Active clinical trials for "Drug-Related Side Effects and Adverse Reactions"

Efavirenz is among the preferred antiretroviral drugs for HIV-infected children. Increasing evidence shows that central nervous system side-effects in adults are more common than previously thought. Still, reliable data in children are lacking. As HIV-infected children nowadays have a prospect of reaching adulthood, there is an urgent need to identify potential long-term central nervous system side-effects, interfering with neurodevelopment and psychosocial maturation. Using validated tools, we assessed (1) competence (social/activities/school) and psychopathology (internalizing/externalizing problems), (2) cognitive performance (intelligence and working memory), and (3) adherence in Tanzanian children on an efavirenz or non-efavirenz based regimen In this cross-sectional observational study the investigators will examine neuropsychiatric and neurocognitive functioning in 126 children (aged 6-11 years) on long-term combination antiretroviral therapy (cART) with or without efavirenz.

The immune-related adverse events (irAEs) linked to the important activation of the immune system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma (NSCLC) have not received a lot of systematic study or been monitored over time outside of clinical trials. This study aims to verify, on the basis of the data collected in a prospective and retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments observed in the target population of the controlled clinical trials are the same as in the general clinical population.

Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%. Aim: To describe the serious ADR in elderly subjects aged over 65 years and assess their preventability. Methods: A retrospective study was conducted at the Regional Pharmacovigilance Center of Champagne-Ardenne (northeast of France) between January and May 2013. Patients aged over 65 years who presented a serious ADR notified to the Regional Pharmacovigilance Center were included in the study.

Patients meeting eligibility criteria will be randomized into two groups, one receiving pharmacogenetic testing and the other not receiving pharmacogenetic testing. In this open-label trial, a pharmacist will make medication therapy recommendations using YouScript® Personalized Prescribing System for patients who receive genetic testing and standard drug information resources per usual for patients who do not undergo pharmacogenetic testing.

Emergency departments (EDs) are a crucial element of health care systems as they constitute the interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hours per day and 365 days a year. Also, many Adverse Drug Events (ADEs) are not identified by emergency physicians. ADEs are injuries resulting from a drug related medical intervention. Their detection, documentation and reporting are essential for adequate medical care and knowledge of risk/benefit profiles of medication throughout their lifecycle. However, a number of studies indicate that in clinical practice the under-reporting of ADEs is a pervasive and widespread problem. The main reasons for under-reporting were difficulty in determining the cause of the ADE, lack of time, poor integration of ADE-reporting systems and uncertainty about reporting procedures. Successful treatment of ADEs depends on the ability of physicians to attribute ADEs to a medication. Some studies have reported that not only pharmacists but also pharmacy student were one of the best health care providers to establish medication history and detected ADEs. It has also been shown that a clinical pharmacist, within the emergency medical team, can improve the detection of ADE through drug expertise and reliable drug history. This approach has been adopted at Montpellier University Hospital since November 2011. During the initial diagnosis of the ADE, the revision of a drug treatment at risk cannot be carried out in emergency department by the emergency physician. Indeed, the latter intervenes punctually but he is not the patient's referring doctor. Guidance and follow-up of the patient throughout the care journey is the responsibility of the referring physician, sometimes accompanied by the pharmacist. It is therefore very important that a relevant information detected at the hospital can be passed on to the referring health professionals who will review and adapt the treatment. The city-hospital link is essential to guarantee the continuity and the consistence of the care process. When a patient is discharging with the emergency department, the outgoing mail often mentions only the reason for admission, and the information concerning the detection or suspicion of an ADE is not systematically stipulated. However, this information is essential to trigger a process of therapeutic revision (therapeutic modification, therapeutic education, referral to specialized consultations ...) that will prevent the recurrence of the ADE and therefore the readmission to emergency department. To date, the rate of readmission to emergency department after a first visit related to an ADE is between 3.6 and 18.7%. Our goal is to evaluate the impact at 6 months of a medical-pharmaceutical follow-up and the optimization of the city-hospital link following an admission at emergency department for ADE, on the readmission to emergency department for the same ADE. This is a single-center randomized, controlled, open-label, two-arm, parallel, "usual information transmission" or "optimized information transmission" study. The duration of a patient's follow-up is 6 months. Each patient with an occurring ADE detected during emergency department admission could be participating in the study. Specific management of the experimental group: Sending to the community referring physician by the emergency department an discharge report containing the reason for emergency consultations (report currently made as part of the treatment). Within 72 hours (working hours), the Emergency Clinical Pharmacist contacts the referring physician and the patient's community pharmacist to discuss how to manage the ADE. In parallel, a second report, summary of the ADE (ADE-report), is sent to them. The ADE-report, written and validated by the investigators (emergency physician and clinical pharmacist), includes the type of ADE, the suspected drug(s) and other recommendations: therapeutic modification, referral to specialized consultations (geriatrics ...) Control group: The emergency department sends to the referring doctor a letter to inform him about the reason of consultations in the emergency department (mail currently realized as part of the care process). Primary outcome measure: Percentage of patients who had at least one readmission for the same reason in the emergency department within 6 months of the initial exit. This information will be collected during a telephone call with the patient and the referring physician.

Metabolic imprints of five different types of alcohol will be investigated in two study groups. The study will be an assessor-blinded, parallel dietary trial (crossover design). The project aims to identify the chemical nature and kinetics of metabolite changes related to alcohol, hops, grapes and other beverage constituents as well as the brewing processes.

The aim of this study is to adescription of mandibular osteomylitis in patients having had a treatment by DENOSUMAB. Indeed, one of the adverse effect ot this molecule is to induce mandibular infection.

The study's objective is to evaluate the predictive accuracy of Cipherome's algorithm in predicting and preventing serious adverse drug reactions (ADRs) experienced by patients while on direct oral anti-coagulants (DOACs).

The present study has assessed the knowledge, attitude and practice of ADRs reporting among pharmacists, and the perceived factors that may influence reporting.

Drug-related problems in newborn babies have been reported with a rate of 4-30%. It is estimated that the higher rates of these problems in hospitalized children under the age of two are related to the variety of drugs used and the differences in the age, weight and diagnosis of the patients. In this context, with the clinical parameters and demographic data obtained in the first 24 hours of the patients hospitalized in the neonatal intensive care unit, machine learning algorithms are used to predict the risks that may arise from possible drug-related problems (prescribing and administration errors, side effects and drug-drug interactions) that may occur during hospitalization. The algorithm, which will be created by modeling with a high number of big data pool, is planned to be transformed into a clinical decision support system software that can be used easily in clinical practice with online and mobile applications. By processing the data of the patients to be included in the model, it is aimed to prevent and manage drug-related problems before they occur, as well as to provide cost-effective medşcation treatment to patients hospitalized in the neonatal intensive care unit, together with a reduction in the risk of drug-related mortality and morbidity.