[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Brazil\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":666},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1372,0,25,[9,46,76,97,125,158,182,212,241,280,305,334,357,383,414,442,472,499,525,551,572,588,609,629,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652278","molecular-ovarian-cancer-assessment-in-latinoamerican-patients-100652278",false,"NCT07771400","Molecular Ovarian Cancer Assessment in LatiNoAmerican PAtients","MOANA","Inclusion Criteria:\n\n1. Participants ≥18 years-old.\n2. Patients diagnosed with ovarian, fallopian tube or peritoneal cancer:\n\n   1. advanced stages stage III or IV by FIGO disease stage\n   2. new diagnosis and persistent or recurrent disease\n3. Diagnosed from 2018 to 2024.\n4. Histologically confirmed diagnosis of serous (low or high grade), endometrioid, mucinous or clear cell ovarian carcinoma.\n5. Accept to participate in the project and sign the informed consent (if applicable).\n6. An archived representative formalin-fixed paraffin-embedded (FFPE) tumor specimen in tumor tissue blocks (preferred) or freshly sectioned unstained slides (at least 20) from biopsy\u002Fsurgery is mandatory.\n\nExclusion Criteria:\n\n1. Histological ambiguous diagnosis upon review.\n2. Diagnosis based on cytology and without any biopsy or surgical specimen.\n3. Patients diagnosed and staged but not receiving any treatment.\n4. Patients without medical records available (lost, empty or irretrievable clinical information).","FEMALE","18 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","This is a multicentric observational study conducted at selected sites across Latin America. Eligible participants will be identified through the medical records of participating institutions. The study aims to describe overlap of expression of folate receptor alpha (FRα), HER2 and PD-L1 using immunohistochemistry (IHC) and HRD and BRCA (somatic and germline) by NGS. Additionally, to describe clinical demographic and socioeconomic variables, as well as treatment patterns, pathological characteristics, outcomes, and genetic and molecular testing part of clinical practice.\n\nAll data (including patient characteristics, treatment patterns, outcomes and available tests) will be collected once, retrospectively from medical records, ensuring adherence to ethical standards and participant confidentiality. Biomarkers analysis (including FRα, HER2 and PD-L1) will be performed prospectively, a Formalin-Fixed Paraffin-Embedded (FFPE) tumor block will be collected to evaluate and describe the expression of folate receptor alpha (FRα) and HER2, using immunohistochemistry (IHC) with the Roche Ventana kit (FOLR1 and HER2 4B5) and Dako's 22C3 for PD-L1. The study will analyze samples collected between 1st January 2018 to 31 December 2024 (analysis of historically collected samples).\n\nThe study comprises a retrospective data collection from medical charts. Participants will continue to receive treatment and clinical evaluations according to what is determined by their medical team, according to the usual standards of treatment and clinical practice of each center. No intervention or prospective follow-up is proposed in this study.",[25,26,27,28,29,30],"Ovarian Cancer by FIGO Stage","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Fallopian Tube Cancer Stage III","Fallopian Tube Cancer Stage IV","Fallopian Tube Cancers",[32],"Peritonial Cancer","NOT_YET_RECRUITING","2026-08-24",{"date":36,"type":37},"2026-08-25","ACTUAL",{"date":39,"type":21},"2026-09",{"date":41,"type":21},"2027-08",{"name":43,"class":44},"Latin American Cooperative Oncology Group","OTHER",17,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100649688","cold-and-nsaid-trial-for-prevention-of-post-ercp-pancreatitis-100649688","NCT07738094","Cold and NSAID Trial for Prevention of Post-ERCP Pancreatitis","Comparison Between Local Cryoprevention Associated With NSAIDs Versus NSAIDs Alone for Reducing the Incidence of Post-ERCP Pancreatitis: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients aged 18 years or older\n* Clinical indication for ERCP\n* Presence of native major duodenal papilla without previous manipulation\n* Ability of the patient or companion to provide informed consent.\n\nExclusion Criteria:\n\n* Contraindication to ERCP (e.g., severe hemodynamic instability, visceral perforation)\n* Ongoing acute pancreatitis (except mild biliary where ERCP is therapeutic and pain has already resolved)\n* Inaccessibility of the duodenal papilla (e.g., Gastrectomies with Billroth II and Roux-en-Y reconstruction, or gastroduodenal obstructions)\n* Pregnant women\n* Refusal to participate in the study or inability to sign the ICF\n* Contraindication to NSAID use.","ALL",{"count":55,"type":21},583,"INTERVENTIONAL",[58],"NA","The standard prophylaxis for post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) is performed with rectal non-steroidal anti-inflammatory drugs (NSAIDs). A recent Japanese study demonstrated the efficacy of irrigating the periampullary region with ice water, however without the concomitant use of NSAIDs. The proposed study is a randomized, single-center, single-blind clinical trial that aims to compare the efficacy of rectal NSAIDs alone versus NSAIDs associated with ice water in the prevention of PEP.",[61],"Pancreatitis, Acute",[63,64,65,66],"Post-ERCP Pancreatitis","Cryoprevention","ERCP","NSAIDs","RECRUITING",{"date":36,"type":37},{"date":70,"type":37},"2026-06-09",{"date":72,"type":21},"2028-08-31",{"name":74,"class":44},"Instituto do Cancer do Estado de São Paulo",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":84,"studyType":22,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100639662","a-study-to-identify-and-characterize-patients-with-type-2-diabetes-mellitus-for-possible-participation-in-ongoing-or-future-type-2-diabetes-mellitus-clinical-studies-100639662","NCT07606066","A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies","Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age at the time of signing the ICF.