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Drug Interaction clinical trials

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NCT ID: NCT06244706 Not yet recruiting - Chronic Pain Clinical Trials

QSPainRelief-STRAT

QSPR-STRAT
Start date: February 1, 2024
Phase: N/A
Study type: Interventional

Investigating the clinical outcomes of drug combinations (opioid + medication acting on the central nervous system) in patients suffering from persistent pain (pain lasting for at least three months) through patient-reported outcomes.

NCT ID: NCT05851222 Not yet recruiting - Acute Kidney Injury Clinical Trials

A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs (NeoAKI STOP)

NeoAKISTOP
Start date: August 1, 2023
Phase:
Study type: Observational

This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach. The main question it aims to answer are: - Develop a model that can predict the occurrence of AKI in infants admitted to the NICU; - Identify the drug or combination of drugs associated with an increased risk of AKI. The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.

NCT ID: NCT05525351 Not yet recruiting - Anesthesia Clinical Trials

The Application and Validation of Triple Drug Response Surface Models on Density Spectral Array in Clinical Anesthesia

Start date: October 2022
Phase:
Study type: Observational

Precision anesthesia is the current trend. The benefits including faster recovery, earlier return to normal activity, increased patient satisfaction and shorter length of stay. In order to avoid unnecessarily deep or too light anesthesia, processed electroencephalogram (EEG) monitors are applied for accurate assessment of the depth of anesthesia (DoA). Bispectral index (BIS) and PSI monitor are among the most widely used. Recently, density spectral array (DSA) has been developed to facilitate the interpretation of EEG signals. Real-time DSA EEG monitoring helps in detecting even subtle changes in the depth of anesthesia and provides more comprehensive information then simple digits. An emerging field of pharmacodynamics in anesthesia is the response surface models. They describe the interaction of different anesthetics during sedation or anesthesia. Our research team has developed the first comprehensive two-drug response surface models for midazolam and alfentanil during gastrointestinal procedural sedations. However, adequate anesthesia is often achieved with multiple drugs. Two-drug models thus have limited applications. We aim to extend the models into three-drug interactions where it can be used for a broader range of clinical scenarios. The main goal of the study is to establish and validate the three-drug response surface model by collecting and analyzing EEG parameters (BIS or PSI values, DSA, SEF95 (95% spectral edge frequency) and MF (Median frequency) ) from 60 patients undergoing general anesthesia for thoracic surgeries. We aim to establish the models that help anesthesiologist to achieve rapid emergence, appropriate analgesia, adequate DoA, and patient safety. The secondary aim is to apply this model to provide a guideline for drug dosage adjustment and improve the quality of anesthesia.

NCT ID: NCT05154942 Not yet recruiting - Acupuncture Clinical Trials

Vmax Detection of Acupuncture-doxofylline as a Whole Probe of CYP1A in Vivo

Start date: December 15, 2021
Phase: N/A
Study type: Interventional

Preliminary studies have shown that before giving combined acupuncture and medicine anesthesia, electroacupuncture (EA) needs to be started three days before in order to produce a sequential effect. In combined acupuncture and drug anesthesia, the core goal is to use acupuncture to reduce the insufficiency of anesthetics in terms of analgesia, sedation, stable circulation, and protection of organs. However, the mechanism of action behind this combination has not yet been changed. The pharmacodynamics or pharmacokinetics has been convincingly explained, or the degree of recognition is not high, such as whether acupuncture has a specific target in the body, if there is a specific target, where the effect target is located ? Will it affect the metabolic enzymes and will it further affect the efficacy or toxicity of the drugs metabolized by the metabolic enzymes? What effect will it have on the pharmacokinetic mechanism? Given that it may involve complex pharmacodynamics and pharmacokinetic mechanisms, this study will first use doxofylline (DOXO) as a probe to study and explain its effect on metabolic enzymes to further clarify whether it will produce therapeutic drugs Influence. Doxofylline (DOXO), as an old drug that has been used for many years, has extremely high safety and strong selectivity. It is a clinical drug with an injectable dosage form. Studies have proved that DOXO can be used as a high-quality P450 mixed-function oxidase CYP1A in vivo probe. DOXO is a metabolic clearance-leading drug in the human body, and it must undergo the initiation metabolism of CYP1A in the cell to be transformed into theophylline acetaldehyde ( TA), and then theophylline acetic acid (TAA) and hydroxyethyl theophylline (ETO) produced by disproportionation. Therefore, quantitative detection of TAA and ETO can calculate the maximum activity of CYP1A. In order to study the kinetics of DOXO and reduce the inconvenience of excessive blood sampling points for long-term continuous administration, we will explore the method of detecting DOXO kinetics by the Vmax method through clinical research to characterize whether acupuncture affects the metabolic enzyme CYP1A

