Acetaminophen overdose is a common toxicological emergency that requires timely and effective intervention. Clinical trials related to acetaminophen overdose primarily explore treatment evaluations aimed at limiting liver damage and improving patient...

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Found 13 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating the use of 18F-DFA PET imaging to evaluate liver injury, a condition involving rapid liver function decline with symptoms like increased liver enzymes, jaundice, and abdominal discomfort. This observational study aims to assess how accurately this imaging method detects liver damage compared to standard clinical biochemical tests and liver biopsy, which is the current gold standard despite its sampling limitations. The study focuses on adults clinically diagnosed with liver damage or liver failure, exploring the correlation between 18F-DFA uptake in the liver and liver function indicators. Participants diagnosed with liver injury will undergo 18F-DFA PET imaging as part of the study. This radioactive tracer, based on vitamin C structure, is used to visualize liver function non-invasively. The imaging process involves a PET-CT scan lasting about 10 minutes, followed by a one-hour waiting period in the examination room before leaving. The study will compare imaging results with clinical liver function tests or liver biopsy findings to determine the sensitivity and specificity of this method. During the study, participants will have their liver function monitored using PET-CT scans and clinical biochemical markers. The primary outcomes include changes in liver uptake values on PET imaging at 6 months and the relationship between imaging results and standard liver function indicators. Participants will be followed up as needed, with assessments including liver enzyme levels and other blood tests. The total study duration depends on individual follow-up, and safety monitoring will address any issues related to PET imaging procedures.

Age: 18Years - 80YearsAll Genders
1 location
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Actively Recruiting

Adolescent overdose deaths are a leading cause of death among youth aged 10 to 19 in the United States, with numbers continuing to rise. Researchers are evaluating a brief overdose prevention education intervention designed for youth in primary care settings. This pilot study aims to assess how feasible and acceptable this intervention is for both healthcare providers and young patients, addressing a gap as there are currently no recommended overdose prevention programs specifically for youth in healthcare. In this two-arm cluster randomized controlled trial, pediatric and family medicine providers are randomly assigned to either deliver the brief overdose prevention education or provide usual care. Providers in the intervention group receive a 45-minute training, conducted in person or via Zoom, which covers overdose prevention education, intervention delivery, practice, and fidelity checklist completion. The intervention includes informing youth about overdose risk factors, safety strategies, recognizing and responding to overdoses, and naloxone use, with naloxone kits offered to take home. Youth participants aged 13 to 26 scheduled for a comprehensive physical exam with participating providers complete assessments at baseline, 2 weeks, and 6 months. Researchers will measure the feasibility and acceptability of the intervention by providers and youth, as well as youth knowledge and skills related to overdose risk, recognition, and response. The study excludes youth unable to consent or with cognitive limitations or acute medical/psychiatric distress. Participation is tracked over six months to evaluate the intervention's impact and acceptability.

Age: 13Years +All GendersPhase Not Applicable
1 location
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Actively Recruiting

Unrecognized abdominal and pelvic injuries from blunt trauma can lead to serious disability or death. Physicians often use computed tomography (CT) scans on many blunt trauma patients to avoid missing injuries, but this exposes many patients to radiation and high costs while finding injuries in only a few. Researchers are evaluating a decision tool to identify "low-risk" patients who may safely avoid CT imaging without missing significant injuries, aiming to reduce unnecessary scans, radiation exposure, and healthcare costs. This observational study involves adult blunt trauma patients who receive abdominal-pelvic CT scans in the emergency department. Physicians will record clinical signs and symptoms such as pain, tenderness, bruising, vital signs, and injury mechanism before imaging. The study will develop and validate decision instruments to classify patients as high or low risk for major or minor abdominal and pelvic injuries based on these clinical findings, without altering standard medical care. Participants will undergo routine clinical evaluations and CT imaging as part of their emergency care. Researchers will analyze the presence or absence of injuries using CT results and patient outcomes to assess the accuracy of the decision instruments. The main outcomes are the instruments' ability to correctly identify major and minor injuries. The study aims to confirm that these tools can safely reduce CT imaging, lowering radiation exposure and costs while maintaining patient safety.

All Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of an emergency department community health worker-peer recovery specialist program called the Substance Misuse Assistance Response Team (SMART) on people with substance use disorders. This observational, prospective case-control study aims to understand participant experiences with SMART, evaluate its effectiveness on recovery outcomes and linkage to treatment, and assess program implementation over time. The study focuses on improving recovery service connections for patients after substance use-related emergency visits, a critical time when the risk of death is elevated. The study compares two groups: patients who receive SMART services and those who do not. SMART provides personalized support, short-term case management, and navigation to social services, harm reduction, recovery, and addiction treatment both inside and outside the emergency department. Services include assistance with buprenorphine initiation, behavioral counseling, and help accessing housing, transportation, and other social resources. Patients not receiving SMART services receive usual care with referral at the emergency department team's discretion. Participants will complete surveys at enrollment, and again at 3 and 6 months after their initial emergency visit. Researchers will link survey data with state administrative databases to measure outcomes such as addiction treatment engagement, recovery capital, social services use, acute care visits, repeat hospitalizations and overdoses, mortality, employment changes, and criminal justice encounters. The study will provide important information about how SMART impacts patient outcomes and program delivery, with follow-up through October 2026.

Age: 18Years +All Genders
1 location
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Actively Recruiting

Tuberculosis (TB) remains a major health concern worldwide, especially in tropical regions like Thailand, where both pulmonary and extrapulmonary TB affect many people. Treatment requires multiple drugs taken for at least six months, but these can cause side effects such as liver damage, known as hepatotoxicity. This risk is higher in individuals with a specific NAT2 gene type called slow acetylators. Previous research suggests that N-acetylcysteine (NAC) may help reduce liver damage, particularly in these slow acetylators, prompting further study of this approach compared to standard treatment. This trial compares two groups of TB patients: one group undergoes NAT2 gene testing before starting treatment, and if identified as slow acetylators, they receive NAC at 600 mg twice daily for eight weeks along with standard anti-TB drugs. Rapid or intermediate acetylators in this group receive only standard treatment. The other group receives standard anti-TB medication without gene testing or NAC. The study monitors the effects of adding NAC guided by gene testing on liver health during TB treatment. Participants will be followed for eight weeks to assess liver health, with hepatitis rates measured at two and eight weeks after treatment begins. Researchers will conduct regular evaluations including liver function tests and monitor for any side effects or adverse reactions. The study aims to determine whether NAC can lower the occurrence of drug-induced liver injury in TB patients, especially those genetically at higher risk. Overall participation lasts at least eight weeks, during which safety and treatment responses will be closely tracked.

Age: 18Years - 80YearsAll GendersPhase 4
1 location
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Actively Recruiting

This research aims to evaluate the hemodynamic effects of intravenous paracetamol in adult patients undergoing emergency laparotomy, a high-risk surgery often complicated by severe physiological disturbances like sepsis. The study addresses concerns about paracetamol's potential to cause hypotension through peripheral vasodilation, especially in critically ill patients, where evidence from intraoperative settings remains limited. Participants will be randomly assigned to receive either 1 gram of intravenous paracetamol infused over 10 minutes or a placebo consisting of saline. Before surgery, fluid administration will be guided by stroke volume changes after a passive leg raising test. Anesthesia will be induced and maintained using specified doses of propofol, fentanyl, succinylcholine, isoflurane, and atracurium. Blood pressure and heart rate will be closely monitored every 2 minutes for 20 minutes after drug administration. Hypotension will be treated with norepinephrine boluses as needed. Throughout the study, mean arterial pressure will be measured primarily 10 minutes after the infusion of the study drug. Secondary outcomes include tracking drug-induced hypotension, heart rate, and mean arterial pressure up to 30 minutes post-infusion. The trial includes continuous assessment of vital signs and response to potential hypotensive events. Participation is expected to last throughout the surgical procedure and immediate monitoring period following the drug infusion.

Age: 21Years - 65YearsAll GendersPhase Not Applicable
1 location
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Actively Recruiting

This research aims to characterize how the drugs paracetamol and cefazolin behave in the bodies of children aged 2 to 15 years who have either normal weight or are overweight. The study focuses on children admitted for minor elective surgeries and investigates how these drugs are processed in the blood and subcutaneous fat tissue. The goal is to understand whether standard drug dosing provides proper exposure for children across different weight categories. Participants receive paracetamol and/or cefazolin as part of their usual perioperative care. During the surgical procedure, multiple blood and tissue-fluid samples are collected to measure drug concentrations over time. Sampling times include before and after drug infusion, covering distribution and elimination phases in blood and plasma, and cefazolin levels in adipose tissue using microdialysis. Throughout the study, blood samples will be analyzed for drug levels and metabolites, along with enzyme and protein biomarkers. The research team will compare pharmacokinetic profiles between normal-weight and overweight children to assess drug exposure. Participants are involved during their surgery and recovery, with detailed sampling timed at specific intervals. The total participation covers the day of surgery with no long-term follow-up specified.

