P01.01 Safety and Efficacy Study of Pembrolizumab in Combination With LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant as Neoadjuvant TherapY——PLENTY Randomized Clinical Trial

BackgroundPatients with hepatocellular carcinoma (HCC) who exceed standard Milan criteria suffered from high post-transplant recurrence rate.This study will evaluate the safety and efficacy of pembrolizumab in combination with lenvatinib as neoadjuvant therapy in participants with HCC exceeding Milan criteria before liver transplant.Materials and MethodsParticipates would be randomly assigned (1:1) to experimental or Comparator/Control by computer-generated allocation based on the envelope method and the hierarchical block randomization method(hierarchy: BCLC stage and AFP level). The envelopes are sealed opaque, and sequentially numbered.Randomization is performed by the trial coordinator.The random number table and the block assignment number table will be kept confidential by the full-time secretary of this project.Center-stratified block-permuted randomization is used in this trial. Then permuted block randomization is used for each stratum with a block size of 4.ResultsThe initial first patient was recruited in August.2020, the primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) Objective Response Rate (ORR).The investigators design a clinical study to explore whether the combination above as a neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce postoperative recurrence and to analyze potential immune biomarker of therapeutic response.ConclusionsThe study is still ongoing and the preliminary short term outcome was positive. HCC patients who exceeded milan criteria may benefit from neoadjuvant immunotherapy combined with TKI before liver transplantation.Disclosure InformationH. Feng: None. Q. Xia: None.

Comparison of RAMP and New Modified RAMP Positioning in Laryngoscopic View During Intubation in Patients with Morbid Obesity: A Randomized Clinical Trial

Background: The prevalence of obesity is increasing worldwide, and anesthesiologists are facing challenges in the airway management of such patients. Excessive adipose tissue influences pharyngeal spaces and affects the laryngoscopic grade. Standard ramp positioning is time-consuming and difficult to prepare, and requires expensive equipment. Objectives: The aim of this study was to compare the standard ramp position with the proposed low-cost and easily accessible modified ramp position in laryngoscopic view during the intubation of patients with morbid obesity. Methods: In this single-blind clinical trial, 84 patients candidate for bariatric surgery at Rasoul Akram Hospital in 2020 were assigned to the rapid airway management positioner (RAMP) (R) and new modified RAMP (MR) groups by the block randomization method. The laryngoscopic view of the glottis based on the Cormack-Lehane scale, ventilation quality, duration of intubation, intubation attempts, oxygen saturation at the end of intubation, and the need for backward, upward, rightward pressure (BURP) maneuver for successful intubation were recorded. Normal distribution tests and Mann-Whitney and Kruskal-Wallis tests were used to analyze the data. Results: The results showed no significant differences between the two groups regarding ventilation score, laryngoscopy grade, number of intubation attempts, duration of intubation, and the need for BURP maneuvers during intubation (P > 0.05). Conclusions: The two methods are not significantly different, and the new modified ramp position can be used with more ease and availability and less cost.

Assessing Consistency in Single-Case Alternation Designs

Consistency is one of the crucial single-case data aspects that are expected to be assessed visually, when evaluating the presence of an intervention effect. Complementarily to visual inspection, there have been recent proposals for quantifying the consistency of data patterns in similar phases and the consistency of effects for reversal, multiple-baseline, and changing criterion designs. The current text continues this line of research by focusing on alternation designs using block randomization. Specifically, three types of consistency are discussed: consistency of superiority of one condition over another, consistency of the average level across blocks, and consistency in the magnitude of the effect across blocks. The focus is put especially on the latter type of consistency, which is quantified on the basis of partitioning the variance, as attributed to the intervention, to the blocking factor or remaining as residual (including the interaction between the intervention and the blocks). Several illustrations with real and fictitious data are provided in order to make clear the meaning of the quantification proposed. Moreover, specific graphical representations are recommend for complementing the numerical assessment of consistency. A freely available user-friendly webpage is developed for implementing the proposal.

Effect of propranolol with and without rosuvastatin on migraine attacks: a triple blind randomized clinical trial

Aim: To investigate the effect of rosuvastatin in combination with propranolol in reducing migraine attacks. Patients & methods: In a clinical trial study with census method, 120 patients with migraine headache were included. Patients were randomly assigned (using block randomization) to either propranolol (10 mg twice a day) with rosuvastatin (10 mg daily; intervention group [n = 60]) or propranolol (10 mg twice a day) with placebo (control [n = 60]). Results: The numbers of attacks were significantly decreased in the intervention group at the end of second, third and fourth weeks from the beginning of the intervention (p < 0.05). Conclusion: In patients with migraine, concomitant administration of propranolol (10 mg twice a day) and rosuvastatin (10 mg daily) is effective in reducing migraine attacks.

THE IMPACT OF MYCORRHIZAL PREPARATION MYKONET ON VALUABLE AGRONOMICAL AND ECONOMIC INDICATORS OF PEPPER

The aim of the present study was to determine the effect of the Indian mycorrhizal preparation Mykonet (Mn) of Endo type on agronomical and economic indicators of the hot and sweet pepper production. The study was conducted with two sweet (Zmrukht and Nush-55) and two hot varieties of pepper (Kon and Punj). The experiments were carried out according to the block randomization method. It has been shown that Mn improves the biological and economic characteristics of sweet and hot peppers, depending on the treatment duration and variety. The most effective was 2 h treatment. The dry matter content was increased slightly, but increased for sugars and ascorbic acid. The best effect was obtained for Zmrukht. Given that Mn has improved the agronomical and economic characteristics of sweet and hot peppers, it can be recommended for pepper production.