[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Slovenia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":692},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,207,0,25,[9,43,74,105,143,172,202,226,253,274,297,327,355,379,401,423,452,480,504,529,550,580,607,635,668],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019",false,"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","ALL","1 Year","35 Years",{"count":22,"type":23},150,"ESTIMATED","INTERVENTIONAL",[26],"PHASE3","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.",[29],"Diabetes Mellitus, Type 1","RECRUITING","2026-08-24",{"date":33,"type":34},"2026-08-25","ACTUAL",{"date":36,"type":34},"2026-01-12",{"date":38,"type":23},"2031-07",{"name":40,"class":41},"Eli Lilly and Company","INDUSTRY",113,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100653219","adjunctive-probiotic-therapy-in-major-depressive-disorder-a-randomized-controlled-trial-promood-100653219","NCT07786285","Adjunctive Probiotic Therapy in Major Depressive Disorder: A Randomized Controlled Trial (ProMOOD)","ProMOOD","Inclusion Criteria:\n\n\\- Age 18-65 years\n\n* Confirmed diagnosis of depression according to ICD 11 (International Classification of Diseases) criteria\n* Written informed consent\n* Stable antidepressant therapy (same medication for at least 6 weeks to ensure stable clinical response)\n\nExclusion Criteria:\n\n* \\- Acute suicidality\n* Severe cardiovascular disease\n* Pregnancy or breastfeeding\n* Substance\u002F alcohol abuse\n* Severe neurological or systemic disease\n* Recent antibiotic use\n* Probiotic use in past year\n* Treatment resistant depression\n* Psychotic depression","18 Years","65 Years",{"count":53,"type":23},200,[55],"NA","A double-blind, randomized controlled trial (RCT) aimed at evaluating the efficacy of probiotic supplementation in patients undergoing concurrent antidepressant therapy.\n\nThe study will also assess gut microbiome composition and function, and correlate microbiome changes with clinical and psychological outcomes.\n\nParticipants will be evaluated by a psychiatrist\u002Fclinician, alongside standardized psychological assessments at:\n\n* Baseline (inclusion)\n* Week 4\n* Week 12\n\nThe following validated instruments will be used:\n\n* HAM-D - Hamilton Depression Rating Scale (clinician-rated depression severity)\n* BDI - Beck Depression Inventory (self-reported severity of depression)\n* PSS - Perceived Stress Scale (self-reported stress perception)\n\nInclusion Criteria\n\n* Age 18-65 years\n* Confirmed diagnosis of depression according to ICD 11 (International Classification of Diseases) criteria\n* Written informed consent\n* Stable antidepressant therapy (same medication for at least 6 weeks to ensure stable clinical response)\n\nExclusion Criteria\n\n* Acute suicidality\n* Severe cardiovascular disease\n* Pregnancy or breastfeeding\n* Substance\u002F alcohol abuse\n* Severe neurological or systemic disease\n* Recent antibiotic use\n* Probiotic use in past year\n* Treatment resistant depression\n* Psychotic depression\n\nSample Size\n\n* Initial recruitment target: 150-200 participants\n* Expected dropout rate: approximately 50%, based on similar studies\n* Final expected sample size: \\~100 participants\n* Sample size calculation based on Nikolova et al., 2023.\n\nPrimary outcome Change in Hamilton Depression Rating Scale (HAM-D-17) score from baseline to Week 12.\n\nSecondary outcomes Change in Beck Depression Inventory-II (BDI-II) score from baseline to Week 12. Change in Perceived Stress Scale (PSS-10) score from baseline to Week 12. Changes in gut microbiome composition and diversity (α-diversity, β-diversity and relative abundance of bacterial taxa) between baseline and Week 12.\n\nSafety and tolerability of probiotic supplementation, assessed by adverse events and treatment discontinuation.\n\nIntervention:\n\nOmniBiotic Stress Repair\n\nMicrobiome Analysis Subgroup\n\nStool samples will be collected at:\n\n* Baseline\n* 1 month\n* 3 months Analysis will follow methodologies similar to Mörkl S et al. (2025).\n\nRemark: Additional sampling at 1 week (as done in the referenced study) is considered unnecessary, as it falls outside routine clinical monitoring.\n\nAntidepressant Strategy\n\n* Include patients receiving SSRI (Selective Serotonin Reuptake Inhibitors) and possibly SNRI (Serotonin-Norepinephrine Reuptake Inhibitors)\n* Advantage: broader applicability\n* Limitation: increased variability",[58],"Depression \u002F Major Depressive Disorder",[60,61,62],"depression","probiotics","randomized controlled study","NOT_YET_RECRUITING","2026-08-21",{"date":33,"type":34},{"date":67,"type":23},"2026-10",{"date":69,"type":23},"2030-10",{"name":71,"class":72},"University Maribor","OTHER",1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":18,"minAge":19,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100602022","innodia-family--friends-early-stage-t1d-detection-protocol-100602022","NCT07118098","INNODIA Family & Friends Early-Stage T1D Detection Protocol","INNODIA DETECT","Inclusion Criteria:\n\n1. Have given written informed consent to participate\n2. Be aged between 1 and 45 years\n3. Have a family relative with T1D or close friend diagnosed with symptomatic T1D at age \\\u003C45 years\n\nExclusion Criteria:\n\n1. Previous diagnosis of stage 3 T1D or other forms of diabetes\n2. Unable\u002Funwilling to consent to participation",true,"45 Years",{"count":84,"type":23},30000,"OBSERVATIONAL","The purpose of INNODIA DETECT is to identify people who are at increased risk of developing T1D. Investigators are doing this by testing for markers in the blood (autoantibodies) that tell them an individuals risk of getting T1D in the future.\n\nWhat is Type 1 Diabetes (T1D)? T1D is a serious disease where the blood glucose (sugar) level is too high because the body cannot make a hormone called insulin.\n\nThis happens when the body's immune system attacks the cells in the pancreas that make insulin (called beta cells), meaning that insulin production stops.\n\nThis is harmful to the body as insulin does an essential job. It allows the glucose in the blood to enter cells and fuel the body, resulting in a lowering of the blood glucose level.\n\nWhat are Autoantibodies? T1D autoantibodies are markers found in the blood that indicate that the destruction of insulin producing cells has begun. The risk of developing T1D increases with the number of autoantibodies detected.\n\nPeople who have 1 autoantibody detected in their blood are at increased risk of developing T1D. The presence of 2 or more autoantibodies indicates that T1D is present but the individual does not show any signs or symptoms yet.\n\nHowever, these autoantibodies can be present for many years before someone develops symptoms of T1D. They often appear in the first few years of life.\n\nThe investigators are asking children and adults across Europe, aged between 1 and 45 years, who have either a family member (parent, child, full or half sibling) or close friend diagnosed with T1D before 45 years of age to provided a small blood sample so they can look at these T1D autoantibodies.\n\nIf a participant's autoantibody results are negative, this means they do not have autoantibodies and are at low risk of developing T1D. No further tests will be required, and they will exit the program.