[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Vietnam\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":646},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,255,0,25,[9,43,74,100,125,147,176,202,223,258,285,308,335,366,389,412,440,461,486,515,540,561,581,600,626],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053328",false,"NCT07698886","Treatment of Recurrent Genital Warts by Combination of CO2 Laser and Geniwa Gel","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Able to read and understand the Patient Information Sheet and the Informed Consent form.\n3. Acceptance in the participation of the essay and signature of the Informed Consent form.\n4. Diagnosis of genital and anal warts with clear clinical manifestations.\n5. Have undergone at least 3 laser treatments and have experienced recurrence in any location.\n6. At least four or more lesions, or a lesion area of at least 0.5 cm2.\n\nExclusion Criteria:\n\n1. Concomitant sexually transmitted infections such as gonorrhea, syphilis, genital herpes, etc., that have not been cured.\n2. Ulceration or suspected malignant transformation of the lesions.\n3. Local infections.\n4. Pregnant women.\n5. Allergies to any component of alpha-lactalbumin-oleic acid gel.","ALL","18 Years",{"count":18,"type":19},70,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","Phase II, a randomized, double-blind, placebo-controlled clinical trial to evaluate the effectiveness and recurrence of genital warts by combination of CO2 laser and Geniwa gel compared to laser CO2 combined with gel placebo. The clinical trial is conducted at National Dermatology Hospital, Hanoi, Vietnam.",[25,26],"HPV (Human Papillomavirus)-Associated","Genital Warts",[28,29],"HPV","Genital warts","NOT_YET_RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":19},"2026-08-01",{"date":38,"type":19},"2027-09-15",{"name":40,"class":41},"KTH Biopharma","INDUSTRY",1,{"id":44,"slug":4,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":66,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100053717","NCT05755386","Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN","A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)","APPARENT","Inclusion Criteria:\n\n* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).\n* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).\n* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization\n* UPCR ≥ 1.0 g\u002Fg (≥ 113 mg\u002Fmmol) sampled from the first morning void urine sample at Day -75 and Day -15\n* Estimated GFR (using the chronic kidney disease \\[CKD\\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml\u002Fmin\u002F1.73m2 at screening and Day -15.\n* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.\n* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.\n\nExclusion Criteria:\n\n* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.\n* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:\n* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including\n\n  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);\n  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections\n  * Protozoa\u002Fother infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis\n\nRenal deposition of immune complexes as a result of a systemic autoimmune disease:\n\n* Systemic lupus erythematosus (SLE)\n* Sjögren syndrome\n* Rheumatoid arthritis\n* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.\n\nFibrillary glomerulonephritis\n\n* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.\n* Kidney biopsy showing interstitial fibrosis\u002Ftubular atrophy (IF\u002FTA) of more than 50%.\n* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.\n* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.\n* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.\n* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \\>7.5 mg\u002Fday (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.\n* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.\n* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.\n* Body mass index (BMI) \\>38 kg\u002Fm2 at screening and randomization. Body weight \\\u003C35 kg at screening and randomization","12 Years","60 Years",{"count":53,"type":19},106,[55],"PHASE3","This study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in idiopathic immune complex mediated membranoproliferative glomerulonephritis.",[58],"IC-MPGN",[60,58,61,62,63,64],"LNP023","iptacopan","UPCR","eGFR","proteinuria","RECRUITING",{"date":33,"type":34},{"date":68,"type":34},"2023-10-02",{"date":70,"type":19},"2029-05-31",{"name":72,"class":41},"Novartis Pharmaceuticals",131,{"id":75,"slug":4,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":15,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":20,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100054316","NCT05562466","A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate\u002FMometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate \u002F Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\\u003C12 years in age at randomization.\n2. Parents\u002Flegal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed\u002Fdocumented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)\u002Flegal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug\u002Fday) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\\u003C1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS\u002FLABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS\u002FLABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and\u002For = 12% (performed according to ATS\u002FERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent\u002Flegal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent\u002Flegal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and\u002For urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma\u002FCOPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and\u002For during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and\u002For during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition\u002Fdisease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol\u002Falbuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps). For UK: with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002F vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","6 Years","11 Years",{"count":83,"type":19},200,[55],"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) \u002F mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.",[87],"Asthma",[87,89,90,91,92],"Pediatric","Breezhaler","QMF149","Budesonide",{"date":33,"type":34},{"date":95,"type":34},"2023-05-11",{"date":97,"type":19},"2028-05-30",{"name":72,"class":41},63,{"id":101,"slug":4,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":15,"minAge":50,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":20,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100599779","NCT07088926","A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","CLEAR","Inclusion Criteria:\n\n1. Participant must be ≥ 12 years of age at the time of signing the informed consent\u002Fassent\n2. Weight ≥ 35 kg\n3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n9. Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n1. Primary lung diagnosis other than bronchiectasis\n2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n7. History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n9. Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening\n12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration",{"count":108,"type":19},435,[22],"AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[112],"Bronchiectasis With Pseudomonas Aeruginosa Colonization",[114],"Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization","2026-07-01",{"date":117,"type":34},"2026-07-02",{"date":119,"type":34},"2025-11-06",{"date":121,"type":19},"2028-06-14",{"name":123,"class":41},"AstraZeneca",185,{"id":126,"slug":4,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":20,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":133,"type":19},15100,[55],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[137],"Cardiovascular Disease",[139],"Atherosclerotic Cardiovascular Disease",{"date":117,"type":34},{"date":142,"type":34},"2025-06-04",{"date":144,"type":19},"2029-10-26",{"name":123,"class":41},1365,{"id":148,"slug":4,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":20,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},"100615317","NCT07291037","Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations","A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","TROPION-Lung17","Inclusion Criteria:\n\n* Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:\n\n  * Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.\n  * Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.\n  * Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.\n* Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n* Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)\u002Fanti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1\u002Fanti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.\n* Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.\n* At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Adequate bone marrow reserve and organ function within 7 days before randomisation.\n\nExclusion Criteria:\n\n* Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.\n* NSCLC disease that is eligible for definitive local therapy alone.\n* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.\n* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.\n* Clinically significant corneal disease.\n* Has active or uncontrolled hepatitis B or C virus infection.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Severe pulmonary function compromise per Investigator discretion.",{"count":155,"type":19},400,[55],"TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).",[159],"Non-small Cell Lung Cancer (NSCLC)",[152,161,162,163,164,165,166,167],"Non-small cell lung cancer (NSCLC)","Advanced non-squamous NSCLC","Metastatic non-squamous NSCLC","Datopotamab deruxtecan (Dato-DXd; DS-1062a)","Docetaxel","Trophoblast cell surface protein 2 (TROP2)","Normalised membrane ratio (NMR)","2026-06-30",{"date":115,"type":34},{"date":171,"type":34},"2025-10-31",{"date":173,"type":19},"2029-01-29",{"name":123,"class":41},205,{"id":177,"slug":4,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":20,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":201},"100590383","NCT06966700","A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin\u002FPaclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive\u002FHuman Epidermal Growth Factor Receptor-2 Negative Breast Cancer","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and\u002For clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+\u002FHER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and\u002For definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and\u002For axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids, has current pneumonitis\u002Finterstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..",{"count":183,"type":19},2400,[55],"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive\u002Fhuman epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy",[187,188,189],"Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive\u002FHER2-Negative Breast Neoplasms",[191,192,193],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":117,"type":34},{"date":196,"type":34},"2025-06-30",{"date":198,"type":19},"2034-12-29",{"name":200,"class":41},"Merck Sharp & Dohme LLC",310,{"id":203,"slug":4,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":222},"100529208","NCT06170788","Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)","A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)","TroFuse-007","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC\n\n  * Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy\n  * Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory\n  * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.\n  * A life expectancy of at least 3 months.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.\n* Has Grade ≥2 peripheral neuropathy.\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.\n* Received prior systemic anticancer therapy for their metastatic NSCLC.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received radiation therapy to the lung that is \\>30 Gy within 6 months of start of study intervention.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Known intolerance to sacituzumab tirumotecan or pembrolizumab and\u002For any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.\n* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n* Active infection requiring systemic therapy\n* Concurrent active Hepatitis B and Hepatitis C virus infection.\n* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* History of allogeneic tissue\u002Fsolid organ transplant.\n* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.",{"count":210,"type":19},614,[55],"The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.