Статті в журналах з теми "3606 Visual arts"

Reseña de: Manzarbeitia Valle, Santiago; Azcárate Luxán, Matilde; González Hernando, Irene (eds.), Pintado en la pared: el muro como soporte visual en la Edad Media. Madrid, Ediciones Complutenses, 2019. ISBN: 978-84-669-3606-4, 499 pp.

Los filmes inmersivos son un nuevo formato para contar historias que utiliza el espacio de la imagen como un elemento audiovisual esencial para entender correctamente la narrativa. Hemos realizado un análisis de contenido sobre una muestra compuesta por vídeos de 3600 narrativos de ficción, a la que aplicamos un modelo compuesto por variables relacionadas con la organización del espacio alrededor del espectador. Los resultados señalan un esquema organizativo centrípeto, similar al teatro inmersivo, donde se da prioridad al entendimiento de la narrativa principal por encima de una verdadera utilización del espacio que proporciona este nuevo formato para contar historias.

Background Renal impairment is a life threatening complication of myeloma with up to 20-25% of patients presenting with renal dysfunction. Around 28% of newly diagnosed myeloma patients with renal failure do not survive beyond 100 days compared with 10% overall. In addition to poor survival, there are no quality of life (QoL) data from published renal failure myeloma studies to guide management. OPTIMAL trial utilizes the EuroQoL (EQ-5D-3L) heath questionnaire, a validated instrument for health outcomes, to measure QoL in these patients. It is a 3 level, 5 dimensional questionnaire, assessing mobility, self-care, usual activity, pain/discomfort and anxiety/depression with either no problems, some problems or extreme problems. Participants also rate their current health on a visual analogue scale (VAS) of 0-100. We hypothesize that reported QoL in typical myeloma trials are better than the QoL for patients with renal impairment such as those recruited into the OPTIMAL trial. Methods OPTIMAL is a randomised, multi-centre phase II trial of newly diagnosed myeloma patients with renal impairment (ClinicalTrials.gov Identifier: NCT02424851). Participants were randomised to receive four 12 week cycles of Bortezomib, Bendamustine and Dexamethasone (BBD) or Thalidomide, Bendamustine and Dexamethasone (BTD); all participants received bendamustine and dexamethasone in 3 week cycles. Participants not considered suitable for autologous stem cell transplant (ASCT) could be given a further 2 cycles of treatment in their respective arms. Patient reported outcomes were measured using the validated EQ-5D-3L. Participants were asked to complete a questionnaire at baseline and on day 1 of each treatment cycle and at 1 month and 12 month follow up visits. Differences in changes of EQ-5D-3L and the VAS scores between baseline and 1 month follow up were assessed by 2 sample t-tests. To compare the EQ-5D-3L data from the OPTIMAL trial to others, a literature search was conducted to see if any data were available that provided further insight into the QoL in patient's diagnosed with myeloma and renal failure. PUBMED and MEDLINE were explored and authors emailed if EQ-5D-3L data was not identified. Results OPTIMAL recruited 31 patients between March 2015 and March 2019 from 7 centres within the UK. Of these, 17 patients completed EQ-5D-3L at baseline and at 1 month follow up; 8 on BBD and 9 on BTD. Sixty five per cent of patients were ≤70 years old, 76% male, 35% were CKD stage 4 and 65% were CKD stage 5, 59% had planned ASCT, 88% had ECOG performance status 0 or 1, 35% were on dialysis and 94% were ISS stage III. At baseline a mean of 35.2% of patients reported some or extreme problems across the 5 QoL domains compared with 36.6% at 1 month follow up (Table 1). No significant changes were detected in mean EQ-5D-3L (p=0.33) or VAS scores (p=0.72) between baseline and 1 month follow up by treatment arm (Table 2). Additionally, no differences in EQ-5D-3L scores were found between age group or dialysis status (p>0.1; Table 3). However, some improvement in anxiety and depression levels were observed overall with 59% of patients reporting none at baseline increasing to 76% at follow up. No changes were reported in self-care or the ability to perform usual activities. Mobility decreased from 71% experiencing no problems to 59%. In order to compare QoL reported by OPTIMAL with QoL reported in published myeloma trials, a literature search was undertaken and identified 48 articles of which only 11 studies reported QoL and only 4 of these reported the EQ-5D-5L. No studies assessed QoL in patients similar to the OPTIMAL trial patient population with renal impairment. However a couple of studies demonstrated improved QoL at 3 months compared to baseline across treatment arms. Conclusion It is well known that treatments used within clinical trials can significantly improve the outcomes for patients but it is important to also measure the impact on patient's QoL. The OPTIMAL trial demonstrated that this poor prognostic set of patients with renal impairment had significant reduction in anxiety and depression at 1 month follow up. It was disappointing that a literature search demonstrated a paucity of QoL data routinely collected and reported within clinical trials. Patients need to know the impact of treatments on outcomes such as survival but also need to know the impact on their QoL. Funding: NAPP Pharmaceuticals, JANSSEN-Cilag Ltd and Blood Cancers UK. Disclosures Ramasamy: Takeda: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria; Bristol Myers Squibb: Research Funding; GSK: Membership on an entity's Board of Directors or advisory committees; Bristol Myers squibb: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Oncopeptides: Honoraria; Janssen: Research Funding; Amgen: Honoraria; Sanofi: Honoraria; Abbvie: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; Amgen: Research Funding; Janssen: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria; Oncopeptides: Membership on an entity's Board of Directors or advisory committees; Takeda: Speakers Bureau. Lindsay:Amgen: Other: Travel Expenses; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Expenses; Takeda: Honoraria, Other: Travel Expenses.

