Clinical trials: Drug Toxicity
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
Breast Cancer
An Integrated Consent Model Study to Compare Two Standard of Care Schedules for Monitoring Cardiac Function in Patients Receiving Trastuzumab for Early Stage Breast Cancer
Several large adjuvant trastuzumab trials have demonstrated improved overall survival in participants with early stage breast cancer, with a 33% decrease in risk of death.
- Trial name
- OTT 15-05 (NCT02696707)
- Testing
- LVEF 3 month, LVEF 4 month
- Where
- 4 sites in Canada
- Volunteers
- 200 people
- Sponsor
- Ottawa Hospital Research Institute
Gastric Adenocarcinoma
Using Genetic Polymorphisms to Predict the Efficacy and Toxicity - A Gastric Adenocarcinoma Study
This is an open-label, non-comparative phase II study of sequential capecitabine plus oxaliplatin followed by docetaxel plus capecitabine in patients with unresectable gastric adenocarcinoma.
- Trial name
- NCT01558011
- Testing
- Capecitabine, Oxaliplatin, Docetaxel
- Where
- Taiwan
- Volunteers
- 51 people
- Sponsor
- National Health Research Institutes, Taiwan
Mesenchymal Stromal Cells, Psoriasis
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment and PSORI-CM01 Granule in Psoriasis Patients
The purpose of this study is to evaluate the efficacy and safety of Adipose derived Mesenchymal Stem Cells (AD-MSCs) plus Calpocitriol Ointment and PSORI-CM01 Granule with moderate to severe psoriasis.
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Trial name
- NCT04275024
- Testing
- Calcipotriol ointment, PSORI-CM01 Granule, adipose-derived multipotent mesenchymal stem cells
- Where
- China
- Volunteers
- 8 people
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Mesenchymal Stromal Cells, Psoriasis
Efficacy and Safety of Expanded UCMSCs On Patients With Moderate to Severe Psoriasis
The purpose of this study is to evaluate the efficacy and safety of Expanded Umbilical Cord Mesenchymal Stem Cells on patients with moderate to severe psoriasis.
- Conditions
- Mesenchymal Stromal Cells, Psoriasis, Drug Effect, Drug Toxicity
- Trial name
- UCMSCs (NCT03745417)
- Testing
- Umbilical cord mesenchymal stem cells
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
Immunosuppression, Kidney Transplant Rejection
The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma
Tacrolimus (TAC) is characterized by a narrow therapeutic window, as well as high inter- and intra-individual variability in pharmacokinetics. Both under- and overexposure may lead to severe adverse effects.
- Conditions
- Immunosuppression, Kidney Transplant Rejection, Kidney Transplant; Complications, Liver Transplant Rejection
- Trial name
- FreeTAC (NCT04657562)
- Testing
- Tacrolimus, Unbound tacrolimus measurement, CYP3A4 and CYP3A5 genotyping
- Where
- Poland
- Volunteers
- 380 people
- Sponsor
- National Science Centre, Poland
Drug/Agent Toxicity by Tissue/Organ, Lymphoma
Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma
Phase I trial to study the effectiveness of irinotecan plus cyclosporine and phenobarbital in treating patients who have solid tumors or lymphoma that is refractory to standard therapy.
- Conditions
- Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Neutropenia, Small Intestine Cancer
- Trial name
- NCT00002759
- Testing
- cyclosporine, irinotecan hydrochloride, phenobarbital
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- National Cancer Institute (NCI)
Gestational Trophoblastic Tumor, Effects of Chemotherapy
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with…
- Conditions
- Gestational Trophoblastic Tumor, Effects of Chemotherapy, Drug Toxicity
- Trial name
- NCT03885388
- Testing
- MTX, MTX+ACTD
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Women's Hospital School Of Medicine Zhejiang University
Cleaning Product Causing Toxic Effect
AvenovaTM as a Sterile Skin Preparation Agent
Aim 1: To determine in vivo capability of AvenovaTM against common cutaneous microbial biome on human skin Aim 2: To compare to povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol against AvenovaTM as a sterile…
- Trial name
- NCT02990013
- Testing
- Avenova, Povidone-iodine 5% solution, 4% chlorhexidine
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Myocarditis, Myocardial Failure
Monitoring Drug-induced Myocarditis (CardiTOX)
Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO)…
- Conditions
- Myocarditis, Myocardial Failure, Myocardial Dysfunction
- Trial name
- CardiTOX (NCT03855982)
- Testing
- Drug inducing myocarditis
- Where
- France
- Volunteers
- 6,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Drug Toxicity
Cytokines Polymorphisms and Acetaminophen Toxicity
Genotyping assays for polymorphisms in the interleukin 10(IL10)gene and the inducible nitric oxide synthase (iNOS) gene will be performed. Genotypes will be compared to the severity of toxicity following overdose.
