n* Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent\n* Patients with known sensitivity to contrast agents who cannot be premedicated.\n* Patients with contraindications or hypersensitivity to sirolimus\n* Patients with a life expectancy of less than 2 years\n* Patients included in other clinical trials",{"count":584,"type":22},3000,"International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.",[587,588],"Coronary Artery Disease (CAD)","Ischemic Heart Disease",[590,591,592],"MDR (Medical Device Regulations)","PMCF (Post-Market Clinical Follow-up)","Drug Eluting Stent",{"date":31,"type":32},{"date":595,"type":32},"2023-08-04",{"date":597,"type":22},"2027-02-01",{"name":599,"class":39},"Fundación EPIC",24,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":50,"phases":610,"briefSummary":611,"conditions":612,"keywords":615,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"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":609,"type":22},626,[52,139],"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.",[613,614],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[616,617,65,614,618,619,620],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":31,"type":32},{"date":623,"type":32},"2020-12-02",{"date":625,"type":22},"2029-10-31",{"name":627,"class":78},"Mirati Therapeutics Inc.",770,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":50,"phases":639,"briefSummary":641,"conditions":642,"keywords":646,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":668},"100311904","phase-4-dabrafenib-andor-trametinib-rollover-study-100311904","NCT03340506","Dabrafenib and\u002For Trametinib Rollover Study","Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and\u002For Trametinib Study","Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib\u002Ftrametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and\u002For trametinib dosing has been interrupted in the parent study.","100 Years",{"count":638,"type":22},100,[640],"PHASE4","This study is to provide access for patients who are receiving treatment with dabrafenib and\u002For trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.",[64,643,442,644,645],"Non Small Cell Lung Cancer","Rare Cancers","High Grade Glioma",[647,648,649,650,651,64,652,653,654,655,656,643,657,658,659,660,645],"Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers",{"date":31,"type":32},{"date":663,"type":32},"2018-01-26",{"date":665,"type":22},"2032-12-28",{"name":667,"class":78},"Novartis Pharmaceuticals",33,""]