Disseny d'assaig clínic seqüencial de comparació de temps de supervivència amb aproximació bayesiana i models d'Ahmed i Beta-Binomial

Aquest treball de màster conté una proposta de disseny d'assaig clínic bayesià seqüencial basat en el model d'Ahmed pel càlcul de la supervivència i en el model conjugat beta-binomial per la variable de seguretat. A més conté dues propostes per a d'estudi aplicat ICO-BEVA-08, estudi el qual s'està duent a terme actualment a l'Institut Català d'Oncologia-L'Hospitalet. . Aquest projecte consisteix en dissenyar un assaig clínic fase III desde l'aproximació bayesiana. Aquest tindrà com a variable principal la supervivència, i a més incorporarà regles d'aturada en funció de o be futilitat, èxit o equivalència del tractament, o bé toxicitat inacceptable. Per aconseguir el millor disseny d'assaig clínic es realitzaran simulacions sobre diversos escenaris d'igualtat, superioritat o inferioritat

Real-world efficacy and safety of eribulin in advanced and pretreated HER2-negative breast cancer in a Spanish comprehensive cancer center

Background Eribulin improves survival in pre-treated HER2-negative advanced breast cancer (ABC). However, limited data exist on co-morbidities and central nervous system (CNS) efficacy. The purpose of this study was to review eribulin's efficacy and safety in everyday clinical practice with special focus on age, body mass index (BMI) and central nervous system (CNS) activity. Methods An observational study was conducted in a series of HER2-negative ABC patients treated from January'14-December'17 outside a clinical trial. Objective Response Rate (ORR), Progression Free Survival (PFS), Overall Survival (OS), and association of clinical and pathological variables with outcome were evaluated. Results Ninety-five women were treated with at least one cycle of eribulin. Median age was 57 (33-83), and 18% were obese. Median number of prior chemotherapies for ABC was 3 (2-5) and 76% of patients had visceral metastases, including 21% with CNS involvement. Most tumors were estrogen receptor-positive (79%). ORR and stable disease (SD) at 6 months were 26.2 and 37.5%, respectively. Remarkably, relevant CNS efficacy was observed with eribulin: 20% of patients obtained partial response and 25% SD. Treatment was generally well tolerated and manageable, with 29% grade 3 and 10.9% grade 4 toxicities. Median PFS and OS were 4.1 months (CI95% 3.2-4.9) and 11.1 months (CI95% 9.5-14.7), respectively. Triple-negative disease, > 2organs involved and being younger than 70 years old were independent prognosis factors for worse OS in multivariate analysis. Most patients (75%) progressed in pre-existing metastases sites. Conclusion In everyday clinical practice, eribulin's efficacy seems similar to pivotal trials. CNS-efficacy was observed. TNBC, > 2 organs involved and being younger than 70 years old were independent prognosis factors for worse OS. Remarkably, less incidence of grade 4-toxicity compared to previous studies was found

Same-day SARS-CoV-2 antigen test screening in an indoor mass-gathering live music event: a randomised controlled trial

