[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Hong Kong\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":697},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1009,0,25,[9,55,81,120,151,182,210,235,268,298,317,342,363,393,419,447,469,491,517,543,568,593,621,641,677],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100630823","phase-2-a-study-of-bms-986504-monotherapy-and-in-combination-with-other-agents-in-participants-with-advanced-andor-metastatic-solid-tumors-with-homozygous-mtap-deletion-mountaintap-5-100630823",false,"NCT07492680","A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination With Other Agents in Participants With Advanced and\u002For Metastatic Solid Tumors With Homozygous MTAP Deletion","Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and\u002For metastatic solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; subjects with liver metastasis or liver cancer must be ≤ 2 × ULN.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion\u002Fexclusion criteria applies.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and\u002For metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.",[27],"Solid Tumors",[29,30,31,32,33,34,35,36,37,38,39,40,41],"MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer PDAC","Pancreatic cancer","Navlimetostat","Navli","RECRUITING","2026-08-24",{"date":45,"type":46},"2026-08-25","ACTUAL",{"date":48,"type":46},"2026-07-27",{"date":50,"type":21},"2032-05-20",{"name":52,"class":53},"Bristol-Myers Squibb","INDUSTRY",57,{"id":56,"slug":57,"hasResults":12,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":64,"type":21},590,[24,66],"PHASE3","The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[69],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[31,71,37,29,30,72,73,40],"Lung cancer","MRTX1719","First-line",{"date":45,"type":46},{"date":76,"type":46},"2026-01-02",{"date":78,"type":21},"2031-08-12",{"name":52,"class":53},320,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":89,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE","100 Years",{"count":92,"type":21},940,[66],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[96],"Prostate Cancer",[98,99,100,101,102,103,104,105,106,107,108,109,87,110,111],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":45,"type":46},{"date":114,"type":46},"2025-07-01",{"date":116,"type":21},"2032-11-04",{"name":118,"class":53},"Novartis Pharmaceuticals",93,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":7},"100579387","an-international-multicenter-study-on-transcatheter-device-closure-of-perimembranous-ventricular-septal-defects-100579387","NCT06823635","An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects","PERI-CLOSE","Inclusion Criteria:\n\n1. Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.\n2. Defect size between 3 mm and \\\u003C20 mm on the left ventricular side, as measured by 2D echocardiography.\n3. Age ≥1 month and body weight ≥5 kg.\n4. Left-to-right ventricular shunt.\n\nExclusion Criteria:\n\n1. Patients or legal guardians refusing the use of personal data for research purposes.\n2. Failure to attend any follow-up visit post-discharge.","1 Month",{"count":129,"type":21},2000,"OBSERVATIONAL","The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).",[133],"Perimembranous Ventricular Septal Defect",[135,136,137,138,139,140,141,142],"Cardiovascular Abnormalities","Congenital Heart Disease","Device Closure","Heart Defects, Congenital","Heart Septal Defects","Heart Septal Defects, Ventricular","Transcatheter Interventions","Ventricular Septal Defects",{"date":45,"type":46},{"date":145,"type":46},"2025-01-01",{"date":147,"type":21},"2027-06-30",{"name":149,"class":150},"Fondation Hôpital Saint-Joseph","OTHER",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100502809","phase-3-phase-iiib-study-of-ribociclib--et-in-early-breast-cancer-100502809","NCT05827081","Phase IIIb Study of Ribociclib + ET in Early Breast Cancer","A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)","Adjuvant WIDER","Key Inclusion criteria:\n\n* Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).\n* Participant has a histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor positive and\u002For progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.\n* Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.\n* Participants may have already received any standard neoadjuvant and\u002For adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.\n* For participants with prior ET treatment \\> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.\n* The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.\n* Participant has no contraindication to receive adjuvant ET in the study.\n* Participant after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:\n\n  * Anatomic Stage Group III, or\n  * Anatomic Stage Group IIB, or\n  * A subset of Anatomic Stage Group IIA.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Participant has adequate bone marrow and organ function.\n* ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:\n\n  * QTcF interval at Screening \\\u003C 450 msec (QT interval using Fridericia's correction).\n  * Mean resting heart rate 50-99 beats per minute (determined from the ECG).\n\nKey Exclusion criteria:\n\n* Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and\u002For evidence of recurrence after curative surgery.\n* Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.\n* Participant has any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.\n* Clinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality.\n* Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.\n* Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":160,"type":21},1400,[66],"The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).",[164],"Early Breast Cancer",[166,167,168,169,170,171,172,173,174],"Hormone receptor positive (HR+)","Human epidermal growth factor receptor-2 negative (HER2-)","Early breast cancer (EBC)","premenopausal","postmenopausal","male breast cancer","ribociclib","LEE011","Endocrine therapy (ET)",{"date":45,"type":46},{"date":177,"type":46},"2024-02-28",{"date":179,"type":21},"2030-09-20",{"name":118,"class":53},228,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":190,"type":21},626,[24,66],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[194,195],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[197,198,37,195,199,200,201],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":45,"type":46},{"date":204,"type":46},"2020-12-02",{"date":206,"type":21},"2029-10-31",{"name":208,"class":53},"Mirati Therapeutics Inc.",770,{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":22,"phases":219,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100653358","a-behavioural-sleep-intervention-for-people-with-mild-cognitive-impairment-and-mild-dementia-100653358","NCT07784946","A Behavioural Sleep Intervention for People With Mild Cognitive Impairment and Mild Dementia","A Behavioural Sleep Intervention Enabled by a Virtual Coach for People With Mild Cognitive Impairment and Mild Dementia: A Proof-of-concept Study","Inclusion Criteria:\n\n* diagnosis of mild cognitive impairment or dementia with the global deterioration scale (GDS) score at 4 or lower; endorse one or more sleep problems; experience sleep issues an average of 3 or more nights per week over the past month; reachable by phone; ability to provide informed consent and willingness to participate in the study.