\n\nAll participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.",[159],[191,215,193],"Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)",{"date":117,"type":34},{"date":218,"type":34},"2023-12-15",{"date":220,"type":19},"2030-05-27",{"name":200,"class":41},220,{"id":224,"slug":4,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":230,"minAge":16,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":235,"conditions":236,"keywords":244,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":42},"100644889","NCT07675213","Endometrial Peristalsis and Pregnancy Outcomes in Hormone Replacement Therapy (HRT) - Frozen Embryo Transfer (FET) Cycles","Correlation Between Endometrial Peristalsis And Pregnancy Outcomes In Patients Undergoing Frozen Embryo Transfer With Hormone Replacement Therapy for Endometrial Preparation Protocol","CONCO","Inclusion Criteria:\n\n* Women aged 18 - 42 years old\n* Scheduled for frozen embryo transfer cycles using hormone replacement therapy protocol\n* Transferred no more than two cleavage embryos or one good-quality blastocyst or no more than two poor-quality blastocysts\n* Provision of written informed consent to participate\n\nExclusion Criteria:\n\n* Having an allergy and contraindications for exogenous hormone administration (e.g., breast cancer, thromboembolic disease)\n* Cycles with preimplantation genetic testing, oocyte donation, or in vitro maturation\n* Having untreated uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus, endometrial polyp, large leiomyoma ≥5 cm in diameter, hydrosalpinx, endometrial hyperplasia)\n* Use of uterine relaxants or intralipid infusion during the embryo transfer process\n* Use of a GnRH-agonist for downregulation within one month","FEMALE","42 Years",{"count":233,"type":19},442,"OBSERVATIONAL","Endometrial peristalsis may influence embryo implantation and pregnancy outcomes, but its role during hormone replacement therapy (HRT)-prepared frozen embryo transfer (FET) cycles remains unclear. This prospective observational study will assess endometrial peristalsis at predefined time points during HRT-prepared FET cycles using transvaginal ultrasonography and evaluate its association with pregnancy outcomes. The study aims to clarify the clinical significance of endometrial peristalsis in HRT-prepared FET cycles and to provide evidence supporting endometrial assessment in assisted reproductive technology.",[237,238,239,240,241,242,243],"Infertility","Endometrial Peristalsis","Uterine Contraction","Endometrial Waves","Frozen Embryo Transfer (FET)","Uterine Peristalsis","Hormone Replacement Therapy (HRT)",[245,246,247,248,249],"endometrial peristalsis","uterine contractions","endometrial waves","frozen embryo transfer","artificial cycles","2026-06-29",{"date":115,"type":34},{"date":168,"type":19},{"date":254,"type":19},"2027-12-01",{"name":256,"class":257},"Mỹ Đức Hospital","OTHER",{"id":259,"slug":4,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":20,"phases":266,"briefSummary":267,"conditions":268,"keywords":271,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"100572300","NCT06731478","Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer","A Multicenter, Randomized, Open-Label, Phase 3 Trial of Trastuzumab Deruxtecan (Enhertu®) Plus Chemotherapy Plus or Minus Pembrolizumab Versus Chemotherapy Plus Trastuzumab Plus or Minus Pembrolizumab as First-Line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Gastric Or Gastroesophageal Junction (GEJ) Cancer (Destiny-Gastric05)","Inclusion Criteria\n\n1. Sign and date the Tissue Prescreening ICF, prior to central HER2 and PD-L1 CPS testing. Sign and date the Main Screening ICF, prior to the start of any trial-specific qualification procedures. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma histologically confirmed by pathology report. Prior treatment in the perioperative and\u002For adjuvant setting is permissible, provided there is \\>6 months between the end of perioperative or neoadjuvant treatment and the diagnosis of recurrent disease.\n\n   Note: Prior use of IO (ie, anti-PD-1\u002FPD-L1) therapy in the (neo)adjuvant setting is allowed as long as there is \\>6 months between the end of IO therapy and the diagnosis of recurrent disease.\n4. Centrally determined HER2-positive (IHC 3+ or IHC 2+\u002FISH-positive) gastric or GEJ cancer as classified by the American Society of Clinical Oncology-College of American Pathologists for GC on a tumor biopsy as detected by prospective central test on new (core, incisional, excisional biopsy) or existing tumor tissue taken at the time of diagnosis of locally advanced or metastatic disease.\n\n   Note: Archival samples taken from a previous diagnostic or surgical biopsy not previously irradiated can be accepted. Details pertaining to tumor tissue submission can be found in the Study Laboratory Manual.\n5. Centrally determined tumor PD-L1 CPS using the PD-L1 assay:\n\n   * For the Main Cohort: PD-L1 CPS ≥1\n   * For the Exploratory Cohort: PD-L1 CPS \\\u003C1\n6. All participants must provide a tumor sample for tissue-based IHC staining to centrally determine HER2 expression, PD-L1 CPS, and other correlatives. The mandatory FFPE or new biopsy tumor sample can be from either the primary tumor or metastatic biopsy. Specimens with limited tumor content (as centrally determined) and cytology samples are inadequate for defining tumor HER2 and PD-L1 status.\n7. At least 1 target measurable lesion on CT or MRI, assessed by the investigator based on RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.\n8. LVEF ≥50% within 28 days before randomization.\n\nExclusion Criteria\n\n1. Prior exposure to other HER2-targeting therapies (including ADCs).\n2. Lack of physiological integrity of the upper gastrointestinal tract (ie, severe Crohn disease that results in malabsorption) or malabsorption syndrome that would preclude feasibility of oral chemotherapy for participants planned to be offered capecitabine as part of the study treatment.\n3. Known total or partial DPD enzyme deficiency. Note: Screening for DPD enzyme deficiency is required only in regions\u002Fcountries where DPD testing is SoC and with unknown DPD status. For regions\u002Fcountries where DPD testing is not SoC, local practice should be followed. In Spain and Italy, screening for DPD enzyme deficiency is mandatory for all participants with unknown DPD status.\n4. Contraindications to trastuzumab, 5-FU, capecitabine, cisplatin, or oxaliplatin treatment as per local label.\n5. Medical history of myocardial infarction within 6 months before randomization or symptomatic CHF (New York Heart Association Class II to IV). Participants with troponin levels above ULN at Screening (as defined by the manufacturer) and without any myocardial infarction -related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n6. Has a corrected QT interval (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on the average of the screening triplicate 12-lead ECG.\n7. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening\n8. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc).",{"count":265,"type":19},726,[55],"This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \\\u003C1 gastric or GEJ cancer.",[269,270],"Gastric Cancer","Gastroesophageal Junction Cancer",[272,273,274,275,276],"Enhertu","Trastuzumab Deruxtecan","Chemotherapy","DS-8201a","HER2 positive",{"date":115,"type":34},{"date":279,"type":34},"2025-02-27",{"date":281,"type":19},"2030-02-01",{"name":283,"class":41},"Daiichi Sankyo",250,{"id":286,"slug":4,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":290,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":230,"minAge":16,"maxAge":231,"enrollmentInfo":292,"targetDuration":4,"studyType":20,"phases":294,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":42},"100534480","NCT06239376","Artificial Cycle With or Without GnRH Agonist Pre-treatment for Frozen Embryo Transfer in Adenomyosis Patients","The Effectiveness of the Two Different Endometrial Preparation Regimes for Frozen Embryo Transfer in Patients With Adenomyosis","FET-ADE","Inclusion Criteria:\n\n* Confirm diagnosis with adenomyosis by using transvaginal ultrasonography (MUSA consensus) and\u002For pelvic magnetic resonance imaging.