Clinical trials: Therapeutic Agent Toxicity
Hepatitis, Toxic
Cholestatic Drug-induced Liver Injury
Cholestatic drug-induced liver injury (DILI) is the severe form of DILI with a grave outcome. Drug-metabolizing enzymes play an important role in the metabolism of drugs.
- Trial name
- DILI (NCT01141322)
- Testing
- Ursodeoxycholic Acid
- Where
- Taiwan
- Volunteers
- 180 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Respiratory Insufficiency, Overdose of Opiate
ARM-ED: Advanced Respiratory Monitoring Events in Drug Toxicity
There is a drug-related death crisis in Scotland. The majority of these deaths have involved the misuse of opiates (e.g. heroin) and benzodiazepines (e.g. valium) which cause an individual to stop breathing.
- Conditions
- Respiratory Insufficiency, Overdose of Opiate, Sedative Overdose, Sedative Toxicity
- Trial name
- ARM-ED (NCT05358132)
- Testing
- Pneumowave Device placement and data capture
- Where
- United Kingdom
- Volunteers
- 78 people
- Sponsor
- NHS Greater Glasgow and Clyde
Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome
Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis
To test the ability of palifermin (a recombinant human keratinocyte growth factor) to decrease mucocutaneous injury and to promote epithelial repair in Toxic Epidermal Necrolysis and Stevens-Johnson Syndrome-Toxic Epidermal…
- Trial name
- NCT02037347
- Testing
- Palifermin
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Brett King
Drug/Agent Toxicity by Tissue/Organ, Pancreatic Cancer
Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more tumor cells.
- Trial name
- NCT00024427
- Testing
- fluorouracil, gemcitabine hydrochloride, triacetyluridine
- Where
- 29 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Wellstat Therapeutics
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.
Small Cell Lung Cancer
G-Step: Gemcitabine Based Small-cell Lung Cancer Treatment in Elderly Patients
The purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with…
- Trial name
- G-Step (NCT00401609)
- Testing
- gemcitabine, vinorelbine, cisplatin
- Where
- 21 sites in Italy
- Volunteers
- 85 people
- Sponsor
- National Cancer Institute, Naples
Toxic Epidermal Necrolysis, Immunotherapy
New Therapeutic Target for Toxic Epidermal Necrolysis (TEN) Using Anti-CD38+ Monoclonal Antibodies.
Toxic Epidermal Necrolysis (TEN) are rare diseases that are dermatologic emergencies characterized by widespread epidermal necrosis and sloughing of skin. A hundred patients are affected each year in France.
- Conditions
- Toxic Epidermal Necrolysis, Immunotherapy, Cutaneous Adverse Drug Reactions (CADR)
- Trial name
- NET-CD38 (NCT07110662)
- Testing
- DARATUMUMAB (DARZALEX®)
- Where
- France
- Volunteers
- 9 people
- Sponsor
- Hospices Civils de Lyon
CDK4/6 Inhibitor, Breast Cancer
Pharmacogenomic and Circulating Biomarkers for CDK4/6 Inhibitors
The goal of this research study is to reduce adverse effects of anti-cancer medications known as kinase inhibitors, while preserving their therapeutic benefits. There have been major advances in the way cancers are treated.
- Conditions
- CDK4/6 Inhibitor, Breast Cancer, CYP3A4 Protein, Human, Drug Interaction
- Trial name
- NCT07100054
- Testing
- Whole gene sequencing, Drug-drug interaction analysis, Biomarker analysis
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer
Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation…
- Conditions
- Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Radiation Toxicity
- Trial name
- NCT00003583
- Testing
- amifostine trihydrate, cisplatin, etoposide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Mental Disorders, Metabolism Medication Toxicity
Pharmacogenomic Profiling of Pediatric Patients
The purpose of this study is to determine the proportion of children presenting to a pediatric emergency department with an acute mental health/behavioral crisis or clinical drug toxicity who have a "match" or "mismatch" between…
- Conditions
- Mental Disorders, Metabolism Medication Toxicity, Pediatric Disorder
- Trial name
- NCT02770339
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of Alabama at Birmingham
Cardiotoxicity Induced by Drug Therapy for Breast Cancer
The Use of Shengmai San to Prevent Anthracycline Sequential Trastuzumab Therapy Related Cardiac Toxicity
To evaluate the effectiveness and safety of Shengmai San in preventing anthracycline sequential trastuzumab therapy related cardiac toxicity through a prospective randomized controlled study.