\n\nIf results indicate a participant has 1 or more positive T1D autoantibodies, a member of the clinical team will contact and invite them to the hospital for a venous blood sample to confirm the result. This confirmation test will be done as part of routine clinical care by the participants clinical team. INNODIA DETECT will end here and, if confirmed positive, the participant will be invited to attend further follow-up by entering in a separate protocol (named INNODIA MONITOR).",[88,89],"Type 1 Diabetes (T1D)","Pre Diabetes",[91,92,93,94,95,96],"Type 1 diabetes","Autoantibodies","Screening","Pre-T1D","Stage 1","Stage 2",{"date":31,"type":34},{"date":99,"type":34},"2025-06-25",{"date":101,"type":23},"2027-12",{"name":103,"class":72},"INNODIA iVZW",21,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":142},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":113,"type":23},492,[26],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[117],"Multiple Myeloma",[119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135",{"date":31,"type":34},{"date":137,"type":34},"2024-02-08",{"date":139,"type":23},"2027-12-30",{"name":141,"class":41},"Pfizer",270,{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":24,"phases":154,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"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","75 Years",{"count":153,"type":23},390,[155,26],"PHASE2","The purpose of this study is to determine whether BHV-7000 is effective in the treatment of refractory focal epilepsy.",[158],"Focal Epilepsy",[158,160,161,162,163],"Epilepsy","Seizure","Refractory Epilepsy","Partial Epilepsy",{"date":31,"type":34},{"date":166,"type":34},"2024-03-14",{"date":168,"type":23},"2026-12",{"name":170,"class":41},"Biohaven Therapeutics Ltd.",124,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":81,"sex":18,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":24,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":73},"100644142","polarized-aerobic-training-and-vascular-adaptations-in-apparently-healthy-individuals-100644142","NCT07665632","Polarized Aerobic Training and Vascular Adaptations in Apparently Healthy Individuals","Adaptations of Vascular and Cardiorespiratory Function to a 6-week Polarized Aerobic Training Model in Apparently Healthy Individuals","ACT-ON-CHRONIC","Inclusion Criteria:\n\n* Men and women aged 30-50 years\n* Apparently healthy individuals without diagnosed cardiovascular, metabolic, or renal disease\n* Sedentary lifestyle verified using the Global Physical Activity Questionnaire (GPAQ) and current physical activity classification criteria\n* Ambulatory blood pressure values within the normotensive range (\\\u003C140 mmHg systolic and \\\u003C90 mmHg diastolic)\n* Body mass index (BMI) \\\u003C30 kg\u002Fm²\n* No regular participation in structured exercise training\n\nExclusion Criteria:\n\n* Ambulatory blood pressure values ≥140 mmHg systolic and\u002For ≥90 mmHg diastolic\n* Moderate or high physical activity level according to the Global Physical Activity Questionnaire (GPAQ)\n* Diagnosed chronic cardiovascular, metabolic, renal, respiratory, or other systemic disease\n* Use of prescribed medication influencing cardiovascular or metabolic function\n* Musculoskeletal injury of the lower extremities within the previous six months\n* Menopause\n* Absence of a regular menstrual cycle\n* Pregnancy\n* Current smoking or tobacco use","30 Years","50 Years",{"count":183,"type":23},30,[55],"This randomized controlled trial will investigate the effects of a 6-week polarized aerobic training intervention on vascular and cardiorespiratory function in apparently healthy sedentary adults aged 30-50 years. Polarized training is characterized by a high proportion of low-intensity aerobic exercise combined with a smaller volume of high-intensity interval exercise, potentially providing complementary haemodynamic and physiological stimuli that support vascular adaptations and cardiovascular health. Although polarized training has been extensively studied in athletic populations, its effects on vascular function in sedentary adults remain insufficiently understood.\n\nThirty participants will be randomly assigned in a 1:1 ratio to either a supervised polarized aerobic training group or a non-exercising control group. The intervention will consist of a 6-week supervised cycle ergometer training program performed three times per week and prescribed according to individual ventilatory thresholds obtained during cardiopulmonary exercise testing. Training sessions will combine low-to-moderate-intensity continuous exercise and high-intensity interval exercise. Participants allocated to the control group will maintain their habitual sedentary lifestyle throughout the study period.\n\nThe primary outcome will be endothelial function assessed by brachial artery flow-mediated dilation. Secondary outcomes will include arterial stiffness assessed by pulse wave velocity, central haemodynamics, microvascular function, cardiorespiratory fitness, skeletal muscle function, pulmonary function, respiratory muscle strength, and circulating biomarkers related to vascular health. Outcome measures will be assessed at baseline and after completion of the 6-week intervention period. The findings of this study may improve understanding of vascular and systemic adaptations to polarized aerobic training and help inform future exercise-based strategies for cardiovascular risk reduction in apparently healthy sedentary adults.",[187],"Sedentary Lifestyle",[189,190,191,192,193],"Polarized training","Vascular function","Flow-mediated dilation","Pulse wave velocity","Randomized controlled trial","2026-08-20",{"date":31,"type":34},{"date":197,"type":23},"2026-09-25",{"date":199,"type":23},"2027-12-20",{"name":201,"class":72},"University of Ljubljana",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":24,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100607359","phase-2-safety-and-efficacy-of-human-anti-thymocyte-immunoglobulin-sab-142-arresting-progression-of-type-1-diabetes-100607359","NCT07187531","SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes","A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients With Stage 3 New Onset of Type 1 Diabetes (NOT1D)","SAFEGUARD","Inclusion Criteria:\n\n1. Participant and\u002For appropriate legal guardian for participants below the legal age of consent must have given written informed consent and\u002For assent according to local, regional and\u002For country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Participants and legal guardians must be capable of providing informed consent and not be incapacitated.\n2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\\*, inclusive, at the time of randomisation in Part B.\n3. Weight ≥16.0 kg at time of randomisation. Participants age 18-40 will have a body mass index (BMI) from 16 to 32 (inclusive).\n4. Participant has received a diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: Unless previously diagnosed with preclinical (Stage 1 or Stage 2 T1D), participant must have initiated insulin therapy by the time of randomisation. An extension of no more than 14 days is permitted if a participant has planned and\u002For is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.\n5. Participant has random C-peptide levels of ≥0.2 nmol\u002FL, measured during Screening. One random C-peptide retest during screening period is allowed.\n6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.\n7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:\n\n   * Glutamic acid decarboxylase 65 (GAD65)\n   * Islet antigen 2 (IA-2)\n   * Zinc transporter 8 (ZnT8)\n   * Insulin autoantibodies (if testing within the first 14 days of insulin treatment)\n8. Female participants:\n\n   a. Must be of nonchildbearing potential, i.e., pre-pubertal\\*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin \\[β-HCG\\]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.\n\n   ii. Agree not to become pregnant or donate ova from the time of signing the consent form until the end of study visit.\n\n   iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from the time of signing the consent and for the duration of the study.\n\n   \\* Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)\u002Fguardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.\n9. Male participants, if not biologically or surgically sterilised, must:\n\n   1. Agree not to donate sperm from the time of signing the consent form until EOS.\n   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from time of signing the consent form until EOS.\n   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.