\n* Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World\n\nHealth Organization or local diagnostic standards, inadequately managed with:\n\n1. Lifestyle management alone, AND\u002FOR\n2. A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF.\n\n   * Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required.\n   * Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis.\n\nExclusion Criteria:\n\n* Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol).\n* Diagnosed with Type 1 diabetes mellitus.\n* Known pregnancy at the time of visit or having the intention to become pregnant.",{"count":83,"type":21},2150,"1 Day","The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.",[87],"Type 2 Diabetes",{"date":36,"type":37},{"date":90,"type":37},"2026-05-06",{"date":92,"type":21},"2027-03-31",{"name":94,"class":95},"AstraZeneca","INDUSTRY",76,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":53,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":56,"phases":108,"briefSummary":109,"conditions":110,"keywords":116,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":75},"100638363","photobiomodulation-effects-on-fatigue-and-muscle-damage-induced-by-nmes-100638363","NCT07602933","Photobiomodulation Effects on Fatigue and Muscle Damage Induced by NMES","Effects of Photobiomodulation on Fatigue and Muscle Damage Induced by Neuromuscular Electrical Stimulation in Healthy Individuals: a Randomized Clinical Trial","Inclusion Criteria:\n\n* Healthy male and female volunteers.\n* Age between 18 and 45 years.\n* Practice physical activity regularly\n* No history of musculoskeletal injuries in the lower limbs in the last 6 months\n* Ability to tolerate NMES\n\nExclusion Criteria:\n\n* Have sensory intolerable changes due to NMES\n* Consumed coffee or another stimulant in the last 12 hours\n* Have a body mass index (BMI) greater than 30 kg\u002Fm2 (grade I obesity)\n* Present any contraindication for the performance of maximum effort\n* Abnormal increase in blood pressure after maximal exertion",true,"45 Years",{"count":107,"type":21},36,[58],"Neuromuscular electrical stimulation (NMES) is widely used to improve muscle strength and mitigate atrophy. However, its clinical efficacy is often limited by early neuromuscular fatigue, muscle damage, and discomfort, which reduce patient tolerance and contraction time. Photobiomodulation (PBM) has emerged as a potential therapy to enhance muscle performance and accelerate recovery by minimizing fatigue and damage. Despite its potential, few studies have investigated the effects of PBM applied specifically before an NMES-evoked fatigue protocol. This randomized, double-blind, placebo-controlled trial aims to evaluate the acute effects of PBM on neuromuscular fatigue, muscle damage, and functional outcomes in healthy young subjects. Participants will receive either active PBM (cluster probe: 5 lasers 810nm\u002F200mW; 4 LEDs 660nm\u002F10mW; Total Energy: 249.6 J per limb) or sham treatment 5 minutes before a fatiguing NMES protocol (80 contractions at 20% MVIC, 80 Hz, 1ms pulse width) applied to the quadriceps muscle. Assessments will be performed at baseline, immediately post-intervention, and at 24h, 48h, and 72h post-intervention. Primary outcomes include maximum and evoked isometric strength, mechanical work, and electrical muscle activity. Secondary outcomes include muscle damage (ultrasound echo-intensity), delayed onset muscle soreness (DOMS), functional performance (unilateral vertical jump), and clinical discomfort. The study seeks to determine if PBM can effectively modulate NMES-induced fatigue and muscle damage, potentially optimizing its clinical application.",[111,112,113,114,115],"Photobiomodulation","Fatigue","Discomfort","Electrical Stimulation","Muscle Damage",[111,112,113,115,117],"Electrical stimulation",{"date":36,"type":37},{"date":120,"type":37},"2026-06-01",{"date":122,"type":21},"2026-09-30",{"name":124,"class":44},"Federal University of Rio Grande do Sul",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":53,"minAge":133,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":56,"phases":136,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100622055","phase-2-study-to-evaluate-the-pharmacodynamics-safety-and-efficacy-of-sky-0515-in-participants-with-huntingtons-disease-100622055","NCT07378644","Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","A Phase 2\u002F3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","FALCON-HD","Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain\u002Fspinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","25 Years",{"count":135,"type":21},400,[137,138],"PHASE2","PHASE3","The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.",[141],"Huntington Disease",[143,144,145,146,141,147,148,149],"SKY-0515","Skyhawk","HTT","Neurodegenerative","mRNA","Splicing","Mutant Huntingtin protein",{"date":36,"type":37},{"date":152,"type":37},"2026-01-06",{"date":154,"type":21},"2029-08",{"name":156,"class":95},"Skyhawk