PubMed Journals Articles About "Immunogenicity And Safety Evaluation Of QIS In Healthy Subjects" - Page: 3 RSS

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Showing "Immunogenicity Safety Evaluation Healthy Subjects" PubMed Articles 51–75 of 20,000+

Agreement between clinical and non-clinical digital manometer for assessing maximal respiratory pressures in healthy subjects.

Measurement of respiratory muscles strength such as maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are used to detect, diagnose and treat respiratory weakness. However, devices used for these measurements are not widely available and are costly. Currently, the use of a digital manometer is recommended. In industry, several inexpensive devices are available, but these have not been validated for clinical use. Our objective was to determine the agreement between maximal respiratory p...

Efficacy, immunogenicity, and safety of an oral influenza vaccine: a placebo-controlled and active-controlled phase 2 human challenge study.

Influenza is an important public health problem and existing vaccines are not completely protective. New vaccines that protect by alternative mechanisms are needed to improve efficacy of influenza vaccines. In 2015, we did a phase 1 trial of an oral influenza vaccine, VXA-A1.1. A favourable safety profile and robust immunogenicity results in that trial supported progression of the vaccine to the current phase 2 trial. The aim of this study was to evaluate efficacy of the vaccine in a human influenza challen...

Healthy lifestyle behavior and personal control in people with schizophrenia with healthy controls: A cross-sectional comparative study.

The aim of the article was to compare persons with schizophrenia and healthy controls about their life style on their physical health and personal control. Evidences highlights that it helps to change risk behaviours associated with co morbid physical health problems. Subjects were recruited from adult mental health services in tertiary level psychiatric center.Comparisons between the groups were done by using the lifestyle and personal control questionnaire. Subjects were 86 with schizophrenia, 72 were hea...

The assessment of the peak of reflex cough in subjects with Acquired Brain Injury and tracheostomy and healthy controls.

There is no standard procedure to evaluated the peak of reflex cough flow (PCF-reflex) in the literature, which is important assessment in subjects with acquired brain injury and tracheostomy cannula. The present study aims to investigate the PCF of the reflex cough in a broad sample of healthy controls and, furthermore, the presence and the strength of voluntary and reflex cough in subjects with ABI with tracheostomy cannula.

Phase I study of KRP-116D, a 50% w/w dimethyl sulfoxide aqueous solution, on the systemic absorption from bladder by intravesical instillation in healthy Japanese subjects.

This was a single-institution, single-dose, single-arm phase 1 study in healthy adult males to evaluate the safety and absorption of dimethyl sulfoxide (DMSO) from the bladder into the body when KRP-116D (a 50% w/w DMSO solution) was intravesically administered and allowed to remain in the bladder for 15 minutes.

Multiple administrations of fluconazole increase plasma exposure to ruxolitinib in healthy adult subjects.

Ruxolitinib is metabolized by cytochrome P450 (CYP)3A4 and CYP2C9. Dual inhibitors of these enzymes (like fluconazole) lead to increased ruxolitinib exposure relative to a single pathway inhibition of CYP3A4 or CYP2C9. The magnitude of this interaction, previously assessed via physiologically based pharmacokinetic (PBPK) models, was confirmed in an open-label, phase 1 study in healthy subjects.

Relationship between thickness of deep neck muscles synergy and painful side in patients with cervicogenic headache.

: This study was conducted to evaluate changes in the thickness of the upper deep neck muscles in patients with cervicogenic headache (CGH). : The thickness of the longus capitis (LCap) muscle, rectus capitis posterior major (RCPM), and obliquus capitis superior (OCS) muscles was measured by B-mode ultrasonography in 22 CGH patients matched with 22 healthy subjects. Data were analyzed using SPSS version 16. : The thickness of all muscles in the CGH group was less than healthy subjects. The thickness of the ...

Population pharmacokinetic modeling and simulation of fremanezumab in healthy subjects and patients with migraine.

Fremanezumab is a fully humanized IgG Δa/kappa monoclonal antibody specific for calcitonin gene-related peptide (CGRP) developed and approved for the preventive treatment of migraine in adults. The population pharmacokinetics (PK) of fremanezumab were characterized in healthy subjects and patients with chronic migraine (CM) and episodic migraine (EM), including the effects of intrinsic and extrinsic factors on PK variability.

Nonalcoholic fatty liver disease is an early predictor of metabolic diseases in a metabolically healthy population.

The relationship between nonalcoholic fatty liver disease and incident metabolic syndrome in metabolically healthy subjects is unknown. We aimed to investigate whether nonalcoholic fatty liver disease is a predictor of future metabolic syndrome in metabolically healthy subjects.

Discovery of potential serum protein biomarkers in Ankylosing Spondylitis using TMT-based quantitative proteomics.

Ankylosing Spondylitis (AS) is a systemic, chronic and inflammatory rheumatic disease that affects 0.2% of the population. Current diagnostic criteria for disease activity rely on subjective Bath Ankylosing Spondylitis Disease Activity Index scores. Here, we aimed to discover a panel of serum protein biomarkers. First, TMT-based quantitative proteomics was applied to identify differential proteins between 15 pooled active AS and 60 pooled healthy subjects. Second, cohort 1 of 328 humans, including 138 activ...

Immunogenicity of Diphtheria Booster Vaccination in Adolescents With Inflammatory Bowel Disease.

The aim of this prospective study was to assess the immunogenicity and safety of booster vaccine against diphtheria in children with inflammatory bowel disease on and without immunosuppression treatment. Immunoprotection was achieved in 93% of the children. No significant differences depending on the treatment used and no serious adverse events or flares of inflammatory bowel disease were observed.

Effectiveness, immunogenicity, and safety of influenza vaccines with MF59 adjuvant in healthy people of different age groups: A systematic review and meta-analysis.