\n* Age between 18 - 42\n* Undergo less or equal to three previous IVF cycles\n* Indicate for frozen embryo transfer\n* Agree to have not more than two day-3 embryo or one blastocyst (day-5 and day-6) transferred\n* Not participating in any other study\n\nExclusion Criteria:\n\n* Embryos from IVM cycle\n* Having uterine or adnexal abnormalities (e.g., intrauterine adhesions, unicornuate\u002F bicornuate\u002F arcuate uterus; unremoved hydrosalpinx, endometrial polyp, submucosal leiomyoma, or leiomyoma with endometrial cavity distortion)\n* Having contraindications for exogenous hormones administration: breast cancer, risks of venous thromboembolism\n* Embryos from the oocyte donation cycle.\n* Patients with a history of GnRH injection within three months, measured from the last GnRHa injection to the study screening date.",{"count":293,"type":19},222,[295],"NA","This randomized clinical trial aims to assess the comparative effectiveness of two distinct endometrial preparation protocols for frozen embryo transfer (FET) among women with adenomyosis undergoing IVF\u002FICSI. Specifically, it seeks to address the following key questions:\n\n1. Does the protocol involving the combination of GnRH agonist and letrozole for down regulation with exogenous steroids (GnRHa+AI - AC) result in a higher live birth rate compared to the use of exogenous steroids alone (AC) in women with adenomyosis undergoing frozen embryo transfer?\n2. What are the common side effects of the GnRHa+AI - AC regimen?\n\nEligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of two groups: GnRHa+AI - AC or AC. In the GnRHa+AI - AC group, participants will be pre-treated with GnRH agonist and letrozole two months before endometrial preparation. After this period, participants will return for endometrial preparation, and any side effects resulting from the down regulation will be evaluated. In contrast, the AC group will receive standard treatment.",[298,299,300],"Adenomyosis","IVF","Frozen Embryo Transfer","2026-06-27",{"date":115,"type":34},{"date":304,"type":34},"2024-02-19",{"date":306,"type":19},"2027-05-30",{"name":256,"class":257},{"id":309,"slug":4,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":15,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":234,"phases":4,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100598310","NCT07069829","Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo","Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri\u002FTrixeo in Routine Care Settings","iCHOROS","Inclusion Criteria:\n\nThe study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:\n\n1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.\n2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.\n3. Patients providing a written Informed Consent\\* prior to inclusion to the study.\n\n   \\*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.\n4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be eligible to participate in the study:\n\n1. Patients with COPD due to documented α-1 antitrypsin deficiency.\n2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).\n3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.\n4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.\n5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.\n6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.\n7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.\n8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.","30 Years","80 Years",{"count":318,"type":19},1400,"Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI\u002FTRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life.\n\nThe iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \\& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations",[321],"Chronic Obstructive Pulmonary Disease",[323,324,325,326],"COPD","Moderate to Severe Chronic Obstructive Pulmonary Disease","Severe Exacerbations","BGF - Budesonide\u002FGlycopyrrolate\u002FFormoterol Fumarate","2026-06-26",{"date":250,"type":34},{"date":330,"type":34},"2025-12-15",{"date":332,"type":19},"2027-09-30",{"name":123,"class":41},36,{"id":336,"slug":4,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":20,"phases":343,"briefSummary":344,"conditions":345,"keywords":347,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":365},"100564320","NCT06627647","A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC","A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)","Inclusion Criteria:\n\n* Histologically or cytologically documented non-squamous NSCLC.\n* Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.\n* Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.\n* Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.\n* Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.\n* At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Presence of small cell and neuroendocrine histology components.\n* Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.\n* Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and\u002For definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \\> 12 months after the end of treatment.\n* Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.\n* Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* Active primary immunodeficiency\u002Factive infectious disease(s).\n* Active tuberculosis infection.",{"count":342,"type":19},878,[55],"The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.",[346],"Non-squamous Non-small Cell Lung Cancer",[348,349,350,351,352,353,354,355,356,357,358],"ARTEMIDE-Lung03","Rilvegostomig (AZD2936)","Non-squamous non-small cell lung cancer (NSCLC)","Bi-specific antibody","T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT)","EGFR, ALK and ROS1 testing","Programmed cell death protein (PD-L1)","Pembrolizumab","Carboplatin","Cisplatin","Pemetrexed",{"date":250,"type":34},{"date":361,"type":34},"2024-11-27",{"date":363,"type":19},"2030-11-18",{"name":123,"class":41},286,{"id":367,"slug":4,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":20,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":382,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":388},"100428715","NCT04862663","Capivasertib + CDK4\u002F6i + Fulvestrant for Advanced\u002FMetastatic HR+\u002FHER2- Breast Cancer (CAPItello-292)","A Phase Ib\u002FIII, Open-label, Randomised Study of Capivasertib Plus CDK4\u002F6 Inhibitors and Fulvestrant Versus CDK4\u002F6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)","CAPItello-292","Key inclusion criteria for both phases:\n\n1. Adult females (pre-\u002Fperi-\u002F and post-menopausal), and adult males.