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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 12 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

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
E

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 teams 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
S

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 paracetamols 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
S

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 andor 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
S

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 methods 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
S

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
S

Actively Recruiting

This research focuses on liver injury caused by immune checkpoint inhibitors ICIs, a cancer treatment that helps the immune system fight tumors. Although ICIs are effective, they can lead to immune-related side effects such as liver inflammation known as ICI-induced hepatitis or CHILI. The study aims to understand CHILIs clinical patterns, treatment responses, and risks of recurrence, particularly examining different types of liver injury to improve treatment decisions. Participants are adult cancer patients who have received at least one ICI injection and developed hepatitis with specific liver enzyme elevations or severe hepatitis symptoms. The study observes patients treated with ICIs alone or in combination with other cancer therapies. Blood samples are collected to monitor liver injury types and progression over time, following real-world treatment approaches as guided by international recommendations or pragmatic care when no consensus exists. During the study, participants will have their liver injury type ratios measured at multiple time points up to 12 months. Data collection includes blood tests and clinical evaluations to track treatment effects and liver inflammation. The study will provide insights into managing ICI-related liver toxicity, with involvement lasting up to 12 months or longer depending on follow-up needs.

Age: 18Years +All Genders
1 location
S

Actively Recruiting

Researchers are studying whether phycocyanin, a natural protein from spirulina, can protect the liver and support recovery in adults undergoing partial liver removal due to intrahepatic cholangiocarcinoma. The study aims to find out if phycocyanin reduces liver injury after surgery, helps the liver regrow, and to assess its safety compared to a placebo. About 30 participants will take part in this randomized trial where neither the participants nor researchers will know who receives phycocyanin or placebo. Participants will take 1.5 grams of phycocyanin or a maltodextrin placebo orally once daily for 3 weeks before surgery and continue for 3 weeks after surgery. All participants will receive the standard medical care for partial hepatectomy. Researchers will collect blood and stool samples before and after treatment, study a small piece of liver tissue removed during surgery, and monitor recovery. During the study, participants will be followed up for up to 90 days after surgery. Researchers will measure changes in blood markers of liver function and inflammation, and assess liver cell growth using specific proteins. Safety will also be monitored for possible side effects. The study provides a thorough evaluation of liver healing and recovery after surgery with or without phycocyanin.

Age: 18Years - 75YearsAll GendersPhase Not Applicable
1 location
S

Actively Recruiting

Researchers are investigating genetic factors that might make some people in the Chinese population more likely to develop liver injury after taking acetaminophen APAP, a common pain reliever. This study compares individuals who have experienced drug-induced liver injury DILI from APAP with those who have not, aiming to find genetic differences that could explain susceptibility. Previous genetic findings from U.S. populations did not apply well to Chinese individuals, so this research focuses specifically on a Chinese group. Participants are divided into two groups based on whether they developed liver injury after APAP use. Inclusion requires a clear history of acetaminophen ingestion or positive testing for its components, along with liver enzyme levels ALT or AST of 1000 IUL or higher, and a causality score indicating APAP caused the injury. The study uses gene analysis methods, including genotyping over two million marker sites and immune gene typing, to identify genetic variations associated with liver injury risk. Strict protocols and quality controls ensure accurate data collection and management. During the study, participants provide clinical information and samples for genetic testing. Researchers collect data on acetaminophen exposure, liver enzyme levels, and causality assessments. The main outcome is the difference in genetic polymorphisms between those with and without liver injury, measured over two years. Data is carefully monitored and analyzed using statistical software to understand genetic links to APAP-induced liver injury. The study aims to improve understanding of genetic risks in this population and potentially guide safer medication use.

Age: 14Years +All Genders
1 location

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