Clinical Trials
Category Added in a WPeMatico Campaign
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Risk of drug-induced liver injury in multiple system atrophy patients treated with KM-819 is potentially associated with the HLA-DPB1*05:01:01:01 allele
KM-819, a first-in-class inhibitor of Fas-associated factor 1 (FAF1), was investigated in a Phase 2 clinical trial in Korean patients with multiple system atrophy (MSA). Among 34 KM-819-treated patients, 11 met the case definition for suspected DILI, and 9 of these (26%) were adjudicated by an independent hepatic adjudication committee (HAC) as KM-819-related DILI; no…
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Efficacy of a needle-free blood collection device (PIVO Pro) for avoiding contaminated blood culture sets in Australian emergency departments: protocol for an adaptive group sequential randomised controlled trial
INTRODUCTION: Blood cultures are essential for diagnosing bloodstream infections and guiding antimicrobial therapy, but sample contamination can influence test sensitivity and treatment decision-making. The ‘PIVO Pro’ is a needle-free device which allows blood collection from a peripheral intravenous catheter (PIVC), with its use potentially avoiding sample contamination and decreasing the amount of venepuncture instances. However,…
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Stenting Technique and Clinical Outcome in True Bifurcation PCI: Insights From the OCTOBER Trial
CONCLUSIONS: Clinical indication, LMCA bifurcation, and SB disease severity predicted 2-stent PCI. MACE did not differ according to planned strategy, whereas actual 2-stent PCI had higher MACE rates, likely reflecting a higher burden of complexity. The lowest event rates were observed with OCT-guided 1-stent PCI.
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Effect of prenatal genetic counseling on anxiety and test attitudes in pregnant women: a randomized trial
CONCLUSION: These findings support the potential role of nurse-led prenatal genetic counseling in reducing anxiety and improving attitudes toward prenatal testing. Larger multicenter studies with longer follow-up are required before educational or policy recommendations can be made.
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Evaluation of a Mental Health Care App-Based Fatigue Management Program for Patients With Inflammatory Bowel Disease in Remission: Protocol for a Randomized Controlled Trial
CONCLUSIONS: This study may contribute valuable knowledge regarding participant engagement and the potential impact of a multicomponent mobile cognitive behavioral intervention package on fatigue in patients with IBD. The findings will support future refinement of the intervention and inform large-scale evaluations and implementation efforts.
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Impact of previous skin hydration on postsclerotherapy hyperpigmentation: a prospective, randomized, comparative study (SKINCARE Study)
CONCLUSIONS: In this randomized, double-arm, prospective, pilot study, the use of moisturizer 30 days before polidocanol 0.5% sclerotherapy did not reduce PSH.
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Empagliflozin Promotes Natriuresis in Diabetic Patients with Cirrhotic Refractory Ascites: A Proof-of-Concept Study
CONCLUSIONS: In this open-label, proof-of-concept study, empagliflozin was associated with improved short-term natriuretic indices over 10 days in diabetic patients with decompensated cirrhosis and refractory ascites, without serious adverse events. Larger, blinded, longer-term trials are warranted to confirm these preliminary findings.
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High-Frequency Oscillatory Ventilation Combined With Inhaled Nitric Oxide for Persistent Pulmonary Hypertension of the Newborn: A Single-Center Randomized Clinical Trial
CONCLUSIONS: In the observed per-protocol population, HFOV + iNO was associated with fewer deaths or ECMO events and faster improvement in oxygenation and right-ventricular echocardiographic measures than either comparator. Because 12 randomized infants were excluded and the overall comparison was not robust to the differential worst-case missing-outcome assumption, confidence in the apparent treatment effect is…
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Continuous Versus Routine EEG in Critically Ill Patients Without Primary Neurologic Condition: Analysis of a Randomized Controlled Trial
CONCLUSION: In critically ill adults without a primary neurologic condition, cEEG was not associated with measurable benefits in survival, neurological recovery, or epileptiform activity detection compared with repeated rEEG, in a cohort without detected electrographic seizures or status epilepticus. Pending larger, ideally prospective comparative studies, repeated routine EEG may represent a reasonable alternative in resource-limited…
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The Effect of Carbetocin on Cardiac Repolarization: A Randomized, Placebo- and Positive-Controlled QT/QTc Study in Healthy Adults
Carbetocin is an oxytocin receptor agonist used for postpartum hemorrhage prevention. While oxytocin is known to transiently prolong the QT/QTc interval, robust QTc data for carbetocin are limited. Carbetocin is known to elevate HR, which can impact QTc analyses; thus, a dose that did not overly elevate HR was important to select. This randomized, placebo-…