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Drug Overdose clinical trials

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NCT ID: NCT05146336 Recruiting - Sepsis Clinical Trials

CytOSorb TreatMent Of Critically Ill PatientS Registry

COSMOS
Start date: June 22, 2022
Phase:
Study type: Observational [Patient Registry]

Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care

NCT ID: NCT05072249 Recruiting - Opioid Overdose Clinical Trials

European Cohort Study of the Effectiveness of Take Home Naloxone

NalPORS
Start date: June 8, 2021
Phase:
Study type: Observational

This study aims to assess the effectiveness of take-home naloxone (THN) to reverse opioid overdose when administered by lay persons in a real world setting. This multicentre, prospective, observational cohort study will be conducted across Europe using a mixed method approach. Recruiting 6000 individuals to whom a supply of THN has been provided, for n=600 to witness an opioid overdose. The co-primary outcomes are to determine the rate of administration of naloxone and frequency of deaths in the 24 hours subsequent to the administration of naloxone. This will be captured through structured interviews with those who report witnessing an opioid overdose in the 6 month study period, approximately n=600, to elicit further information on the overdose and any naloxone administered. Naloxone training materials and education provided will be examined through questions in the structured interview. In-depth qualitative interviews will also be conducted with 60 participants who have witnessed an overdose, in order to better understand the use, safety and effectiveness of different naloxone products (particularly Nyxoid). As part of the qualitative analysis, interview transcripts will be assessed by an expert clinician panel for accuracy of diagnosis, actions taken and aftercare. Routine data from national health registers will be used to gather mortality data. This study will report on the use of different formulations of naloxone. In addition, this study serves as a Post Authorisation Efficacy Study (PAES) for the intranasal (IN) naloxone, Nyxoid developed by MundiPharma and focuses on drug safety and training.

NCT ID: NCT04987801 Recruiting - Drug Toxicity Clinical Trials

Evaluation of Drug Overdose Poisoning Cases and Indications for ICU Admission

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

1. Evaluation of drug overdose cases presented to Assiut university hospitals' adults and pediatric emergency departments (EDs) in one year period. 2. Evaluation the role of intensive care unit (ICU) admission in these cases and possible scoring system for common groups of drug overdose.

NCT ID: NCT04815590 Recruiting - Opioid-Use Disorder Clinical Trials

Extended-release Injectable Buprenorphine for Individuals at High Risk of Overdose

FASTER-BUP
Start date: October 17, 2022
Phase:
Study type: Observational [Patient Registry]

This pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among individuals at high-risk for overdose (OD).

NCT ID: NCT04799184 Recruiting - Surgery Clinical Trials

PK/PD Levobupivacaine With and Without Epinephrine After Ultrasound Guided ESP Block

Start date: April 3, 2019
Phase: Phase 4
Study type: Interventional

Currently there is no standardized management or single technique to manage postoperative pain after Video-assisted thoracic surgery (VATS), there are many options available ranging from intravenous opioids, morphine or fentanyl Patient-controlled analgesia (PCA), peripheral nerve blocks, intercostals, paravertebral and epidural blocks. Erector Spinal Block (ESP), this blocks the ventral and dorsal branch of the unilateral thoracic roots. It corresponds to an interfacial block that produces an extensive multidermatomal sensitive block with a single puncture, covering the anterior, lateral and posterior aspect of the thorax. One of its main advantages would be safety, possible less damage to nerves and pneumothorax, as well as the simplicity of execution of this block. What has positioned it as another analgesic alternative in this type of surgery. The pharmacokinetic profile that local anesthetics would have when injected into this interfacial compartment has not yet been described, and what the real impact of the use of vasoconstrictor will be in terms of plasma levels and duration of the block. Our objective is to compare the plasma levels of levobupivacaine achieved after performing an ESP Block with or without epinephrine.

NCT ID: NCT03968237 Recruiting - Opioid Overdose Clinical Trials

Measures to Improve Outcomes After an Opioid Overdose

Start date: August 1, 2019
Phase:
Study type: Observational

This is a pilot study that aims to develop good clinical practices to improve outcomes after an opioid overdose and transition of care from the Emergency Department (ED) into an Office Based Opioid Treatment (OBOT) clinic for patients with opioid overdose/Opioid Use Disorder (OUD). We intend to involve UVA Emergency Medicine and Medical Toxicology physicians with buprenorphine waiver or an interest in becoming waived at our institution to implement early initiation of buprenorphine protocol. We hope that this change in practice will result in better management of patients with OUD and opioid overdose, reduce relapse and improve engagement in addiction treatment. Subjects who meet criteria will be consented in the ED and receive a buprenorphine/naloxone induction protocol, prior to discharge and referral to the OBOT clinic. Subjects who consent to take part in this study will be entered in a database to track their involvement in treatment (s) at UVA and or any opioid related UVA health visits including OPIOID OVERDOSE.

NCT ID: NCT03933345 Recruiting - Opioid Use Clinical Trials

Overdose Risk Management and Naloxone

Start date: April 5, 2019
Phase:
Study type: Observational

A growing body of research underscores the life- and cost-saving advantages of equipping people who use opioids with naloxone, but very little is known about: 1) barriers to naloxone awareness and access, and 2) the potential psychosocial and behavioral impacts of being "protected" by naloxone while engaging in overdose risk behaviors, of using naloxone on someone else, and of surviving an overdose in which naloxone is used. This research will provide insight into both of these domains to yield a richly contextualized understanding of the processes and mechanisms underlying changes in overdose risk behaviors related to naloxone access and use and will illuminate the disparities that may limit access to naloxone for some or result in compensatory behavior following naloxone exposure for others. Findings from this study will provide an empirical basis to strengthen and refine existing overdose prevention efforts and to design tailored interventions to engage opioid users who have recently survived or reversed an overdose.

NCT ID: NCT03924505 Recruiting - Opioid Overdose Clinical Trials

Preventing Opioid Overdose Mortality in the United States

Start date: September 3, 2019
Phase: N/A
Study type: Interventional

This study aims to generate knowledge regarding the process of implementing naloxone within syringe service programs (SSPs), and to test whether external facilitation can improve implementation of naloxone within SSPs throughout the country. Together, these efforts can improve access to naloxone for people at high risk of overdose, thereby improving our nation's response to the opioid overdose epidemic.

NCT ID: NCT03845699 Recruiting - Clinical trials for Opioid-Related Disorders

Development of an Algorithm That Predicts Hypoventilation Due to an Opioid Overdose

Start date: May 15, 2019
Phase:
Study type: Observational

RTM Vital Signs, LLC is developing a miniature wearable tracheal sound sensor that communicates with a cell phone containing a machine-learning diagnostic algorithm designed to detect and predict the onset of mild, moderate, and severe hypoventilation (respiratory depression) due to an opioid overdose. The purpose of this clinical trial is to develop/validate diagnostic algorithms capable of detecting/predicting the onset of hypoventilation induced by a controlled intravenous infusion of fentanyl. The wearable sensor and algorithms will provide a series of alerts and alarms to the person, caregiver, and/or emergency personnel.