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Adverse Drug Event clinical trials

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NCT ID: NCT04984538 Withdrawn - Elderly Clinical Trials

Implementation of a Pharmacist-led Pharmacogenomic Clinical Service

Start date: July 1, 2021
Phase:
Study type: Observational

Tabula Rasa HealthCare (TRHC), doing business as CareKinesis, is the first national pharmacy that provides science-based medication risk identification and mitigation technologies and services. CareKinesis utilizes medication decision support tools and pharmacists certified in geriatrics to provide pharmacy services for various healthcare organizations including PACE organizations (described above). Presently, CareKinesis services more than 35 PACE organizations, including approximately 100 PACE sites, across the United States. As a national PACE pharmacy provider since 2011, CareKinesis focuses on improving medication regimens to reduce medication-related risks while enhancing economic, clinical and humanistic outcomes. Pharmacist-led PGx clinical services and medication safety reviews are currently being offered to PACE organizations under the direction of licensed healthcare prescribers by TRHC (CareKinesis). Our aim is to extend and meticulously study PGx testing for more PACE patients and conduct a prospective preemptive PGx study to determine feasibility of implementation and effect on outcomes. After mutual agreement, these services may also be extended to other organizations where TRHC provides pharmacy services, and data will be collected with patient consent.

NCT ID: NCT04899960 Recruiting - Adverse Drug Event Clinical Trials

Drug-Related Problems in Neonatal Patients

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04791150 Recruiting - Arthritis Clinical Trials

Rheumatologic Adverse Events and Cancer Immunotherapy

Start date: May 7, 2021
Phase: N/A
Study type: Interventional

In this study, every patient with cancer who is going to be treated by immunotherapy will fill in a form. In this form, we try to determine if he presents rheumatologic complications of his immunotherapy. If the patient answers yes to one question on the form, the patient will be see in rheumatologic consultation to explore his clinical signs. The number of patients referred in consultation thanks to this questionnaire will be compared to the number of patients who would have been spontaneously referred by the oncologist. The aim of this questionnaire is to optimise the management of rheumatological effects secondary to immunotherapy.

NCT ID: NCT04770922 Completed - Adverse Drug Event Clinical Trials

Pharmacogenomic Analysis in Pediatric Acute Lymphoblastic Leukemia

Start date: February 23, 2021
Phase:
Study type: Observational

This is a retrospective biobank study evaluating the impact of novel genetic variants in a population of 6-mercaptopurine treated pediatric acute lymphoblastic leukemia patients.

NCT ID: NCT04762303 Enrolling by invitation - Polypharmacy Clinical Trials

Spread and Scale of a Polypharmacy App

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Medication overload is an epidemic causing widespread harm, particularly to older Canadians. While most prescriptions are intended to help people live longer and healthier lives, taking multiple medications can increase frailty, and lead to dangerous side effects.This is a mixed-methods study to determine the impact of MedReviewRx on prescribing in New Brunswick Nursing Homes (NBNHs). MedReviewRx is an application which allows MedSafer to analyze a person's medications and medical conditions and produce a report with suggestions for how to simplify medications and make them safer. MedSafer reports will be used to assist physicians and pharmacists identify potentially inappropriate medications (PIMs) and conduct medication reviews in NBNHs. The prevalence of PIMs in NBNHs before MedReviewRx will be measured and the change in PIM use after implementation will be calculated. User experience with MedSafer reports and MedReviewRx will be explored. Patient and Family attitudes towards deprescribing will also be studied. Investigators hypothesize that implementing MedReviewRx in New Brunswick Nursing Homes (NBNHs) will promote deprescribing which will lead to a decrease in the number of PIMs and a decrease in medication costs for older adults living in NBNHs.

NCT ID: NCT04740645 Recruiting - Adverse Drug Event Clinical Trials

NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

Start date: July 13, 2021
Phase:
Study type: Observational

A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.

