Clinical Trials
Category Added in a WPeMatico Campaign
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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)…
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Bimekizumab treatment for sustained improvements in patient symptoms and health-related quality of life to 3 years in axial spondyloarthritis: results from the BE MOBILE studies and their open-label extension
CONCLUSIONS: Bimekizumab treatment led to rapid and sustained improvements in key patient symptoms and HRQoL to 3 years, emphasising its long-term value in controlling symptoms which profoundly affect patients’ experience and daily lives.
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Vutrisiran in Patients With Transthyretin Amyloidosis With Cardiomyopathy and Renal Impairment: Analyses From HELIOS-B
CONCLUSIONS: Vutrisiran may slow eGFR decline and is effective and well-tolerated in patients with ATTR-CM with declining renal function, including those developing CKD stage ≥4.
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Providing information to prepare breast cancer patients for their surgical consultation: barriers and recommendations (an analysis from Alliance A231701CD)
CONCLUSION: Our study highlights that breast cancer patients want information prior to the consultation, but patient-centered challenges can lead to non-review. When sharing pre-consult information, clinics should communicate how reviewing information can help patients feel less overwhelmed and improve their discussion with the surgeon.
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Acute placebo responsiveness predicts longitudinal expectation effects in antidepressant treatment
Positive treatment expectations are known to enhance antidepressant efficacy. Experimental placebo studies aim to provide mechanistic insights into this association, yet their findings have not been clearly linked to clinical expectation effects within individual patients. In a randomized crossover trial, 61 participants with major depressive disorder (31 women, 30 men) completed an emotion classification task…
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Prophylactic tranexamic acid for the prevention of postpartum haemorrhage in women with placenta praevia: multicentre, double blind, randomised, placebo controlled, phase 3 trial
CONCLUSIONS: In women with placenta praevia who underwent caesarean delivery and received prophylactic oxytocin, treatment with tranexamic acid resulted in a statistically significant yet modest reduction in the incidence of postpartum haemorrhage, with no signal of increased serious adverse events.
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Regulatory B cell expansion and type 1 innate lymphoid cell suppression characterise immune modulation in paediatric lupus nephritis
CONCLUSIONS: BAFF inhibition in paediatric LN is associated with rebalancing of innate and adaptive immunity through enhancement of Breg function and suppression of ILC1-driven inflammation.