\n\nExclusion Criteria:\n\n* have a prior diagnosis of a primary sleep disorder (e.g., sleep apnoea); have a severe chronic illness that may cause sleep problems (e.g., emphysema); currently receiving medical, psychological, or psychiatric treatment for sleep disturbance or depression; severe visual or hearing impairment; uncontrolled medical conditions that may interfere with participation.",{"count":218,"type":21},60,[220],"NA","This is two arm pilot randomized controlled trial, with the intervention gorup receiving AI-supported behavioral sleep intervention and control group receiving usual care",[223,224,225],"Mild Cognitive Impairment","Dementia","Sleep","2026-08-21",{"date":45,"type":46},{"date":229,"type":46},"2026-01-01",{"date":231,"type":21},"2027-07",{"name":233,"class":150},"The Hong Kong Polytechnic University",1,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":267},"100653195","e-health-lifestyle-intervention-for-arthritis-a-pilot-rct-on-feasibility-100653195","NCT07786038","E-Health Lifestyle Intervention for Arthritis: A Pilot RCT on Feasibility","Community Healthy Asian Lifestyle for Ameliorating Arthritis With Navigational E-health: A Pilot Randomized Controlled Trial on Feasibility and Acceptability","CHALAANE","Inclusion Criteria:\n\n* Inclusion criteria:\n\n  1. South Asian\n  2. Men and women aged 40 to 75 years, with obesity (body mass index≥25 kg\u002Fm2, Hong Kong Centre for Health Protection obesity definition)\n  3. Knee osteoarthritis (European League Against Rheumatism (EULAR) clinical criteria): age≥40 with movement-related joint pain, morning knee stiffness\\\u003C30 min, and functional limitations, and crepitus\u002Freduced range\u002Fbony enlargement)\n  4. Pain less than 2 years\n\nExclusion Criteria:\n\n1. Unwillingness\u002Finability to change eating\u002Fphysical activity habits\n2. Severe knee OA daily resting pain (NPRS\\>8\u002F10) or (Kellgren-Lawrence grade=4) that could not tolerate further conservative management\n3. inflammatory arthritis like rheumatoid arthritis, etc.\n4. Previous knee surgery\n5. immediate requirement for joint replacement, e.g. bone loss\n6. Planning to leave HK \\>2 months during the study period\n7. cognitive impairment, vision and hearing impairment precluding use of Smartband+App\n8. losing\u002Fgaining \\>5% weight in 6months or on dieting\n9. high levels of psychological distress (Kessler 10 questionnaire-K10 score \\>29）","40 Years","75 Years",{"count":246,"type":21},50,[220],"Knee osteoarthritis and obesity are common health problems in Hong Kong, especially among South Asian communities, where obesity rates are much higher than the general population. These two conditions often make each other worse-pain from arthritis leads to less physical activity, which can lead to more weight gain and more joint pain.\n\nThis pilot study is testing a new digital health program called CHALAANE(Community health asian lifestyle for ameliorating arthritis with navigational e-health), which means \"walk\" in Hindi and Urdu. The program uses a smartband and a mobile app with artificial intelligence to help participants track their activity and diet. It also includes a 12-week supervised program with group walking sessions and lifestyle education.\n\nThe study will include 50 South Asian adults aged 40 to 75 years who have knee osteoarthritis and obesity. Participants will be randomly assigned to one of two groups. The intervention group will receive the full CHALAANE program with an activated smartband and mobile app. The control group will receive an inactivated smartband for activity monitoring only. The study will last 10 months, with assessments at multiple time points.\n\nThe main goal of this pilot study is to see if a larger future study would be feasible. The researchers will measure how many participants follow the program as instructed and how many complete the full 10-month study. They will also look at whether the program is acceptable to the South Asian community and gather early data on pain, physical function, and body composition.\n\nThe study is a collaboration between the Department of Orthopaedics \\& Traumatology at Queen Mary Hospital and The Duchess of Kent Children's Hospital. A total of 50 participants will be recruited. Results will help inform the design of a future full-scale trial to improve health outcomes in this underserved population.",[250,251],"Knee Osteoarthristis","Obesity & Overweight",[253,254,255,256,257,258],"Knee Osteoarthritis","Obesity","Digital Health","mHealth","Artificial Intelligence","Lifestyle Intervention","NOT_YET_RECRUITING",{"date":45,"type":46},{"date":262,"type":21},"2026-09-01",{"date":264,"type":21},"2029-05-31",{"name":266,"class":150},"The University of Hong Kong",2,{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":274,"maxAge":4,"enrollmentInfo":275,"targetDuration":277,"studyType":130,"phases":4,"briefSummary":278,"conditions":279,"keywords":282,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":234},"100653187","optimizing-elderly-hearing-loss-care-in-hong-kong-a-cost-effectiveness-and-satisfactory-analysis-of-a-pilot-collaborative-model-between-otorhinolaryngologists-and-family-medicine-specialists-100653187","NCT07782177","Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists","Inclusion Criteria:\n\n* Aged 65 years or above.\n* Attending the Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic or the ENT elderly hearing clinic at Specialist Outpatient Clinic at Tseung Kwan O Hospital.\n* Bilateral progressive hearing loss for more than 1 month without acute ear infection; or earwax impaction affecting hearing; or referred for hearing-aid assessment, prescription, fitting, or follow-up.\n* Able to provide written informed consent independently, or with caregiver support sufficient to facilitate completion of study questionnaires.