Clinical Trials
Category Added in a WPeMatico Campaign
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Inpatient versus outpatient management of young infants with a single low-mortality-risk sign of possible serious bacterial infection in sub-Saharan Africa and south Asia: an open-label, multicentre, two-arm, randomised controlled trial
BACKGROUND: Research has shown low mortality in young infants with a single low-mortality-risk possible serious bacterial infection (PSBI) sign. Outpatient treatment of young infants (age <2 months) with a single low-mortality-risk PSBI sign might be as effective and safe as hospitalisation. Outpatient treatment overcomes the challenges of hospitalisation and improves access in low-resource settings. Our…
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When are postpartum haemorrhages diagnosed? A nested observational study within the E-MOTIVE cluster-randomised trial
BACKGROUND: The definition of primary postpartum haemorrhage as blood loss of 500 mL or more within 24 h after vaginal birth underemphasises the early postpartum hours due to limited data on the timing of postpartum haemorrhage diagnosis. Understanding postpartum haemorrhage diagnosis timing and diagnostic methods is important for guiding diagnostic and therapeutic strategies. The E-MOTIVE…
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Cortical gyrification predicts initial treatment response in adults with ADHD
While the need for personalised treatment approaches grows in recognition, predicting treatment outcomes for adults with Attention-Deficit/Hyperactivity Disorder (ADHD) remains underexplored. Recent interest has turned to the brain’s surface and its association with treatment response. Although the precise interplay between cortical gyrification and ADHD treatment outcomes remains to be elucidated, preliminary investigations suggest a promising…
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Nailfold capillaroscopy in patients with systemic sclerosis-associated interstitial lung disease: a substudy of the SENSCIS trial
CONCLUSION: In a substudy of the SENSCIS trial, numerical differences in changes in capillary density assessed by NC over 52 weeks may suggest a potential effect of nintedanib in patients at risk of ILD progression.
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Efficacy of a Mobile Multidisciplinary Digital Therapeutics App for Patellofemoral Pain: Randomized Controlled Trial
CONCLUSIONS: This multidisciplinary DTx intervention was associated with significant pain reduction, improved functional disability, and increased knee extension strength in patients with PFP. These findings underscore the promise of DTx in PFP management and their potential to enhance patient outcomes.
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EYE-ECG2: Addressing medical student feedback in an RCT with eye-tracking videos featuring cued retrospective reporting and modified learning sequences for ECG interpretation skills training
CONCLUSION: The ECG training significantly improved participants’ ECG interpretation skills, with a strong start in the training session playing a key role in these improvements. Student feedback indicated that certain subgroups, particularly those with prior cardiological experience, may derive a greater self-reported benefit from the EYE-ECG2 videos.
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Sodium Reduction Program Incorporating Genetic Profile and an AI-Based App: A Randomized Clinical Trial
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial conducted among individuals with elevated blood pressure and a sodium-sensitive genotype, a sodium reduction program combining a genetic profile and an AI-based app with sodium-specific information did not significantly reduce salt intake. These findings highlight the challenges of achieving dietary behavior change through genetic personalized plus digital…
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Bilateral posterior tibial nerve stimulation as a neuromodulation strategy for obstructed defecation: a randomized controlled trial
CONCLUSION: BT-PTNS is a safe and effective noninvasive treatment for ODS without anatomical abnormalities, significantly improving symptom severity and quality of life. Further multicentric trials are warranted to standardize treatment protocols and assess long-term outcomes.
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Indocyanine green (ICG) fluorescence guided lymph node mapping for determination of resection margins in colon cancer — ISCAPE trial
CONCLUSIONS: In this trial, metastatic LNs were confined within ICG AFL in 95.6% of pN + cases. Although the predefined sensitivity threshold was not met, the result suggests potential for ICG mapping to guide resection margins in colon cancer surgery.
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Effects of Aerobic-Resistance Training and Nutritional Intervention on Adiponectin, Interleukin-6, and hs-CRP Concentrations in Men with Abdominal Obesity-A Randomized Controlled Trial
The objective of this study was to assess the changes in adiponectin concentrations and inflammatory markers in men with abdominal obesity following physical exercise and exercise combined with dietary intervention. This study included 44 males with abdominal obesity (mean age 34.7 ± 5.5 years, waist circumference [WC] 110.3 ± 8.5, BMI 32.0 ± 3.9), who…