Clinical trials: Drug Reactions
Neonatal Hypotonia, Antidepressant Drug Adverse Reaction
Neonatal Hypotonia Associated With in Utero Exposure to Antidepressant
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases.
- Conditions
- Neonatal Hypotonia, Antidepressant Drug Adverse Reaction, Pregnancy Related
- Trial name
- NCT04830241
- Testing
- Antidepressant
- Where
- France
- Volunteers
- 10,000 people
- Sponsor
- University Hospital, Caen
Nicotine Dependence
Drug /Cue Interactions In Alcohol-Tobacco Comorbidity
The purpose of this study is to determine how people react to different combinations of alcohol and nicotine.
- Trial name
- NCT00816231
- Testing
- Tobacco, Alcoholic Beverage
- Where
- United States
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term)
Cancer Therapy-Related Cardiac Dysfunction Associated With EGFR-TKIs in Advanced EGFR-mutant Non-small Cell Lung Cancer
This study investigated the incidence of cardiac dysfunction in patients with advanced or recurrent epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer treated with EGFR- tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer (MeSH Term: Carcinoma, Non-Small-Cell Lung), Drug-Related Side Effects and Adverse Reactions (MeSH Term), Egfr Tyrosine Kinase Inhibitor, Cardiotoxicity
- Trial name
- NCT07267247
- Testing
- EGFR-TKI, EGFR tyrosine kinase inhibitor
- Where
- Taiwan
- Volunteers
- 100 people
- Sponsor
- Taichung Veterans General Hospital
Breast Cancer
Early Cardiac Toxicity of Adjuvant CT in Elderly BC.
The primary objective is to evaluate the difference in cardiac strain rate evolution in elderly early BC patients treated with (neo) adjuvant anthracycline-based chemotherapy compared with a non-anthracycline regimen…
- Trial name
- NCT01301040
- Testing
- epirubicin, cyclophosphamide, docetaxel
- Where
- Belgium
- Volunteers
- 2 people
- Sponsor
- Jules Bordet Institute
Infection
Adverse Drug Reactions of Different Brands of Ceftazidime Injection
The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.
- Trial name
- NCT00173901
- Testing
- ceftazidime
- Where
- Taiwan
- Volunteers
- 536 people
- Sponsor
- National Taiwan University Hospital
Atrial Fibrillation, Deep Vein Thrombosis
Association Between Genetic Variant Scores and Warfarin Effect
Study objective is to determine whether there is an association between genetic variant risk scores and clinical outcomes (percent time in therapeutic range, time to reach therapeutic international normalized ratio (INR), INR ≥…
- Conditions
- Atrial Fibrillation, Deep Vein Thrombosis, Intracardiac Thrombus, Pulmonary Embolism
- Trial name
- AWARE1 (NCT03894878)
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Cipherome, Inc.
Allergy Drug
De-labeling of Patients With False Diagnosis of Penicillin Allergy
The purpose of this study is to estimate the prevalence of penicillin allergy, evaluate the diagnostic value of the allergologic work-up used in the study, and the health effects of penicillin allergy.
- Trial name
- NCT03581604
- Testing
- Allergy work-up, Blood samples
- Where
- Norway
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Oslo University Hospital
Cardiotoxicity, HER2-positive Breast Cancer
Imaging Versus Cardiac Biomarker Monitored HER2 Directed Therapy in Patients With Breast Cancer
Due to a risk of heart failure during HER2 directed therapy in breast cancer, treatment is monitored with imaging of myocardial function, which is resource demanding for both patients and the health care system.
- Trial name
- HER2BIC (NCT05406635)
- Testing
- Biomarkers: Troponins and natriuretic peptides
- Where
- 3 sites in Denmark
- Volunteers
- 191 people
- Sponsor
- Odense University Hospital
Simvastatin Adverse Reaction, Pharmacogenomics
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups.
- Conditions
- Simvastatin Adverse Reaction, Pharmacogenomics, Accurate Medication
- Trial name
- NCT03261908
- Testing
- detection of genotype
- Where
- China
- Volunteers
- 2,200 people
- Sponsor
- Cui Yimin
Breast Cancer, Cardiotoxicity
Cardiotoxicity Prevention in Breast Cancer Patients Treated With Anthracyclines and/or Trastuzumab
The aim of the study is to analyze the protective impact on the cardiac damage of beta blockers and ACE inhibitors for breast cancer patients treated with anthracyclines-based chemotherapy with or without trastuzumab.
