[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-resistance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-resistance":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,94,126],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100598408","phase-2-intestinal-low-dose-radiotherapy-combined-with-immunotherapy-in-immune-resistant-metastatic-malignant-solid-tumors-100598408",false,"NCT07071103","Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Malignant Solid Tumors","Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1\u002FPD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1\u002FPD-L1 Treatment","ILDR-02","Inclusion Criteria:\n\n* Age ≥18 years, ≤80 years, regardless of gender.\n* ECOG level 0-2.\n* Expected life span\\>3 months.\n* At least one accessible and measurable lesion should be selected as the target lesion for observation according to RECIST criteria.\n* Patients with metastatic solid tumors (of any histology) without standard therapy options, who have previously received immunotherapy, immunotherapy combined with chemotherapy, or immunotherapy combined with anti-angiogenesis treatment and have shown disease progression.\n* Patients should not be considered eligible for surgical treatment.\n* Patients with brain metastases that are assessed as clinically stable after treatment through repeated CT and\u002For MRI scans are eligible.\n* Patients have complete clinical and pathological information.\n* Patients should not be borthered by any psychological, family, social or geographical conditions that may hinder compliance with the research protocol.\n* Patients should be able to understand the informed consent form, voluntarily participate, and sign the informed consent form.\n* Other indicators accord with the general inclusion criteria for clinical trials.\n\nExclusion Criteria:\n\n* Patients with contraindications to radiation therapy and immunotherapy.\n* Previous occurrence of unacceptable immune related toxic side effects (immune myocarditis, pneumonia, etc.).\n* Patients who were assessed as hyperprogressive disease (HPD).\n* Patients who have received pelvic and abdominal radiation therapy within 6 months prior to enrollment.\n* The adverse reactions from prior treatment have not yet recovered to a CTCAE5.0 rating of ≤ 1 (excluding toxicity that has been determined to be risk-free, such as fatigue or hair loss).\n* Patients with active uncontrolled systemic bacterial, viral, or fungal infections despite optimal treatment.\n* Significant liver or kidney dysfunction (i.e., laboratory values \\>3 times the upper limit of normal).\n* Active hepatitis B, hepatitis C, HIV, or syphilis.\n* Brain disorders, symptomatic central nervous system (CNS) or meningeal metastases, or impaired cognitive function.\n* Hypersensitivity to any drug included in the trial.\n* Drug and\u002For alcohol abuse.\n* Pregnant or breastfeeding women.\n* Concurrent participation in another therapeutic clinical trial.\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within ≤14 days after intervention).\n* Major surgery within 30 days.\n* Use of antibiotics, antifungals, antivirals, antiparasitics, or probiotics within 4 weeks before enrollment.","ALL","18 Years","80 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Preclinical and clinical evidence suggests that intestinal low-dose radiotherapy (ILDR) may enhance antitumor immune responses by modulating the gut microenvironment, thereby improving the efficacy of immune checkpoint inhibitors (ICBs) in refractory solid tumors. Based on these findings, the investigators initiate a multicohort phase II clinical trial to evaluate the clinical benefit and safety of ILDR combined with PD-1\u002FPD-L1 monoclonal antibody therapy in patients with metastatic solid tumors resistant to prior ICB treatment.\n\nIn this study, patients are stratified into three parallel cohorts by tumor type (lung cancer, esophageal cancer, and other solid tumors), with 16 patients per cohort (48 in total, including subjects enrolled from the ILDR-01 study). Eligible participants includes patients with advanced metastatic solid tumors progressing after monotherapy or combination ICB treatment, meeting criteria of ECOG performance status 0-2, life expectancy ≥3 months, and have at least one measurable lesion. Exclusion criteria encompasses prior pelvic radiotherapy, ongoing infections, major organ dysfunction, or concurrent antitumor therapies.\n\nThe primary endpoints includes objective response rate (ORR), disease control rate (DCR), progression-free survival after ILDR (PFS2), and the incidence of abscopal effects. Secondary endpoints includes overall survival (OS), treatment safety, α\u002Fβ diversity changes in gut microbiota, peripheral blood immune cell subset dynamics, and tumor immune microenvironment remodeling characteristics. All patients receives a 1 Gy jejunoileal radiotherapy followed by PD-1\u002FPD-L1 monoclonal antibody administration (in accordance to prior protocols or guidelines) within 24 hours, with maintenance therapy up to 2 years. Therapeutic efficacy is assessed via RECIST v1.1, while therapeutic toxicity is assessed according to CTCAE v5.0.