Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials.

Composite scale data consists of numerous categorical questions/items that are often summed as a total score and are commonly utilized as primary endpoints in clinical trials. These endpoints are conceptually discrete and constrained by nature. Item response theory (IRT) is a powerful approach for detecting drug effects in composite scale data from clinical trials, but estimating all parameters requires a large sample size and all item information, which may not be available.

Immunogenicity of Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV; Sinopharm) and Short-Term Clinical Outcomes in Vaccinated Solid Organ Transplant Recipients: A Prospective Cohort Study.

BackgroundImmunocompromised patients have lower seroconversion rate in response to COVID-19 vaccination. The aim of this study is to evaluate the humoral immune response with short-term clinical outcomes in solid organ transplant recipients vaccinated with SARS-CoV-2 vaccine (BBIBP-CorV; Sinopharm).MethodsThis prospective cohort was conducted from March to December 2021 in Abu Ali Sina hospital, Iran.

Effects of Panax Ginseng on Health-Related Quality of Life in Patients with Non-Metastatic Breast Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Ginseng for HRQOL in Breast Cancer.

Being diagnosed with cancer and chemotherapy impose distressing symptoms on patients' Health-Related Quality of Life (HRQOL). This study evaluated ginseng efficacy on improving multiple aspects of HRQOL in breast cancer patients. Forty women with non-metastatic early breast cancer were enrolled in the study.

Frequency of Visual Fields Needed to Detect Glaucoma Progression: A Computer Simulation Using Linear Mixed Effects Model.

Prcis: Irregular visual field test frequency at relatively short intervals initially and longer intervals later on in the disease provided acceptable results in detecting glaucoma progression.

Purpose: It is challenging to maintain a balance between the frequency of visual field testing and the long-term costs that may result from insufficient treatment of glaucoma patients. This study aims to simulate real-world circumstances of visual field data to determine the optimum follow-up scheme for the timely detection of glaucoma progression using a linear mixed effects model (LMM).

Quality of life associated with immunosuppressant treatment adherence in liver transplant recipients: A cross-sectional study.

Transplanted organ survival after solid organ transplantation highly correlates with the adherence levels of the patients to their immunosuppressive drugs. On the other hand, one of the main goals of liver transplantation is to increase the overall quality of life (QOL) for the patient. This study is aimed to analyze the relationship between adherence and QOL in adult liver transplant recipients of the biggest liver transplant center in Asia.

Metformin attenuates symptoms of osteoarthritis: role of genetic diversity of Bcl2 and CXCL16 in OA.

Objective: This study aimed to evaluate the effectiveness of metformin versus placebo in overweight patients with knee osteoarthritis (OA). In addition, to assess the effects of inflammatory mediators and apoptotic proteins in the pathogenesis of OA, the genetic polymorphisms of two genes, one related to apoptosis (rs2279115 of Bcl-2) and the other related to inflammation (rs2277680 of CXCL-16), were investigated.

Methods: In this double-blind placebo-controlled clinical trial, patients were randomly divided to two groups, one group receiving metformin (n = 44) and the other one receiving an identical inert placebo (n = 44) for 4 consecutive months (starting dose 0.

Pharmacokinetic assessment of vancomycin in critically ill patients and nephrotoxicity prediction using individualized pharmacokinetic parameters.

Therapeutic drug monitoring (TDM) and pharmacokinetic assessments of vancomycin would be essential to avoid vancomycin-associated nephrotoxicity and obtain optimal therapeutic and clinical responses. Different pharmacokinetic parameters, including trough concentration and area under the curve (AUC), have been proposed to assess the safety and efficacy of vancomycin administration. Critically ill patients receiving vancomycin at Nemazee Hospital were included in this prospective study.

Protective effects of Panax ginseng against doxorubicin-induced cardiac toxicity in patients with non-metastatic breast cancer: A randomized, double-blind, placebo-controlled clinical trial.

Introduction: Anthracycline-based chemotherapy increases the risk of cancer therapeutics-related cardiac dysfunction. Recently, evidences from in vitro experiments and animal studies have shown that ginsenosides may exert cardiovascular protection against cancer therapeutics-related cardiac dysfunction. Here, we aimed to evaluate this effect in a clinical situation.

Evaluation of the therapeutic regimen in COVID-19 in transplant patients: where do immunomodulatory and antivirals stand?

Background: The management of COVID-19 in organ transplant recipients is among the most imperative, yet less discussed, issues based on their immunocompromised status along with their vast post-transplant medication regimens. No conclusive study has been published to evaluate proper anti-viral and immunomodulator medications effect in treating COVID-19 patients to this date.

Method: This retrospective study was conducted in Shiraz Transplant Hospital, Iran from March 2020 to May 2021 and included COVID-19 diagnosed patients based on SARS-CoV-2 RT-PCR positive test who had been hospitalized for at least 48 h before enrolling in the study.

A longitudinal item response model for Aberrant Behavior Checklist (ABC) data from children with autism.

This manuscript aims to present the first item response theory (IRT) model within a pharmacometric framework to characterize the longitudinal changes of Aberrant Behavior Checklist (ABC) data in children with autism. Data were obtained from 120 patients, which included 20,880 observations of the 58 items for up to three months. Observed scores for each ABC item were modeled as a function of the subject's disability.

Adjusted adaptive Lasso for covariate model-building in nonlinear mixed-effect pharmacokinetic models.

One important aim in population pharmacokinetics (PK) and pharmacodynamics is identification and quantification of the relationships between the parameters and covariates. Lasso has been suggested as a technique for simultaneous estimation and covariate selection. In linear regression, it has been shown that Lasso possesses no oracle properties, which means it asymptotically performs as though the true underlying model was given in advance.

Growth Velocity of Infants From Birth to 5 Years Born in Maku, Iran.

Background: Growth velocity standards are essential for proper evaluation of child growth. The goal of this study was to construct weight, height and head circumference growth velocity charts for infants.

Methods: This study includes 256 infants (124 boys and 132 girls) born in Maku, Northwest of Iran, and monitored from birth until they were 5 years.

Longitudinal standards for growth velocity of infants from birth to 4 years born in West Azerbaijan Province of northwest Iran.

Objectives: Growth velocity is an important factor to monitor for appropriate child growth. This study presents the growth velocity of infants based on length, weight, and head circumference.

Methods: The subjects of this study were 308 neonates (160 boys and 148 girls) born in West Azerbaijan Province of northwestern Iran who were followed from birth for 4 years.

Child Weight Growth Chart and Its Associated Factors in Birth Cohort of Maku Using a Growth Curve Model and LMS Method.

Background: Infant growth is defined as a positive change in body size over a period of time, and is a sensitive predictor of social health. The most effective way to determine child growth is by measuring birth weight and constructing a weight growth trajectory. Many studies were conducted on the effects of different factors on birth weight, but investigations of these effects on growth trajectory are really sparse.

Breast cancer risk factors in a defined population: weighted logistic regression approach for rare events.

Purpose: This study aimed to determine out risk factors for female breast cancer in a low socioeconomic population in Iran.

Methods: Between 2007 and 2009, a total of 25,592 women who were ensured by the Imam Khomeini Relief Foundation participated in this screening program. The characteristics of patients diagnosed with breast cancer (n=111) were compared with those of control cases (n=25,481).