Therapeutics, Inc.",22,{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":53,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":56,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":181},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":169,"type":21},150,[138],"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.",[173],"Diabetes Mellitus, Type 1",{"date":36,"type":37},{"date":176,"type":37},"2026-01-12",{"date":178,"type":21},"2031-07",{"name":180,"class":95},"Eli Lilly and Company",113,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":56,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":205,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":20},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":191,"type":21},590,[137,138],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[195],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[197,198,199,200,201,202,203,204],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":36,"type":37},{"date":207,"type":37},"2026-01-02",{"date":209,"type":21},"2031-08-12",{"name":211,"class":95},"Bristol-Myers Squibb",{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":56,"phases":222,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":221,"type":21},210,[137],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[225],"Graves' Disease",[227,228,229,230,231,232],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":36,"type":37},{"date":235,"type":37},"2025-06-19",{"date":237,"type":21},"2027-05",{"name":239,"class":95},"Immunovant Sciences GmbH",163,{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":249,"minAge":18,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":56,"phases":253,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","100 Years",{"count":252,"type":21},940,[138],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[256],"Prostate Cancer",[258,259,260,261,262,263,264,265,266,267,268,269,247,270,271],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":36,"type":37},{"date":274,"type":37},"2025-07-01",{"date":276,"type":21},"2032-11-04",{"name":278,"class":95},"Novartis Pharmaceuticals",93,{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":56,"phases":290,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":304},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":289,"type":21},390,[137],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[293],"Metastatic Colorectal Cancer",[293,295,296],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":36,"type":37},{"date":299,"type":37},"2025-04-24",{"date":301,"type":21},"2028-04",{"name":303,"class":95},"AbbVie",65,{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":53,"minAge":313,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":56,"phases":317,"briefSummary":318,"conditions":319,"keywords":323,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":326,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":333},"100568620","sealion-study-on-supplemental-oxygenation-via-nasal-cannula-for-young-children-during-intubation-100568620","NCT06683599","SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation","SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula","SEALION","Inclusion Criteria:\n\n* Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.\n* Neonates and infants up to 52 weeks post-conceptual age.\n* Written informed consent provided by legal guardians prior to the intervention.\n\nExclusion Criteria:\n\n* Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.\n* Requirement for an alternative technique to direct laryngoscopy to secure the airway.\n* Specific conditions, such as congenital heart disease requiring FiO₂ \\\u003C 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.","1 Minute","52 Weeks",{"count":316,"type":21},240,[58],"Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ \\\u003C80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L\u002Fkg\u002Fmin) can extend safe apnea time.\n\nThis study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.",[320,321,322],"Difficult Airway","Difficult Airway Intubation","Neonate",[324,325,322],"Difficult intubation","Apneic oxygenation",{"date":36,"type":37},{"date":328,"type":37},"2024-12-10",{"date":330,"type":21},"2027-12-01",{"name":332,"class":44},"Vinícius C Quintão, MD, MSc, PhD",4,{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":104,"sex":53,"minAge":4,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":56,"phases":344,"briefSummary":346,"conditions":347,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":349,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":45},"100555869","phase-1-safety-and-pharmacokinetics-study-of-pgt121414ls-alone-and-in-combination-with-vrc07-523ls-in-infants-exposed-to-hiv-1-100555869","NCT06517693","Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Open-Label, Phase I Study of the Safety and Pharmacokinetics of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1","Inclusion Criteria:\n\n* Birthing parent is of legal age or circumstance to provide independent informed consent and is willing and able to provide written informed consent for themselves and permission for their infant's participation in this study.\n* Birthing parent has confirmed HIV-1 infection based on positive test results from two samples collected from two separate blood collection tubes.\n* Infant was singleton or twin.\n* Infant's gestational age at birth was at least 36 weeks.\n* At birth, infant's weight was at least 2 kg.