Background The banning of mass-gathering indoor events to prevent SARS-CoV-2 spread has had an important effect on local economies. Despite growing evidence on the suitability of antigen-detecting rapid diagnostic tests (Ag-RDT) for mass screening at the event entry, this strategy has not been assessed under controlled conditions. We aimed to assess the effectiveness of a prevention strategy during a live indoor concert. Methods We designed a randomised controlled open-label trial to assess the effectiveness of a comprehensive preventive intervention for a mass-gathering indoor event (a live concert) based on systematic same-day screening of attendees with Ag-RDTs, use of facial masks, and adequate air ventilation. The event took place in the Sala Apolo, Barcelona, Spain. Adults aged 18–59 years with a negative result in an Ag-RDT from a nasopharyngeal swab collected immediately before entering the event were randomised 1:1 (block randomisation stratified by age and gender) to either attend the indoor event for 5 hours or go home. Nasopharyngeal specimens used for Ag-RDT screening were analysed by real-time reverse-transcriptase PCR (RT-PCR) and cell culture (Vero E6 cells). 8 days after the event, a nasopharyngeal swab was collected and analysed by Ag-RDT, RT-PCR, and a transcription-mediated amplification test (TMA). The primary outcome was the difference in incidence of RT-PCR-confirmed SARS-CoV-2 infection at 8 days between the control and the intervention groups, assessed in all participants who were randomly assigned, attended the event, and had a valid result for the SARS-CoV-2 test done at follow-up. The trial is registered at ClinicalTrials.gov, NCT04668625. Findings Participant enrollment took place during the morning of the day of the concert, Dec 12, 2020. Of the 1140 people who responded to the call and were deemed eligible, 1047 were randomly assigned to either enter the music event (experimental group) or continue with normal life (control group). Of the 523 randomly assigned to the experimental group, 465 were included in the analysis of the primary outcome (51 did not enter the event and eight did not take part in the follow-up assessment), and of the 524 randomly assigned to the control group, 495 were included in the final analysis (29 did not take part in the follow-up). At baseline, 15 (3%) of 495 individuals in the control group and 13 (3%) of 465 in the experimental group tested positive on TMA despite a negative Ag-RDT result. The RT-PCR test was positive in one case in each group and cell viral culture was negative in all cases. 8 days after the event, two (<1%) individuals in the control arm had a positive Ag-RDT and PCR result, whereas no Ag-RDT nor RT-PCR positive results were found in the intervention arm. The Bayesian estimate for the incidence between the experimental and control groups was –0·15% (95% CI –0·72 to 0·44). Interpretation Our study provides preliminary evidence on the safety of indoor mass-gathering events during a COVID-19 outbreak under a comprehensive preventive intervention. The data could help restart cultural activities halted during COVID-19, which might have important sociocultural and economic implications.Primavera Sound Group and the #YoMeCorono InitiativePeer ReviewedPostprint (author's final draft

Post-Franco Theatre

In the multiple realms and layers that comprise the contemporary Spanish theatrical landscape, “crisis” would seem to be the word that most often lingers in the air, as though it were a common mantra, ready to roll off the tongue of so many theatre professionals with such enormous ease, and even enthusiasm, that one is prompted to wonder whether it might indeed be a miracle that the contemporary technological revolution – coupled with perpetual quandaries concerning public and private funding for the arts – had not by now brought an end to the evolution of the oldest of live arts, or, at the very least, an end to drama as we know it

Time to Switch to Second-line Antiretroviral Therapy in Children With Human Immunodeficiency Virus in Europe and Thailand.

Background: Data on durability of first-line antiretroviral therapy (ART) in children with human immunodeficiency virus (HIV) are limited. We assessed time to switch to second-line therapy in 16 European countries and Thailand. Methods: Children aged <18 years initiating combination ART (≥2 nucleoside reverse transcriptase inhibitors [NRTIs] plus nonnucleoside reverse transcriptase inhibitor [NNRTI] or boosted protease inhibitor [PI]) were included. Switch to second-line was defined as (i) change across drug class (PI to NNRTI or vice versa) or within PI class plus change of ≥1 NRTI; (ii) change from single to dual PI; or (iii) addition of a new drug class. Cumulative incidence of switch was calculated with death and loss to follow-up as competing risks. Results: Of 3668 children included, median age at ART initiation was 6.1 (interquartile range (IQR), 1.7-10.5) years. Initial regimens were 32% PI based, 34% nevirapine (NVP) based, and 33% efavirenz based. Median duration of follow-up was 5.4 (IQR, 2.9-8.3) years. Cumulative incidence of switch at 5 years was 21% (95% confidence interval, 20%-23%), with significant regional variations. Median time to switch was 30 (IQR, 16-58) months; two-thirds of switches were related to treatment failure. In multivariable analysis, older age, severe immunosuppression and higher viral load (VL) at ART start, and NVP-based initial regimens were associated with increased risk of switch. Conclusions: One in 5 children switched to a second-line regimen by 5 years of ART, with two-thirds failure related. Advanced HIV, older age, and NVP-based regimens were associated with increased risk of switch

