Clinical trials: Therapeutic Agent Toxicity
Drug Toxicity
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
Arm 1: Primary Objective: To determine the safety and tolerability of multiple ascending, supratherapeutic doses of HPN-100. Arm 2: Primary Objective: To assess the effects of steady-state levels of HPN-100 metabolites (4…
- Trial name
- NCT01135680
- Testing
- HPN-100, Moxifloxacin
- Where
- United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Amgen
Renal Impairment, Gout
Evaluation of Colchicine and Nonsteroidal Anti-inflammatory Drug Combination Therapy and Renal Function in Gout Patients
Our findings are expected to provide real-world evidence of the renal-adverse effects of colchicine and NSAIDs combination therapy in patients with gout, which will guide healthcare professions in optimizing gout treatment…
- Conditions
- Renal Impairment, Gout, Colchicine Adverse Reaction, Nonsteroidals (NSAIDs)Toxicity
- Trial name
- NCT05006001
- Testing
- Colchicine and NSAID
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- En Chu Kong Hospital
Breast Cancer, Chemotherapeutic Agent Toxicity
Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer
RATIONALE: Gathering information over time from laboratory tests, imaging scans, and assessment tests may help doctors learn more about the side effects of chemotherapy and plan the best treatment.
- Conditions
- Breast Cancer, Chemotherapeutic Agent Toxicity, Cognitive/Functional Effects, Fatigue
- Trial name
- NCT00755313
- Testing
- trastuzumab, aromatase inhibition therapy, carboplatin
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis
HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-Effectiveness
Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS), are rare but life-threatening complications that…
- Conditions
- Gout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis, Gout and Hyperuricemia
- Trial name
- HLA-SCREEN (NCT07369622)
- Testing
- HLA-B*58:01 Genotyping, Allopurinol Tablet, Febuxostat
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Haiphong University of Medicine and Pharmacy
Drug Toxicity
Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
The purpose of this research study is to examine the safety of specific soy components, known as isoflavones, and to find out what effects (good and bad) these components have on tissues that are sensitive to the hormone estrogen…
- Trial name
- NCT00491595
- Testing
- High Dose Soy isoflavones
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- University of North Carolina
Atrial Fibrillation, Medication Adherence
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
In patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the Danish National Prescription Registry and pillcount and will be related to…
- Conditions
- Atrial Fibrillation, Medication Adherence, Blood Coagulation Tests, Anticoagulants; Circulating, Hemorrhagic Disorder
- Trial name
- ARCADE (NCT03280368)
- Testing
- Bloodtest, Questionnaires
- Where
- Denmark
- Volunteers
- 430 people, healthy volunteers welcome
- Sponsor
- Hospitalsenheden Vest
Cardiovascular Diseases, Cardiotoxicity
Cancer Treatment Related Cardiovascular Toxicity: Comprehensive Myocardial and Vascular Phenotyping
Observational prospective cohort study designed to assess the mechanisms of fluoropyrimidine induced cardiovascular toxicity.
- Conditions
- Cardiovascular Diseases, Cardiotoxicity, Fluorouracil Adverse Reaction, Malignancy
- Trial name
- PC-TOX (NCT06048458)
- Testing
- Cardiovascular magnetic resonance with stress perfusion, CT coronary angiography, Retinal OCT angiography
- Where
- United Kingdom
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University College, London
Analgesia, Obstetrical, Coagulation Defect; Postpartum
IV Ketorolac on Platelet Function Post-Cesarean Delivery
Cesarean delivery has become the most common surgical procedure in the US. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to improve the quality of post-cesarean analgesia and markedly reduce opioid consumption.
- Conditions
- Analgesia, Obstetrical, Coagulation Defect; Postpartum, Nonsteroidals (NSAIDs)Toxicity, Postpartum Hemorrhage
- Trial name
- KetoPltAgg (NCT03805607)
- Testing
- Ketorolac Tromethamine 30 MG/ML
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Drug Toxicity, Healthy
Aminotransferase Trends During Prolonged Acetaminophen Dosing
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to…
- Trial name
- NCT00743093
- Testing
- acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 398 people, healthy volunteers welcome
- Sponsor
- Denver Health and Hospital Authority
Hospitalized for Voluntary Drug Intoxication
Divided Drug Delivery
This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.
- Trial name
- DEFIMED-1 (NCT02869724)
- Testing
- Weekly divided delivery, Monthly divided delivery
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
Analgesia, Obstetrical, Postpartum Hemorrhage
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
In this randomized, double-blind control trial to evaluate the effect of ketorolac given at the time of cord clamp has on estimated blood loss and postcesarean pain control.