\n* At entry, infant is less than 72 hours of age and is anticipated to receive study product within 72 hours after birth.\n* At screening, infant has the following laboratory test results:\n\n  * Hemoglobin, normal or grade 1 (≥13 g\u002FdL or ≥8.05 mmol\u002FL)\n  * Platelets, normal or grade 1 (≥100,000 cells\u002Fmm3 or ≥100.000 x10\\^9 cells\u002FL)\n  * Absolute neutrophil count (ANC), normal or grade 1\n\n    1. ≤24 hours old (≥4,000 cells\u002Fmm3 or ≥4.000 x10\\^9 cells\u002FL)\n    2. \\>24 hours old (≥1,250 cells\u002Fmm3 or ≥1.250 x10\\^9 cells\u002FL)\n  * Alanine transaminase (ALT), normal (\\\u003C1.25 x ULN)\n* At entry, infant is generally healthy as determined by the site investigator based on review of all available medical history information and physical examination findings.\n* Cohorts 1 and 2, Strata BF only: At entry, infant is breastfeeding or the birthing parent has indicated an intention to initiate breastfeeding.\n* Cohorts 1 and 2, Strata FF, only: At entry, infant is not breastfeeding and the birthing parent has indicated no intention to breastfeed.\n* At entry, infant is at increased risk of HIV acquisition.\n\nCohorts 1 and 2, Strata FF only:\n\n* Birthing parent had acute HIV during this pregnancy; or\n* Birthing parent with detectable viral replication (plasma HIV RNA results at least 50 copies\u002FmL) during pregnancy who did not have confirmed viral suppression, defined as at least two consecutive plasma HIV RNA results less than 50 copies\u002FmL from specimens obtained at least four weeks apart with the latest result within four weeks prior to delivery; or\n* Birthing parent not receiving appropriate ART for at least two weeks, with any part of the two-week period occurring within four weeks prior to delivery, based on birthing parent's report or available medical records.\n\nCohorts 1 and 2, BF only:\n\n* Per birthing parent's report, intends to breastfeed\n\nExclusion Criteria:\n\n* Birthing parent has received any investigational product during this pregnancy.\n* Infant has received any active or passive HIV immunotherapy or any investigational product.\n* At entry, infant with a documented positive HIV Nucleic Acid Test (NAT) result.\n* Birthing parent or infant has any condition that, in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.","72 Hours",{"count":343,"type":21},48,[345],"PHASE1","The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.",[348],"HIV-1",{"date":36,"type":37},{"date":351,"type":37},"2026-01-05",{"date":353,"type":21},"2028-06-30",{"name":355,"class":356},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":17,"minAge":365,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":56,"phases":368,"briefSummary":369,"conditions":370,"keywords":372,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100522211","phase-3-study-of-volrustomig-in-women-with-high-risk-locally-advanced-cervical-cancer-evolve-cervical-100522211","NCT06079671","Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","eVOLVECervical","Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\\u003C 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO\u002FECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg\u002Fday of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","15 Years",{"count":367,"type":21},800,[138],"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.",[371],"Locally Advanced Cervical Cancer",[373,374,375],"Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig",{"date":36,"type":37},{"date":378,"type":37},"2023-09-22",{"date":380,"type":21},"2030-09-30",{"name":94,"class":95},205,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":250,"enrollmentInfo":391,"targetDuration":4,"studyType":56,"phases":393,"briefSummary":394,"conditions":395,"keywords":397,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":392,"type":21},1400,[138],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[396],"Early Breast Cancer",[398,399,400,401,402,403,404,405,406],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":36,"type":37},{"date":409,"type":37},"2024-02-28",{"date":411,"type":21},"2030-09-20",{"name":278,"class":95},228,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":56,"phases":423,"briefSummary":424,"conditions":425,"keywords":428,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":441},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":422,"type":21},626,[137,138],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[426,427],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[429,430,199,427,431,432,433],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":36,"type":37},{"date":436,"type":37},"2020-12-02",{"date":438,"type":21},"2029-10-31",{"name":440,"class":95},"Mirati Therapeutics Inc.",770,{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":450,"enrollmentInfo":451,"targetDuration":4,"studyType":56,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":471},"100590984","phase-2-subdermal-implant-bioabsorbable-oxandrolone-pellet-for-rehabilitation-following-anterior-cruciate-ligament-acl-surgical-reconstruction-100590984","NCT06974526","Subdermal Implant-bioabsorbable Oxandrolone Pellet For Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction","Randomized, Multicenter, Double-blind, Parallel, Placebo-controlled Study to Investigate the Safety and Exploratory Efficacy of the Oxandrolone Subdermal Bioabsorbable Implant as an Adjuvant Treatment in Rehabilitation Following Anterior Cruciate Ligament (ACL) Surgical Reconstruction (IMOX Study)","IMOX","Inclusion Criteria:\n\nFor male and female participants:\n\n* Ability to confirm voluntary participation and approve the Informed Consent Form;\n* Men and women aged 18 to 60 years (inclusive);\n* Body weight between 50-120 kg for men and 40-90 kg for women;\n* BMI ≤34.9 kg\u002Fm²;\n* Complete ACL rupture visualized by pre-operative magnetic resonance imaging (MRI);\n* Having undergone arthroscopic knee surgery for anterior cruciate ligament (ACL) coverage using an autologous hamstring tendon graft;\n* Presenting with an isolated ACL injury or combined with ligamentous, meniscal, or cartilage lesions visualized by MRI, provided they do not interfere with the rehabilitation protocol.