Abstract Background: Survival of DLBCL patients with high IPI treated with RCHOP immunochemotherapy is poor. In this population, the combination of RCHOP with new drugs is an attractive approach, along with performing an evaluation with PET/CT after 2 to 4 cycles to change the therapy if an early complete response is not achieved. Methods : We performed a clinical trial comparing 6 cycles of RCHOP vs 6 cycles of BRCAP, a modified RCHOP regimen changing vincristine by bortezomib 1.3 mg/m2 sc days 1, 8, and 15 of a 21-day cycle. Pre-phase therapy was permitted for patients who could not wait the results of the screening procedures to start therapy due to the aggressiveness of the disease. (ClinicalTrials.gov Identifier: NCT01848132). Patients younger than 71 yrs diagnosed with DLBCL and an age-adjusted IPI (aaIPI) 2-3 or aaIPI 1 with increased beta2microglobulin were eligible. The primary endpoint was the proportion of patients who survives free of event at 2 years. Centralized anatomopathology review was performed in all cases; samples were classified as germinal center B-cell-like (GCB) vs non-GCB subtypes by immunohistochemistry according to the Hans algorithm. PET/CTs were performed baseline, after 2, 4 and 6 cycles (PET2, PET4, and PET6), and were reviewed at real time by at least 3 experts of a central panel. Response at the end of therapy was analyzed following the visual method with the Deauville scale, and response after PET2 and PET4 was evaluated using the semiquantitative method. Persistent disease at PET4 was considered as failure of therapy and these patients were removed from trial treatment. EFS was calculated from diagnosis until event defined as death from any cause, relapse, progression or need of salvage therapy (defined as PET4 or PET6 positive). Overall survival (OS) was calculated from diagnosis until death for any cause. We present here a preliminary analysis of results. Results: One hundred and twenty-one patients were included; data on 113 are presented (diagnosis not confirmed in 6, data missing in 2). Median age was 57.1 yrs (range 23-70), 57 (50.4%) were males. Characteristics at diagnosis were: non-GCB subtype 32/87 (36.8%), immunohistochemical co-expression of myc/bcl2 56/82 (77.8%), stage III-IV 107 (94.7%), ≥2 extranodal locations 55/76 (72.5%), ECOG 2-3 36 (32.1%), increased LDH 88 (77.9%), increased beta 2 microglobulin 73 (64.6%), aaIPI 3: 32 (28.3%). No differences were found between treatment arms. Fifty-five patients were treated in the experimental arm (EA) and 58 in the control arm (CA). Twenty-eight (28.3%) out of 99 patients required of pre-phase treatment. The mean relative dose intensity for bortezomib was 88.3%. Data about the most frequent toxicity are shown in table 1. Twenty-nine (30.2%) out of 96 patients who have finished 4 cycles had a positive PET4 according to central review and were withdrawn to receive salvage therapy. Complete remission (CR) at the end of therapy (PET4-/PET6-) was observed in 44 (45.8%) patients. After a median follow-up of 9 months, estimated 12-mo EFS was 36.6%, and 12-mo OS was 82.9% in the whole series. Data of the subgroup analysis according the immunohistochemistry subtypes by Hans algorithm are show in table 2. Conclusions: In the present preliminary analysis, no significant differences were found between RCHOP and BRCAP in terms of CR and EFS in this very high-risk population of young DLBCL patients. However, in the subgroup analysis of patients with non-GCB disease, we found a significantly better CR rate in patients treated with BRCAP. A longer follow-up is needed to evaluate the real impact of this therapy on survival. Disclosures González-Barca: Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria; Servier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Sanofi: Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria. Martín:Sevier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria; Gilead: Membership on an entity's Board of Directors or advisory committees. Sancho:Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celltrion, Inc: Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. López-Jiménez:Abbvie: Membership on an entity's Board of Directors or advisory committees; Velgene: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; MSD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; MundiPharma: Honoraria, Membership on an entity's Board of Directors or advisory committees. López-Guillermo:Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; MundiPharma: Membership on an entity's Board of Directors or advisory committees; Roche: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Ramírez:Bristol-Myers-Squibb: Honoraria; Novartis: Honoraria; Roche: Honoraria; Janssen: Membership on an entity's Board of Directors or advisory committees. Conde:Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria; Amgen: Membership on an entity's Board of Directors or advisory committees; Servier: Membership on an entity's Board of Directors or advisory committees.