- Trial name
- NCT00166608
- Testing
- Blood sampling
- Where
- 7 sites in United States
- Volunteers
- 111 people
- Sponsor
- Arkansas Children's Hospital Research Institute
Small Cell Lung Cancer, Soft Tissue Sarcoma
Study of the Safety, Pharmacokinetics and Efficacy of Tinostamustine in Patients With Advanced Solid Tumors.
Tinostamustine (EDO-S101) is a first-in-class alkylating deacetylase inhibitor designed to improve drug access to deoxyribonucleic acid (DNA) strands, induce DNA damage and counteract its repair in cancer cells.
- Conditions
- Small Cell Lung Cancer, Soft Tissue Sarcoma, Triple-negative Breast Cancer, Ovarian Cancer
- Trial name
- EDO-S101 (NCT03345485)
- Testing
- Tinostamustine 60mg/m2 over 30min, Tinostamustine 80mg/m2 over 30min, Tinostamustine 100mg/m2 over 30min
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Mundipharma Research Limited
Charcoal, Decontamination, Poisoning
Activated CHARcoal in Poisoned Patient - Pilot Trial
The goal of this clinical pilot trial is to determine the feasibility of the clinical trial. Then the large-scale CHARPP will be conducted in order to determine the efficacity of activated charcoal as a treatment for acute…
- Trial name
- CHARPP-Pilot (NCT05471479)
- Testing
- Activated Charcoal, No activated charcoal
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- Laval University
Breast Cancer Patients
Study of ABCB1,SLC22A16 Drug Transporter Genes and Doxorubicin and Cyclophosphamide Toxicity in Brest Cancer Patient
polymorphisms of drug transporter genes may influence of Doxorubicin-Cyclophosphamide toxicity in breast cancer patients. the investigators want to evaluate the association between associations between genetic polymorphisms of…
- Trial name
- NCT04654195
- Testing
- polymorphism analysis, Doxorubicin-Cyclophosphamide regimen
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Damanhour University
Brain and Central Nervous System Tumors, Breast Cancer
BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain
RATIONALE: Osmotic blood-brain barrier disruption uses certain drugs, such as mannitol, to open the blood vessels around the brain and allow tumor-killing substances to be carried directly to the brain.
- Conditions
- Brain and Central Nervous System Tumors, Breast Cancer, Cognitive/Functional Effects, Drug/Agent Toxicity by Tissue/Organ
- Trial name
- NCT00397501
- Testing
- trastuzumab, carboplatin, methotrexate
- Sponsor
- OHSU Knight Cancer Institute
Toxicity, Drug, Maculopathy
Studying the Performance of OCT C-scan in the Screening for Retinopathy Related to Synthetic Antimalarials
Maculopathy induced by retinal toxicity of synthetic antimalarials is to be screened at the sub-clinical stage. Indeed, when the first visual symptoms appear, macular damage is already irreversible and the clinical picture may…
- Trial name
- PERFOCTAPS (NCT02719002)
- Testing
- spectral domain optical coherence tomography C-scan and multifocal electroretinogram
- Where
- France
- Volunteers
- 109 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
Radiodermatitis, Radiation Toxicity
Efficacy of the Mepitel® Film on the Prevention of Radiodermatitis in the Inguinal Fold.
The aim is to quantify the efficiency of the Safetac product Mepitel® Film on the prevention of radiodermatitis for cancer patients treated with external beam radiation therapy near the inguinal fold(s).
- Conditions
- Radiodermatitis, Radiation Toxicity, Radiotherapy Side Effect
- Trial name
- NCT04617730
- Testing
- Mepitel® film, Flamigel®
- Volunteers
- 35 people
- Sponsor
- Jules Bordet Institute
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
Epilepsy
Outcome Study in Refractory Epilepsy (SOPHIE)
Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment.
- Trial name
- SOPHIE (NCT03939507)
- Testing
- AEP score available to the treating physician
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- University of Pavia
Head and Neck Cancer, Ototoxicity
Intensity-Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Decreasing Hearing Loss in Patients Who Have Undergone Surgery for Parotid Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal…
- Conditions
- Head and Neck Cancer, Ototoxicity, Radiation Toxicity
- Trial name
- NCT01216800
- Testing
- adjuvant therapy, assessment of therapy complications, quality-of-life assessment
- Where
- United Kingdom
- Volunteers
- 84 people
- Sponsor
- Institute of Cancer Research, United Kingdom