- Conditions
- Analgesia, Obstetrical, Postpartum Hemorrhage, Opioid Use, Nonsteroidals (NSAIDs)Toxicity
- Trial name
- NCT02509312
- Testing
- Ketorolac
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Drug Toxicity
Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics of KD101 in Healthy Male Subjects
To Evaluate the safety and tolerability after KD101 single oral dosing in healthy male subjects To Evaluate the pharmacokinetic property after KD101 single oral dosing in healthy male subjects To Evaluate the effect of food on…
- Trial name
- NCT01979380
- Testing
- KD101
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kwang Dong Pharmaceutical co., ltd.
Cardiotoxicity, Childhood Cancer
Prediction of Delayed Toxic Cardiomyopathy in Children
Longitudinal analysis of myocardial function using "Speckle Tracking Echocardiography" STE analysis and prediction of delayed toxic induced cardiomyopathy in young patients who received anthracycline therapy in childhood.
- Trial name
- SpeckleAnthra2 (NCT05781672)
- Testing
- cardiac ultrasound with speckle tracking analysis
- Where
- France
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Drug Toxicity
Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity
Over-the-counter drugs like acetaminophen (e.g., Tylenol®) can be detrimental. In space, astronauts who have pain and constant discomfort use acetaminophen extensively.
- Trial name
- NCT06214468
- Testing
- Acetaminophen and Nicotinamide Riboside, Acetaminophen
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- University of South Alabama
Volunteers Repeated Drug Poisoning, Alcoholic
Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging
France is one of the European countries with the highest rate of death by suicide, more than 10 400 deaths each year, about 16 people out of 100 000.
- Conditions
- Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
- Trial name
- Phenot IMVr (NCT02889042)
- Testing
- MRI and biological assessment
- Where
- France
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
Anxiety, Surgery
Could Music be an Alternative to Sedation in Patients Treated Total Knee Arthroplasty With Regional Anesthesia?
Background: Anxiety is a common phenomenon in hospitalized patients. In order to reduce it during the surgical procedure, sedatives and anxiolytics are used, which can cause undesirable side effects for patients.
- Conditions
- Anxiety, Surgery, Drug Toxicity, Anesthesia
- Trial name
- NCT03882541
- Testing
- Music therapy, Sedation with midazolam
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Consorci Sanitari de l'Anoia
Neoplasms, Medication Toxicity
Study of Orally-Administered AMXT 1501 Dicaprate in Normal Healthy Volunteers
This is a Phase 1 study, which will assess the safety, PK, and pharmacodynamics (PD) of orally-administered AMXT 1501 dicaprate in normal healthy male volunteers.
- Conditions
- Neoplasms, Medication Toxicity, Tolerance
- Trial name
- NCT03077477
- Testing
- AMXT 1501
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Aminex Therapeutics, Inc.
Drug Toxicity, Platelet Dysfunction
The Influence of Tramadol on Platelet Function
The aim of this ex-vivo study is to quantify the effect of tramadol on platelet aggregation.
- Conditions
- Drug Toxicity, Platelet Dysfunction, Clotting Disorder
- Trial name
- NCT05237492
- Testing
- Tramadol
- Where
- Austria
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Medical University of Graz
Mood Disturbance, Mood Change
Mood and Cognitive Effects of Psilocybin in Healthy Participants
This study is seeking to find the optimal microdose or low dose of psilocybin (magic mushrooms) that provides general enhancements to mood, memory, sleep, and other measures of general well-being without any hallucinogenic…
- Conditions
- Mood Disturbance, Mood Change, Sleep Disturbance, Drug Effect
- Trial name
- MELO (NCT05252598)
- Testing
- Psilocybin, Inonotus Obliquus Whole Extract
- Volunteers
- healthy volunteers welcome
- Sponsor
- Optimi Health Corporation
Drug Mechanism, Metabolism Medication Toxicity
Pharmacology Space Kit (PSK) - Dried Blood Spot for Caffeine Pharmacokinetics Under Microgravity Conditions
The PSK study is preliminary to the study of drug metabolism in space flight conditions. The investigators propose to use simplified blood sampling methods that can be applied in microgravity.
- Conditions
- Drug Mechanism, Metabolism Medication Toxicity, Space Motion Sickness
- Trial name
- PSK (NCT06431984)
- Testing
- prick test
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France