Influenza is a severe disease burden among all age groups. This study aimed to review the efficacy of inactivated influenza vaccines with MF59 adjuvant and non-adjuvanted inactivated influenza vaccines among all age groups against specific influenza vaccine strains.

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Liver-Targeting Acetyl-CoA Carboxylase Inhibitor (PF-05221304): A Three-Part Randomized Phase 1 Study.

PF-05221304 is a liver-targeted inhibitor of acetyl-CoA carboxylase, an enzyme that catalyzes the first committed step in de novo lipogenesis (DNL). This first-in-human study investigated safety/tolerability and pharmacokinetics of single and multiple ascending oral PF-05221304 doses, and fructose-stimulated DNL inhibition with repeated oral doses. Healthy subjects (n = 96) received single (1-240 mg) or repeated (2-200 mg daily) doses for 14 days or single 100-mg doses with and without food. PF-0522130...

The relation between anxious personality traits and fear generalization in healthy subjects: A systematic review and meta-analysis.

Anxious personality characteristics form a risk factor for anxiety disorders. A proposed mechanistic pathway is that anxious personality could lead to greater vulnerability by increasing fear generalization. Here, we investigate if there is evidence for this relationship before the onset of pathological anxiety, with a meta-analysis in healthy subjects.

Differences in Gluteal and Quadriceps Muscle Activation During Weight-Bearing Exercises Between Female Subjects With and Without Patellofemoral Pain.

Glaviano, NR and Saliba, S. Differences in gluteal and quadriceps muscle activation during weight-bearing exercises between female subjects with and without patellofemoral pain. J Strength Cond Res XX(X): 000-000, 2019-Therapeutic exercises targeting gluteal and quadriceps muscles have been previously investigated; however, these studies have only been conducted on healthy individuals. Female subjects with patellofemoral pain (PFP) present with weakness in their gluteal and quadriceps muscles and commonly p...

Development and evaluation of an intervention based on the provision of patient feedback to improve patient safety in Spanish primary healthcare centres: study protocol.

Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.

Molecular characterisation of the synovial fluid microbiome in rheumatoid arthritis patients and healthy control subjects.

The presence and identity of bacterial and fungal DNA in the synovial fluid of rheumatoid arthritis (RA) patients and healthy control subjects was investigated through amplification and sequencing of the bacterial 16S rRNA gene and fungal internal transcribed spacer region 2 respectively. Synovial fluid concentrations of the cytokines IL-6, IL-17A, IL22 and IL-23 were determined by ELISA.

Sprint exercise for subjects with mild-to-moderate Parkinson's disease: Feasibility and biomechanical outputs.

High-intensity training, a still unexplored exercise for individuals with Parkinson's disease, is positively related with increased functionality and aerobic profile in healthy individuals. The aim of this work was to evaluate the feasibility, safety, and acceptance of sprint running in individuals with mild-to-moderate Parkinson's. Additionally, we compared sprint biomechanical outputs of force, velocity and power between individuals with Parkinson's disease and healthy.

Short-term biological variation and diurnal rhythm of cardiac troponin I (Access hs-TnI) in healthy subjects.

The availability of high-sensitivity cTnI (hs-cTnI) assays has improved the accuracy of cTn measurements at concentrations around and below the 99th percentile, allowing the evaluation of biological variation.

Safety and efficacy results of simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine in healthy subjects: a comparative phase 2/3 trial.

We conducted a clinical trial to assess the safety and putative efficacy of an additional human rabies immune globulin (HRIG; KEDRAB) versus an older product (Comparator, HyperRAB S/D® [Grifols]) and determine whether HRIG interferes with development of endogenous antibodies versus Comparator, when each is given with an active rabies vaccine. This was a prospective, double-blind, single-period, non-inferiority study in which subjects were randomized (1:1) to a single dose (20 IU/kg) of HRIG or Comparator o...

Safety and Efficacy Evaluation of Aspiration Thrombectomy with Large Bore Catheters in a Porcine Model.

Thrombectomy with aspiration catheters has shown to be effective for treatment of intracranial large vessel occlusion (LVO). We present preclinical evaluation of the safety and efficacy of React68 and React71 catheters in animal models of LVO.

The morphometric measurement of the brain stem in Turkish healthy subjects according to age and sex.

This paper was determined the morphometric measurements of the brainstem including mesencephalon, pons and medulla using MRI in Turkish healthy population.

Analysis of Immunogenicity Data in the Product Information of Biological Drugs: A Need to Report Immunogenicity Data Systematically.

The aim of this analysis was to evaluate whether the current unsystematic assessment leads to sufficient reporting of immunogenicity-related information in the Summary of Product Characteristics (SmPCs) of biological products approved in the European market.

Vitamin E sequestration by liver fat in humans.

BACKGROUND We hypothesized that obesity-associated hepato-steatosis served as a pathophysiologic chemical depot for fat-soluble vitamins and altered normal physiology. Using α-tocopherol (vitamin E) as a model vitamin, pharmacokinetics and kinetics principles were utilized to determine whether excess liver fat sequestered α-tocopherol in women with obesity-associated hepato-steatosis vs healthy controls.METHODS Custom-synthesized deuterated α-tocopherols (d3- and d6-α-tocopherols) were administered to h...

Preliminary observation on imbalance degree of impedance in extracellular fluid of cells in the twelve meridians in healthy subjects.

To calculate the imbalance degree (IBD) of left-right meridian (IBD-LRM), IBD of exterior-interior meridian (IBD-EIM) and IBD of hand-foot meridians (IBD-HFM) of impedance in extracellular fluid of cells in twelve meridians of healthy subjects, so as to provide foundation for meridian diagnosis.

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