\n10. Prior to receiving study drug, participant must agree to receive locally, regionally and\u002For country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and\u002For country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.\n11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and\u002For stimulate pancreatic β cell regeneration or insulin secretion.\n12. Participant has suitable venous access for blood sampling.\n13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n14. Part C: Participant has completed Month 12 assessments for Part A and Part B and meets all applicable eligibility requirements for participation in Part C.\n\nExclusion Criteria:\n\n1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications). This includes participants with Hereditary Fructose Intolerance.\n2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.\n3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV) 2 (Parts A and B) or 28 days prior to Day 1, TP3 (Part C)\n4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.\n5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and\u002For efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.\n6. Participant has any autoimmune disease other than T1D (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.\n7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.\n8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.\n9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and\u002For TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.\n10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus \\[CMV\\], Epstein-Barr Virus \\[EBV\\] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I\u002FE are met. Participants who have an active infection and\u002For fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.\n11. Participant has a diagnosis of significant liver disease or at screening ALT and\u002For AST \\>2× or total bilirubin of \\>1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enroll if only total and\u002For indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.\n12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:\n\n    * Lymphocyte count: \\\u003C1000\u002FμL\n    * Neutrophil count: \\\u003C1500\u002FμL\n    * Platelet count: \\\u003C100 000 platelets\u002FμL\n    * Haemoglobin: \\\u003C10 g\u002FdL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and\u002For is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges.\n13. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed.\n14. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \\[glucagon-like peptide-1\\], dipeptidyl peptidase-4 \\[DPP-IV\\] inhibitors, or amylin).\n15. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin).\n16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug.\n17. Recent or planned vaccinations as follows:\n\n    Countries within EU member states only:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): From 30 days before dosing through 6 months following administration or SAB-142 for each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: From 30 days before dosing or within 60 days following dosing; or planned\u002Frequired within 30 days prior to or 60 days following Day 1 of TP2.\n\n    All other countries:\n    * Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days following Day 1 of each TP.\n    * Recombinant, inactivated or otherwise \"non-live\" vaccines: Within the 30 days before dosing before dosing or within 30 days following dosing; or planned\u002Frequired within 30 days prior to or 30 days following Day 1 of TP.\n18. Female is lactating and\u002For plans to lactate with the intent to provide her own breast milk to a baby at any point during the study.\n19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and\u002For country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit\u002Fhyperactivity disorder (ADHD) or others are allowed to participate in the study.\n20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial.\n21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site.\n22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI, or if participation in the study may place the participant at risk.\n23. An individual who has been placed in an institute by official or court order.","5 Years","40 Years",{"count":213,"type":23},159,[155],"This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).",[217],"Type 1 Diabetes",{"date":31,"type":34},{"date":220,"type":34},"2025-11-25",{"date":222,"type":23},"2028-12",{"name":224,"class":41},"SAb Biotherapeutics, Inc.",70,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":24,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":252},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":234,"type":23},162,[155],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[238],"Chronic Inflammatory Demyelinating Polyneuropathy",[238,240,241,242,243,244],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","CIDP","Imeroprubart",{"date":64,"type":34},{"date":247,"type":34},"2025-03-18",{"date":249,"type":23},"2030-05",{"name":251,"class":41},"Immunovant Sciences GmbH",141,{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":24,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":273},"100548691","phase-3-a-study-to-test-whether-vicadrostat-in-combination-with-empagliflozin-helps-people-with-heart-failure-100548691","NCT06424288","A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","Inclusion criteria:\n\n1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\\u003C27 kg\u002Fm²: ≥300 pg\u002FmL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg\u002Fm² to \\\u003C35 kg\u002Fm²: ≥220 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg\u002Fm²: ≥125 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg\u002FmL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg\u002FmL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg\u002Fg, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local\u002Finternational guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery\u002FCABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.",{"count":261,"type":23},6000,[26],"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat\u002Fempagliflozin group: participants take vicadrostat\u002Fempagliflozin as tablets once a day.\n* Placebo\u002Fempagliflozin group: participants take placebo\u002Fempagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.",[265],"Heart Failure",{"date":64,"type":34},{"date":268,"type":34},"2024-06-17",{"date":270,"type":23},"2028-05-22",{"name":272,"class":41},"Boehringer Ingelheim",652,{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":24,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":296},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":283,"type":23},1700,[26],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[287,288],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis","2026-08-19",{"date":194,"type":34},{"date":292,"type":34},"2024-05-06",{"date":294,"type":23},"2027-05-05",{"name":272,"class":41},373,{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":81,"sex":18,"minAge":50,"maxAge":20,"enrollmentInfo":304,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":73},"100652160","biological-profile-of-primary-and-secondary-lymphedema-inflammatory-endothelial-metabolic-lymphatic-and-fibrotic-markers-100652160","NCT07770399","Biological Profile of Primary and Secondary Lymphedema: Inflammatory, Endothelial, Metabolic, Lymphatic, and Fibrotic Markers","LYMPH5","General inclusion criteria for all participants:\n\n* Adults aged 18 to 45 years.\n* Ability to understand the study information and provide written informed consent.\n* Willingness and ability to attend one study visit and undergo the planned clinical assessment, blood sampling, and skin swab collection.\n\nAdditional inclusion criteria for participants with primary lymphedema:\n\n* Clinically and, where appropriate, imaging-confirmed primary lymphedema of an upper or lower extremity.