- Trial name
- START (NCT06214195)
- Testing
- Shengmai San (ingredients include ginseng, Ophiopogon japonicus, and Schisandra chinensis)
- Where
- China
- Volunteers
- 276 people
- Sponsor
- Zhejiang Cancer Hospital
Cancer Therapy-related Cardiovascular Toxicity
Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy and the Preventive of Probiotics
The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and…
- Trial name
- NCT05730777
- Testing
- Bifidobacterium Bifidum Oral Capsule, Cisplatin, Carboplatin
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Peking University Third Hospital
Maximum Tolerated Dose, GIST
Selinexor as Single Agent and With Imatinib in Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (SeliGIST)
This is a single-arm, two cohort, open label phase I/II clinical trial studying the combination of oral imatinib 400 mg, once daily, and oral selinexor given once weekly (Cohort A); and single-agent oral selinexor 60 mg BIW…
- Conditions
- Maximum Tolerated Dose, GIST, Metastatic Adult Soft Tissue Sarcoma, Drug Toxicity
- Trial name
- SeliGIST (NCT04138381)
- Testing
- Selinexor, Imatinib
- Where
- 6 sites in Spain
- Volunteers
- 30 people
- Sponsor
- Grupo Espanol de Investigacion en Sarcomas
Coronary Artery Disease, Cardiac Disease
The CAROLE (CArdiac Related Oncologic Late Effects) Study
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them…
- Conditions
- Coronary Artery Disease, Cardiac Disease, Cardiac Toxicity, Radiation
- Trial name
- CAROLE (NCT03235427)
- Where
- United States
- Volunteers
- 201 people
- Sponsor
- Northwell Health
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
Cancer Survivors, Cardiotoxicity
In-Bedroom Renewed Air as Anti-inflammatory Adjuvant Therapy in Cancer Survivors
The BREATHS trial aims to investigate whether overnight in-bedroom air filtration reduces inflammation and cardiac biomarkers in adult survivors of cancer who are at high risk for cardiovascular complications.
- Conditions
- Cancer Survivors, Cardiotoxicity, Cardiovascular Toxicity Induced by Antitumoral Drugs
- Trial name
- BREATHS (NCT06778122)
- Testing
- High efficiency particulate air filtration system (nightly administration), High efficiency particulate air filtration system (nightly and daily administration)
- Where
- 3 sites in Spain
- Volunteers
- 10 people
- Sponsor
- University College, London
Breast Cancer, Cardiac Toxicity
Side Effects Involving the Heart in Women With Breast Cancer Receiving Doxorubicin and Trastuzumab
RATIONALE: Studying samples of blood and tissue in the laboratory from women receiving doxorubicin and trastuzumab for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers for…
- Conditions
- Breast Cancer, Cardiac Toxicity, Cardiovascular Complications
- Trial name
- PACE in BC (NCT00875238)
- Testing
- trastuzumab, doxorubicin hydrochloride, polymorphism analysis
- Where
- 4 sites in United States
- Volunteers
- 133 people
- Sponsor
- Vanderbilt University
Long QT Syndrome, Drug Toxicity
Genetics of QT Prolongation With Antiarrhythmics
To assess the ability of common genetic variants in aggregate to predict drug-induced QT prolongation in patients being loaded with dofetilide or sotalol.
- Trial name
- DOFEGEN (NCT02439658)
- Testing
- Dofetilide and/or sotalol
- Where
- 5 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Massachusetts General Hospital
Heart Failure, Cardiotoxicity
The STOP-MED CTRCD Trial
Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients.
- Conditions
- Heart Failure, Cardiotoxicity, Cardiac Toxicity, Antineoplastics Toxicity
- Trial name
- STOP-MED CTRCD (NCT06183437)
- Testing
- Stopping Heart Failure Medication(s)
- Where
- 14 sites in United States, Australia and 4 more
- Volunteers
- 335 people
- Sponsor
- Dinesh Thavendiranathan
Melanoma Stage III, Melanoma Stage IV
Infliximab for Treatment of Immune Checkpoint Inhibitor Colitis
The goal of this clinical trial is to compare the safety and effectiveness of infliximab compared to steroids for the treatment of immune checkpoint inhibitor-induced colitis (ICI colitis) in patients with stage III/IV skin…
- Conditions
- Melanoma Stage III, Melanoma Stage IV, Skin Cancer Stage III, Skin Cancer Stage IV
- Trial name
- NCT04305145
- Testing
- Infliximab, Methylprednisolone, Prednisone
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Massachusetts General Hospital