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Supplemental material, sj-pdf-1-smm-10.1177_09622802231176034 for qTPI: A quasi-toxicity probability interval design for phase I trials with multiple-grade toxicities by Haodong Ling, Haolun Shi, Nan Yuan, Yuan Ji and Xiaolei Lin in Statistical Methods in Medical Research

Supplemental material, sj-pdf-1-smm-10.1177_09622802231176034 for qTPI: A quasi-toxicity probability interval design for phase I trials with multiple-grade toxicities by Haodong Ling, Haolun Shi, Nan Yuan, Yuan Ji and Xiaolei Lin in Statistical Methods in Medical Research

This paper proposes a decentralized cooling system combined with a traditional computer room air conditioning unit and server-level heat pipe exchangers for thermal environment optimization in a data center. Two cooling strategies, with heat exchangers installed above and below the servers respectively, are proposed and compared with the original CRACs system in terms of thermal environment. The simulation results of the original data center model are in good agreement with the on-site measurement results, and thus its reliability can be validated. The results show that a decentralized cooling system can effectively improve the thermal environment in data centers. To obtain the highest cooling efficiency, altogether 18 cases, where heat pipe exchangers were installed at different locations and heights, are analyzed and compared. The results show that the thermal environment is optimal when heat pipe exchangers are installed 0.01 m below each server. The local hotspot temperature is reduced by 6.8 °C, and the temperature distribution of the rack is the most uniform, which can effectively reduce the heat accumulation in data centers.

Supplemental material, sj-pdf-1-smm-10.1177_09622802211052746 for Probability-of-decision interval 3+3 (POD-i3+3) design for phase I dose finding trials with late-onset toxicity by Zichun Xu and Xiaolei Lin in Statistical Methods in Medical Research

We propose BaySize, a sample size calculator for phase I clinical trials using Bayesian models. BaySize applies the concept of effect size in dose finding, assuming the MTD is defined based on an equivalence interval. Leveraging a decision framework that involves composite hypotheses, BaySize utilizes two prior distributions, the fitting prior (for model fitting) and sampling prior (for data generation), to conduct sample size calculation under desirable statistical power. Look-up tables are generated to facilitate practical applications. To our knowledge, BaySize is the first sample size tool that can be applied to a broad range of phase I trial designs.

Additional file 1.

Los avances tecnológicos van a pasos agigantados, con ellos marcan nuevas tendencias que emergen para dominar el mercado, productos que antes era novedosos y que ahora deben adaptarse para seguir siendo competitivos. Por ello, el equipo compuesto por 3 estudiantes de la FIB ¿ UPC (Arthur Bernal, Marc Méndez y Xiaolei Lin) y dirigido por el profesor y director Francisco Jordan proponen en este proyecto nuevas tecnologías innovadoras que marcará el futuro tecnológico e incorporarlo en el producto TrustedX. Este proyecto se dividirá en dos partes, la primera que es la parte comuna es realizada por todos los integrantes del equipo y la segunda, la parte individual la realiza solo el autor de esta tesis. La parte comuna se basa en expandir e incorporar los componentes necesarios en el producto TrustedX on-premise para que pueda funcionar como TrustedX as a Service (TXaaS) y un sistema multi-tenant. Este nuevo producto tendrá la capacidad de cumplir los Reglamentos de eIDAS para ofrecer firmas digitales en el Cloud y tener la misma validez que las firmas notariales manuscritas. La parte individual consiste en crear un prototipo de archivado basado en timestamp utilizando la tecnología Blockchain e integrarlo en TXaaS. Para ello, se estudia el funcionamiento de esta tecnología y las diferentes opciones disponibles en el mercado. Además, se diseña e implementa todos los componentes requeridos para cumplir el objetivo. Technologies advance in leaps and bounds, they mark new trends that emerge to dominate the market, products that were previously novel and nowadays that must be adapted to remain competitive. For this reason, the team, that is made up of 3 students from the FIB - UPC (Arthur Bernal, Marc Méndez and Xiaolei Lin) and is led by the professor and director Francisco Jordan, proposes in this project new innovative technologies that will mark the technology of future and incorporate it into the TrustedX product. This project will be divided into two parts. The first consists of the communal part, which is carried out by all team members and the second, is the individual part that is realized only by the author of this thesis. The common part is based on expanding and incorporating all necessary components in the TrustedX on-premise product in order that it can function as TrustedX as a Service (TXaaS) and a multi-tenant system. This new product will have the ability to comply with eIDAS Regulation to offer digital signatures in the Cloud and have the same validity as the handwritten notarial signatures. The individual part consists of creating a timestamp-based archiving prototype by using Blockchain technology and, integrating it into TXaaS. To fulfill with this, the operation of this technology and the different available options in the market are studied. In addition, all components which are required will be designed and implemented in order to rach with the objective.

Ecological Momentary Assessment (EMA) studies usually produce intensively measured longitudinal data with large numbers of observations per unit, and research interest is often centered around understanding the changes in variation of people’s thoughts, emotions and behaviors. Hedeker et al.(1) developed a two level mixed effects location scale model that allows observed covariates as well as unobserved variables to influence both the mean and the within-subjects variance, for a two level data structure where observations are nested within subjects. In some EMA studies, subjects are measured at multiple waves and within each wave subjects are measured over time, Li and Hedeker(2) extended the original two level model to a three level data structure where observations are nested within days and days are then nested within subjects, by including a random location and scale intercept at the intermediate wave level. However, the three level random intercept model assumes constant response change rate for both the mean and variance. To account for changes in variance across waves, as well as clustering attributable to waves, we propose a more comprehensive location scale model that allows subject heterogeneity at baseline as well as across different waves, for a three level data structure where observations are nested within waves and waves are then further nested within subjects. The model parameters are estimated using Markov Chain Monte Carlo methods. We provide details on the Bayesian estimation approach and demonstrate how the Stan statistical software can be used to sample from the desired distributions and achieve consistent estimates. The proposed model is validated via a series of simulation studies. Data from an adolescent smoking study are analyzed to demonstrate this approach. The analyses clearly favor the proposed model and show significant subject heterogeneity at baseline as well as change over time, for both mood mean and variance. The proposed three level location scale model can be widely applied to areas of research where the interest lies in the consistency in addition to the mean level of the responses.

Rationale: To report a case of late spontaneous reattachment of Descemet membrane (DM) detachment after deep anterior lamellar keratoplasty (DALK). Patient concerns: A 50-year-old woman with stromal corneal scarring underwent a DALK with the big bubble technique. The DM detachment and double anterior chamber were observed on the first day after operation. Diagnoses: Descemet membrane detachment after deep anterior lamellar keratoplasty [Oculus Dexter (OD), indicates right eye]. Interventions: Sterile air injection was unsuccessful. Conservative observation was performed. Outcomes: During the follow-up, the donor cornea kept transparent and no edema was observed. The DM reattached spontaneously at the fifth months post-DALK. Lessons: The present case suggests that the retained host DM may result in DM detachment after DALK. For the DM detachment without roll rim, the detachment may spontaneously reattach in several months after surgery.

PurposeTrial RTOG 9202 was a phase 3 randomized trial designed to determine the optimal duration of androgen deprivation therapy (ADT) when combined with definitive radiation therapy (RT) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate. Long-term follow-up results of this study now available are relevant to the management of this disease.Methods and materialsMen (N=1554) with adenocarcinoma of the prostate (cT2c-T4, N0-Nx) with a prostate-specific antigen (PSA)