NCT ID: NCT04463576 Not yet recruiting - Drug Interaction Clinical Trials

Drug Interactions in Hospital Information System. The PRoSIT System..

PROSIT
Start date: May 2024
Phase:
Study type: Observational

The French Public Health strategy 2018-2022 aims to reduce inappropriate prescriptions, as potentially dangerous for individuals and collectively. The reduction of co-prescriptions at Risk of Drug Interactions (RoDI) could decrease the prevalence of iatrogenic diseases, and increase the persistence of treatments with a growing efficacy of treatments, in particular in elderly populations. A recent study conducted by our team showed that, in out-patient setting, 2.7% of co-prescriptions contains medications at RoDI of high degree of severity (object of a contra-indication or non-recommended). Up today, there is no French experience concerning the identification of RoDI among the prescriptions performed at the end of a hospitalisation. In France, the recent development of hospital data warehouses is a huge opportunity to develop a system that can identify efficiently co-prescriptions at RoDI and provide feedback directly to prescribers in order to reduce their frequency in hospital context. The primary objective of this study is to evaluate the capacity of a system, called PRoSIT system, to automatically identify the RoDI of high level of severity at hospital discharge.

NCT ID: NCT04170790 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Evaluation of Drug Interactions of Saxagliptin With Sildenafil in Healthy Volunteers

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

Patients with diabetes are three times more likely to develop erectile dysfunction (ED), and longer duration of diabetes is strongly associated with ED. The possibility of pharmacokinetic interactions may occur as the two drugs are metabolized by hepatic CYP3A4 and their co administration may affect their plasma concentrations. the aim of work is to investigate the effect of sildenafil a CYP3A4 substrate and inhibitor on the pharmacokinetics and safety of Saxagliptin, a CYP3A4 substrate Subjects and Methods: Eighteen healthy volunteers will be recruited in Sequential, single center study to determine pharmacokinetic parameters of Saxagliptin, and sildenafil,(AUC0→∞), (AUC0→t); Cmax; tmax; t½, k; ka) will be measured using validated LC-MS/MS method. Therapeutic doses will be given to volunteers as follows: Sildenafil 50 mg single dose on day 1, then washout period from day 2 till day 8. Saxagliptin 5 mg once/day will be given from day 9 till day 12, then on day 13 the two drugs will be co-administered. Blood samples (5ml) for pharmacokinetic analysis will be collected on days 1 and 13 for Sildenafil as well as on days 12 and 13 for Saxagliptin.

NCT ID: NCT03920566 Not yet recruiting - Drug Interaction Clinical Trials

The Effect of ENZAlutamide on the Anti-Xa Levels of Patients Receiving DOACs

ENZA-D
Start date: May 2019
Phase:
Study type: Observational

This study aims to determine the nature and significance of the theoretical drug interaction between enzalutamide (a drug used to treat prostate cancer) and the direct-acting oral anticoagulant drugs (DOACs). This will be done in two ways: a laboratory study which will take place at the University of Brighton, and a clinical study in which patients will be identified who are currently taking DOACs and are due to start treatment with enzalutamide. The activity of the DOAC will be monitored using anti-Xa levels before and after commencing treatment with enzalutamide.