\n* Adequate language proficiency, including Cantonese where applicable, to complete the validated study questionnaires.\n\nExclusion Criteria:\n\n* Sudden sensorineural hearing loss.\n* Acute otitis, otorrhoea, or other acute ear infection requiring urgent assessment.\n* Tympanic-membrane perforation.\n* Suspected cholesteatoma or other serious middle-ear disease.\n* Other red-flag otologic presentations requiring urgent ENT specialist evaluation.\n* Severe cognitive impairment that, in the clinician's judgement, prevents meaningful informed consent or completion of study questionnaires.","65 Years",{"count":276,"type":21},500,"1 Year","This study will evaluate a new collaborative elderly hearing-loss service in Hong Kong. The service is based in Family Medicine (FM) and supported by Ear, Nose and Throat (ENT) specialist nurses and audiology services. It aims to provide earlier hearing assessment, counselling, hearing-aid referral or fitting where appropriate, and referral to ENT specialists when more complex ear problems are suspected.\n\nThe study will compare this new service with the existing ENT elderly hearing clinic. About 500 adults aged 65 years or above with progressive hearing loss will be enrolled. Researchers will compare the time to hearing assessment and hearing-related abilities and quality of life score, satisfactory score related to the care in the FM and ENT cohort, compliance to hearing aids, and referral to ENT services. The findings may help determine whether the new service is safe, cost-effective and improves access to hearing care.",[280,281],"Hearing Loss, Age-Related","Presbycusis",[283,281,284,285,286,287,288,289,290],"Hearing Loss","Age-related Hearing Loss","Hearing rehabilitation","Primary care","Family Medicine","Otolaryngology","Nurse-led clinic","Health services research",{"date":43,"type":46},{"date":293,"type":21},"2026-09",{"date":295,"type":21},"2028-08",{"name":297,"class":150},"Tseung Kwan O Hospital, Hong Kong",{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":274,"enrollmentInfo":305,"targetDuration":4,"studyType":22,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":234},"100649970","electroacupuncture-on-neck-muscle-stiffness-in-chronic-neck-pain-100649970","NCT07741227","Electroacupuncture on Neck Muscle Stiffness in Chronic Neck Pain","The Immediate Effect of Electroacupuncture on Neck Muscle Stiffness in Individuals With Chronic Neck Pain","Inclusion Criteria:\n\n1. Aged 18-65 years\n2. Chronic non-specific neck pain persisting for ≥3 months\n3. Average pain intensity ≥3 on a 0-10 Numeric Rating Scale over the past week\n4. Pain primarily located in the posterior cervical region, which may radiate to the upper trapezius muscles\n5. Able to provide informed consent and sufficient language proficiency to complete questionnaires\n\nExclusion Criteria:\n\n1. Specific pathological causes for neck pain (cervical radiculopathy or myelopathy, fracture, infection, tumour, systemic rheumatic disease)\n2. History of neck or shoulder surgery\n3. Contraindications to acupuncture (severe needle phobia, bleeding disorders, pregnancy)\n4. Received acupuncture or other physical therapy for neck pain within the past 6 months",{"count":306,"type":21},66,[220],"This randomized, single-blind, placebo-controlled clinical trial aims to investigate the immediate physiological effects of a single session of electroacupuncture (EA) on neck muscle stiffness in individuals with chronic neck pain. While acupuncture is a widely used complementary therapy for musculoskeletal pain, high-quality, objective evidence demonstrating its immediate effects on muscle biomechanics remains limited. This study will utilize Shear Wave Elastography (SWE)-a non-invasive, objective ultrasound-based technology-to measure these changes.\n\nAdult participants aged 18 to 65 with non-specific chronic neck pain (lasting\n\n≥ 3 months) will be randomly allocated into one of two groups:\n\n1. True Electroacupuncture (EA) Group: Participants will receive a 20-minute session of active electroacupuncture with comfortable electrical stimulation at specific neck and tender points.\n2. Sham Acupuncture (Placebo) Group: Participants will receive a 20-minute session of non-penetrating sham acupuncture with a deactivated electroacupuncture device to ensure participant blinding.\n\nThe primary objective is to evaluate immediate changes in the stiffness of the upper trapezius muscle, measured objectively via SWE (as Young's Modulus in kPa) before and immediately after the intervention. Secondary objectives include assessing immediate post-treatment changes in subjective pain and stiffness (Visual Analogue Scale), Pressure Pain Threshold (PPT), and active Cervical Range of Motion (CROM), alongside a 7-day post-intervention follow-up questionnaire on neck function.",[310],"Chronic Neck Pain",{"date":43,"type":46},{"date":313,"type":46},"2026-05-01",{"date":315,"type":21},"2026-10-30",{"name":233,"class":150},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":324,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":336,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":267},"100626139","the-use-of-dual-coil-transcranial-magnetic-stimulation-to-measure-and-modulate-poststroke-interhemispheric-inhibition-100626139","NCT07431749","The Use of Dual-coil Transcranial Magnetic Stimulation to Measure and Modulate Poststroke Interhemispheric Inhibition.","Using Dual-coil Transcranial Magnetic Stimulation to Measure and Modulate Poststroke Interhemispheric Inhibition (IHI): A Concurrent TMS-EEG-EMG Study","Inclusion Criteria:\n\n* (1) have a diagnosis of ischemic or hemorrhagic stroke, with time after stroke onset≥6 months. For stroke patients, we will invite participants to receive a structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience to verify their actual lesion location; (2) aged between 18 and 80 years old; (3) with residual upper limb functions from 4-7 levels in the Functional Test for the Hemiplegic Upper Extremity (Hong Kong version); (4) have evocable MEP from both M1; (5) able to give informed written consent to participate in the study. (6) able to understand and communicate with Chinese.\n\nExclusion Criteria:\n\n(1) any contraindications to TMS (screened by the safety checklist by Rossi); (2) any concomitant neurological disease; (3) any sign of moderate-to-severe cognitive problems, i.e., the abbreviated mental test Hong Kong version\\\u003C6 out of 10 points \\[22\\]; and (4) Modified Ashworth score\\>2 in hand, wrist or elbow extensor muscle in their hemiparetic upper limbs.