Camrelizumab Plus Carboplatin and Pemetrexed as First-Line Treatment for Advanced Nonsquamous NSCLC: Extended Follow-Up of CameL Phase 3 Trial.

Introduction: In CameL phase 3 study (ClinicalTrials.gov: NCT03134872), addition of camrelizumab to first-line chemotherapy significantly improved the progression-free survival in patients with stages IIIB to IV nonsquamous NSCLC. Here, we present outcomes after a minimum follow-up of 43.

Effects of oral Δ9-tetrahydrocannabinol and cannabidiol combinations on a sustained attention task in rats.

A well-documented side effect of cannabis and Δ9-tetrahydrocannabinol (THC) acute administration is deficits in cognition and attention. Cannabidiol (CBD), a nonintoxicating constituent of cannabis, may modulate THC's impairing effects. A goal of this study was to determine the effects of THC and CBD, alone and in combination, on performance in the rodent Psychomotor Vigilance Test (rPVT), a translational paradigm used to quantify sustained attention.

Alterations in prefrontal cortical neuregulin-1 levels in post-pubertal rats with neonatal ventral hippocampal lesions.

Genetic studies in humans have implicated the gene encoding neuregulin-1 (NRG-1) as a candidate susceptibility gene for schizophrenia. Furthermore, it has been suggested that NRG-1 is involved in regulating the expression and function of the -methyl-D-aspartate receptor and the GABA receptor in several brain areas, including the prefrontal cortex (PFC), the hippocampus, and the cerebellum. Neonatal ventral hippocampal lesioned (NVHL) rats have been considered as a putative model for schizophrenia with characteristic post-pubertal alteration in response to stress and neuroleptics.

Efficacy Endpoints in Phase II Clinical Trials for Meningioma: An Analysis of Recent Clinical Trials.

Background: Response Evaluation Criteria in Solid Tumors (RECIST)-based response rates are commonly used as efficacy endpoints in phase II clinical trials for solid tumors. However, no consensus has been reached concerning adequate efficacy endpoints for phase II clinical trials targeting meningioma. Irregularity of lesions after resection, and varying degrees of dysplasia and histologic subtypes make establishing an appropriate efficacy evaluation difficult.

Dalpiciclib partially abrogates ER signaling activation induced by pyrotinib in HER2HR breast cancer.

Recent evidences from clinical trials (NCT04486911) revealed that the combination of pyrotinib, letrozole, and dalpiciclib exerted optimistic therapeutic effect in treating HER2HR breast cancer; however, the underlying molecular mechanism remained elusive. Through the drug sensitivity test, the drug combination efficacy of pyrotinib, tamoxifen, and dalpiciclib to BT474 cells was tested. The underlying molecular mechanisms were investigated using immunofluorescence, Western blot analysis, immunohistochemical staining, and cell cycle analysis.

First-in-human phase I dose-escalation and dose-expansion trial of the selective MEK inhibitor HL-085 in patients with advanced melanoma harboring NRAS mutations.

Background: HL-085 is a selective, orally administered MEK1/2 inhibitor. We aimed to evaluate the safety and efficacy of HL-085 in patients with advanced melanoma harboring NRAS mutations.

Methods: This was a multicenter phase 1 study.

Effect of eplerenone on clinical stability of Japanese patients with acute heart failure.

Background: In the EARLIER (Efficacy and Safety of Early Initiation of Eplerenone Treatment in Patients with Acute Heart Failure) trial, eplerenone did not reduce heart failure (HF) hospitalizations or all-cause mortality in 300 patients admitted for acute HF (AHF). However, the trial might have been underpowered for these endpoints, and a comprehensive overview of the effect of eplerenone on diuretic doses and patients' clinical stability is warranted.

Methods: The EARLIER trial included Japanese patients hospitalized for AHF randomly assigned to eplerenone or placebo over 6 months.

Maternal Plasma Choline during Gestation and Small for Gestational Age Infants.

Objective: Small for gestational age (SGA) infants are at increased risk for neonatal morbidity and developmental problems in childhood. No current interventions during human pregnancy address this problem. This study investigated the possible relationship between maternal choline concentration during pregnancy and SGA infants.

Antiresorptive Drugs and the Risk of Femoral Shaft Fracture in Men and Women With Osteoporosis: A Cohort Study Using the National Database of Health Insurance Claims of Japan.

Background: This cohort study aimed to estimate incidence rates of femoral shaft fracture in patients who were treated with antiresorptive drugs.

Methods: We used data from the National Database of Health Insurance Claims of Japan from April 2009 and October 2016. All patients with new use of an antiresorptive drug, prescription-free period of ≥3 months, and no prior femoral fractures were included.

Urinary catheterization prior to PCI worsens clinical outcomes in patients with acute myocardial infarction.

Background: Indwelling urethral catheters (IUCs) are used to measure urine volume, keep patients on bed rest, or keep the groin area clean in patients with acute myocardial infarction (AMI). However, the association between IUC use and in-hospital urinary-related complications is unknown.

Methods: This was a single-center retrospective analysis of 303 patients admitted to our hospital in 2018-2020 who had AMI without cardiogenic shock.

Lidocaine Intraoperative Infusion Pharmacokinetics during Partial Hepatectomy for Living Liver Donation.

Background: Postoperative pain associated with open partial hepatectomy can be intense and persistent. The multimodal approach used to lessen this problem includes an intraoperative intravenous infusion of lidocaine hydrochloride. Decreased hepatic metabolism after resection raises concerns about safe lidocaine dosing in this patient population.

Comparison of dynamic changes in the peripheral CD8 T cells function and differentiation in ESCC patients treated with radiotherapy combined with anti-PD-1 antibody or concurrent chemoradiotherapy.

