Clinical Trials
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Metastatic tropism of molecularly defined clear-cell renal cell carcinoma clusters
BACKGROUNDThe relationship between molecular subgroups in clear-cell renal cell carcinoma (ccRCC) and metastatic tropism is poorly understood.METHODSWe analyzed over 5,000 metastatic sites from 305 treatment-naive ccRCC patients in the IMmotion150 phase II clinical trial, where patients were randomized to atezolizumab, atezolizumab/bevacizumab, or sunitinib.RESULTSAngiogenic tumors (clusters 1 and 2) had a higher rate of pancreatic (21%…
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Safety, tolerability, and concordance with interferon-gamma release assays of a recombinant ESAT6-MPT64 skin test: a phase 1 randomized clinical trial
CONCLUSION: The recombinant EM skin test is safe, well-tolerated, and demonstrates preliminary diagnostic accuracy comparable to IGRAs. By successfully validating the translational utility of the MPT64 (RD2) antigen in a human cohort, this study provides a strong proof-of-concept for the EM skin test as a scalable, specific, and cost-effective immunodiagnostic tool.
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Correction: Safety, tolerability, and concordance with interferon-gamma release assays of a recombinant ESAT6-MPT64 skin test: a phase 1 randomized clinical trial
[This corrects the article DOI: 10.3389/fimmu.2026.1780294.].
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Morning versus afternoon administration of immune checkpoint inhibitors in metastatic non-small-cell lung cancer
CONCLUSIONS: Morning ICI infusions confer a modest but clinically meaningful survival benefit that is absent in chemotherapy controls, supporting a causal chronotherapeutic effect. Scheduling ICIs before noon represents a low-cost, immediately actionable strategy warranting prospective confirmation.
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Efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam compared with imipenem-cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis (Integral-1): a double-blind, randomised phase 3 trial
BACKGROUND: Nacubactam (OP0595) is a newly developed diazabicyclooctane β-lactamase inhibitor used in combination with cefepime or aztreonam. We assessed the efficacy and safety of cefepime-nacubactam and aztreonam-nacubactam versus imipenem-cilastatin in complicated urinary tract infection (cUTI) or acute uncomplicated pyelonephritis.
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What Have We Learned From the Idiopathic Intracranial Hypertension Treatment Trial the William F. Hoyt Lecture
CONCLUSIONS: Acetazolamide plus diet gave statistically significant improvements of visual function, papilledema, CSF pressure, and quality of life in patients with IIH with mild visual loss. A maximally tolerated dose up to 4 g/day is recommended.
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Treatment of Clinically Diagnosed Alzheimer’s Disease by External Counterpulsation A Randomized Clinical Trial
ObjectiveTo assess external counterpulsation (ECP) effects on cognitive and functional decline in early AD.MethodsThis 12-month, multicenter, blinded, randomized, sham-controlled trial enrolled 190 patients with early AD (MCI due to AD or mild AD per NIA-AA clinical criteria). Participants received either full-pressure ECP (150-300 mmHg) or sham (25 mmHg): 3-5 weekly one-hour sessions for 35 treatments,…
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Mode Effects Between Mobile Web and Telephone Surveys on Patient Experience Scores in South Korea: Secondary Analysis of a Randomized Controlled Trial Under Various Missingness Scenarios
CONCLUSIONS: Mobile surveys may yield substantially lower patient experience scores than telephone surveys. Unlike previous studies, our study analyzes randomized experimental data under various missingness scenarios and provides evidence that this mode effect is unlikely to be attributable to analytical methods or heterogeneity in respondent characteristics between the 2 survey administration modes. Accordingly, caution is…
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Health-related quality of life comparing standard and prolonged time-to-surgery after neoadjuvant chemoradiotherapy for esophageal cancer: results from the multicenter, randomized, controlled NeoRes II trial
Standard time-to-surgery after neoadjuvant chemoradiotherapy for esophageal cancer has historically been 4-6 weeks. Observational studies have suggested improved oncological outcomes and health-related quality of life in patients after prolonged time-to-surgery. This study aimed to investigate whether prolonged time-to-surgery is associated with improved health-related quality of life compared to the standard interval. This study is a…
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![A Phase 1 Oral Mass Balance and Combined Intravenous [14C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans](https://i.aidevmd.com/wp-content/uploads/2025/03/itinai.com_A_close-up_shot_of_a_scientist_wearing_a_pristine__db6a7c73-f520-44e3-bb74-10eabe38d600_3.png)
A Phase 1 Oral Mass Balance and Combined Intravenous [14C] Microtracer Study to Characterize the Absorption, Metabolism, Excretion, and Pharmacokinetics of Antitumor Drug E7386 in Humans
E7386, an orally active protein-protein interaction inhibitor, is reported to impair the interaction between transcriptional co-activator CREB-binding protein and β-catenin. A competent study design exploring the concomitant dosing routes, sensitive intravenous (IV; [^(14)C]) microtracer technology, and oral [^(14)C] radiolabeled dosing was successfully implemented to determine the absolute bioavailability and the absorption, metabolism, and excretion (AME)…