1,222 results match your criteria: "and ‡Late Clinical Research and Development[Affiliation]"

Purpose: Cannabichromene (CBC) is a phytocannabinoid commonly found in cannabis, yet its acute post-dose pharmacokinetics (PK) have not been examined in humans. This is a secondary data analysis from a trial investigating Spectrum Yellow oil, an oral cannabis product used for medical purposes that contained 20 mg cannabidiol (CBD), 0.9 mg Δ-tetrahydrocannabinol (THC), and 1.

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Purpose: This phase 4, randomized, open-label, multicenter study in healthy Indian infants and toddlers evaluated the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated in a multidose vial (MDV) or single prefilled syringe (PFS).

Methods: Healthy Indian infants (6 weeks of age) were randomized 1:1 to receive either PCV13-MDV or PCV13-PFS concomitant with routine pediatric vaccines. Subjects received a single dose of either PCV13-MDV or PCV13-PFS as a 4-dose schedule (infant series: 1 dose at 6, 10, and 14 weeks of age; toddler dose: 12 months of age).

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Vitamin D attenuates inflammatory responses to viral respiratory infections. Hence, vitamin D deficiency may be a highly significant prognostic factor for severity and mortality in COVID-19 patients. To evaluate the complications and mortality in different vitamin D status groups in COVID-19 hospitalized patients, we conducted this retrospective study on 646 laboratory-confirmed COVID-19 patients who were hospitalized in Shahid Modarres Hospital, Tehran, Iran from 16th March 2020 until 25th February 2021.

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Background: Circulating tumor cells (CTCs) are a prognostic marker in patients with metastatic colorectal cancer (mCRC). However, little is known about the characterization of CTCs in mCRC at the single-cell level using RNA sequencing. The purpose of this study was to validate the capability to detect and isolate single CTCs for single-cell RNA sequencing (scRNA-seq) and to identify clinical significance at a single CTC level.

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Background: The currently licensed quadrivalent MenACWY-CRM conjugate vaccine presentation consists of two vials (lyophilised MenA and liquid MenCWY) to be reconstituted before injection. A new fully liquid formulation in a single vial has been developed to further improve the vaccine presentation. Since the MenA structure is subject to hydrolytic degradation, this study was conducted to compare the immunogenicity and safety of the investigational MenACWY-CRM liquid vaccine with the licensed vaccine.

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Multiple sclerosis is a chronic, progressive neurological disease that, due to its special nature, has various physical and mental influences on the patients and their family's lives, decreasing the quality of life and threatening the meaning of life. The purpose of the present study was to evaluate the effectiveness of the group hope therapy training on the quality and the meaning of life in patients with multiple sclerosis and their family caregivers. This quasi-experimental study was performed using pretest-posttest and control group.

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A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10-40 years).

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Objectives: Acquired coagulopathy may be associated with bleeding risk. Approaches to restore haemostasis include administration of coagulation factor concentrates, but there are concerns regarding potential prothrombotic risk. The present study assessed the prothrombotic potential of four-factor prothrombin complex concentrate (4F-PCC) versus activated PCC (aPCC) and recombinant factor VIIa (rFVIIa), using three preclinical animal models.

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Background: TOURMALINE-MM1 was a global study that demonstrated a significant improvement in progression-free survival with ixazomib plus lenalidomide and dexamethasone compared with placebo plus lenalidomide and dexamethasone, in patients with relapsed and/or refractory multiple myeloma. The current study was conducted to evaluate further the efficacy and safety of ixazomib plus lenalidomide and dexamethasone in Japanese patients.

Methods: This phase 2, open-label, single-arm, multicenter study enrolled patients aged ≥ 20 years with relapsed and/or refractory multiple myeloma at 16 sites in Japan.

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The quadrivalent A, C, W and Y meningococcal vaccine conjugated to nontoxic mutant of diphtheria toxin (MenACWY-CRM) has been licensed since 2010 for the prevention of invasive meningococcal disease (IMD), an uncommon but life-threatening condition. Here, we summarize the experience accrued with MenACWY-CRM during the first decade since its licensure, by providing an overview of clinical trials investigating the safety, immunogenicity and co-administration of MenACWY-CRM with other vaccines as well as presenting real-world evidence regarding the impact of MenACWY-CRM vaccination on carriage and IMD incidence. MenACWY-CRM has demonstrated an acceptable clinical safety profile across a wide range of age groups; no safety concerns have been reported in special populations, such as immunocompromised infants and toddlers, or pregnant women.

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Reduction in X-ray exposure during cardiac catheterization is important to reduce radiation risks to operators and personnel. Reducing scattered radiation from the patient can achieve this goal. The goal of this study was to evaluate the reduction in radiation using simple partial shielding of patients undergoing cardiac catheterization.

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Background: This open-label, single-arm, phase 3 study evaluated safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal vaccine-naive Japanese individuals aged 6-64 years at increased risk of pneumococcal disease (PD).

Methods: Participants received 1 PCV13 dose. Reactogenicity events were recorded for 7 days (individuals aged 6- to 17-year-old) or 14 days (individuals aged 18 to 64 years old) postvaccination.

