View clinical trials related to Interaction.
Filter by:The purpose of this pilot study is to gather preliminary data on the (1) contribution of the understudied drug metabolizing enzyme, UDP-glucuronosyltransferase (UGT) 2B17, to the metabolism of a widely used medication, diclofenac, and (2) impact of the UGT2B17 inhibitor and natural product, curcumin, on diclofenac pharmacokinetics. Results will inform future studies aimed to assess the effects of UGT2B17 genetic polymorphisms and co-consumed xenobiotics on the pharmacokinetics and toxicity risk of diclofenac and other UGT2B17 drug substrates.
Despite the extensive research on prevention and prediction strategies, hamstrings strains injury (HSI) persists at a high rate in team sports and specifically in football. An initial injury increases the risk for re-injury and affects performance, whereas the financial cost for athletes and teams is crucial due to the time needed for appropriate rehabilitation. For that reason, it is critical to formulate better strategies in order to predict and prevent HSI. This study aims to develop a system dynamics (SD) model to evaluate HSI risk. First, a literature review will be carried out on the current approaches and identification of intrinsic and extrinsic risk factors of hamstrings strain injuries. Second, co-creation workshops based on the method of Group Modeling Building (GMB) will be applied to develop the SD for the HSI model. This co-creation process will involve stakeholders such as sports physiotherapists, doctors, and sports scientists. After creating the SD for HSI model, a one-year prospective cohort study will be performed to validate the model with real data and evaluate the ability of the model to predict HSIs. Sports teams will be invited to take part in the validation of the model. Multiple biomechanical parameters and other personal characteristics will be collected. Then, athletes will be monitored for the occurrence of injury and their exposure to injury risk during training and games. The factors' non-linear interaction will be assessed with the statistical method of structural equation modeling and factor analysis. In this way, the factors' interactions extracted for the qualitative phase of the study (group modeling building process) will be quantitatively evaluated. Validating the model with real data will provide a computer simulation platform to test plausible strategies for preventing hamstrings strain injuries prior to implementation and optimize intervention programs.
The objective of this study is to confirm the feasibility of using a panel of endogenous substrates/metabolites as a robust biomarker of OCTs and OATs by conducting a controlled, comprehensive clinical drug-drug interaction study in healthy adult volunteers. Metformin and furosemide will be used as probe drugs for OCTs and OATs, respectively; cimetidine and probenecid will be used as corresponding inhibitors. Results from this study will validate this novel approach, which will be extended to children by collaborators at Children's Mercy Hospital in Kansas City, MO.
With this study the investigators aim to assess if drug metabolism changes in patients with rheumatoid arthritis when an interleukin (IL)-6 inhibitor is initiated. Patients with rheumatoid arthritis have an increased level of inflammation in the body which can lead to decreased expression and activity of drug metabolizing enzymes in the liver. This will lead to a decreased metabolism and excretion of drugs. The inflammation is driven by a number of proinflammatory cytokines e.g., IL-6. The investigators hypothesize that patients with rheumatoid arthritis initiating treatment with an IL-6-receptor inhibitor (anti-IL-6R) will obtain a normalization of the activated IL-6-pathway resulting in increased expression and activity of drug metabolizing enzymes and hence increased metabolism. Ultimately, this normalization of drug metabolism could lead to insufficient efficacy of a wide variety of drugs. The investigators will perform a clinical pharmacokinetic trial. The study will include patients with active rheumatoid arthritis and a need to initiate treatment with an IL-6 receptor antibody. Patients will ingest a 6-drug cocktail consisting of probes for specific CYP enzymes. Plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. Patients will then initiate IL-6 receptor antibody treatment and to assess both short- and long-term impact of altered inflammation, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. To help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.
BACKGROUND: The diagnosis of pancreatic adenocarcinoma (PDAC) in many cases is completely unforeseen by the patient, who often faces a disease that is already at an advanced stage, with poor prognosis. The clinical visit during which the diagnosis is communicated together with the first information regarding the planned treatments is of paramount importance. It is hypothesized that the clarity of such information is able to influence patients's engagement and thus the compliance. AIMS: The aim of this study is to collect quantitative data on the level of PDAC patient engagement and the rate of understanding of the information received from the doctor, and investigate the possible association between these two variables and with the patient's level of compliance. METHODS: This is a single-center, observational, cross-sectional cohort study focused on patients diagnosed with PDAC, approved by the Ethics Committee of the San Raffaele Hospital. As no preliminary data are available on the association between PDAC patient's understanding rate and their level of engagement and of compliance no power calculation is possible. This is a pilot study, aimed at enrolling at least 45 PDAC patients during a 3 months frame. CONCLUSION: COMMUNI.CARE will be the first study specifically investigating whether there is a relation between PDAC patients' rate of understanding, their engagement and compliance at time of diagnosis.
Despite its poor abundance in the liver, CYP2D6 is the second most important CYP in drug metabolism, metabolizing 20% of drugs. The high inter-individual variability in CYP2D6 expression is explained by genetic variations, but also by drug-drug interactions (DDIs). Recent studies have pointed out the poor therapeutic predictable value of DDI. Indeed, the clinical outcomes of a DDI may involve several intrinsic factors affecting the vulnerability to and extent of DDI, such as genetic polymorphisms, comorbidities, age and sex. In this regard, the present research project aims to investigate the effect of genetic polymorphism on DDIs involving CYP2D6 (gene-environment interaction) and its implications for tramadol efficacy and safety in a clinical setting. In a previous study, we demonstrated differences in both the rate of phenoconversion and the magnitude of DDI in healthy volunteers, that were either heterozygote normal metabolizers (NMs) carrying a non-functional CYP2D6 allele (activity score (AS) 1) and homozygous NM carrying two fully-functional CYP2D6 alleles (AS 2). This prospective study will include patients scheduled for a general surgery of less than 3 hours and planned to be treated with oral tramadol as a routine post-operative pain management. Patients taking part in the study may receive diagnosis, therapeutic or other interventions but the groups of individuals (controls vs inhibited) are predefined based on the routine treatment of the patients. There will be no assigned specific interventions to the study participants and CYP2D6 phenotypes will be classified in five activity score groups (0.5, 1, 1.5, 2, >2) in the absence or presence of a potent CYP2D6 inhibitor received as part of routine medical care. PK of tramadol and its active metabolite (M1), as well as its analgesic and PD effects and safety, will be compared between groups. Finally, the data generated will be used to build a physiologically-based PK (PBPK) model for tramadol in different sub-groups. The model will aim to predict the effect of CYP2D6 inhibition in virtual populations with different genetically-related CYP2D6 activities. This should allow prospective dose adjustment of tramadol (or appropriate drug selection) based on patients' genotype in the presence of a CYP2D6 inhibitor.
An Open-label, 2-period, Single-sequence, Crossover Study to Evaluate the Effect of Multiple Oral Dosing of Itraconazole on BCT197 Systemic Exposure in Healthy Male Participants.
An open-label, single-sequence study to evaluate the effect of azithromycin on BCT197 exposure in healthy male subjects.
The investigators study whether four equipotent combinations of propofol and remifentanil (as predicted by interaction models for "tolerance of laryngoscopy") result in identical haemodynamic conditions, independent of their relative different balance between the concentration of propofol and remifentanil.
The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.