\n* Lymphedema classified as Stage I or II according to the applicable clinical classification. Participants with Stage III disease may be included if disease progression is associated with recurrent cellulitis or erysipelas and this is documented separately.\n* Current treatment or follow-up at the Department of Dermatovenereology, University Medical Centre Ljubljana.\n\nAdditional inclusion criteria for participants with secondary lymphedema:\n\n* Clearly established acquired cause of lymphedema.\n* Comparable anatomical location and, where feasible, disease stage to the primary lymphedema group.\n* Completion of active oncological treatment, where secondary lymphedema is cancer-related.\n\nHealthy control participants:\n\n* No clinical signs or previous history of lymphedema.\n* Comparable age and sex distribution to the lymphedema groups.\n\nExclusion Criteria\n\n* Other major causes of limb swelling, including heart failure, nephrotic syndrome, clinically significant thyroid disease, or medications likely to cause edema when the effect cannot be adequately accounted for.\n* Acute systemic infection or cellulitis\u002Ferysipelas within 4 weeks before study enrollment.\n* Pregnancy or breastfeeding.\n* Active oncological treatment.\n* Active smoking.\n* Active inflammatory skin disease that could substantially affect the skin microbiome or systemic inflammatory biomarkers.\n* Clinically manifest cardiovascular disease or previous cardiovascular event.\n* Treatment with medications that are expected to substantially affect the selected immunological or metabolic outcomes when their effects cannot be adequately accounted for in the analysis.\n* Inability to provide valid informed consent.\n\nGender eligibility:\n\n\\- Eligibility is not restricted by gender identity. Biological sex will be recorded where relevant for clinical and laboratory analyses, including sex-specific calculation of selected metabolic indices.\n\nWithdrawal:\n\nParticipants may withdraw from the study at any time without providing a reason and without any effect on their subsequent medical care.",{"count":305,"type":23},90,"This observational, cross-sectional study aims to characterize the biological profile of primary and secondary lymphedema by investigating five interconnected biological domains: T helper 2 (Th2)-related inflammation, endothelial activation, metabolic dysfunction, lymphatic biology, and tissue fibrosis.\n\nLymphedema is traditionally considered a disorder of impaired lymphatic drainage resulting in the accumulation of interstitial fluid. However, increasing evidence suggests that its development and progression involve chronic inflammation, endothelial dysfunction, metabolic alterations, abnormal lymphatic signaling, adipose tissue accumulation, and progressive tissue fibrosis. While these mechanisms have been investigated predominantly in secondary lymphedema, the systemic biological profile of primary lymphedema remains insufficiently characterized.\n\nThe study will include approximately 90 participants aged 18-45 years: 30 participants with primary lymphedema, 30 participants with secondary lymphedema, and 30 healthy control participants matched by age and sex. Each participant will attend one study visit lasting approximately 45-60 minutes.\n\nClinical assessment will include medical history, demographic characteristics, blood pressure, body measurements, assessment of lymphedema location and clinical stage, pitting edema, Stemmer sign, skin changes, limb volume measurement by perometry, and assessment of tissue firmness. Venous blood samples will be collected to assess routine laboratory parameters and a panel of inflammatory, endothelial, metabolic, lymphatic, and fibrotic biomarkers. A standardized skin swab will also be collected for exploratory skin microbiome analysis.\n\nFor the primary analysis, one representative marker will be selected in advance for each of the five biological domains: interleukin-13 (IL-13) for Th2-related inflammatory activity, soluble vascular cell adhesion molecule-1 (sVCAM-1) for endothelial activation, homeostatic model assessment of insulin resistance (HOMA-IR) for metabolic dysfunction, vascular endothelial growth factor C (VEGF-C) for lymphatic biology, and transforming growth factor beta 1 (TGF-β1) for tissue fibrosis. These five variables will constitute the co-primary outcome measures.\n\nSecondary analyses will evaluate additional biomarkers within each biological domain and their associations with clinical severity, including lymphedema stage, limb volume, pitting edema, Stemmer sign, and skin fibrosis. The study will also investigate relationships between the different biological domains and assess differences between primary and secondary lymphedema.\n\nExploratory analyses will characterize the skin microbiome of affected and standardized comparison sites and investigate associations between microbiome composition, clinical disease characteristics, and systemic biomarkers. In participants with primary lymphedema without a previously established genetic diagnosis, selected genetic variants associated with primary lymphedema will also be investigated.\n\nThe study will provide a comprehensive assessment of biological alterations associated with lymphedema and may help clarify differences between primary and secondary disease. The findings may contribute to a better understanding of lymphedema as a complex biological and tissue disorder and provide a basis for future studies of more targeted diagnostic and therapeutic approaches.",[308,309],"Primary Lymphedema","Secondary Lymphedema",[311,312,313,314,315,316,317,318],"lymphedema","primary lymphedema","secondary lymphedema","inflammation","endothelial activation","metabolic dysfunction","tissue fibrosis","skin microbioma","2026-08-18",{"date":194,"type":34},{"date":322,"type":23},"2026-09",{"date":324,"type":23},"2028-10",{"name":326,"class":72},"University Medical Centre Ljubljana",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":337,"conditions":338,"keywords":342,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":354},"100078039","product-performance-report-evaluate-long-term-reliability--performance-of-medtronic-marketed-cardiac-therapy-products-100078039","NCT00271180","Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products","Medtronic CRDM Product Performance Report","PPR","Subjects who meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.\n\nInclusion Criteria:\n\n• Subject or appropriate legal guardians provide written informed consent and\u002For authorization for access to and use of health information as required by an institution's IRB\u002FMEC\u002FREB\n\nAND one of the following must also apply:\n\n* Subject is indicated for implant or within 30 days post-implant of at least one Medtronic market-released product used for a pacing, sensing or defibrillation application\n* Subjects who participated in a qualifying study (IDE) of a Medtronic market-released product with complete implant and follow-up data and subject or appropriate legal guardian authorizes release of subject study data\n\nExclusion Criteria:\n\n* Subjects who are, or will be inaccessible for follow-up\n* Subjects with exclusion criteria required by local law (EMEA only)\n* Subjects receiving an implant of a Medtronic device at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant\n* Subjects implanted with a Medtronic device whose predetermined enrollment limit for that specific product has been exceeded",{"count":336,"type":23},20000,"The main purpose of the Product Performance Report (formerly referred to as System Longevity Study) is to evaluate long-term performance of Medtronic market-released cardiac rhythm products by analyzing product survival probabilities.",[339,340,265,341],"Arrhythmia","Bradycardia","Sinus Tachycardia",[343,344,345,346],"Cardiac Pacing","Implantable Cardioverter Defibrillator","pacemaker","Sinus Bradycardia",{"date":194,"type":34},{"date":349,"type":34},"1983-01",{"date":351,"type":23},"2040-12",{"name":353,"class":41},"Medtronic",333,{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":73},"100652762","effects-of-kefir-on-celiac-disease-100652762","NCT07777666","Effects of Kefir on Celiac Disease","Effects of Kefir Consumption on Celiac Disease Symptoms","CeliKef","Inclusion Criteria:\n\n* Adults aged 18 years or older with a confirmed diagnosis of celiac disease.