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Background And Objectives: causes several gastrointestinal diseases, including asymptomatic gastritis, chronic peptic ulcer, duodenal ulcer, lymphoma of the mucosa-associated lymphoid tissue (MALT), and gastric adenocarcinoma. In recent years, failure to eradicate infections has become an alarming problem for physicians. It is now clear that the current treatment strategies may become ineffective, necessitating the development of innovative antimicrobial compounds as alternative treatments.

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Scaffold Hopping to Imidazo[1,2-]pyrazin-8-one Positive Allosteric Modulators of Metabotropic Glutamate 2 Receptor.

ACS Omega

September 2021

Discovery Chemistry, Discovery Sciences, Janssen Research & Development, Division of Janssen-Cilag S.A., Jarama 75A, Toledo 45007, Spain.

Glutamate hyperfunction is implicated in multiple neurological and psychiatric diseases. Activation of the mGlu2 receptor results in reduced glutamate release and decreased excitability representing a promising novel therapeutic agent for the treatment of disorders such as epilepsy, schizophrenia, mood, anxiety, and other neuropsychiatric disorders. We have previously reported substantial efforts leading to potent and selective mGlu2 PAMs from different chemical series.

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Background And Aims: Incomplete microscopic colitis (MCi) is a subtype of microscopic colitis (MC). Budesonide is recommended as a first-line treatment for MC. However, randomised trials on efficacy of treatment in MCi are missing.

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Protective Effects of against Gentamicin Induced Nephrotoxicity in Rats.

Iran J Pharm Res

January 2021

Clinical Research and Development Center, Shahid Modarres Hospital, Department of Nephrology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Several studies have tried to find an efficient agent to prevent or reverse gentamicin (Gm) induced acute kidney injury (AKI). In this study, we assessed the potential renal protective effects of (L.) Webb ex Prantl against Gm-induced nephrotoxicity in rats.

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Reducing invasive meningococcal disease (IMD) through MenACWY immunization is a critical healthcare strategy in the Kingdom of Saudi Arabia (KSA). Robust IMD surveillance is essential to help assess the need for additional immunization initiatives in target populations. This is particularly important in KSA, where mass gatherings accompanying Hajj/Umrah pilgrimages have been associated with IMD outbreaks within the local KSA population, and subsequent intercontinental spread via returning pilgrims.

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Modern vaccinology has experienced major conceptual and technological advances over the past 30 years. These include atomic-level structures driving immunogen design, new vaccine delivery methods, powerful adjuvants, and novel animal models. In addition, utilizing advanced assays to learn how the immune system senses a pathogen and orchestrates protective immunity has been critical in the design of effective vaccines and therapeutics.

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Purpose: The 13-valent pneumococcal conjugate vaccine (PCV13) was recently approved in India for the prevention of pneumococcal disease in children aged 6 to 17 years based on global data as well as immunogenicity and safety findings from a phase 3 study. The current phase 4 study in India further evaluated the safety profile of PCV13 in this age group to support the positive benefit-risk profile of PCV13.

Methods: Healthy male and female children aged 6 to 17 years in India were administered a single intramuscular injection of PCV13.

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Background: Recent reports have indicated the beneficial role of strain measurement in COVID-19 patients.

Hypothesis: To determine the association between right and left global longitudinal strain (RVGLS, LVGLS) and COVID-19 patients' outcomes.

Methods: Hospitalized COVID-19 patients between June and August 2020 were included.

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Anxiety during the COVID-19 pandemic in hospital staff: systematic review plus meta-analysis.

BMJ Support Palliat Care

June 2023

Social Determinants of Health Research Center, Research Institute for Prevention of Non-communicable Disease, Qazvin University of Medical Sciences, Qazvin, Iran

Background: This study was conducted to systematically review the existing literature examining the prevalence of anxiety among hospital staff and identifying the contributing factors to address the complications of this disorder and develop effective programmes for reducing the complications of this mental health problem.

Methods: We searched the electronic databases including PubMed, EMBASE, Scopus, Web of Science and Google Scholar from January 2020 to February 2021. To perform meta-analysis, the random effects model was used.

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Background: Patients with end-stage renal disease undergoing haemodialysis experience a variety of stressors leading to decreased level of quality of life (QoL). Thus, in this study, we aimed to review the current literature and identify factors affecting the health-related QoL (HRQoL) in these patients.

Methods: A total of 147 studies were extracted from databases of Web of Science, PubMed, Scopus, Google Scholar, and Embase published between January 2000 and December 2020.

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Constipation is one of the most common gastrointestinal discomforts that affects various age groups in humans. Different mechanical cleansing devices have been introduced yet. However, they are very expensive and not available in our country.

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Background: This phase 2 observer-blind, randomized, multicenter, dose-ranging study evaluated immunogenicity and safety of different formulations of an AS03-adjuvanted H5N1 influenza vaccine in children 6-35 months of age.

Methods: One hundred eighty-five children randomized into 5 groups [1.9 µg hemagglutinin (HA)/AS03B, 0.

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Objective: Maternal depression during gestation is an adverse factor in fetal brain development that manifests in later childhood behavioral problems. Fetal heart rate variability (FHRV) mediated by parasympathetic input is a marker of gestational nervous system development. Biological mediators of adverse effects of maternal depression may involve the mother's corticosteroids; however, links between depression, corticosteroids, and early nervous system development remain inconclusive.

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