Articles: disease.
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Randomized Controlled Trial Multicenter Study
Safety and immunogenicity of 2-dose heterologous Ad26.ZEBOV, MVA-BN-Filo Ebola vaccination in children and adolescents in Africa: A randomised, placebo-controlled, multicentre Phase II clinical trial.
Reoccurring Ebola outbreaks in West and Central Africa have led to serious illness and death in thousands of adults and children. The objective of this study was to assess safety, tolerability, and immunogenicity of the heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimen in adolescents and children in Africa. ⋯ The heterologous 2-dose vaccination was well tolerated in African adolescents and children with no vaccine-related SAEs. All vaccinees displayed anti-EBOV GP antibodies after the 2-dose regimen, with higher responses in the 56-day interval groups. The frequency of pyrexia after vaccine or placebo was higher in children than in adolescents. These data supported the prophylactic indication against EBOV disease in a paediatric population, as licenced in the EU.
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Randomized Controlled Trial
Effect of amlodipine versus bisoprolol in hypertensive patients on maintenance hemodialysis: A randomized controlled trial.
Left ventricular hypertrophy and asymmetric dimethylarginine (ADMA) are surrogate markers of cardiovascular disease (CVD) in the dialysis population. This study aimed to evaluate the effect of a calcium channel blocker-based antihypertensive regimen compared to a beta-blocker-based antihypertensive regimen on left ventricular mass index (LVMI) and ADMA levels in hypertensive patients on hemodialysis (HD). ⋯ This study showed that compared to a bisoprolol-based regimen, an amlodipine-based antihypertensive regimen resulted in a significantly greater reduction in LVMI and ADMA levels from baseline in hypertensive patients on HD despite similar BP reduction in both groups. These findings support the re-evaluation of amlodipine as a potential first-line antihypertensive treatment in patients on HD without previous CVD.
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Randomized Controlled Trial Multicenter Study Comparative Study
Trial of Spesolimab for Generalized Pustular Psoriasis.
Generalized pustular psoriasis (GPP) is a rare, life-threatening, inflammatory skin disease characterized by widespread eruption of sterile pustules. Interleukin-36 signaling is involved in the pathogenesis of this disorder. Spesolimab, a humanized anti-interleukin-36 receptor monoclonal antibody, is being studied for the treatment of GPP flares. ⋯ In a phase 2 randomized trial involving patients with GPP, the interleukin-36 receptor inhibitor spesolimab resulted in a higher incidence of lesion clearance at 1 week than placebo but was associated with infections and systemic drug reactions. Longer and larger trials are warranted to determine the effect and risks of spesolimab in patients with pustular psoriasis. (Funded by Boehringer Ingelheim; Effisayil 1 ClinicalTrials.gov number, NCT03782792.).
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Multicomponent Strategy with Decentralized Molecular Testing for Tuberculosis.
Effective strategies are needed to facilitate the prompt diagnosis and treatment of tuberculosis in countries with a high burden of the disease. ⋯ A multicomponent diagnostic strategy that included on-site molecular testing plus implementation supports to address barriers to delivery of high-quality tuberculosis evaluation services led to greater numbers of patients being tested, receiving a diagnosis, and being treated for confirmed tuberculosis. (Funded by the National Heart, Lung, and Blood Institute; XPEL-TB ClinicalTrials.gov number, NCT03044158.).
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Randomized Controlled Trial
Effects of high-flow nasal cannula with oxygen on self-paced exercise performance in COPD: A randomized cross-over trial.
Studies have demonstrated that noninvasive ventilation improves exercise intolerance in patients with chronic obstructive pulmonary disease (COPD). The role of heated humidified high-flow nasal cannula (HFNC) therapy in patients with COPD on self-paced exercise performance remains unclear. Therefore, the purpose of the present study was to determine whether HFNC-aided supplemental oxygen during a 6-minute walk test (6MWT) would change self-paced exercise performance and cardiopulmonary outcomes in patients with stable COPD. ⋯ Walking distance and arterial oxygen saturation improved in stable COPD patients receiving HFNC with additional oxygen support. However, HFNC did not affect transcutaneous carbon dioxide tension and the self-reported dyspnea score during the walking test. The present study demonstrated the feasibility and safety of using HFNC in self-paced exercise.