Articles: disease.
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Multicenter Study
Clinical differentiation of inflammatory bowel disease (IBD) in Latin America and the Caribbean.
The aim of the present study was to describe the epidemiological and clinical characteristics of inflammatory bowel disease (IBD), including medical and surgical treatments, in several countries in Latin America and the Caribbean. IBD is recognized as a global health problem because its incidence and prevalence have increased significantly over the last few years. This multicenter retrospective cohort study included 4714 patients with IBD diagnosed from 9 countries in Latin America and the Caribbean: Colombia, Cuba, Dominican Republic, Ecuador, Mexico, Peru, Puerto Rico, Uruguay, and Venezuela. ⋯ The following clinical characteristics were more frequent in the Caribbean: penetrating behavior in CD, steroid dependence, steroid resistance, intolerance to thiopurines, extraintestinal manifestations, surgeries, hospitalizations due to IBD, and family history of IBD. The factors associated with the use of biological therapy were pancolitis in ulcerative colitis, penetrating behavior in CD, steroid resistance and dependence, presence of extraintestinal manifestations, and the need for surgery. This study from Latin America and the Caribbean demonstrated the different epidemiological and clinical characteristics of IBD.
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Randomized Controlled Trial Multicenter Study
The effect of lung-conduction exercise in chronic obstructive pulmonary disease: Randomized, assessor-blind, multicenter pilot trial.
Pulmonary rehabilitation (PR) is a management modality that improves the quality of life of patients with chronic obstructive pulmonary disease (COPD); however, PR is not readily accessible. Therefore, we developed lung-conduction exercises (LCE) that can be performed easily without any limitations. The purpose of this randomized, assessor-blind, multicenter pilot trial was to compare the effects of LCE with PR and standard care (SC) in COPD patients. ⋯ In this trial, PR showed more improvement in symptoms and quality of life than SC alone. To seek a more precise use of LCE, further full-sized studies with a long duration and additional outcome measures such as psychological assessment tools and cost-effectiveness ratio should be conducted.
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Multicenter Study
Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer.
Human epidermal growth factor receptor 2 (HER2)-targeted therapies have not been approved for patients with non-small-cell lung cancer (NSCLC). The efficacy and safety of trastuzumab deruxtecan (formerly DS-8201), a HER2 antibody-drug conjugate, in patients with HER2-mutant NSCLC have not been investigated extensively. ⋯ Trastuzumab deruxtecan showed durable anticancer activity in patients with previously treated HER2-mutant NSCLC. The safety profile included interstitial lung disease that was fatal in two cases. Observed toxic effects were generally consistent with those in previously reported studies. (Funded by Daiichi Sankyo and AstraZeneca; DESTINY-Lung01 ClinicalTrials.gov number, NCT03505710.).
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Multicenter Study
Epidemiological investigation and ultrasonic diagnosis of developmental dysplasia of the hip in Chinese infants: A large multi-center cohort study.
Developmental dysplasia of the hip (DDH) is common among Chinese infants, but a lack of large-scale, multi-center epidemiological studies has made it difficult to characterize the risk factors associated with this disease. This multi-center cohort study included 19,833 Chinese infants aged 14 days to 6 months. A multi-center ultrasound protocol was used to diagnose hip abnormalities, and epidemiological data of the infants were collected through questionnaires. ⋯ Family history, breech presentation, oligohydramnios, musculoskeletal deformities, and female sex are high-risk factors for DDH in Chinese infants. The incidence of DDH gradually decreases with age. The results of this study provide evidence for the epidemiology of infant DDH in China.
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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.