\n* Following a strict gluten-free diet.\n\nExclusion Criteria:\n\n* Other chronic gastrointestinal diseases.\n* Pregnancy.\n* Known allergy or intolerance to milk or dairy products or other components of kefir.",{"count":183,"type":23},[55],"This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. The study will use a randomized cross-over design in which participants will consume kefir during one study period and continue their usual diet without kefir during another period.",[367],"Celiac Disease",[369,370,371],"celiac disease","kefir","gluten","2026-08-17",{"date":194,"type":34},{"date":375,"type":23},"2026-09-30",{"date":377,"type":23},"2027-11-29",{"name":71,"class":72},{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":7},"100652747","severe-complications-during-ventricular-tachycardia-or-premature-ventricular-complex-ablation-100652747","NCT07777744","Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation","Severe Complications During Ventricular Tachycardia or Premature Ventricular Complex Ablation - an International Multicenter Collaborative Study Group","Inclusion Criteria:\n\n* Centers : Centers participating in the present collaborative study group. Invitation to participate will be based either upon personal referral of one of the investigator, previous collaboration or based on a meta-analytic review of the literature published on the subject within the past 20 years.\n* Patients: Females and males of \\>18 years undergoing any type of VT\u002FPVC ablation. While we will accept redo-procedure we will ask for a unique patient-identifier to link procedures belonging to the same patients together.\n* Interventions: VT\u002FPVC ablation (first intervention or re-do) as routinely performed by the participating centers\n* Outcomes: Severe complications, defined as hemodynamic instability requiring mechanical intensive-care management, tamponade, stroke, cardiac arrest, myocardial infarction, phrenic nerve palsies, major bleeding requiring transfusion, vascular or cardiac complication requiring surgery, procedure-related death.\n* Setting: Observational cohort studies, registries, retrospective cohort studies. Data stemming from RCTs (Randomized controlled trials) will not be collected as they likely do not represent a \"real-life\" setting.\n* Length of follow-up: Peri-procedural complications\n* Years considered: Not limited to a specific time-frame, but to reflect common ablation practices, we will focus on data from the 20 past years.\n* Number of patients provided : No lower limit of patients provided per dataset or ablation volume per year to include high- as well as low-volume centers\n\nExclusion Criteria:\n\n* Refusal of the center to participate.\n* Less than 10 procedures available in the dataset (no case reports)\n* Missing essential baseline characteristics, missing collection of sufficient details regarding each complication.",{"count":387,"type":23},15000,"The investigators aim to characterize patients presenting with a severe ventricular tachycardia (VT) and premature ventricular complex (PVC)-ablation-related complication including patient characteristics, procedural details and subsequent management of the complication by gathering existing patient-level data.",[390,391],"Ventricular Tachycardia (VT)","Premature Ventricular Complexes",[393],"Ablation",{"date":194,"type":34},{"date":396,"type":34},"2024-07-01",{"date":398,"type":23},"2028-12-31",{"name":400,"class":72},"University Hospital, Basel, Switzerland",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":416,"completionDateStruct":418,"leadSponsor":420,"locationsCount":422},"100571974","real-world-study-of-trastuzumab-deruxtecan-in-patients-with-unresectable-or-metastatic-her2-low-breast-cancer-100571974","NCT06727227","Real-world Study of Trastuzumab Deruxtecan in Patients With Unresectable or Metastatic HER2-low Breast Cancer","REal-world Study of Trastuzumab deruXtecan in Patients With unresectabLe or Metastatic Breast Cancer Expressing HER2-lOw From BulgaRia and SlovEnia (EXPLORE)","EXPLORE","Inclusion Criteria:\n\n* Adult patient (age ≥18 years) with histological or cytological confirmed diagnosis of unresectable or mBC.\n* Documented HER2-low status (IHC1+, IHC2+\u002FISH-) in patients who have received prior chemotherapy in the metastatic setting or documented HER2-low status (IHC 1+, IHC 2+\u002FISH-) in patients who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.\n* Recent prior decision to initiate therapy of T-DXd per SmPC (up to 30 days). Documentation confirming this decision will be required and collected.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* History of other primary malignancies in 2 years prior to unresectable or mBC diagnosis.\n* Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n* HER2-low status patients who have previously documented HER2+ status in the same tumor.",{"count":410,"type":23},138,"A longitudinal, non-interventional study with trastuzumab deruxtecan for patients with HER2-low expressing unresectable or metastatic breast cancer in Bulgaria and Slovenia",[413],"Breast Cancer","2026-08-14",{"date":372,"type":34},{"date":417,"type":34},"2025-01-29",{"date":419,"type":23},"2027-10-31",{"name":421,"class":41},"AstraZeneca",14,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":451},"100652519","intracardiac-echocardiography-guided-versus-electroanatomical-mapping-guided-pulsed-field-ablation-for-paroxysmal-atrial-fibrillation-100652519","NCT07772518","Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation","Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)","PFA-VISION","Inclusion Criteria:\n\n* History of paroxysmal AF.\n* Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.\n\nExclusion Criteria:\n\n* Any contraindication to AF catheter ablation.\n* History of previous left atrial ablation.\n* Need for additional ablation beyond pulmonary vein isolation.\n* Inability to provide written informed consent.\n* Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* NYHA class III\u002FIV heart failure\n* Major cardiovascular events within 90 days\n* Secondary AF owing to reversible causes\n* Intracardiac thrombus or other conditions making left atrial instrumentation unsafe\n* Severe valvular disease",{"count":432,"type":23},292,[55],"This is a prospective, randomized clinical trial, which will be conducted in selected European centers. The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF). Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure. The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months. The primary safety endpoint will be the incidence of predefined safety outcomes.",[436],"Paroxysmal Atrial Fibrillation (PAF)",[438,439,440,441,442,443],"atrial fibrillation","paroxysmal atrial fibrillation","intracardiac echocardiography","ICE","FARAVIEW","pulsed field ablation","2026-08-13",{"date":289,"type":34},{"date":447,"type":34},"2026-08-01",{"date":222,"type":23},{"name":450,"class":72},"Mitera Hospital",8,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":459,"minAge":50,"maxAge":151,"enrollmentInfo":460,"targetDuration":4,"studyType":24,"phases":462,"briefSummary":464,"conditions":465,"keywords":467,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":73},"100652193","phase-4-the-effect-of-empagliflozin-and-metformin-on-oxidative-capacity-and-microvascular-reactivity-of-skeletal-muscle-in-patients-with-type-2-diabetes-mellitus-100652193","NCT07771010","The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus","EMPOWER","Inclusion Criteria:\n\n* Male sex\n* Age 18-75 years\n* Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment\n* Body mass index (BMI) 25-35 kg\u002Fm²\n* Currently managed at a diabetes outpatient clinic\n* No known chronic diabetes-related complications\n* No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas\n\nExclusion Criteria:\n\n* Other forms of diabetes mellitus (i.e., not type 2)\n* Type 2 diabetes mellitus known for more than 2 years\n* Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia\n* Known mitochondrial disease\n* Heart failure, NYHA class II or higher\n* Chronic kidney disease, stage 3 or higher\n* Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism)\n* Recurrent urinary tract infections\n* Active malignancy currently undergoing oncologic treatment\n* Life expectancy less than 3 months\n* Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol\u002FL, HbA1c ≥ 10%\n* Unwillingness to provide informed consent","MALE",{"count":461,"type":23},54,[463],"PHASE4","The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle? The study will enroll 54 individuals with type 2 diabetes in a prospective, randomized, interventional, open-label study. Participants will be randomized into 3 equally sized groups: 1) a group receiving empagliflozin; 2) a group receiving metformin; and 3) a group receiving a combination of both drugs (empagliflozin and metformin). The investigators will analyze the clinical variables of the subjects, near-infrared spectroscopy (NIRS) measurements over the flexor digitorum superficialis muscle of the non-dominant arm at rest, after submaximal muscular work, and during transient brachial artery occlusion at specified time intervals (14 days, 1 month, 3 months, 6 months), as well as body composition, physical performance, and glycemic control following the pharmacological intervention.",[466],"Diabetes Type 2",[468,469,470,471,472,473],"type 2 diabetes mellitus","Empagliflozin","Metformin","Skeletal muscle oxidative capacity","Near-infrared spectroscopy","Microvascular reactivity",{"date":319,"type":34},{"date":476,"type":34},"2026-04-16",{"date":478,"type":23},"2028-07-31",{"name":326,"class":72},{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":24,"phases":489,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100590162","phase-3-a-study-of-mezagitamab-in-adults-with-kidney-condition-called-iga-nephropathy-100590162","NCT06963827","A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy","* Inclusion Criteria:\n\nTo be eligible to participate in this trial, participants must meet all the following criteria:\n\n1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g\u002Fg) or urine protein excretion (UPE) ≥1 grams per day (g\u002Fday), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).\n2. eGFR greater than (\\>)30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).\n3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).\n4. The participant is aged ≥ 18 years or the local legal age as applicable.\n5. The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \\[ICF\\]) and any required privacy authorization before the initiation of any clinical trial procedures.\n6. Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.\n7. Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and\u002For angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n8. Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.\n9. Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin \\[hCG\\]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).\n10. Any one of the following (only applicable for participants in the open-label cohort):\n\n    1. Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \\>0.5 g\u002Fg or UPE \\>0.5 g\u002Fd calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\>30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    2. UPCR \\\u003C0.8 g\u002Fg and UPE ≥0.75 and \\\u003C1.0 g\u002Fday, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\> 30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    3. UPCR ≥ 0.8 g\u002Fg or UPE ≥ 1.0 g\u002Fd by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n\n       * Exclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).\n2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.\n3. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).\n4. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \\>3.5 g\u002Fday and hypoalbuminemia (\\\u003C3.0 grams per deciliter \\[g\u002FdL\\]) with or without peripheral edema.\n5. Renal or other organ transplantation prior to or expected during the clinical trial.\n6. Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.\n7. If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:\n\n   1. The last dose was received within 6 months before the signing of the ICF.\n   2. The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.\n\n   Note: Participants who have received the last dose of anti-CD20 treatment \\>12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.\n8. Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.\n9. The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.\n10. Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n11. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n12. The participant has had any of the following types of infections within the specified timeframes where applicable:\n\n    1. Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.\n    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.\n    3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.\n    4. Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.\n    5. For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.\n13. In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.\n14. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.\n15. The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.\n\n    Note: Major surgery typically requires at least 1 night in the hospital.\n16. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.\n17. The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.\n18. The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal at screening.\n19. The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.\n20. The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n21. The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n22. In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and\u002For unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).",{"count":488,"type":23},347,[26],"Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.\n\nParticipants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month.\n\nIn the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.\n\nDuring the study, participants will visit their study clinic several times.",[492],"Kidney Disease",[494,495],"TAK-079","Drug Therapy",{"date":414,"type":34},{"date":498,"type":34},"2025-07-15",{"date":500,"type":23},"2030-01-14",{"name":502,"class":41},"Takeda",176,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":24,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":522,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":461},"100383674","landmark-trial-a-randomised-controlled-trial-of-myval-thv-100383674","NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.",{"count":513,"type":23},988,[55],"The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)",[517],"Aortic Valve Stenosis",[519,520,521],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series",{"date":372,"type":34},{"date":524,"type":34},"2020-11-04",{"date":526,"type":23},"2033-12-31",{"name":528,"class":41},"Meril Life Sciences Pvt. Ltd.",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":536,"targetDuration":538,"studyType":85,"phases":4,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":547,"locationsCount":549},"100546360","pulseselect-pfa-global-registry-100546360","NCT06393920","PulseSelect™ PFA Global Registry","PulseSelect PFA Global Registry, a Part of the Medtronic Cardiac Ablation Post-Market Study Platform","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age or minimum age as required by local regulations.