NCT ID: NCT04635956 Recruiting - Chemotherapy Clinical Trials

Camrelizumab Combined With Chemotherapy for Recurrent or Advanced Cervical Neuroendocrine Carcinomas

Start date: November 15, 2020
Phase: Phase 2
Study type: Interventional

Recurrent or advanced cervical neuroendocrine carcinoma (NEC) is refractory to multimodal treatment, even to extensive therapy. Chemotherapy, consisting of platinum and etoposide, remains the main therapy for recurrent or advanced cervical NEC. In addition, bevacizumab has shown progression-free benefits in recurrent or advanced cervical cancer. Case report suggested anti-PD-1 antibody may have antitumor activities in NEC. Based on these evidences, a phase 2, single arm trial is conducted to explore the objective response rate (ORR) of platinum/etoposide/bevacizumab/anti-PD-1 antibody (camrelizumab) for the treatment of recurrent or advanced cervical NEC. This trial is to enroll 20 patients, who would accept 6 courses of platinum/etoposide/bevacizumab/camrelizumab. If the patient achieved complete or partial remission, a total period of 12 months bevacizumab/camrelizumab will be given as maintain therapy. The primary endpoint is ORR. The second endpoints are severe adverse events according to criteria of Common Terminology Criteria for Adverse Events (CTCAE) and iRECIST Guideline, and critical changes of laboratory testing.

NCT ID: NCT04574648 Not yet recruiting - Adverse Drug Event Clinical Trials

Evaluating ActionADE on Adverse Drug Event Due to Non-Adherence

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Repeat non-adherence to medications is a common cause of preventable adverse drug events. Health information technologies have the potential to improve information continuity. However, they rarely interoperate to ensure providers can view non-adherence information documented in other systems. The investigators designed ActionADE to enable rapid documentation of adverse drug events, including non-adherence, and communicate the information across health sectors by integrating ActionADE with legacy systems. The investigators will leverage ActionADE's implementation to conduct a randomized trial on patients diagnosed with an adverse events due to non-adherence. This study will take place in Vancouver, British Columbia, Canada.

NCT ID: NCT04568668 Not yet recruiting - Adverse Drug Event Clinical Trials

Evaluating ActionADE in Reducing Adverse Drug Reactions

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Repeat exposures to culprit medications are a common cause of preventable adverse drug events. Health information technologies have the potential to reduce repeat adverse drug events by improving information continuity. However, they rarely interoperate to ensure providers can view adverse drug events documented in other systems. The investigators designed ActionADE to enable rapid documentation of adverse drug events, and communication of standardized information across health sectors by integrating ActionADE with legacy systems. The investigators will leverage ActionADE's implementation to conduct a randomized trial on patients diagnosed with adverse drug reactions in the main trial. This study will take place in Vancouver, British Columbia, Canada.

NCT ID: NCT04395326 Recruiting - Adverse Drug Event Clinical Trials

Monitoring of Metabolic Adverse Events of Second Generation Antipsychotics in a Naive Pediatric Population

MEMAS
Start date: January 1, 2017
Phase:
Study type: Observational

Introduction: Second Generation Antipsychotics (SGAs) are widely used in the pediatric population. It is currently established that SGAs may induce undesirable metabolic adverse events (AEs) such as weight gain, metabolic changes in blood lipids or glucose with risk of potential cardiovascular morbidity and mortality. The Canadian Alliance for Monitoring Effectiveness and Safety of Antipsychotics in children (CAMESA) has published recommendations for monitoring the metabolic AEs of SGAs in the pediatric population. Factors that may be associated with the onset of SGA's metabolic AEs and long term consequences are less studied in the literature. The objectives of our research are to evaluate some factors that can influence the development of the SGA's metabolic AEs, and to study clinical adherence to CAMESA guidelines. Methods and analysis: The MEMAS study (Monitoring des Effets Métaboliques des Antipsychotiques de Seconde Génération) design is a multicenter, prospective, longitudinal observational study with repeated measures of metabolic monitoring up to 24 months of follow-up. Two recruiting centers have been selected for patients under 18 years of age, previously naïve of antipsychotics, starting an SGA or who have started an SGA for less than 4 weeks regardless of the diagnosis that motivated the prescription. Assessments are performed at inclusion and during follow-up for anthropometric measures (AM), blood pressure (BP) and blood tests (BT) at baseline and 1, 2, 3, 6, 9, 12 and 24 months of follow-up. Ethics and dissemination: The study protocol was approved by the Centre Hospitalier Universitaire (CHU) Sainte-Justine's Research Ethics Board (MP-21-2016-1201) in 2016 and obtained institutional suitability for the "Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l'Île-de-Montréal" (CIUSSS NIM) Research Center in May 2018. For all participants, written consent will be obtained from parents/caregivers as well as the participant's assent in order to enable their participation in this research project. The results of this research will be published.