\n\nIn addition, a group of right-hand-dominant healthy adults, without any known neurological and psychiatric diseases, will be enrolled.",true,"80 Years",{"count":327,"type":21},20,[220],"Objectives: This project will (1) establish the test-retest reliability of a novel transcranial magnetic stimulation-electroencephalography (TMS-EEG) interhemispheric inhibition (IHI) measure and (2) validate it against the TMS-EMG-based IHI measure (the gold standard). It will also (3) compare effects of dual-coil cortico-cortical paired associative stimulation (ccPAS) protocols with different interstimulus intervals (ISI) on this TMS-EEG-based IHI marker in poststroke patients. Methods: Study 1: IHI will be conducted in 20 stroke patients and 20 healthy counterparts using TMS-EEG and TMS-EMG; furthermore, both measures will be repeated after one week for test-retest reliability. Study 2: A randomized-crossover trial where 20 stroke patients undergo a single-session ccPAS in three separate visits (ISI: 8ms: LTD-like, 12ms: LTP-like, 100ms: sham) to investigate the differential modulatory effects in IHI.",[331],"Cortico-cortical Paired Associative Stimulation",[333,334,335],"cortico-cortical paired associative stimulation","transcranial magnetic stimulation","stroke",{"date":43,"type":46},{"date":338,"type":46},"2026-07-15",{"date":340,"type":21},"2029-06-01",{"name":233,"class":150},{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":349,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":267},"100590979","effects-of-blood-flow-restriction-training-on-muscle-strength-and-physical-function-for-stroke-related-sarcopenia-100590979","NCT06974461","Effects of Blood Flow Restriction Training on Muscle Strength and Physical Function for Stroke-Related Sarcopenia","Effects of Blood Flow Restriction Training on Physical Performance in Individuals With Stroke-Related Sarcopenia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Diagnosed with chronic stroke (≥6 months post-stroke)\n* Sarcopenia will be diagnosed using the Asian Working Group for Sarcopenia (AWGS) 2025 criteria, defined as the concurrent presence of low muscle strength and low appendicular skeletal muscle mass. Muscle strength will be assessed using handgrip strength measured on the non-paretic side. Low muscle strength will be defined as handgrip strength \\\u003C28 kg for men and \\\u003C18 kg for women aged ≥65 years, and \\\u003C34 kg for men and \\\u003C20 kg for women aged 50-64 years. Appendicular skeletal muscle mass will be measured using bioelectrical impedance analysis, and the appendicular skeletal muscle mass index will be calculated as appendicular skeletal muscle mass divided by height squared. Low muscle mass will be defined as an appendicular skeletal muscle mass index \\\u003C7.0 kg\u002Fm² for men and \\\u003C5.7 kg\u002Fm² for women aged ≥65 years, and \\\u003C7.6 kg\u002Fm² for men and \\\u003C5.7 kg\u002Fm² for women aged 50-64 years.\n\nExclusion Criteria:\n\n* Stroke occurred within the past 6 months\n* Resting systolic blood pressure \\> 200 mmHg\n* Resting diastolic blood pressure \\> 100 mmHg\n* Presence of implanted electronic or metallic devices that interfere with blood flow restriction cuffs\n* Contraindication to bioelectrical impedance analysis (e.g., pacemaker, ICD)","50 Years",{"count":351,"type":21},64,[220],"Effects of Blood Flow Restriction Walking on Muscle Strength and Physical Function in Chronic Stroke Patients with Sarcopenia: A Randomized, Sham-Controlled Trial Primary Objective: To evaluate the effects of BFR walking on muscle strength and physical function in chronic stroke patients with sarcopenia, compared to sham-BFR walking.\n\nSecondary Objective: (1) To explore the potential impact of BFR walking on muscle mass and vascular function in chronic stroke patients with sarcopenia. (2) To assess the influence of BFR walking on quality of life in chronic stroke patients with sarcopenia.",[355,356],"Sarcopenia","Chronic Stroke Patients",{"date":43,"type":46},{"date":359,"type":46},"2025-09-01",{"date":361,"type":21},"2027-12-28",{"name":233,"class":150},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":22,"phases":373,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":392},"100574886","phase-3-neladalkib-nvl-655-for-tki-naive-patients-with-advanced-alk-positive-nsclc-100574886","NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization",{"count":372,"type":21},450,[66],"Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[376,377],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[37,71,379,380,381,382,383,384],"Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive",{"date":45,"type":46},{"date":387,"type":46},"2025-07-17",{"date":389,"type":21},"2029-12",{"name":391,"class":53},"Nuvalent Inc.",158,{"id":394,"slug":395,"hasResults":12,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":399,"eligibilityCriteria":400,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":401,"targetDuration":4,"studyType":22,"phases":403,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100570795","phase-3-phase-iii-extension-study-of-efficacy-and-safety-of-ianalumab-with-or-without-study-treatment-withdrawal-in-participants-with-lupus-nephritis-sirius-ln-extension-100570795","NCT06711887","Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","SIRIUS-LN ext","Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.",{"count":402,"type":21},348,[66],"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR\u002FPRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.",[406],"Lupus Nephritis",[408,409,410,411],"Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736",{"date":43,"type":46},{"date":414,"type":46},"2025-05-19",{"date":416,"type":21},"2035-08-01",{"name":118,"class":53},47,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":22,"phases":430,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100568362","phase-1-phase-1-study-to-evaluate-safety-and-antiviral-activity-of-pbgene-hbv-in-adult-patients-with-chronic-hepatitis-b-100568362","NCT06680232","Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B","A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)","ELIMINATE-B","Key Inclusion Criteria:\n\n* Male or women of non-child bearing potential\n* BMI 18.0 to 35.0\n* Good overall health deemed by the study Investigator\n* CHB infection documented at least 12 months prior to screening\n* HBeAg-negative CHB\n* Must be virologically suppressed on current NA treatment\n\nKey Exclusion Criteria:\n\n* No history of cirrhosis of the liver\n* No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.