\n\nPaired pre- and post-treatment samples (including wumor tissue, stool, peripheral blood etc.) are collected for metagenomic sequencing, metabolomic analysis, and multi-omics integrative modeling to systematically elucidate the regulation mechanism of gut microbiota-metabolite-immune axis mediated by ILDR. This approach aims to provide theoretical foundations for optimizing treatment strategies in immunotherapy-resistant tumors and identify biomarkers that potentially associated with therapeutic efficacy.",[28,29,30,31,32,33],"Radiotherapy","Metastatic Solid Cancers","Immune Checkpoint Blockade","Esophageal Neoplasms Malignant","Lung Neoplasm Malignant","Drug Resistance","RECRUITING","2025-11-17",{"date":37,"type":38},"2025-11-20","ACTUAL",{"date":40,"type":38},"2025-09-26",{"date":42,"type":22},"2028-01-01",{"name":44,"class":45},"Chuangzhen Chen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":73,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":46},"100608614","phase-4-modulation-of-gut-microflora-with-rifaximin-to-reduce-high-platelet-reactivity-in-post-acs-patients-on-ticagrelor-100608614","NCT07203846","Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor","Modulation of Gut Microflora With Rifaximin to Reduce High Platelet Reactivity in Post-Acute Coronary Syndrome Patients on Ticagrelor (FLORA-ACS)","FLORA-ACS","Inclusion criteria:\n\n* Between 18 and 80 years of age\n* History of acute coronary syndrome no sooner than 1 month and no later than 12 months prior to study inclusion\n* Current treatment with ticagrelor (90 mg orally twice a day)\n* High platelet reactivity assessed with multiple electrode aggregometry method (AUC of \\>46 U)\n* Provision of informed consent prior to any study procedures\n\nExclusion criteria:\n\n* History of hypersensitivity to rifaximin or other rifamycin-derived agent\n* Ongoing treatment with rifamycins\n* Platelet count \\\u003C 100×10\\^9\u002FL or \\> 450×10\\^9\u002FL\n* Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion\n* History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor\n* Infection, including gastrointestinal infection, within a month prior to study inclusion\n* History of Clostridium difficile infection\n* Current use of specific medications (warfarin, glycoprotein IIb\u002FIIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)\n* Impaired liver function classified as Child-Pugh class B or C\n* Hemodynamic instability\n* Pregnancy or breastfeeding\n* Patients considered by the investigator to be uncooperative",{"count":56,"type":22},50,[58],"PHASE4","The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.",[61,62,63,64,65,66,67,68,33,69,70,71,72],"ACS - Acute Coronary Syndrome","Ticagrelor","Microbiota","Platelet Aggregation","Myocardial Infarction (MI)","Blood Platelets","Drug Effects","Platelet Aggregation Inhibitors","Platelet Function Tests","Dysbiosis","Anti-Bacterial Agents","Rifaximin",[74,75,76,77,78,79,80,81,82,83],"high platelet reactivity","HPR","Multiplate aggregometry","multiple electrode aggregometry","MEA","microbiome","gut flora","eubiotic","16S rRNA sequencing","P2Y12 inhibitor","NOT_YET_RECRUITING","2025-09-25",{"date":87,"type":38},"2025-10-02",{"date":89,"type":22},"2026-01-01",{"date":91,"type":22},"2027-06-30",{"name":93,"class":45},"Collegium Medicum w Bydgoszczy",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":5},"100599282","epidemiology-of-antimicrobial-use-and-antimicrobial-resistant-infections-in-four-hospitals-in-thailand-100599282","NCT07082465","Epidemiology of Antimicrobial-use and Antimicrobial-resistant Infections in Four Hospitals in Thailand","For primary objectives Inclusion Criteria\n\n* All age and gender\n* Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024\n* Received a parenteral antibiotic for at least four consecutive days\n* Were still hospitalized on day 8 after starting a parenteral antibiotic\n\nExclusion Criteria\n\n* Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024\n* Had a clinical specimen collected within 2 calendar days of starting a parenteral antibiotic culture positive for an antimicrobial-resistant organism or Staphylococcus aureus\n\nAntimicrobial-resistant (AMR) organism is defined as an organism that is resistant to Access and Low Watch antibiotics, and if the organism is the cause of infection, the recommended antimicrobial therapy involves the use of Medium Watch, High Watch or Reserve antibiotics. The common organisms include methicillin-resistant S. aureus, methicillin-resistant coagulase-negative Staphylococcus spp., ampicillin-resistant Enterococcus spp., vancomycin-resistant Enterococcus spp., 3rd-generation cephalosporin-resistant Gram-negative bacterium and carbapenem-resistant Gram-negative bacterium. The definition of organism includes organisms frequently associated with contamination including coagulase-negative staphylococci, viridans group streptococci, Corynebacterium spp., Bacillus spp., Diptheroid spp., Micrococcus spp. and Propionibacterium spp.. All types of specimens are included (e.g. sputum and tracheal suction). We excluded such patients because the study has no clinical data to differentiate whether the isolated AMR organisms are causing infections or represent colonization.