Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study.

Objective: To evaluate the short term safety and potential therapeutic effect of allogenic adipose tissue-derived stromal/stem cells (ASCs) + cholecalciferol in patients with recent-onset T1D. Methods: Prospective, phase II, open trial, pilot study in which patients with recent onset T1D received ASCs (1 × 106 cells/kg) and cholecalciferol 2000 UI/day for 3 months (group 1) and were compared to controls with standard insulin therapy (group 2). Adverse events, C-peptide (CP), insulin dose, HbA1c, time in range (TIR), glucose variability (continuous glucose monitoring) and frequency of CD4+FoxP3+ T-cells (flow cytometry) were evaluated at baseline (T0) and after 3 months (T3). Results: 13 patients were included (8: group 1; 5: group 2). Their mean age and disease duration were 26.7 ± 6.1 years and 2.9 ± 1.05 months. Adverse events were transient headache (n = 8), mild local reactions (n = 7), tachycardia (n = 4), abdominal cramps (n = 1), thrombophlebitis (n = 4), mild floaters (n = 2), central retinal vein occlusion (n = 1, complete resolution). At T3, group 1 had lower insulin requirement (0.22 ± 0.17 vs. 0.61±0.26IU/Kg; p = 0.01) and HbA1c (6.47 ± 0.86 vs. 7.48 ± 0.52%; p = 0.03) than group 2. In group 1, 2 patients became insulin free (for 4 and 8 weeks) and all were in honeymoon at T3 (vs. none in group 2; p = 0.01). CP variations did not differ between groups (-4.6 ± 29.1% vs. +2.3 ± 59.65%; p = 0.83). Conclusions: Allogenic ASCs + cholecalciferol without immunosuppression was associated with stability of CP and unanticipated mild transient adverse events in patients with recent onset T1D. ClinicalTrials.gov registration: NCT03920397.

Satisfaction and gains perceived by nursing students with medium and high-fidelity simulation: A randomized controlled trial.

BACKGROUND: The use of simulation to reproduce the experience of health care settings and its use as a strategy in the teaching of nurses has grown at an unprecedented rate. There is little scientific evidence to examine the differences in satisfaction and gains perceived by the students with the use of medium and high fidelity. OBJECTIVES: To analyse and benchmark gains and satisfaction perceived by nursing students, according to their participation in medium- and high-fidelity simulated practice. DESIGN: Randomized control trial post-test only design with control group. SETTING AND PARTICIPANTS: Students of the 4th year of the Bachelor's Degree in Nursing who performed medium and high-fidelity simulated practice in a Simulation Centre environment. METHODS: A satisfaction scale and a scale of perceived gains from the simulation were applied to the students who underwent simulated practice in a medium-fidelity environment (control group) and high-fidelity environment (experimental group). Statistical analysis was performed and a significance level of p<0.05 was established. RESULTS: Of the 85 students who participated in the study, the majority were female (92.94%), with an average age of 21.89years (SD=2.81years). Satisfaction is statistically significant in the realism dimension and overall satisfaction. In the gains perceived with the simulation there is a statistically significant difference in the dimension recognition/decision. CONCLUSION: Students are very satisfied with the realism of high-fidelity simulated practice and consider that this helps them more with recognition and decision compared with the medium-fidelity simulation.

Dosagem da atividade da adenosina deaminase no líquido pleural para o diagnóstico da tuberculose pleural / Pleural fluid adenosine deaminase detection for the diagnosis of pleural tuberculosis

INTRODUÇAO: O diagnóstico da tuberculose pleural permanece um desafio, pois a sensibilidade dos testes tradicionais é baixa. O exame histopatológico da pleura é o método mais preciso, com até 80 por cento de sensibilidade. A dosagem da adenosina deaminase foi introduzida mais recentemente, mas sua utilidade no diagnóstico da tuberculose pleural no Brasil não foi suficientemente esclarecida. OBJETIVO: Verificar a sensibilidade e a especificidade de um método experimental de dosagem da atividade da adenosina deaminase em uma série de pacientes com derrame pleural investigados entre agosto de 1998 e novembro de 2002 no Rio de Janeiro (RJ). RESULTADOS: De 137 casos, em 111 havia amostras de líquido pleural disponíveis, das quais 83 pertenciam a pacientes com tuberculose pleural. Entre os 67 pacientes testados com tuberculose pleural, 10 apresentavam co-infecção pelo vírus da imunodeficiência humana (14,9 por cento). O valor de corte da adenosina deaminase de 35U/L foi determinado por uma curva receiver operator characteristic. A sensibilidade, especificidade, e razões de verossimilhança positiva e negativa da adenosina deaminase foram de 92,8 por cento, 93,2 por cento, 25,8 e 13,9, respectivamente. A média de adenosina deaminase no grupo com tuberculose pleural foi de 84,7 ± 43,1 U/L e no grupo com outras doenças de 15,9 ±11,1 U/L. Não houve diferença significativa na dosagem da adenosina deaminase entre pacientes com tuberculose pleural co-infectados ou não pelo vírus da imunodeficiência humana. CONCLUSAO: A dosagem da adenosina deaminase no líquido pleural é um método sensível e específico para o diagnóstico da tuberculose pleural e seu uso rotineiro pode reduzir a necessidade de realização de biópsias pleurais na abordagem inicial de um derrame pleural. O valor de corte de 35U/L para a adenosina deaminase é recomendado.