\n* No signs of hepatocellular carcinoma\n* Not received an organ transplant\n* No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer)\n* No investigational agent received within 6 months of screening","70 Years",{"count":429,"type":21},45,[431],"PHASE1","This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.",[434],"HEPATITIS B CHRONIC",[434,436,437,438],"Gene Therapy","Gene Editing","PBGENE-HBV",{"date":43,"type":46},{"date":441,"type":46},"2024-11-14",{"date":443,"type":21},"2027-06",{"name":445,"class":53},"Precision BioSciences, Inc.",7,{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":325,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":234},"100555261","priming-theta-burst-stimulation-for-stroke-a-study-of-intensity-100555261","NCT06509789","Priming Theta Burst Stimulation for Stroke: A Study of Intensity","Optimizing the Intensity of Priming Theta Burst Stimulation to Improve Hemiparetic Upper Limb Motor Functions After Stroke: a Randomized Controlled Trial","Inclusion Criteria\n\n1. Unilateral upper limb motor dysfunction caused by ischemic or hemorrhagic stroke, with stroke onset≥6 months. Diagnosis will be verified using discharge summary and radiological reports issued by Hospital Authority. Qualifying participants will undergo structural magnetic resonance imaging (MRI) at the University Research Facility in Behavioral and Systems Neuroscience (UBSN) at PolyU to further confirm their lesion location in the period of experimental participation.\n2. Age between 18 and 80 years.\n3. Residual upper limb functions between levels 2-7 in the FTHUE, indicating moderately-to-severely impaired upper limb motor functions.\n4. Capable of providing informed written consent. Exclusion Criteria\n\nPatients who meet any of the following criteria will be excluded:\n\n1. any contraindications to TMS (screened by the safety checklist by Rossi(33)) and\u002For MRI (screened by the MRI safety checklist offered by UBSN \\[see supplement\\]).\n2. Diagnosed with any concomitant neurological disease other than stroke.\n3. signs of cognitive impairment, with a Montreal cognitive assessment score\\\u003C21\u002F22 out of 30 (34).\n4. Severe spasticity in the hemiparetic upper limb muscles, with a Modified Ashworth score \\> 2 (35).",{"count":455,"type":21},100,[220],"Objectives: To compare the effects of low intensity priming intermittent theta burst stimulation (iTBS) with those derived from conventional intensity priming iTBS, nonpriming iTBS, and sham stimulation in terms of improving hemiparetic upper limb motor functionality and modulating cortical excitation\u002Finhibition in patients with stroke.\n\nHypothesis to be tested: We hypothesize that low intensity priming iTBS can maximize the induction of therapeutically beneficial metaplasticity, and that this will be reflected in enhanced cortical excitation and reduced cortical inhibition, thereby enabling superior upper limb motor recovery in patients with stroke.\n\nDesign and subjects: A randomized controlled trial involving 108 patients with chronic stroke.\n\nStudy instruments: Transcranial magnetic stimulation (TMS) and electroencephalography (EEG).\n\nInterventions: Participants will be randomly assigned into one of the following four groups: (1) low intensity priming iTBS (55% resting motor threshold \\[RMT\\] continuous theta burst stimulation \\[cTBS\\]+70% RMT iTBS); (2) conventional intensity priming iTBS (70% RMT cTBS+70% RMT iTBS); (3) nonpriming iTBS (sham cTBS+70% RMT iTBS); and (4) sham stimulation (sham cTBS+sham iTBS). All participants will receive 60-minute standard motor training after completion of the stimulation program. The intervention will last four weeks, with three sessions per week.\n\nMain outcome measures: Upper limb motor tests and levels of cortical excitation\u002Finhibition measured by TMS-evoked EEG potentials.\n\nData analysis: Analysis of variance (ANOVA). Expected results: The low intensity priming iTBS protocol will be the most efficacious protocol for enhancing cortical excitation and reducing cortical inhibition in post-stroke patients and will thereby produce superior outcomes with regard to upper limb motor functionality.",[459],"Stroke",[459,461,462],"Transcranial magnetic stimulation","Theta burst stimulation",{"date":43,"type":46},{"date":465,"type":46},"2025-07-02",{"date":467,"type":21},"2027-09-30",{"name":233,"class":150},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100507964","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-inavolisib-in-combination-with-phesgo-versus-placebo-in-combination-with-phesgo-in-participants-with-pik3ca-mutated-her2-positive-locally-advanced-or-metastatic-breast-cancer-100507964","NCT05894239","A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer","INAVO122","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* Confirmation of HER2 biomarker eligibility based on valid results from central testing of tumor tissue documenting HER2-positivity\n* Confirmation of PIK3CA-mutation biomarker eligibility based on valid results from central testing of tumor tissue documenting PIK3CA-mutated tumor status\n* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of \\>= 6 months\n* LVEF (left ventricular ejection fraction) of at least 50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)\n* Adequate hematologic and organ function prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior treatment in the locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway\n* Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer prior to initiation of induction therapy\n* History or active inflammatory bowel disease\n* Disease progression within 6 months of receiving any HER2-targeted therapy\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Participants with active HBV infection\n* Clinically significant and active liver disease, including severe liver impairment, viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Symptomatic active lung disease, including pneumonitis or interstitial lung disease\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Serious infection requiring IV antibiotics within 7 days prior to Day 1 of Cycle 1\n* Any concurrent ocular or intraocular condition that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye",{"count":478,"type":21},230,[66],"This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).",[482],"Metastatic Breast Cancer",{"date":45,"type":46},{"date":485,"type":46},"2023-09-08",{"date":487,"type":21},"2032-12-28",{"name":489,"class":53},"Hoffmann-La Roche",192,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":22,"phases":500,"briefSummary":501,"conditions":502,"keywords":504,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":509,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100323125","phase-3-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-3475-587keynote-587-100323125","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":499,"type":21},3500,[66],"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.",[27,503],"Hematologic