\n* Classification as very active, active, or irregularly active type A according to the International Physical Activity Questionnaire (IPAQ), based on pre-ACL injury physical activity;\n\nInclusion criteria assessed at the Randomization Visit (VR\u002FV2):\n\n* Continue to meet all inclusion criteria verified during the Selection Visit (VS\u002FV1)\n* Adherence to the rehabilitation protocol, having initiated postoperative physiotherapy treatment;\n* Functional range of motion from 0 to 120º and ability to ambulate without crutches;\n* Blood pressure in the seated position in the doctor's office \\\u003C180\u002F95 mmHg;\n* Hematocrit ≤ 50%;\n* ALT less than three times the upper limit of normal;\n* Serum creatinine \\\u003C2 mg\u002FdL;\n* Total bilirubin \\\u003C 3.0 mg\u002FdL;\n* Albumin ≥ 3.5 g\u002FdL;\n\nFor male participants only:\n\n\\- Total PSA ≤ 4.1 ng\u002FmL.\n\nExclusion criteria:\n\nFor female participants only:\n\n* Confirmed or suspected pregnancy;\n* History of childbirth, abortion, or lactation in the last 3 months;\n* Refusal to use permitted contraceptive methods during the study and for 90 days after the end of participation in the study, unless surgically sterile or expressly declaring themselves exempt from the risk of pregnancy due to not engaging in sexual activity or engaging in non-reproductive activity;\n* Clinical signs of hyperandrogenization characterized by: hirsutism defined by a Ferriman-Gallwey score ≥ 8; or alopecia defined by hair loss of at least 50% of the participant's normal hair, which is not obvious from a distance but is only noticeable upon closer inspection; a different haircut may be necessary to cover the hair loss, but does not necessarily require a wig or hairpiece to camouflage it; or Grade 5 acne defined by a predominance of inflammatory acne lesions in the facial area;\n* Polycystic Ovary Syndrome;\n* Known or suspected breast carcinoma;\n\nFor male participants only:\n\n\\- Known or suspected carcinoma of the prostate or male breast;\n\nFor male and female participants:\n\n* Previous serious injury or history of surgery on the lower limbs;\n* Knee injury more than 36 months ago;\n* Meniscal tear requiring repair or suturing during ACL reconstruction surgery that interferes with postoperative rehabilitation (e.g., immobilization or limitation of range of motion);\n* Use of patellar, quadriceps, or other hamstring tendon grafts during ACL reconstruction;\n* Known contraindication to hormone use;\n* Any condition that worsens under hormone treatment;\n* Personal history of deep vein thrombosis (DVT);\n* Known coagulopathy;\n* Known chromosomal disorders;\n* Hypersensitivity to anabolic androgenic steroids;\n* Previous treatment failure with Oxandrolone;\n* Concomitant use of testosterone (or analogues) and other anabolic androgenic steroids, or prior use without completion of an adequate washout period before baseline serum testosterone sampling for study eligibility determination and randomization, in any pharmaceutical formulation within the last 3 months. Practical clinical washout will be based on recovery of baseline serum testosterone levels to \\\u003C300 ng\u002FdL. The minimum recommended washout periods are 2-3 days for transdermal gel formulations, 3 weeks for short-acting testosterone esters (enanthate or cypionate; intramuscular or subcutaneous), and 8 weeks for long-acting testosterone esters (undecanoate; intramuscular).\n* Pituitary tumor;\n* Creatinine levels \\>2 mg\u002FdL or history of chronic kidney disease;\n* Myocardial infarction in the last 6 months;\n* Uncontrolled dyslipidemia;\n* Uncontrolled diabetes;\n* Patients with chronic obstructive pulmonary disease (COPD) unresponsive to bronchodilators;\n* Concomitant use of warfarin or another oral anticoagulant during experimental treatment.\n* Irregularly active type B or sedentary classification on the International Physical Activity Questionnaire (IPAQ), based on pre-ACL injury physical activity;\n* Athlete engaged in paid physical activity;\n* Known psychiatric diagnosis, including disorder Major or persistent depressive disorder, bipolar disorder, anxiety, social phobia, specific phobias or obsessive-compulsive disorder, psychotic disorder, personality disorder, eating disorder, neurocognitive disorders, and developmental or somatoform disorders (somatization or hypochondria);\n* Presence of voiding disorder;\n* Known diagnosis of fibromyalgia;\n* Participation in other clinical trial protocols in the last 30 days;\n* Participant who, in the investigator's opinion, presents other conditions or clinical or laboratory alterations that make them ineligible to participate in the study;\n\nExclusion criteria assessed at the Randomization Visit (VR\u002FV2):\n\n* The participant came to meet any exclusion criterion verified at the Selection Visit (SV\u002FV1);\n* Presenting postoperative complications such as stiffness