Clinical Trials
Category Added in a WPeMatico Campaign
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Effects of 8-week brisk walking combined with table tennis exercise on cardiovascular function in middle-aged and elderly individuals
CONCLUSION: Collectively, the BT intervention elicited the numerically greater cardiovascular function benefits, independent of weight loss, potentially via reducing arterial stiffness, enhancing parasympathetic activity, and modulating key cardiovascular biomarkers. However, the majority of these favorable numerical changes did not reach statistical significance when compared with standalone brisk walking (BW) or table tennis (TT). Meanwhile, several…
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National support for a healthy checkout policy: a randomised message-framing experiment
CONCLUSIONS: Support for a healthy checkout policy was high, especially when framed around benefits to child health. Adults with certain socio-demographic and clinical characteristics may especially support healthy checkout policies.
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Cost-effectiveness of onabotulinumtoxinA versus topiramate in chronic migraine in the US: an economic analysis of the FORWARD randomized trial
CONCLUSION: OnabotA was a cost-effective preventive treatment of chronic migraine versus topiramate. Although OnabotA had higher drug acquisition costs, these were offset by reduced HCRU costs due to fewer migraines, resulting in a low incremental cost per headache-day avoided versus topiramate.
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Effects of Lactobacillus crispatus-Containing Probiotics and Metformin on Insulin Resistance, Inflammation, and Gut Microbiome in Polycystic Ovary Syndrome: Protocol for an Open-Label Randomized Controlled Trial
CONCLUSIONS: This trial will provide critical, mechanistic evidence on whether the targeted action of L. crispatus can work additively with metformin to heal the intestinal mucosal barrier, arrest systemic endotoxemia, and rescue disrupted gut-brain-endocrine signaling. By validating this novel metabolic-inflammatory regimen against localized (calprotectin) and systemic (AGH and HOMA-IR) end points, this study intends to…
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Efficacy of chlorhexidine vaginal preparation in reducing postoperative infections during emergency cesarean deliveries for women in labor: a randomized controlled trial
CONCLUSION: In this single-center trial, preoperative chlorhexidine vaginal cleansing produced lower rates of postcesarean endometritis and SSI and of related infectious morbidity. As a low-cost intervention that can be integrated into existing perioperative workflows, it is a promising strategy for reducing maternal infection; however, adverse events were not systematically solicited, and neonatal exposure was not…
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Long-term effects of a parenting program for advanced cancer: A randomized controlled trial
OBJECTIVES: This study examines effects over time of a telephone-delivered 5-session manualized parenting education program for child-rearing parents with advanced cancer. Primary outcomes were parents’ depressed mood and anxiety, parenting skills, parenting self-efficacy, and child behavioral-emotional adjustment.
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Biomarker-dependent detection of contrast-associated acute kidney injury after intra-arterial contrast procedures: an exploratory randomized trial
CONCLUSIONS: CA-AKI ascertainment after intra-arterial contrast exposure is strongly biomarker-dependent. Historical creatinine-based definitions may underestimate early functional renal impairment and influence interpretation of preventive strategies. These findings highlight the importance of endpoint selection in CA-AKI clinical trials and support further investigation of sensitive functional biomarkers in larger prospective studies.
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A randomized comparison of comprehensive weight loss intervention vs. usual care on recurrences of atrial fibrillation in obese patients after catheter ablation: HOBIT-AF trial
CONCLUSION: HOBIT-AF trial showed that despite the beneficial effect of body weight reduction on metabolic profile of obese patients with predominantly paroxysmal AF after CA, no reduction in AF/AT recurrence was observed in comparison with control patients. This may be likely due to low AF burden after previous CA, limiting further improvement.
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Extended in vivo activity of VRC01 HIV-1 prophylaxis entails initial protective efficacy and subsequent breakthrough infections
The two parallel antibody-mediated prevention (AMP) efficacy trials evaluated whether intravenous infusion of the anti-CD4 binding site broadly neutralizing antibody VRC01 prevents HIV-1 acquisition. Here, we analyzed HIV-1 acquisition in AMP through the week 104 final study visit. Against viruses considered highly sensitive to VRC01 [80% inhibitory concentration (IC(80)) < 1 microgram/milliliter], VRC01 prophylaxis maintained…
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Transbronchial Cryobiopsy for the Diagnosis of Peripheral Pulmonary Lesions: A Prospective Randomized Controlled Study
Peripheral pulmonary lesions (PPLs) are increasingly detected by chest computed tomography, yet bronchoscopic diagnosis remains challenging for small and distal lesions. This prospective, single-center, randomized controlled study evaluated radial endobronchial ultrasound combined with a guide sheath (R-EBUS-GS)-assisted transbronchial cryobiopsy using a 1.1-mm ultrathin cryoprobe. Fifty patients with PPLs were randomized after successful R-EBUS-GS localization to…