Malignancies",[505,506,507,508],"PD1","PD-1","PDL1","PD-L1",{"date":45,"type":46},{"date":511,"type":46},"2018-08-21",{"date":513,"type":21},"2043-08-04",{"name":515,"class":53},"Merck Sharp & Dohme LLC",782,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":524,"maxAge":525,"enrollmentInfo":526,"targetDuration":4,"studyType":22,"phases":528,"briefSummary":529,"conditions":530,"keywords":532,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":234},"100652942","acupressure-as-long-term-intervention-to-slow-the-progression-of-earlymild-alzheimers-disease-100652942","NCT07779863","Acupressure as Long-term Intervention to Slow the Progression of Early\u002FMild Alzheimer's Disease","Caregiver-administered Acupressure as Long-term Intervention to Slow the Progression of Early\u002FMild Alzheimer's Disease With Blood Amyloid and Tau Biomarkers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* have at least one of the following abnormal plasma amyloid and tau levels: Aβ42\u002FAβ40 ratio ≤ 0.17, p-tau217 \\> 0.15 pg\u002Fml, or\u002Fand p-tau181 \\> 3.3 pg\u002Fml\n* have mild neurocognitive disorder with the Montreal Cognitive Assessment, Hong Kong version (HK-MoCA) in classifying mild neurocognitive disorder, in which mild neurocognitive disorder is defined as those whose HK-MoCA score falls between the 16th and 2nd percentile of his\u002Fher peers adjusted for age and education\n\nExclusion Criteria:\n\n* show moderate-to-severe dementia, as evidenced by a HK-MoCA score falling below the 2nd percentile of his\u002Fher peers adjusted for age and education\n* cannot proficiently communicate due to language function impairment\n* have severe skin lesions on acupressure areas\n* had a surgery on the head or neck\n* have a medical condition that is a contraindication for acupressure.","60 Years","85 Years",{"count":527,"type":21},188,[220],"This is an assessor-blinded, randomized controlled trial. A total of 188 older adults aged 60-85 years with early\u002Fmild AD will be recruited from care and attention homes for the elderly and elderly activity centers. Participants will be randomly assigned to receive least acupressure control (LAC, n = 94) and Comfy Acupressure for the Elderly (CAE, n = 94), administered by caregivers (i.e., trained research assistants), for 3 sessions a week for 12 months. The primary outcome is the change in the Montreal Cognitive Assessment (MoCA) score from baseline. The secondary outcomes include functional independence, psychological well-being, sleep quality, and health-related quality of life. The outcomes will be assessed at baseline and once bimonthly thereafter, totaling 7 sessions. A linear mixed-effect model will be applied to compare the primary and secondary outcomes. Three blood samples will be collected at baseline, 6 months, and 12 months, respectively, and the baseline blood sample will be immediately measured for the measurement of plasma Aβ42, Aβ40, p-tau181, and p-tau217, blood glial fibrillary acidic protein (GFAP) and neurofilament light chain protein (NfL). Repeated two-way variance (ANOVA) will be used to detect significant differences in blood biomarkers between the two groups. Linear regression will be conducted to examine inter-correlations between clinical outcomes and biomarker levels. Health and social care resource use will additionally be recorded at baseline, 6 months, and 12 months for the economic evaluation to examine the cost-effectiveness of the CAE intervention compared with LAC.",[531],"Alzheimer's Disease",[533,534,224,535],"Alzheimer's disease","Acupressure","Amyloid and tau biomarkers","2026-08-20",{"date":43,"type":46},{"date":539,"type":21},"2027-01-01",{"date":541,"type":21},"2030-08-31",{"name":266,"class":150},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":550,"maxAge":551,"enrollmentInfo":552,"targetDuration":4,"studyType":22,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":259,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":562,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":234},"100652021","efficacy-of-cognitive-behavioural-therapy-for-insomnia-and-bright-light-therapy-in-adolescents-with-adhd-insomnia-and-evening-chronotype-100652021","NCT07767617","Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD, Insomnia, and Evening Chronotype","Efficacy of Cognitive Behavioural Therapy for Insomnia and Bright Light Therapy in Adolescents With ADHD and Comorbid Insomnia and Evening Chronotype: A Randomised, Assessor Blind, Parallel-group Trial","Inclusion criteria:\n\nAn adolescent who meets the following criteria will be eligible for taking part in this study:\n\n1. aged 10-24 years old;\n2. ADHD diagnosis confirmed by DISC-IV;\n3. DSM-5 diagnosis of insomnia disorder with an ≥ 9 (suggested cut-off for adolescents);\n4. Being classified as evening chronotype according to the score on the Horne-Östberg Morning-Eveningness Questionnaire (MEQ) and having a sleep onset time of 11:15pm or later for 12 year olds, 11:30pm or later for 13-14 year olds, 12:00am or later for 15-17 years old \\[64\\], 10:56pm or later for 18-24 years old at least 3 nights per week in the past 3 months and as confirmed by a 7-day sleep diary;\n5. Written informed consent from the participant and their parent\u002Fguardian (for those aged under 18);\n6. Being able to comply with the study protocol;\n7. Either not on ADHD medication or stabilized on medications for at least 6 months.