and\u002For healing in the knee requiring additional procedures.","60 Years",{"count":452,"type":21},96,[137],"Rehabilitation of knee stability and function after anterior cruciate ligament (ACL) reconstruction is slow and costly. The use of anabolic steroids, such as oxandrolone, may aid in the recovery of muscle mass and strength, as well as functional capacity. Oxandrolone, derived from dihydrotestosterone, has high anabolic activity and low androgenic activity (a 13:1 ratio), making it more effective in promoting weight gain with fewer side effects compared to other steroids. Registered by the FDA and previously by ANVISA, the National Health Surveillance Agency in Brazil, it is indicated for cases of post-trauma or post-surgery weight loss. The subdermal use of oxandrolone implants is proposed to release the drug directly into the bloodstream, improving efficacy and reducing issues related to oral administration. This study evaluates the safety and tolerability of the oxandrolone subdermal bioabsorbable implant for 24 weeks versus placebo implant in both men and women as an adjuvant treatment during rehabilitation following anterior cruciate ligament (ACL) surgical reconstruction. The serum and pharmacokinetic profile of the oxandrolone subdermal bioabsorbable implant will be monitored.",[456],"Anterior Cruciate Ligament (ACL) Reconstruction",[458,459,460,461,462],"Anterior cruciate ligament (ACL)","Oxandrolone","Subdermal bioabsorbable implant","Adverse effects","Sarcopenia","2026-08-23",{"date":36,"type":37},{"date":466,"type":37},"2025-11-28",{"date":468,"type":21},"2027-04-30",{"name":470,"class":44},"Science Valley Research Institute",6,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":56,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":75},"100640776","volume-stable-collagen-matrix-versus-subepithelial-connective-tissue-graft-for-multiple-gingival-recessions-100640776","NCT07613775","Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions","Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial","VCMX-SCTG","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Presence of at least two Cairo RT1 gingival recessions in anterior teeth and\u002For premolars.\n* Gingival recession depth greater than or equal to 2 mm.\n* Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.\n* Indication for root coverage treatment due to esthetic concern and\u002For dentin hypersensitivity.\n* Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.\n* Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.\n\nExclusion Criteria:\n\n* Current smokers or individuals who stopped smoking less than 12 months before enrollment.\n* Decompensated systemic diseases.\n* Pregnancy or lactation.\n* Active periodontal disease.\n* Untreated root caries.\n* Previous mucogingival surgery in the study area.",{"count":481,"type":21},40,[58],"Gingival recession is a clinical condition in which the gingival margin is displaced apically, exposing the root surface. This condition may be associated with esthetic concerns, dentin hypersensitivity, and difficulties in oral hygiene. Subepithelial connective tissue grafting is considered a standard surgical approach for root coverage, but it requires harvesting tissue from the palate, which may increase postoperative discomfort. Volume-stable xenogeneic collagen matrices have been proposed as an alternative biomaterial to reduce the need for a palatal donor site.\n\nThis randomized controlled clinical trial will compare a volume-stable xenogeneic collagen matrix with an autogenous subepithelial connective tissue graft for the treatment of multiple gingival recessions. Participants will be allocated to one of two treatment groups. The test group will receive root coverage surgery using a volume-stable collagen matrix, while the control group will receive root coverage surgery using a subepithelial connective tissue graft. Clinical, patient-reported, esthetic, and digital outcomes will be assessed at baseline and during follow-up visits up to 12 months.\n\nThe primary outcome will be the change in gingival recession depth from baseline to 12 months. Secondary outcomes will include keratinized tissue width, gingival thickness, percentage of root coverage, complete root coverage, dentin hypersensitivity, patient-reported satisfaction, early wound healing, and digital volumetric changes assessed by intraoral scanning.",[485],"Gingival Recession",[487,488,489,490],"Multiple Gingival Recessions","Volume-Stable Collagen Matrix","Subepithelial Connective Tissue Graft","Coronally Advanced Flap","2026-08-22",{"date":36,"type":37},{"date":494,"type":21},"2026-10-01",{"date":496,"type":21},"2028-12-01",{"name":498,"class":44},"University of Sao Paulo",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":56,"phases":509,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":524},"100653263","phase-3-a-study-to-evaluate-effect-of-azd6234-in-adult-participants-with-obesity-or-overweight-with-weight-related-comorbidity-without-type-2-diabetes-mellitus-100653263","NCT07784725","A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus","A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity Without Type 2 Diabetes Mellitus (SELENE 1)","SELENE 1","Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥30 kg\u002Fm2 OR BMI ≥27 kg\u002Fm2 with at least one of the following weight related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* History of Type 1 or Type 2 Diabetes Mellitus, HbA1c ≥6.5% (48 mmol\u002Fmol), and\u002For treatment with