Age: 2Years - 15YearsAll Genders
1 location
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Actively Recruiting

Researchers are investigating how intravenous paracetamol (acetaminophen) behaves and works in morbidly obese and non-obese patients undergoing laparoscopic surgery. The study aims to validate a prediction model for blood levels of paracetamol and its metabolites over 30 hours and explore the safety concerns related to higher doses in obese patients, especially regarding liver toxicity linked to metabolic dysfunction-associated liver disease. The study also compares traditional venous blood sampling with a new minimally invasive finger stick method called Volumetric Absorptive MicroSampling (VAMS). Participants receive standard care doses of intravenous paracetamol: a 2g loading dose after anesthesia induction, followed by 1g every 6 hours up to 30 hours. Both obese patients (BMI > 35) and non-obese patients (BMI 18.5-30) undergoing laparoscopic surgery are included. Blood samples are collected at multiple time points from veins and capillaries to measure paracetamol and its toxic metabolites. Pain relief is supported with intravenous ibuprofen and a patient-controlled analgesia pump delivering piritramide. Liver function tests are done before and after the 30-hour period. During the study, participants have blood drawn at scheduled intervals up to 30 hours to monitor drug levels and liver markers. Pain is assessed using Visual Analog Scale (VAS) scores and the Surgical Pleth Index (SPI) both at rest and after movement. The amount of piritramide used is recorded to evaluate analgesic needs. The researchers compare measured drug concentrations to model predictions and assess the VAMS method's accuracy. Data analysis includes statistical tests to explore differences between groups and validate the sampling methods. Total participation covers the 30-hour postoperative monitoring period.

Age: 18Years - 70YearsAll Genders
1 location
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Actively Recruiting

Healthy Volunteer

Researchers are evaluating whether a combination of N-acetylcysteine and simethicone can improve the cleanliness of the mucosal surface during upper gastrointestinal endoscopy in adults aged 18 to 99 years. This randomized, double-blind, placebo-controlled phase 2 trial includes both healthy individuals and those with non-bleeding gastrointestinal symptoms. The study aims to determine if this combination enhances mucosal visibility based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS) and to assess its safety and tolerability in this population. Participants will be randomly assigned to receive a single oral dose of either N-acetylcysteine (600 mg) combined with simethicone (100 mg) or a placebo (water) 20 to 60 minutes before undergoing a routine upper gastrointestinal endoscopy. Both participants and endoscopists will be blinded to the treatment allocation. The study will compare mucosal visibility scores between the two groups and monitor for any adverse effects or intolerance related to the premedication. During the study, participants will undergo the scheduled endoscopy where endoscopists will evaluate mucosal cleanliness using the TUGS scoring system. Additional data such as age, sex, body mass index, fasting duration, and endoscope model will be recorded for analysis. Researchers will also document any significant endoscopic findings, histological diagnoses, and the presence of Helicobacter pylori infection. Safety monitoring will be conducted throughout the procedure and follow-up, with all data collected anonymously for statistical evaluation.

Age: 18Years - 99YearsAll GendersPhase 2
2 locations
D

Actively Recruiting

Immune checkpoint inhibitors (ICIs) are a breakthrough treatment for cancer that help the immune system fight tumors. However, they can cause immune-related side effects such as liver inflammation, known as ICI-induced hepatitis or CHILI, affecting up to 25% of patients. This study aims to better understand CHILI, including its clinical patterns, how patients respond to treatment, and the risk of the liver injury returning. It focuses on different types of liver injury to support improved treatment decisions for patients. The study is observational and will collect real-world data from adult cancer patients who have received at least one ICI injection as part of their treatment, either alone or combined with other therapies like chemotherapy or radiotherapy. Researchers will follow patients with liver injury after ICI treatment, classified by liver enzyme levels and severity grade. Blood samples will be taken to monitor liver injury types and progression at multiple time points, including Day 0, Day 14, Day 30, Day 90, Month 6, and Month 12. Participants will be monitored over time with regular assessments of liver injury patterns using blood tests. The main outcome measured is the ratio of different liver injury types at scheduled visits up to one year. The study will help guide treatment strategies by observing how liver injury evolves and responds to care. Participation involves providing blood samples and medical data while following the course of liver inflammation related to immune therapy.

Age: 18Years +All Genders
1 location

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