\n\nExclusion criteria:\n\nAn adolescent who meets one or more of the following criteria will be excluded from the study:\n\n1. Substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia, ASD, organic mental disorders, or intellectual disabilities;\n2. Prominent medical condition affecting sleep (e.g., severe eczema, GERD);\n3. Clinically diagnosed sleep disorder other than insomnia disorder, such as narcolepsy, sleep-disordered breathing, and restless leg syndrome;\n4. Concurrent, regular use of medications(s) known to affect sleep continuity and quality including both prescribed medications (e.g., hypnotics, steroids) and over-the-counter OTC medications (e.g., melatonin, Traditional Chinese Medicine, TCM), except for ADHD stimulants;\n5. Ongoing psychological treatment for sleep problems;\n6. With hearing or speech deficit;\n7. Having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt).","10 Years","24 Years",{"count":553,"type":21},150,[220],"Attention-deficit\u002Fhyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by persistent inattention, hyperactivity, and impulsivity. In adolescents and young people, ADHD is commonly accompanied by insomnia and circadian delay. These co-occurring sleep and circadian disturbances may negatively affect daytime functioning and overall clinical outcomes. Although cognitive behavioural therapy for insomnia (CBT-I) is considered the first-line treatment for insomnia, and bright light therapy may help address circadian issues, their efficacy in adolescents with ADHD and comorbid insomnia and eveningness remains unexplored. This study aims to evaluate whether CBT-I, with or without bright light therapy, improves insomnia, sleep, and circadian as well as other clinical outcomes, and cognitive functioning in youths with ADHD and whether these interventions can also lead to improvements in mood and other clinical symptoms, as well as cognitive functioning.",[557,558,559,560,561],"Insomnia","ADHD","Eveningness","Chronotype","Treatment Effectiveness",{"date":43,"type":46},{"date":564,"type":21},"2026-08-10",{"date":566,"type":21},"2029-08-31",{"name":266,"class":150},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":89,"minAge":349,"maxAge":325,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":577,"briefSummary":578,"conditions":579,"keywords":582,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":234},"100651392","transurethral-thermodilatation-vs-prostatic-urethral-lift-for-moderate-to-severe-bph-100651392","NCT07759752","Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH","Transurethral Thermodilatation Versus Prostatic Urethral Lift for Moderate-to-Severe BPH: A Randomised Controlled Non-Inferiority Trial","THRIVE","Inclusion Criteria:\n\nParticipants must satisfy ALL of the following:\n\n* Male, aged ≥ 50 and ≤ 80 years\n* Moderate-to-severe LUTS due to BPH: IPSS total score ≥ 13 at screening\n* Peak urinary flow rate (Qmax) ≥ 5 and ≤ 12 mL\u002Fs with minimum voided volume ≥ 125 mL on free uroflowmetry. The lower Qmax bound of ≥ 5 mL\u002Fs excludes near-complete retention with likely detrusor underactivity, as adopted in the Rezūm pivotal trial\n* Prostate volume 30-80 g by transrectal ultrasound (TRUS) or multiparametric MRI, consistent with the L.I.F.T. and Rezūm pivotal study ranges\n* Post-void residual (PVR) ≤ 250 mL by bladder ultrasound\n* Currently on, or has previously tried, medical therapy for BPH (alpha-blocker and\u002For 5-alpha-reductase inhibitor) for ≥ 4 weeks with inadequate symptom control, or documented intolerance to medical therapy\n* Able to provide written informed consent\n* Able and willing to attend all study follow-up visits\n\nExclusion Criteria:\n\nParticipants will be excluded if ANY of the following apply:\n\n* Intravesical prostatic protrusion \\> 10 mm on TRUS.\n* Presence of metallic pelvic implants, penile prosthesis, femoral metallic implant, cardiac pacemaker, or implantable cardioverter-defibrillator.\n* Previous transurethral resection of the prostate (TURP), HoLEP, or any prior endoscopic prostate surgery.\n* Prior pelvic radiation therapy.\n* Prostatic urethral length \\\u003C 1.2 cm or \\> 5.5 cm.\n* Confirmed or suspected prostate carcinoma (unresolved elevated PSA without negative biopsy, or any known malignancy).\n* Active urinary tract infection at screening.\n* Bladder stone, bladder tumour, or suspected bladder malignancy.\n* Urethral stricture or bladder neck contracture precluding catheter passage (Foley ≥ 18 Fr).\n* Neurogenic bladder or known clinically significant detrusor underactivity.\n* History of acute urinary retention.\n* Coagulopathy or therapeutic anticoagulation that cannot be bridged perioperatively.\n* Renal impairment: eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² (Cockcroft-Gault).\n* Desire to preserve fertility (due to risk of retrograde ejaculation with either device).\n* IPSS QoL bother score \\\u003C 3 (patient not sufficiently bothered to warrant procedural intervention).\n* Participation in another interventional clinical trial within the preceding 30 days.",{"count":553,"type":21},[220],"This clinical trial aims to determine whether Prolieve® (microwave with balloon dilation) is as effective as UroLift® (prostate implants) for treating moderate-to-severe lower urinary tract symptoms in men aged 50-80 with enlarged prostates (BPH) who have failed oral medications.\n\nThe main questions are:\n\n1. Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months?\n2. Does Prolieve cause less pain and avoid the need for injected anaesthesia?\n\nResearchers will compare Prolieve (LA urethral gel only, no injections) against UroLift (LA urethral gel with or without local anaesthetic injection) to see if Prolieve offers similar relief with better tolerability.\n\nParticipants will stop their BPH medications for 2-4 weeks, undergo one of the two same-day office procedures, and attend follow-ups at 1, 3, 6, and 12 months for symptom scores, flow tests, and bladder scans.",[580,581],"BPH (Benign Prostatic Hyperplasia)","LUTS(Lower Urinary Tract Symptoms)",[583,584,585,586],"Transurethral Thermodilatation","Prostatic Urethral Lift","BPH","LUTS",{"date":43,"type":46},{"date":589,"type":21},"2026-08-06",{"date":591,"type":21},"2029-11-05",{"name":266,"class":150},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":524,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":22,"phases":603,"briefSummary":604,"conditions":605,"keywords":608,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":615,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":234},"100646079","efficacy-of-cbt-i-with-adjuvant-melatonin-in-older-adults-chronic-insomnia-100646079","NCT07695246","Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia","Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial","SOAM","Inclusion Criteria:\n\n1. Chinese aged ≥ 60.\n2. Provision of written informed consent.\n3. Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).\n4. Having a score of \\> 14 on the ISI, indicating clinical insomnia.\n\nExclusion Criteria:\n\n1. Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.\n2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).\n3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).\n4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder.\n5. Having mild to significant cognitive impairment, defined by having a score of \\\u003C 22 on MOCA.\n6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).\n7. Receiving concurrent psychological treatment for insomnia.\n8. Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).