Abstract Background Penicillin G Benzathine (PGB) is the cornerstone of syphilis treatment. However, its intramuscular (IM) administration is associated with pain at the site of injection. The dilution of PGB with local anesthetics is recommended in some guidelines, but the evidence that supports it, particularly in adults and in HIV infection, is scarce. Preliminary clinical experience also suggests that the IM administration of PGB through increased needle gauges might improve its tolerability. The aim of the study to identify less painful ways of administering IM PGB in the treatment of syphilis in adults. Methods Multicenter, randomized, double-blinded clinical trial in patients diagnosed with primary syphilis that required a single IM injection of PGB 2400,00 IU. Patients were randomized to receive PGB diluted with 0.5 mL mepivacaine 1% (MV) or PGB alone, and both groups either with a long 19G or short 21G IM needle. The primary objective was the effect on local pain immediately after the administration through a visual scale questionnaire on pain (0 to 10). Results One hundred eight patients were included, 27 in each group. Ninety-four (94.4%) were male, and 41.7% were also HIV-infected. Mean age 36.6 years (SD 11). Significant differences in immediate pain intensity were observed when comparing the long 19G group with anesthesia (mean pain intensity, [MPI] 2.92 [CI 95% 1.08-4.07]) vs long 19G without anesthesia (MPI 5.56 [CI 95% 4.39-6.73), p < 0.001; and also between short 21G group with anesthesia (MPI 3.36 [CI 95% 2.22-4.50]) vs short 21G without anesthesia (MPI 5.06 [CI 95% 3.93-6.19]), p = 0.015). No significant differences in immediate pain were observed between 19G and 21G in the presence or absence of anesthesia (p = 1.0 in both cases). No differences were found between study arms after 6 and 24 h. Conclusions The IM administration of 1% mepivacaine-diluted PGB induces significantly less immediate local pain as compared to PGB alone. The needle gauge did not have any effect on the pain. Based on these results, we suggest anesthetic-diluted IM PGB as the standard treatment for primary syphilis. Trial registration EudraCT 2014-003969-24 (Date of registration 18/09/2014).