glucose-lowering agent(s) within 3 months prior to Screening\n* Significant hepatobiliary disease and\u002For any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation.",{"count":508,"type":21},2500,[138],"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment",[512],"Obesity or Overweight",[514,515,516],"Obesity","Overweight","AZD6234","2026-08-21",{"date":36,"type":37},{"date":520,"type":37},"2026-08-19",{"date":522,"type":21},"2029-05-21",{"name":94,"class":95},212,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":56,"phases":534,"briefSummary":535,"conditions":536,"keywords":538,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":547,"leadSponsor":549,"locationsCount":550},"100645337","phase-3-study-of-izalontamab-brengitecan-bms-986507-in-combination-with-osimertinib-versus-osimertinib-monotherapy-or-osimertinib-in-combination-with-platinum-based-chemotherapy-for-egfrmt-non-small-cell-lung-cancer-izabright-lung02-100645337","NCT07680790","Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB\u002FIIIC), metastatic (Stage IVA\u002FIVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and\u002For spinal cord compression\n* Participants must not have history of ILD\u002Fpneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD\u002Fpneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":533,"type":21},850,[138],"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy",[537],"Non-Small Cell Lung Cancer",[199,539,540,541,542,543,544],"EGFR","First line","Izalontamab brengitecan","Osimertinib","ADC","IZABRIGHT-Lung02",{"date":34,"type":37},{"date":122,"type":21},{"date":548,"type":21},"2031-12-30",{"name":211,"class":95},208,{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":558,"enrollmentInfo":559,"targetDuration":4,"studyType":56,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":565,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":570,"locationsCount":571},"100630086","phase-2-a-study-of-ly4395089-and-mirikizumab-ly3074828-given-together-and-mirikizumab-alone-in-adults-with-crohns-disease-100630086","NCT07483099","A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089\u002FMirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1\u002Fglucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1\u002Fglucagon (Gcg) RAs, GLP-1\u002FGIP\u002FGcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol","80 Years",{"count":560,"type":21},60,[137],"The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.",[564],"Crohn Disease",{"date":34,"type":37},{"date":567,"type":37},"2026-05-04",{"date":569,"type":21},"2028-03",{"name":180,"class":95},70,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":558,"enrollmentInfo":579,"targetDuration":4,"studyType":56,"phases":580,"briefSummary":581,"conditions":582,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":584,"startDateStruct":585,"completionDateStruct":586,"leadSponsor":587,"locationsCount":571},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol",{"count":560,"type":21},[137],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[583,564],"Colitis, Ulcerative",{"date":34,"type":37},{"date":567,"type":37},{"date":569,"type":21},{"name":180,"class":95},{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":4,"eligibilityCriteria":594,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":595,"enrollmentInfo":596,"targetDuration":4,"studyType":56,"phases":598,"briefSummary":599,"conditions":600,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":608},"100624674","phase-1-a-study-of-bms-986528-in-participants-with-refractory-rheumatoid-arthritis-100624674","NCT07412704","A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","A Phase 1\u002F2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","65 Years",{"count":597,"type":21},84,[345,137],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).",[601],"Arthritis, Rheumatoid",{"date":34,"type":37},{"date":604,"type":21},"2026-09-15",{"date":606,"type":21},"2030-09-02",{"name":211,"class":95},39,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":4,"studyType":56,"phases":617,"briefSummary":618,"conditions":619,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100624093","phase-1-a-clinical-trial-of-ifinatamab-deruxtecan-in-people-with-advanced-esophageal-cancer-mk-3475-06f-100624093","NCT07405151","A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L\u002F3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)\n* Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC\n* Has measurable disease\n* If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention\n* Has clinically significant corneal disease\n* Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event\n* If infected with HIV, has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has uncontrolled or significant cardiovascular disease\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)\u002Fpneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has active infection requiring systemic therapy other than those permitted.