\n2. Histologically confirmed HR+\u002F HER2- breast cancer determined from the most recent tumour sample (primary or metastatic) per the American Society of Clinical Oncology and College of American Pathologists guideline. To fulfil the requirement of HR+ disease, a breast cancer must express ER with or without co-expression of progesterone receptor.\n3. Eligible for fulvestrant therapy and at least one of the following: palbociclib, ribociclib, or abemaciclib, as per local investigator assessment. Previous tolerance to specific CDK4\u002F6 inhibitors and dose levels required.\n4. Adequate organ and bone marrow functions.\n5. Consent to provide a mandatory FFPE tumour sample.\n\nKey inclusion criteria only for phase III:\n\n1. Previous treatment with an ET (tamoxifen, AI, or oral SERD) as a single agent or in combination, with radiological evidence of breast cancer recurrence or progression while on, or within 12 months of, completing a (neo)adjuvant ET regimen.\n2. Provision of mandatory blood samples at screening for central testing using an investigational ctDNA test to be stratified based on PIK3CA\u002FAKT1\u002FPTEN status.\n3. Be eligible for fulvestrant and at least one out of palbociclib or ribociclib (depending on the available CDK4\u002F6i options at time of enrolment), as per local investigator assessment.\n4. Have measurable lesion(s) according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) or, in the absence of measurable disease, lytic or mixed bone lesions that can be assessed by computed tomography (CT) or magnetic resonance imaging (MRI).\n\nKey exclusion criteria for both phases:\n\n1. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.\n2. Radiotherapy within 2 weeks prior to study treatment initiation.\n3. Major surgery or significant traumatic injury within 4 weeks of the first dose of study treatment.\n4. Persistent toxicities (CTCAE Grade \\>1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss or peripheral sensory neuropathy) after consultation with the AstraZeneca study physician.\n5. Spinal cord compression, brain metastases or leptomeningeal metastases unless these lesions are definitively treated (eg. radiotherapy, surgery) and clinically stable off steroids for management of symptoms for at least 4 weeks prior to study treatment initiation.\n6. Any of the following cardiac criteria at screening:\n\n   (a). Mean resting corrected QT interval (QTcF): (i) Participants to be treated with palbociclib:: QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (ii) Participants to be treated with ribociclib: QTcF ≥ 450 ms obtained from the average of 3 consecutive (triplicate) ECGs (iii) Participants to be treated with abemaciclib (Phase Ib only): QTcF ≥ 470 ms obtained from the average of 3 consecutive (triplicate) ECGs (b). Any clinically important abnormalities in cardiac rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart block) (c). Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (d). Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) grade ≥ 2 (e). Uncontrolled hypotension (f) uncontrolled hypertension (g). Cardiac ejection fraction outside institutional range of normal or \\\u003C 50% (whichever is higher)\n7. uncontrolled or high grade or symptomatic arrhythmia and atrial fibrillation\n8. Any of these clinically significant abnormalities of glucose metabolism at screening:\n\n   1. . diabetes mellitus type I or type II requiring insulin treatment\n   2. . Glycated haemoglobin (HbA1c) ≥ 8.0% (63.9 mmol\u002Fmol)\n9. Previous allogeneic bone marrow transplant or solid organ transplant.\n\nKey exclusion criteria for the phase III only:\n\n1. Any prior treatment with, AKT, PI3K or mTOR inhibitors.\n2. Prior treatment with CDK4\u002F6 inhibitors in the metastatic setting (prior CDK4\u002F6 inhibitors permitted in the adjuvant setting provided there was a CDK4\u002F6i treatment free interval of at least 12 months).\n3. More than 1 line of chemotherapy for metastatic disease.\n4. Any line of endocrine-based therapy for inoperable locally advanced or metastatic disease.","99 Years",{"count":375,"type":19},895,[55],"A Phase Ib\u002FIII Open-label, Randomised Study of Capivasertib plus CDK4\u002F6 Inhibitors and Fulvestrant versus CDK4\u002F6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)",[379],"Locally Advanced (Inoperable) or Metastatic Breast Cancer",[381],"Locally advanced (inoperable) or Metastatic Breast Cancer",{"date":250,"type":34},{"date":384,"type":34},"2021-05-10",{"date":386,"type":19},"2029-08-14",{"name":123,"class":41},284,{"id":390,"slug":4,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":395,"sex":15,"minAge":396,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":20,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":411},"100596349","NCT07044297","A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011)","A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is confirmed HIV-uninfected based on negative HIV-1\u002FHIV-2 test results\n* Is a cisgender man, transgender woman (assigned male sex at birth), transgender man (assigned female sex at birth), or gender nonbinary person\n* Has had condomless receptive anal sex in the 12 months prior to screening (not including sex occurring in a mutually monogamous relationship) and has at least 1 of the following: receptive anal sex with 2 or more partners in the 3 months prior to screening (regardless of condom use), rectal or urethral gonorrhea or chlamydia or incident syphilis in the 6 months prior to screening, or any self-reported stimulant drug use with sex in the 3 months prior to screening\n* Weighs ≥35 kg\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has hypersensitivity or other contraindication to any component of the study interventions\n* Has evidence of acute or chronic hepatitis B infection\n* Has a history of malignancy within 5 years of screening except for adequately treated basal cell or squamous cell skin cancer, or in situ anal or cervical cancers\n* Has taken cabotegravir, lenacapavir, or any other long-acting HIV prevention product at any time\n* Is receiving or is anticipated to require any prohibited therapies from 30 days prior to Day 1 through the study duration\n* Has received an HIV vaccine at any time (ie, through past participation in an investigational clinical study) or monoclonal antibodies to HIV within 12 months before Day 1\n* Is expecting to donate eggs at any time during the study",true,"16 Years",{"count":398,"type":19},4390,[55],"Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection.\n\nThe goals of this study are to learn:\n\n* If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day\n* About the safety of MK-8527 and if people tolerate it",[402,403],"Human Immunodeficiency Virus (HIV)","HIV Pre-Exposure Prophylaxis","2026-06-25",{"date":250,"type":34},{"date":407,"type":34},"2025-07-31",{"date":409,"type":19},"2027-07-22",{"name":200,"class":41},81,{"id":413,"slug":4,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":20,"phases":421,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":439},"100573164","NCT06742723","A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure","A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure","BaxDuo-Pacific","Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with (a) or (b):\n\n   a) eGFR 30-59 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 30 mg\u002Fg (3.39 mg\u002Fmmol) and \\\u003C 500 mg\u002Fg (56.5 mg\u002Fmmol) (central laboratory value only), or\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only).\n\n     (b) eGFR 60-75 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) ) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only)\n3. \\[obsolete\\]\n4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.\n5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol\u002FL if eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol\u002FL if eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol\u002FL within 3 months at screening.\n3. Serum sodium \\\u003C 135 mmol\u002FL (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).\n\n4\\. Participants with T1DM will be excluded, except:\n\n1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.\n2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.\n\n   5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol\u002Fmol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).\n\n   6 New York Heart Association functional HF class IV at screening.\n\n   7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.\n\n   8 Documented history of adrenal insufficiency.\n\n   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.\n\n   10 Any acute kidney injury within 3 months prior to the Screening Visit.\n\n   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n\n   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).",{"count":420,"type":19},5000,[55],"International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure",[424],"Chronic Kidney Disease and Hypertension",[426,427,428,429,430,431,432],"Chronic kidney disease","Hypertension","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome",{"date":327,"type":34},{"date":435,"type":34},"2025-03-03",{"date":437,"type":19},"2029-12-18",{"name":123,"class":41},764,{"id":441,"slug":4,"hasResults":11,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":447,"enrollmentInfo":448,"targetDuration":4,"studyType":20,"phases":450,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100539731","NCT06307652","Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin in Patients With Heart Failure and Impaired Kidney Function","A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone\u002FDapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function","BalanceD-HF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)\n* Having had a recent HF event within 6 months (hospitalization or urgent visit)\n* Have a LVEF value from an assessment within the last 12 months\n* Managed with SoC therapy for HF and renal impairment according to local guidelines\n* NT-proBNP must be \\>300 pg\u002FmL (\\>600 pg\u002FmL if concomitant atrial fibrillation or atrial flutter)\n* Not taking an MRA\n* An eGFR ≥ 20 to \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n* Serum\u002Fplasma potassium ≤ 5.0 mmol\u002FL\n\nExclusion Criteria:\n\n* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period\n* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations\n* History of hypertrophic obstructive cardiomyopathy\n* Complex congenital heart disease or severe uncorrected primary valvular disease\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker\n* Systolic BP \\\u003C 90 mmHg, or symptomatic hypotension within the past 24 hours\n* Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment\n* Type 1 diabetes mellitus\n* Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy\n* Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy\n* Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks\n* Treatment with strong or moderate CYP3A4 inhibitor or inducer","130 Years",{"count":449,"type":19},4800,[55],"This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone\u002Fdapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.",[453],"Heart Failure and Impaired Kidney Function",{"date":327,"type":34},{"date":456,"type":34},"2024-04-12",{"date":458,"type":19},"2027-06-11",{"name":123,"class":41},852,{"id":462,"slug":4,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":20,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":485},"100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":468,"type":19},3500,[55],"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[472,473],"Solid Tumors","Hematologic Malignancies",[475,476,477,478],"PD1","PD-1","PDL1","PD-L1",{"date":327,"type":34},{"date":481,"type":34},"2018-08-21",{"date":483,"type":19},"2043-08-04",{"name":200,"class":41},782,{"id":487,"slug":4,"hasResults":11,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":230,"minAge":16,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":20,"phases":494,"briefSummary":495,"conditions":496,"keywords":500,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":42},"100643952","NCT07669441","Early Labor Pre-Marking for Epidural Analgesia: Ultrasound vs Manual Palpation","Efficacy of Ultrasound-Guided Versus Landmark-Based Epidural Labor Analgesia: A Randomized Clinical Trial.","Inclusion Criteria:\n\n* Parturients aged 18 years and older, with gestational age at 37 weeks or older.\n* Actively requesting epidural analgesia for labor pain management without any contraindication to the procedure.\n\nExclusion Criteria:\n\n* Parturients with spinal abnormalities or a history of spinal surgery.\n* Inability to visualize epidural landmarks under ultrasound imaging.\n* Parturients experiencing severe pain requiring immediate, emergent labor analgesia.",{"count":493,"type":19},100,[295],"The goal of this clinical trial is to learn if finding and marking the best spot on the back early in labor helps doctors perform epidural pain relief more successfully in pregnant women. Usually, epidural pain relief is requested when labor pain is already severe, which makes it hard for women to hold still. This makes it difficult to find the right needle spot, leading to more needle attempts\n\nThe main questions this study aims to answer are:\n\n* Does using ultrasound to mark the back early in labor (before severe pain starts) help the doctor place the needle correctly on first try without adjusting it?