Objective: The systematic immune status of cancer patients undergoing immunotherapy is little known. We prospectively identified the function and differentiation traits of peripheral CD8 T cells based on our phase 1b clinical trial (NCT03222440) of radiotherapy combined with camrelizumab in patients with locally advanced esophageal squamous cell carcinoma (ESCC) and compared it with concurrent chemoradiotherapy (CCRT).

Methods: 19 and 18 patients were included in the cohort of radiotherapy plus camrelizumab and cohort of CCRT treatment.

Pharmacokinetics and Safety of Follitropin Delta in Gonadotropin Down-Regulated Healthy Chinese Women.

Background: Follitropin delta, a novel recombinant follicle-stimulating hormone (rFSH) preparation derived from a human cell line, has different pharmacokinetic and pharmacodynamic properties compared with existing rFSH preparations expressed by Chinese hamster ovary cells (CHO).

Objectives: The objective of this study was to assess the pharmacokinetic characteristics, dose proportionality, and safety of follitropin delta in healthy Chinese women.

Methods: This was a phase I, randomized, open-label study.

Subfoveal choroidal thickness following pars plana vitrectomy in tractional diabetic macular edema.

Purpose: To evaluate changes in subfoveal choroidal thickness (SCT) in cases of tractional diabetic macular edema (DME) after pars plana vitrectomy (PPV).

Methods: This prospective study included 31 eyes of 31 patients who underwent PPV for the management of tractional DME. Best-corrected visual acuity (BCVA), SCT, and central macular thickness (CMT) were measured before the operation, as well as one, three, and six months following the surgery in the operated eyes and at baseline, as well as six months in the fellow eyes.

Antibody-mediated Rejection of Kidney Allografts Following COVID-19: A Report of Two Cases.

Increased risk of graft rejection could be the consequence of COVID-19 in kidney transplant recipients (KTRs). We report two cases of kidney transplant (KT) with stable graft function who experienced antibody-mediated rejection (ABMR) following recovery from COVID-19. It seems that reduced immunosuppression during the acute illness, is the main explanation for post-COVID-19 ABMR.

Lot-to-lot consistency, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults: A randomized, double-blind, phase IV trial.

Previous phase I to III clinical trials have shown that the inactivated SARS-CoV-2 vaccine namely CoronaVac has good efficacy, safety, and immunogenicity. This phase IV trial aims to evaluate the lot-to-lot consistency, immunogenicity, and safety on a commercial scale in healthy adults, which could provide data to support stable manufacturing. In this single-center, randomized, double-blind study, 1,080 healthy adults aged 26-45 years were randomly assigned into three groups to receive one of three lots of vaccines.

Ventricular and atrial function assessment with transthoracic echocardiography in patients with rheumatic inflammatory disease.

Background: Inflammatory rheumatic diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and systemic sclerosis (SSc), can cause cardiovascular complications in many cases. This study aimed to compare the ventricular and atrial functions of the heart between rheumatic patients and healthy controls using transthoracic echocardiography (TTE).

Results: The study was performed between 64 patients with mentioned rheumatic diseases and 64 age- and sex-matched healthy controls who all underwent detailed history-taking and TTE.

Comparison of Bitterness Intensity between Prednisolone and Quinine in a Human Sensory Test Indicated Individual Differences in Bitter-Taste Perception.

Prednisolone is a frequently prescribed steroid with a bitter, unpalatable taste that can result in treatment refusal. Oral suspensions or powder dosage forms are often prescribed, particularly to pediatric patients, as they improve swallowability and ease of dose adjustment. Consequently, the bitterness of prednisolone is more apparent in these dosage forms.

The effect of preoperative biliary drainage on postoperative complications of pancreaticoduodenectomy: a triple center retrospective study.

Background: Biliary obstruction which is a major complication of pancreas and periampullary tumors could result in cholangitis, coagulopathies, gastrointestinal symptoms, and impaired wound healing. Pancreaticoduodenectomy (PD) is still the standard approach for pancreas resection and imposes high risk of morbidity and mortality to patients. To reduce the high risk of PD and address the biliary obstruction, the use of preoperative biliary stenting was increased.

Safety and Clinical Activity of SHR7390 Monotherapy or Combined With Camrelizumab for Advanced Solid Tumor: Results From Two Phase I Trials.

Background: SHR7390 is a novel, selective MEK1/2 inhibitor. Here, we report results from two phase I trials conducted to evaluate the tolerability, safety and antitumor activity of SHR7390 monotherapy for advanced solid tumors and SHR7390 plus camrelizumab for treatment-refractory advanced or metastatic colorectal cancer (CRC).

Patients And Methods: Patients received SHR7390 alone or combined with fixed-dose camrelizumab (200 mg every 2 weeks) in an accelerated titration scheme to determine the maximum tolerated dose (MTD).

Effects of on Oxidative Stress Markers and Thirst Alleviation in Hemodialysis Patients: A Randomized Double-Blinded Placebo-Controlled Cross-Over Clinical Trial.

Background: Patients undergoing hemodialysis (HD) are regularly exposed to oxidative stress and inflammation and may suffer from thirst distress with no definitive treatment to address these complications. (DS) has been used to alleviate thirst in traditional Persian medicine. This study aimed to assess the effectiveness of DS on oxidation factors and thirst score in HD patients.

Risk Factors of Recurrent Anal Abscess in Patients with Type 2 Diabetes Mellitus; a 4-Year Retrospective study.

Introduction: Anal abscess is considered as a relatively common compilation in type 2 diabetes mellitus (T2DM) patients. This study aimed to determine the risk factors of recurrent anal abscess in T2DM patients.

Methods: In this 4-year retrospective cross-sectional study, T2DM patients hospitalized due to anal abscess in Shahid Modarres Hospital, Tehran, Iran from December 2016 to December 2020 were studied.