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen",{"count":560,"type":21},[345,137],"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.",[620],"Oesophageal Squamous Cell Carcinoma",{"date":36,"type":37},{"date":623,"type":37},"2026-03-27",{"date":625,"type":21},"2028-06-12",{"name":627,"class":95},"Merck Sharp & Dohme LLC",28,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":635,"eligibilityCriteria":636,"healthyVolunteers":12,"sex":53,"minAge":18,"maxAge":4,"enrollmentInfo":637,"targetDuration":4,"studyType":56,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":646,"locationsCount":647},"100621314","phase-3-a-study-of-eloralintide-ly3841136-in-participants-with-obstructive-sleep-apnea-and-obesity-or-overweight-100621314","NCT07369011","A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight","A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight","ENLIGHTEN-3","Inclusion Criteria:\n\n* Confirmed history of moderate-to-severe OSA\n* Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening\n* Have a BMI ≥27 kg\u002Fm2 at screening\n* Have a stable body weight (\\\u003C5% body weight change) for 90 days prior to screening\n* Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight\n\nFor YSA1 Participants:\n\n* Are unable or unwilling to use PAP therapy\n\nFor YSA2 Participants:\n\n* Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and\u002For device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening\n* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n* Have had within 90 days prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening",{"count":367,"type":21},[138],"The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.\n\nParticipants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.",[641,514,515],"Sleep Apnea, Obstructive",{"date":34,"type":37},{"date":644,"type":37},"2026-02-10",{"date":301,"type":21},{"name":180,"class":95},115,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":4,"eligibilityCriteria":653,"healthyVolunteers":12,"sex":249,"minAge":18,"maxAge":4,"enrollmentInfo":654,"targetDuration":4,"studyType":56,"phases":656,"briefSummary":657,"conditions":658,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":75},"100617289","phase-1-phase-i-study-of-docetaxel-and-177-lutetium-psma-it-in-first-line-treatment-for-patients-with-metastatic-castration-resistant-prostate-adenocarcinoma-100617289","NCT07316686","Phase I Study of Docetaxel and 177-Lutetium-PSMA-I&T in First-Line Treatment for Patients With Metastatic Castration-Resistant Prostate Adenocarcinoma","Inclusion Criteria:\n\n1. Men aged 18 years or older.\n2. Histological or cytological diagnosis of prostate adenocarcinoma. The presence of intraductal or cribriform carcinoma will be allowed.\n3. Presence of metastatic disease on conventional imaging exams (bone scintigraphy and\u002For CT scan or MRI).\n4. Patients with castration-resistant disease, defined as testosterone \\\u003C50 ng\u002FmL in the context of prior orchiectomy or ongoing androgen deprivation therapy (ADT) with LHRH agonists or antagonists, plus at least one of the criteria below:\n5. PSA ≥2.0 ng\u002FmL with at least two consecutive PSA rises at intervals of at least 1 week.\n6. Radiologic progression defined by the investigator.\n7. Clinical progression defined by the investigator.\n8. Performance status per the Eastern Cooperative Oncology Group (ECOG) equal to 0 or 1.\n9. Willingness to continue ongoing ADT.\n10. Adequate organ function as defined below:\n\n    * Parameter Requirement\n    * Neutrophils ≥ 1,500\u002FµL\n    * Hemoglobin ≥ 12 g\u002FdL\n    * Platelets ≥ 100,000\u002FµL\n    * Creatinine ≤ 1.5 x upper limit of normal\n    * Potassium \\> 3.5 mmol\u002FL and \\\u003C5.0 mmol\u002FL\n    * Total Bilirubin ≤ ULN (unless Gilbert's disease)\n    * AST (TGO) ≤ 2.5 x ULN\n    * ALT (TGP) ≤ 2.5 x ULN\n11. 68Ga-PSMA-PET\u002FCT performed during the screening phase showing metastatic (extraprosthetic and extrapelvic) disease with radiotracer uptake and:\n12. SUVmax ≥20 in at least one site;\n13. SUVmax \\>10 in all other measurable metastatic sites.\n14. Lesions with uptake at least 1.5 times greater than hepatic background will be considered measurable.\n\nExclusion Criteria:\n\n1. Presence of any small-cell or neuroendocrine component of prostate carcinoma.\n2. Prior receipt of chemotherapy or radiopharmaceuticals in the castration-resistant setting.\n3. Presence of another active malignancy requiring treatment or a cancer diagnosis within the past 5 years. Carcinoma in situ of any site, squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or papillary bladder tumors will be allowed if previously treated.\n4. Severe urinary incontinence at the investigator's discretion.\n5. 18F-FDG-PET\u002FCT will be performed during screening and will be considered exclusionary if there is discordance with the 68Ga-PSMA-PET\u002FCT. Discordance is defined as FDG-hypermetabolic lesions with absent or low PSMA uptake (SUVmax \\\u003C10) in more than 50% of measurable metastatic lesions.\n6. Patients with brain metastases visible on 68Ga-PSMA-PET\u002FCT.",{"count":655,"type":21},18,[345],"This is a Phase I, open-label, single-center study evaluating the safety, tolerability, and recommended Phase II dose of docetaxel when combined with a fixed dose of 177-Lutetium-PSMA-I\\&T in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). Patients will receive standard androgen deprivation therapy, docetaxel at escalating doses (50 mg\u002Fm², 60 mg\u002Fm², 75 mg\u002Fm² every 3 weeks), and 177Lu-PSMA-I\\&T at a fixed dose of 7.4 GBq every 6 weeks (up to 4 cycles). A 3+3 dose escalation design will be employed. Secondary endpoints include safety profile, treatment-limiting toxicities, treatment completion rate, and delayed toxicity. Exploratory endpoints include PSA response, radiographic progression-free survival (rPFS), and PERCIST-based response rate.",[659],"Prostate Cancer (Adenocarcinoma)",{"date":36,"type":37},{"date":662,"type":37},"2026-06-16",{"date":664,"type":21},"2026-12",{"name":74,"class":44},""]