\n* Subject has been diagnosed with atrial fibrillation (AF)\n* Planned procedure using commercially available PulseSelect™ PFA System.\n* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements.\n\nExclusion Criteria:\n\n* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager.\n* Subject with exclusion criteria required by local law.",{"count":537,"type":23},1950,"12 Months","The PulseSelect™ PFA Global Registry is a prospective, global, multi-center, observational post-approval study. Subjects will be treated with the PulseSelect™ PFA System and followed according to SOC.",[541],"Atrial Fibrillation","2026-08-11",{"date":444,"type":34},{"date":545,"type":34},"2024-07-23",{"date":478,"type":23},{"name":548,"class":41},"Medtronic Cardiac Ablation Solutions",43,{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":556,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":558,"targetDuration":4,"studyType":24,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":73},"100651435","exercise-and-nutritional-intervention-in-patients-with-melanoma-receiving-immunotherapy-100651435","NCT07761871","Exercise and Nutritional Intervention in Patients With Melanoma Receiving Immunotherapy","Effects of Randomized Controlled Exercise and Nutritional Interventions on Muscle Mass, Volume, Fat Infiltration, and Clinical Outcomes in Patients With Malignant Melanoma Receiving Immunotherapy","MEL-FIT-IO","Inclusion Criteria:\n\n* Age 18 years or older.\n* Confirmed diagnosis of malignant melanoma, stage II, III, or IV.\n* Planned first-line or adjuvant treatment with immune checkpoint inhibitors.\n* Life expectancy greater than 6 months.\n* Sufficient knowledge of the Slovenian language.\n* Ability to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n* Previous treatment with immune checkpoint inhibitors or disease recurrence after previous treatment with immune checkpoint inhibitors.\n* Symptomatic brain metastases.\n* Contraindications to magnetic resonance imaging, such as MRI-incompatible metallic implants.\n* Neurological diseases affecting the skeletal muscular system, such as muscular dystrophy.\n* Any condition that, in the investigator's judgment, prevents participation or the safe performance of study assessments.\n* Participation in another study that includes structured physical exercise as part of its protocol.",{"count":559,"type":23},40,[55],"The purpose of this randomized study is to evaluate whether a six-month program of structured resistance exercise combined with individualized nutritional support can preserve or improve skeletal muscle mass and muscle quality in adults with stage II to IV malignant melanoma who are starting treatment with immune checkpoint inhibitors.\n\nParticipants will be randomly assigned either to the exercise and nutritional intervention in addition to standard oncology care or to standard oncology care alone. The study aims to obtain complete measurements from at least 40 participants.\n\nAssessments will be performed at baseline, after 3 months, and after 6 months. They will include magnetic resonance imaging of the thigh, dual-energy X-ray absorptiometry, bioelectrical impedance analysis, indirect calorimetry, clinical data, and patient-reported outcomes. The study will compare changes in skeletal muscle mass and volume, fatty infiltration of skeletal muscle, sarcopenia, body composition, resting energy expenditure, quality of life, fatigue, treatment tolerance, treatment delays, and early treatment discontinuation between the two groups.\n\nTreatment with immune checkpoint inhibitors is provided as part of routine clinical care and is not the investigational intervention.",[563],"Melanoma",[565,566,567,568,569,570],"Immune Checkpoint Inhibitors","Resistance Exercise","Nutritional Intervention","Skeletal Muscle Mass","Muscle Quality","Sarcopenia","2026-08-10",{"date":573,"type":34},"2026-08-12",{"date":575,"type":23},"2026-08",{"date":577,"type":23},"2029-06",{"name":579,"class":72},"Institute of Oncology Ljubljana",{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":24,"phases":589,"briefSummary":590,"conditions":591,"keywords":593,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":606},"100521142","phase-3-a-study-to-evaluate-efficacy-and-safety-of-giredestrant-compared-with-fulvestrant-plus-a-cdk46-inhibitor-in-participants-with-er-positive-her2-negative-advanced-breast-cancer-resistant-to-adjuvant-endocrine-therapy-pionera-breast-cancer-100521142","NCT06065748","A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4\u002F6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)","A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4\u002F6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy","Inclusion Criteria:\n\n* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent\n* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)\n* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing\n* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \\>\u002F=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4\u002F6i is allowed (if relapse occurred \\>\u002F=12 months since completion).\n* No prior systemic anti-cancer therapy for advanced disease\n* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1\n* For pre\u002Fperimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment\n\nExclusion Criteria:\n\n* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer\n* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents\n* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n* Active cardiac disease or history of cardiac dysfunction\n* Clinically significant history of liver disease",{"count":588,"type":23},1050,[26],"This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4\u002F6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.",[592],"Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer",[594,595,596],"oral Selective Estrogen Receptor Degrader (SERD)","CDK4\u002F6 inhibitor (CDK4\u002F6i)","ESR1 mutation","2026-08-03",{"date":599,"type":34},"2026-08-05",{"date":601,"type":34},"2023-12-11",{"date":603,"type":23},"2029-02-12",{"name":605,"class":41},"Hoffmann-La Roche",352,{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":18,"minAge":211,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":24,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":634},"100568255","elevate-hfpef-clinical-study-100568255","NCT06678841","ELEVATE-HFpEF Clinical Study","Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)","ELEVATE-HFpEF","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Documented EF ≥50% within the preceding 12 months\n3. HFpEF defined as:\n\n   1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR\n   2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n      * Interstitial \u002F pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure\n      * Elevated NT-proBNP in the last year defined as \\>400 pg\u002Fm for patients with no AF or paroxysmal AF, or \\>900 pg\u002Fml for patients with ≥persistent AF\n      * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)\n      * Echo criteria defined by ≥2 of:\n\n        * LV wall thickness ≥ 12 mm\n        * LV mass index (BSA indexed LVH): sex at birth male \\>115 g\u002Fm2, sex at birth female \\>95 g\u002Fm2\n        * Relative wall thickness ≥0.42\n        * E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation) OR septal \\\u003C7 cm\u002Fs or lateral e' \\\u003C10cm\u002Fs\n        * Tricuspid regurgitation (TR) velocity \\>2.8 m\u002Fs\n        * Left atrial (LA) enlargement, defined by LA volume index \\>34 ml\u002Fm2\n4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days\n5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)\n6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).\n\nExclusion Criteria:\n\n1. Improved or recovered EF (i.e., prior LVEF\\\u003C50%)\n2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))\n3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)\n4. Average heart rate \\\u003C50 bpm or symptomatic bradycardia\n5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.