Articles: disease.
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Multicenter Study Observational Study
A clinical study to observe the efficacy and safety of Besunyen Detox Tea for constipation.
Functional constipation (FC) is a common functional gastrointestinal disease and is one of the most common outpatient diseases. The purpose of this study was to investigate the efficacy and safety of the traditional Chinese medicine Besunyen Detox Tea (BDT) for FC and to compare the effect of BDT between constipation patients with and non-dryness-heat syndrome. ⋯ This is the first registry-based study to collect real-world data of participants diagnosed with FC receiving BDT treatment. The results of this registry may also reflect these characteristics and provide direct clinical evidence to verify the importance of syndrome differentiation and treatment for the use of TCM health care products.
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Multicenter Study
A phase II, multicenter, open-label trial to evaluate the safety and efficacy of ISU303 (Agalsidase beta) in patients with Fabry disease.
Fabry disease (FD) is caused by a deficiency in the activity of the lysosomal enzyme, α-galactosidase A (α-Gal A), which leads to globotriaosylceramide (Gb3) deposition in multiple tissues. The current management of FD is enzyme replacement therapy (ERT). We report on the efficacy and safety of a new agalsidase beta, ISU303, in FD. ⋯ This study showed the efficacy and safety of ISU303. Treatment with ISU303 significantly resulted in plasma and urine Gb3 decrease in patients with FD. These results suggest that ISU303 is safe and effective and can alternative ERT for FD.
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Multicenter Study Observational Study
Validation of the neutrophil-to-lymphocyte ratio as a new simple biomarker of adult onset Still's disease: A STROBE-Compliant prospective observational study.
This study was performed to investigate the role of neutrophil-to-lymphocyte ratio (NLR) in the diagnosis of adult onset Still disease (AOSD) and its performance to improve the sensitivity of the classifications criteria (Yamaguchi and Fautrel Classifications). We conducted a multicenter prospective nationwide case-control study in Internal medicine, Rheumatology and Infectious disease departments, to include successively patients with suspected AOSD (2 or more major criteria of Yamaguchi or Fautrel classifications). All clinical and biological features were collected in a consensual and standardized clinical assessment at baseline and during follow-up. ⋯ The association of NLR as a major criterion with the classification of Yamaguchi or Fautrel improved their sensitivity, respectively for Fautrel (76.3% to 92.5%, P = .004) and Yamaguchi (78.8% to 90%, P = .05). This study validates the NLR as a good simple biomarker of AOSD with a cutoff value of 4 and high sensitivity (93.8%). The addition of NLR (NLR ≥ 4) as a major criterion to the classifications (Yamaguchi and Fautrel) improved significantly their sensitivity and accuracy.
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Multicenter Study Observational Study
Association between smoking and COVID-19 severity: A multicentre retrospective observational study.
The relationship between smoking and coronavirus disease 2019 (COVID-19) severity remains unclear. This study aimed to investigate the effect of smoking status (current smoking and a smoking history) on the clinical severity of COVID-19. Data of all enrolled 588 patients, who were referred to 25 hospitals in Jiangsu province between January 10, 2020 and March 14, 2020, were retrospectively reviewed. ⋯ In the random forest model, smoking history was ranked sixth in mean decrease accuracy. Active smoking may be significantly associated with an enhanced risk of COVID-19 progression towards severe disease. However, additional prospective studies are needed to clarify the complex relationship between smoking and COVID-19 severity.
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Infants younger than 6 months of age are at high risk for complications of coronavirus disease 2019 (Covid-19) and are not eligible for vaccination. Transplacental transfer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) after maternal Covid-19 vaccination may confer protection against Covid-19 in infants. ⋯ Maternal vaccination with two doses of mRNA vaccine was associated with a reduced risk of hospitalization for Covid-19, including for critical illness, among infants younger than 6 months of age. (Funded by the Centers for Disease Control and Prevention.).