\n* Does this early marking method lower the number of needle attempts and the time it takes to finish the procedure? Researchers will compare marking the back using an ultrasound machine to the standard method of feeling the spine with hands. Both methods will be done early in the waiting room to avoid the challenges caused by severe pain. Importantly, neither the pregnant women nor the doctors performing the epidural will know which marking method was used. This design prevents personal beliefs or expectations from affecting the procedure, making the study results objective and trustworthy.\n\nParticipants will, if consented and participated in the study:\n\n* Have their lower back examined and marked by a doctor early in labor using either an ultrasound machine or the doctor's hands.\n* Receive an epidural pain relief in the delivery room when they request it. This will be done by a different doctor who does not know how the back was marked.\n* Answer short questions about their pain level and how happy they are with the procedure.",[497,498,499],"Labor Pain","Epidural Analgesia for Labour and Delivery","Neuraxial Ultrasound",[501,497,499,502,503,504,505,506],"Epidural Analgesia","Preprocedural Spinal Ultrasound","Anatomical Landmark Palpation","Obstetric Anesthesia","Regional Anesthesia","First-pass success","2026-06-24",{"date":250,"type":34},{"date":510,"type":34},"2026-06-01",{"date":512,"type":19},"2026-08-30",{"name":514,"class":257},"University Medical Center Ho Chi Minh City (UMC)",{"id":516,"slug":4,"hasResults":11,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":316,"enrollmentInfo":521,"targetDuration":4,"studyType":20,"phases":523,"briefSummary":524,"conditions":525,"keywords":529,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":42},"100643118","NCT07642336","Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Open Liver Resection","Comparison of Postoperative Analgesic Efficacy Between Erector Spinae Plane Block and Thoracic Epidural Analgesia in Open Hepatectomy: A Randomized Controlled Trial","Inclusion Criteria:\n\n* \\* Patients aged between 18 and 80 years old.\n\n  * American Society of Anesthesiologists (ASA) physical status classification I to III.\n  * Scheduled to undergo elective open liver resection (open hepatectomy).\n  * Patient provides written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Severe coagulation profile derangement prior to surgery (defined as International Normalized Ratio \\[INR\\] \\> 1.5 or 2.0, or Platelet count \\[PLT\\] \\\u003C 50 G\u002FL or 100 G\u002FL).\n\n  * Severe hepatic impairment (Child-Pugh Class C).\n  * Severe chronic obstructive pulmonary disease (COPD GOLD stage III-IV).\n  * Severe cardiac dysfunction with an ejection fraction (EF) \\\u003C 35%.\n  * Severe obesity with a Body Mass Index (BMI) \\> 40 kg\u002Fm².\n  * Localized infection at the planned puncture\u002Fneedle insertion site.\n  * Known allergy or hypersensitivity to local anesthetics (e.g., Ropivacaine) or opioids (e.g., Morphine).\n  * Pregnancy or current lactation.",{"count":522,"type":19},60,[295],"Background: Open liver resection is associated with severe postoperative pain. While thoracic epidural analgesia (TEA) is considered the gold standard for pain control, its clinical application is often limited by postoperative coagulation profile derangement, which increases the risk of epidural hematoma. Continuous erector spinae plane block (ESPB) has emerged as a promising, safer alternative with a lower risk of bleeding complications. Objective: This study aims to compare the postoperative analgesic efficacy, safety profiles, and impacts on respiratory function between ultrasound-guided continuous ESPB and TEA in patients undergoing elective open liver resection. Hypothesis: The investigators hypothesize that continuous ESPB using a programmed intermittent bolus (PIB) regimen is non-inferior to TEA regarding 72-hour postoperative pain scores at rest, while offering superior hemodynamic stability and fewer technique-related risks.",[526,527,528],"Liver Neoplasms","Hepatic Resection","Liver Cancer",[530,531,527],"Postoperative Pain","Acute Pain","2026-06-23",{"date":404,"type":34},{"date":535,"type":34},"2026-06-15",{"date":537,"type":19},"2026-08-20",{"name":539,"class":257},"Nguyen Toan Thang",{"id":541,"slug":4,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":544,"acronym":545,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":20,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":553,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":560},"100631162","NCT07497087","A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis","A Double-blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Oral Nerandomilast Treatment in Patients With Systemic Sclerosis (SSc)","VERANDA™-SSc","Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n2. Patients must be at least 18 years of age and fulfil the 2013 American College of Rheumatology\u002FEuropean Alliance of Associations for Rheumatology (ACR\u002FEULAR) criteria for SSc.\n3. Patients must be diagnosed with limited cutaneous SSc (lcSSc) or diffuse cutaneous SSc (dcSSc), as defined by LeRoy et al. (1988).\n4. Disease onset (defined by first non-RP \\[Raynaud's phenomenon\\] symptom) must be within 7 years of Visit 1.\n5. Trial participants with dcSSc must have evidence of active disease during screening.\n6. Trial participants with lcSSc must have evidence of active disease during screening. LcSSc patients must be anti-centromere antibody (ACA) negative.\n7. FVC % predicted ≥45% at Visit 1.\n8. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) % predicted ≥25% corrected for haemoglobin (Hb) at Visit 1.\n9. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control.\n10. Patients may be either untreated or on stable treatment with permitted immunosuppressive\u002Fimmunomodulatory agents and\u002For nintedanib. All treatments must remain stable prior to Visit 2 and during the screening period\n\nExclusion criteria:\n\n1. Active, unstable, or uncontrolled vasculitis within 8 weeks prior to Visit 1 or during the screening period.\n2. Any suicidal behaviour in the past 2 years.\n3. Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months. Further exclusion criteria apply.",{"count":548,"type":19},448,[55],"Nerandomilast is being developed to help people with systemic sclerosis by potentially improving symptoms and slowing disease progression. This study is open to adults who are at least 18 years old and have systemic sclerosis (SSc). People can join the study if they have limited or diffuse cutaneous SSc with disease onset within 7 years of the first non-Raynaud's symptom. The purpose of this study is to find out whether a medicine called nerandomilast helps people with systemic sclerosis. This study also aims to find out how well nerandomilast is tolerated in people with systemic sclerosis.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take the tablets twice a day.