\n6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and\u002For inotropic drugs.\n7. Severe obesity defined as BMI \\>45.\n8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \\\u003C50 bpm or evidence of ventricular pauses exceeding 6 seconds\n9. Planned AF ablation\n10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)\n11. Hypertrophic cardiomyopathies\n12. Uncontrolled hypertension as defined by BP \\>160\u002F100 mmHg on two measurements ≥15 minutes apart\n13. End Stage Renal Disease (CKD 4 or greater)\n14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)\n15. Significant primary pulmonary disease on home oxygen\n16. Known contraindication for a pacemaker implant\n17. Advanced co-morbidity with life expectancy \\\u003C 1 year\n18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.\n19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).",{"count":616,"type":23},700,[55],"ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).",[620],"Heart Failure With Preserved Ejection Fraction (HFpEF)",[265,622,623,624,625],"Heart Disease","Cardiovascular Disease","Concentric Hypertrophy","Concentric Remodeling","2026-07-30",{"date":597,"type":34},{"date":629,"type":34},"2025-07-09",{"date":631,"type":23},"2029-02",{"name":633,"class":41},"Medtronic Cardiac Rhythm and Heart Failure",50,{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":642,"enrollmentInfo":643,"targetDuration":4,"studyType":24,"phases":645,"briefSummary":646,"conditions":647,"keywords":649,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":667},"100632713","phase-3-an-open-label-extension-ole-study-following-completion-of-ctqj230a12301-to-evaluate-long-term-safety-and-tolerability-of-pelacarsen-tqj230-100632713","NCT07517263","An Open Label Extension (OLE) Study (Following Completion of CTQJ230A12301) to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)","A Single Arm, Multicenter, Open-label Extension (OLE) Trial to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Participants Who Completed the Parent Lp(a)HORIZON Trial","Inclusion Criteria:\n\n* Participants who have provided informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n* Participants who have completed the parent study EOS visit while still on assigned investigational product.\n\nExclusion Criteria:\n\n* Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.\n* Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation, including, but not restricted to conditions outlined in Table 6-3 and Table 6-5.\n* Participants are receiving another investigational drug or device before the open-label treatment period.\n* Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":644,"type":23},5700,[26],"This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).",[648],"Cardiovascular Disease and Lipoprotein(a)",[650,651,652,653,654,655,656,657,658],"Lipoprotein(a),","Lp(a),","cardiovascular disease,","CVD,","myocardial infarction,","stroke,","OLE,","pelacarsen,","open-label","2026-07-29",{"date":626,"type":34},{"date":662,"type":34},"2026-05-11",{"date":664,"type":23},"2030-01-09",{"name":666,"class":41},"Novartis Pharmaceuticals",643,{"id":669,"slug":670,"hasResults":12,"nctId":671,"briefTitle":672,"officialTitle":673,"acronym":674,"eligibilityCriteria":675,"healthyVolunteers":12,"sex":18,"minAge":676,"maxAge":4,"enrollmentInfo":677,"targetDuration":4,"studyType":24,"phases":679,"briefSummary":680,"conditions":681,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":691},"100610455","evaluation-of-the-safety-and-performance-of-the-novel-medtronic-experimental-automated-insulin-delivery-system-nmx8-in-people-living-with-diabetes-nexus-100610455","NCT07227805","Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes (NEXUS)","Evaluation of the Safety and Performance of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in People Living With Diabetes","NEXUS","Inclusion Criteria:\n\n1. Is aged ≥2 years old at time of screening.\n2. Has a clinical diagnosis of Type 1 or Type 2 diabetes for ≥ 6 months prior to screening as determined via medical record by an individual qualified to make a medical diagnosis.\n3. Is on MiniMed™ 780G with Simplera Sync sensor for at least 3 months before screening.\n4. Has a glycosylated hemoglobin (HbA1c) \\\u003C11% (97 mmol\u002Fmol) at time of screening visit as processed at Point of Care (PoC) or local lab.\n5. Must have a minimum daily insulin requirement (Total Daily Dose) of ≥ 6 units and a maximum of 250 units\n6. Willing to switch to approved insulin per insulin pump labeling.\n7. Investigator has confidence that the subject, parent(s)\u002Flegal guardian(s) can successfully operate all study devices and is capable of adhering to study visit schedule per protocol.\n8. Subject, Parent(s)\u002Flegal guardian(s) is willing to participate in all training sessions as directed by study staff.\n9. Subject, Parent(s)\u002Flegal guardian(s) is willing and able to provide written informed consent.\n10. For subject with Type 2 Diabetes only: Is on stable dose of anti-diabetic medication (other than insulin) (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists\u002Fmimetics, metformin, SGLT2 inhibitors) for the last 3 months prior to screening. NB: Subject should not change type or dose of medication during the course of the study.\n11. For Israel only: Subject, Parents(s)\u002Flegal guardian(s) is fluent in English.\n\nExclusion Criteria:\n\n1. Has Addison's disease, growth hormone deficiency, hypopituitarism or definite gastroparesis, uncontrolled coeliac disease, uncontrolled thyroid disorder, or poorly controlled asthma, per investigator judgment.\n2. For subjects with Type 1 Diabetes only: Is using any anti-diabetic medication other than insulin 6 months before screening or plan on using during the study (e.g., pramlintide, DPP-4 inhibitor, GLP-1 and GIP agonists\u002Fmimetics, metformin, SGLT2 inhibitors).\n3. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any chronically oral, injectable, or IV glucocorticoids during the course of the study, per investigator judgement\n4. Has had renal failure defined by creatinine clearance \\\u003C30 ml\u002Fmin, as assessed by local lab test ≤ 6 months before screening or performed at screening at local lab, as defined by the creatinine-based Cockcroft, CKD-EPI or MDRD equations.\n5. Has active or severe retinopathy in the last 6 months before screening\n6. Has any unresolved adverse skin conditions in the area of sensor placement (e.g. psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).\n7. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.\n8. History of 2 or more DKA events in the last 3 months before screening.\n9. Has had Hyperosmolar Hyperglycemic State (HHS) in the last 6 months before screening.\n10. Is using hydroxyurea at time of screening or plans to use it during the study\n11. Women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study.\n12. Women who are breastfeeding.\n13. Is actively participating in an investigational study (drug or device) wherein he\u002Fshe has received treatment from an investigational study drug or device in the last 2 weeks before screening, as per investigator judgment.\n14. Subject is currently abusing illicit drugs, marijuana, alcohol or prescription drugs (other than nicotine), per investigator judgment.\n15. Subject, Parent(s)\u002Flegal guardian(s) are part of research staff involved with the study.\n16. Subject, Parent(s)\u002Flegal guardian (s) are legally incompetent, illiterate, or vulnerable.","2 Years",{"count":678,"type":23},116,[55],"This study will demonstrate the safety and performance of the Novel Medtronic Experimental Automated Insulin Delivery system named MiniMed™ NMX8 system in people living with insulin-requiring diabetes in comparison with the MiniMed™ 780G system.",[682],"Diabetes (Insulin-requiring, Type 1 or Type 2)","2026-07-28",{"date":659,"type":34},{"date":686,"type":34},"2026-07-19",{"date":688,"type":23},"2027-03-17",{"name":690,"class":41},"Medtronic MiniMed, Inc.",9,""]