Disseny d'assaig clínic seqüencial de comparació de temps de supervivència amb aproximació bayesiana i models d'Ahmed i Beta-Binomial

Aquest treball de màster conté una proposta de disseny d'assaig clínic bayesià seqüencial basat en el model d'Ahmed pel càlcul de la supervivència i en el model conjugat beta-binomial per la variable de seguretat. A més conté dues propostes per a d'estudi aplicat ICO-BEVA-08, estudi el qual s'està duent a terme actualment a l'Institut Català d'Oncologia-L'Hospitalet. . Aquest projecte consisteix en dissenyar un assaig clínic fase III desde l'aproximació bayesiana. Aquest tindrà com a variable principal la supervivència, i a més incorporarà regles d'aturada en funció de o be futilitat, èxit o equivalència del tractament, o bé toxicitat inacceptable. Per aconseguir el millor disseny d'assaig clínic es realitzaran simulacions sobre diversos escenaris d'igualtat, superioritat o inferioritat

Disseny d'assaig clínic seqüencial de comparació de temps de supervivència amb aproximació bayesiana i models d'Ahmed i Beta-Binomial

Aquest treball de màster conté una proposta de disseny d'assaig clínic bayesià seqüencial basat en el model d'Ahmed pel càlcul de la supervivència i en el model conjugat beta-binomial per la variable de seguretat. A més conté dues propostes per a d'estudi aplicat ICO-BEVA-08, estudi el qual s'està duent a terme actualment a l'Institut Català d'Oncologia-L'Hospitalet. . Aquest projecte consisteix en dissenyar un assaig clínic fase III desde l'aproximació bayesiana. Aquest tindrà com a variable principal la supervivència, i a més incorporarà regles d'aturada en funció de o be futilitat, èxit o equivalència del tractament, o bé toxicitat inacceptable. Per aconseguir el millor disseny d'assaig clínic es realitzaran simulacions sobre diversos escenaris d'igualtat, superioritat o inferioritat

Actitud y formación, binomio para tener éxito en la universidad y en la empresa: Reflexiones para ser un buen profesional

Editado por: Garcia Montoya, Encarna y Salazar Macian, Ramon. Cada capítulo está escrito por diferentes autoresEn la primera parte se estudian los 5 primeros capítulos/ temas relativos a los conocimientos básicos pedagógicos que se han de tener en cuenta en los estudios universitarios orientados a las ciencias de la salud para conseguir una buena actitud y formación que les permita tener éxito en sus estudios de grado y, eventualmente, en su carrera universitaria 1. Ideas acerca de aprender a estudiar, recordar y aprobar en el siglo XXI. 2. Cómo se prepara una tesis doctoral o un trabajo de investigación en el siglo XXI en el área de la salud. 3. El método científico aplicado a las ciencias de la salud. 4. Lectura y escritura de textos científicos. 5. Cómo preparar un discurso y saber hablar en público. En la segunda parte, a partir del capítulo/tema 6 se describen los principales estudios, que su lectura y ejemplos pueden guiar a los profesionales mejorar su actitud y formación y encontrar trabajo en la empresa. 6. La cultura de trabajar sin prisa, sin pausa y sin nervios. 7. ¿Qué se debe hacer para tener una entrevista de trabajo con éxito? 8. Calidad factor común de las personas con éxito. 9. Cuáles son los factores de éxito de una empresa. 10. Cómo gestionar el cambio en la empresa. 11. Actitud para afrontar los cambios profesionales y como reinventarse para seguir siendo útil. 12. Anexos. Fichas de perfiles de trabajo en la Industria Farmacéutica

Cataluña (Paleoflora)

118 páginasPeer reviewe