\n\nFor secondary objectives\n\nInclusion Criteria:\n\n* All age and gender\n* Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024\n\nExclusion Criteria:\n\n• Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024",{"count":101,"type":22},108000,"OBSERVATIONAL","The main goal of this retrospective observational study is to understand how stepping down antibiotic treatment (called antibiotic de-escalation) affects patients who receive it compared to those who don't after received a short-course (≤7 days) of parenteral antibiotics. The investigators will use past medical records from four public referral hospitals in Thailand from the year 2019 to 2024. The investigators will firstly evaluate which types of patients are more likely to receive antibiotic de-escalation. Then, the investigators will estimate the impact of antibiotic de-escalation, while taking those differences into account. This way, it will help us understand the impact of antibiotic de-escalation in real-world clinical practice. The investigators also aim to assess how accurate automated outbreak detection systems are at detecting outbreaks, evaluate patterns of antimicrobial use and antimicrobial-resistant infections, and develop new indicators for antimicrobial stewardship that are applicable for local and national actions in low and middle-income countries.",[33,105,106],"Bacterial","Bacteremia",[33,105,106,108,109,110,111,112,113,114,115,116],"Inpatients","Antimicrobial Stewardship","Drug Utilization","Drug Utilization Review","Cluster Analysis","Disease Outbreaks","Epidemiology","Quality Indicators","Health Care","2025-07-15",{"date":119,"type":38},"2025-07-24",{"date":121,"type":22},"2025-08-01",{"date":123,"type":22},"2026-08-16",{"name":125,"class":45},"University of Oxford",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":102,"phases":4,"briefSummary":135,"conditions":136,"keywords":142,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":46},"100598612","real-world-study-of-post-resistance-treatment-strategies-in-advanced-breast-cancer-following-cdk46i-pik3ca-inhibitors-or-t-dxd-100598612","NCT07073755","Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4\u002F6i, PIK3CA Inhibitors, or T-DXd","A Real-World Observational Study on Post-Resistance Treatment Outcomes in Advanced Breast Cancer Patients After CDK4\u002F6 Inhibitors, PIK3CA Inhibitors, or Trastuzumab Deruxtecan Therapy","Inclusion Criteria:\n\n1. Adults (≥18 years old) with histologically or cytologically confirmed advanced or metastatic breast cancer\n2. Received prior treatment with at least one of the following: CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted therapies\n3. Documented disease progression following prior targeted therapy\n4. Initiated a subsequent line of systemic therapy (chemotherapy, endocrine therapy, targeted therapy, or combination) after resistance\n5. Available clinical data including baseline characteristics and treatment details\n6. At least one follow-up evaluation after initiation of post-resistance therapy\n\nExclusion Criteria:\n\n1. Incomplete medical records or missing key clinical follow-up data\n2. Concurrent diagnosis of other active malignancies (except non-melanoma skin cancer or in situ cervical cancer)\n3. Known central nervous system disease requiring immediate local treatment (unless clinically stable)\n4. Poor general condition with an Eastern Cooperative Oncology Group (ECOG) performance status ≥2\n5. Life expectancy estimated to be less than 6 months based on clinical judgment",{"count":134,"type":22},200,"This is a real-world observational study aiming to evaluate the effectiveness of post-progression treatment strategies in patients with advanced breast cancer who have developed resistance to prior targeted therapies, including CDK4\u002F6 inhibitors, PIK3CA inhibitors, trastuzumab deruxtecan (T-DXd), or other targeted agents commonly used in clinical practice. As resistance to these therapies becomes increasingly common, optimal sequencing strategies for subsequent treatment remain unclear.\n\nThis study will collect clinical information on post-resistance systemic treatments and their outcomes, including progression-free survival, overall survival, and response rate. Baseline patient and tumor characteristics will also be collected to explore potential prognostic and predictive factors and to develop outcome prediction models that may help guide future clinical decision-making.\n\nThis is a non-interventional study based on retrospective and prospective data from routine medical care. The results are expected to provide real-world evidence to inform personalized treatment strategies for patients with advanced breast cancer following resistance to targeted therapies.",[137,33,138,139,140,141],"Metastatic Breast Cancer","Hormone Receptor-Positive Breast Cancer","HER2-positive Breast Cancer","Triple-Negative Breast Cancer (TNBC)","Treatment Decisions",[143,144,145,137,146],"Real-World Study","Treatment Resistance","Post-Progression Therapy","Predictive Factors","2025-07-09",{"date":149,"type":38},"2025-07-18",{"date":151,"type":38},"2023-01-01",{"date":153,"type":22},"2026-06-01",{"name":155,"class":45},"Hunan Cancer Hospital"]