\n9. Being a night shift worker.",{"count":602,"type":21},183,[220],"This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.",[557,606,607],"Aging","Sleep Disorders",[557,609,610,611,612,225,613,614],"Elderly","CBT","Melatonin","Circadian Rhythm","Randomised controlled trial","Older adults",{"date":226,"type":46},{"date":617,"type":46},"2026-08-01",{"date":619,"type":21},"2029-08-01",{"name":266,"class":150},{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":626,"acronym":4,"eligibilityCriteria":627,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":628,"targetDuration":4,"studyType":22,"phases":630,"briefSummary":631,"conditions":632,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":633,"startDateStruct":634,"completionDateStruct":636,"leadSponsor":638,"locationsCount":640},"100607987","phase-3-beamion-lung-3-adjuvant-zongertinib-vs-standard-treatment-in-people-with-completely-resected-stage-ii-iiib-nsclc-harboring-activating-her2-tkd-mutations-100607987","NCT07195695","Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations","Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","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 ≥18 years old or over the legal age of consent in their country\n3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual 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 is provided in the patient information and in the study protocol\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n   * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n   * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology\u002Fpositive neuroendocrine markers (synaptophysin\u002FCD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n   * Active or known pre-existing or history of non-infectious interstitial lung disease\u002Fpneumonitis\n   * Active infectious disease requiring systemic therapy\n   * Uncontrolled gastrointestinal disorders affecting drug intake\u002Fabsorption\n   * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n   * Significant and\u002For uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \\>470 msec, or ejection fraction \\\u003C50% Further exclusion criteria apply.",{"count":629,"type":21},400,[66],"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.\n\nParticipants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.",[376],{"date":226,"type":46},{"date":635,"type":46},"2026-01-16",{"date":637,"type":21},"2036-09-02",{"name":639,"class":53},"Boehringer Ingelheim",202,{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":654,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":669,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":676},"100605631","phase-3-a-master-protocol-of-multiple-agents-in-adults-with-metabolic-dysfunction-associated-steatotic-liver-disease-synergy-outcomes-100605631","NCT07165028","A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)","A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes","Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\\u003C20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\\u003C25 kilogram per square meter (kg\u002Fm2)\n* Prior decompensated liver disease (history of esophageal\u002Fgastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes",{"count":649,"type":21},4500,[66],"The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.",[653],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[655,656,657,658,659,660,661,662,663,664,665,666,667,668],"Nonalcoholic Steatohepatitis","NASH","Fatty Liver","Fatty Liver Disease","SLD","Metabolic Dysfunction-Associated Fatty Liver Disease","MAFLD","Non-alcoholic Fatty Liver Disease","NAFLD","Hepatic Steatosis","Liver Related Outcomes","GLP1","Incretin","Non-Invasive Test",{"date":226,"type":46},{"date":671,"type":46},"2025-10-15",{"date":673,"type":21},"2032-08",{"name":675,"class":53},"Eli Lilly and Company",565,{"id":678,"slug":679,"hasResults":12,"nctId":680,"briefTitle":681,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":690,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":696},"100597616","phase-3-a-clinical-study-of-patritumab-deruxtecan-to-treat-breast-cancer-mk-1022-016-100597616","NCT07060807","A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of hormone receptor positive (HR+)\u002Fhuman epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent\n* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the most recent line of therapy (with certain exceptions)\n* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4\u002F6 inhibitor + endocrine therapy (ET) with one of the following:\n\n  * Radiographic disease progression, as assessed by the investigator, on CDK4\u002F6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+\u002FHER2- breast cancer. CDK4\u002F6 inhibitor + ET must be the only line of therapy received in the advanced setting, or\n  * Disease recurrence, either radiographic and\u002For confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4\u002F6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4\u002F6 inhibitor\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option\n* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and\u002For other life-threatening complications\n* Has any of the following: a pulse oximeter reading \\\u003C92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has ≥Grade 2 peripheral neuropathy.\n* Has clinically significant corneal disease\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Has received prior treatment with an anti-HER3 antibody and\u002For antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy\n* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4\u002F6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered\n* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids, has current pneumonitis\u002Finterstitial lung disease, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at Screening\n* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and\u002For any of its excipients\n* Has severe hypersensitivity (≥Grade 3) to all the available TPC and\u002For any of their excipients",{"count":685,"type":21},1000,[66],"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) and either unresectable locally advanced or metastatic.\n\n* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread\n* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2\n* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles\n* Metastatic means the cancer has spread to other parts of the body\n\nTreatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing\u002Fspreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.",[689],"Breast Neoplasms",{"date":43,"type":46},{"date":692,"type":46},"2025-07-21",{"date":694,"type":21},"2033-07-14",{"name":515,"class":53},199,""]