\n\nParticipants are in the study for 1 to about 4 years. During this time, they visit the study site regularly and get phone calls from the site staff. During study visits participants regularly have blood samples taken and doctors check changes in skin thickening, lung function, and internal organs, overall health and the safety and tolerability of study treatment in people with SSc. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[552],"Systemic Sclerosis",{"date":507,"type":34},{"date":555,"type":19},"2026-06-22",{"date":557,"type":19},"2030-03-17",{"name":559,"class":41},"Boehringer Ingelheim",233,{"id":562,"slug":4,"hasResults":11,"nctId":563,"briefTitle":564,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":567,"targetDuration":4,"studyType":20,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":580},"100597898","NCT07064473","EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","EASi-PROTKT™ - 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 Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and\u002For Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously\n  * Other aldosterone synthase inhibitors (e.g. baxdrostat)\n  * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply.",{"count":568,"type":19},11800,[55],"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.",[572,427,573],"Diabetes Mellitus, Type 2","Cardiovascular Diseases",{"date":507,"type":34},{"date":576,"type":34},"2025-07-22",{"date":578,"type":19},"2029-12-21",{"name":559,"class":41},1155,{"id":582,"slug":4,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":20,"phases":589,"briefSummary":590,"conditions":591,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":593,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":599},"100587975","NCT06935370","A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","EASi-HF Reduced - 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 Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) \u003C 40%","Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (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 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 protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\\u003C 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local\u002Finternational guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an 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 an MRA should not be discontinued with the intention of study enrolment.\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   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) 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\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)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), 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, CABG)\n5. Percutaneous coronary intervention (PCI) 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 known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.",{"count":588,"type":19},4200,[55],"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat\u002Fempagliflozin tablets, and the other group takes placebo\u002Fempagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[592],"Heart Failure",{"date":507,"type":34},{"date":595,"type":34},"2025-05-20",{"date":597,"type":19},"2029-02-22",{"name":559,"class":41},635,{"id":601,"slug":4,"hasResults":11,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":605,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":15,"minAge":607,"maxAge":316,"enrollmentInfo":608,"targetDuration":4,"studyType":20,"phases":610,"briefSummary":611,"conditions":612,"keywords":614,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":619,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":625},"100583587","NCT06878261","A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)","A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","JOURNEY","Inclusion Criteria:\n\n1. ≥40 to ≤80 years old\n2. COPD diagnosis ≥1 year,\n3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1\u002FFVC \\\u003C0.70 at screening\n4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1\n5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy\n6. EOS ≥ 150 cells\u002FμL during screening\n7. CAT ≥15 at screening\n8. Former or current smokers ≥10 pack-years\n\nExclusion Criteria:\n\n1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD\n2. Asthma, incl. pediatric, or ACOS\n3. Any unstable disorder that can impact participants safety or study outcomes\n4. Tuberculosis requiring treatment within 12 months prior V2\n5. Malignancies current or past\n\n   Concomitant therapies:\n   * Macrolides (less than 6 months)\n   * Systemic immuno-suppressive, -modulating medications\n6. LTOT \\>4.0 L\u002Fmin or O2 saturation \\\u003C89% despite LTOT","40 Years",{"count":609,"type":19},990,[55],"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)",[613],"Chronic Obstructive Pulmonary Disease (COPD)",[323,615,616,617,618],"Moderate COPD","Severe COPD","Very Severe COPD","chronic obstructive pulmonary disease",{"date":507,"type":34},{"date":621,"type":34},"2025-03-25",{"date":623,"type":19},"2029-06-05",{"name":123,"class":41},268,{"id":627,"slug":4,"hasResults":11,"nctId":628,"briefTitle":629,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":447,"enrollmentInfo":633,"targetDuration":4,"studyType":20,"phases":635,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":639,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":645},"100526063","NCT06129864","A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy","A Phase III, Randomized, Open-Label, Multi-Center, Global Study of Volrustomig (MEDI5752) as Sequential Therapy Versus Observation in Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma, Who Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (eVOLVE-HNSCC)","eVOLVE-HNSCC","Inclusion Criteria:\n\n* Histologically or cytologically documented locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic disease (i.e. M0).\n* Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis (TNM) staging system).\n* Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with curative intent prior to randomization.\n\nExclusion Criteria:\n\n* Histologically\u002Fcytologically confirmed head and neck cancer of any other primary anatomic location in the head and neck not specified in the inclusion criteria including participants with squamous cell carcinoma of unknown primary or non-squamous histologies (eg, nasopharynx or salivary gland). Participants with \\>1 primary tumors are not eligible for the study.\n* Participants with any of the following:\n\n  1. LA-HNSCC that was resected before definitive cCRT\n  2. LA-HNSCC that was treated and is recurrent at the time of screening\n* Participants who have received radiotherapy (RT) alone as definitive local therapy for LA-HNSCC.",{"count":634,"type":19},1145,[55],"The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).",[638],"Locally Advanced Head and Neck Squamous Cell Carcinoma",{"date":507,"type":34},{"date":641,"type":34},"2023-12-14",{"date":643,"type":19},"2031-02-28",{"name":123,"class":41},306,""]