- Trial name
- SAFE (NCT02236806)
- Testing
- Bisoprolol, Ramipril
- Where
- Italy
- Volunteers
- 262 people
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
Adverse Drug Event
Adverse Drug Events at Emergency Department
Emergency departments (EDs) are a crucial element of the health care systems at interface between hospital and communities. The goals of the ED are to make an initial diagnosis and deliver urgent and critical care 24 hour per day…
- Trial name
- ADEsED (NCT03442010)
- Testing
- Detection of adverse drug events
- Where
- France
- Volunteers
- 13,453 people
- Sponsor
- University Hospital, Montpellier
Cardiotoxicity, Cardiac Rehabilitation
Exercise-based Cardiac Rehabilitation for the Prevention of Breast Cancer Chemotherapy-induced Cardiotoxicity
This project aims to determine whether a comprehensive cardiac rehabilitation program including supervised exercise training is able to prevent cardiotoxicity during treatment with anthracyclines and / or anti-HER-2 antibodies in…
- Trial name
- ONCORE (NCT03964142)
- Testing
- Cardiac rehabilitation
- Where
- Spain
- Volunteers
- 122 people
- Sponsor
- Hospital Clinico Universitario de Santiago
Deep Vein Thrombosis, Pulmonary Embolism
Impact of Pharmacists' Training on Oral Anticoagulant Counseling
This study evaluates the impact of community pharmacists' educational training on the nature and adequacy of counseling provided to patients on warfarin, an oral anticoagulant.
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism, Atrial Fibrillation
- Trial name
- NCT03999905
- Testing
- Counseling training
- Where
- Nigeria
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Ibadan
Positron-Emission Tomography, Magnetic Resonance Imaging
Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Using Multi-tracer to early diagnosis of therapy-associated cardiotoxicity using multimodality PET/MRI.
- Trial name
- NCT04555642
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Peking University Cancer Hospital & Institute
Breast Cancer, Neoplasm Metastasis
Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer
This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with…
- Trial name
- MYOHERTAX (NCT00377780)
- Testing
- Non pegylated liposomal doxorubicin, trastuzumab, docetaxel
- Where
- 7 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- Laurence J.C. van Warmerdam
Hand and Foot Syndrome
Effect of Topical Diclofenac on Clinical Outcome in Breast Cancer Patients Treated With Capecitabine
The aim of the study is to evaluate the efficacy of using combination of Urea-based cream (CARBAMIDE®) and topical diclofenac (VOLTAREN®) Emulgel 1% for improving the incidence of Hand-foot syndrome in histologically proven…
- Trial name
- NCT05641246
- Testing
- (CARBAMIDE®), (VOLTAREN®) Emulgel 1%
- Where
- Egypt
- Volunteers
- 86 people
- Sponsor
- German University in Cairo
Non-small Cell Lung Cancer, Cardiac Toxicity
Evaluation of Impedance Cardiography for Assessing Hemodynamic Shifts in Patients With LA-NSCLC During Treatment.
This study aimed to investigate the role of impedance cardiography (ICG) in evaluating hemodynamic changes during the 6-minute walk test (6MWT) in patients with locally advanced non-small cell lung cancer (LA-NSCLC) who underwent…
- Trial name
- NCT06277388
- Testing
- Impedance cardiography
- Where
- China
- Volunteers
- 231 people
- Sponsor
- Sun Yat-sen University
Anal Cancer, Colorectal Cancer
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
RATIONALE: Octreotide may be effective in preventing or controlling diarrhea in patients who are undergoing chemoradiotherapy for anal or rectal cancer. It is not yet known whether octreotide is effective in treating diarrhea.
- Conditions
- Anal Cancer, Colorectal Cancer, Drug/Agent Toxicity by Tissue/Organ, Radiation Enteritis
- Trial name
- NCT00075868
- Testing
- octreotide acetate
- Where
- 112 sites in United States
- Volunteers
- 233 people
- Sponsor
- Radiation Therapy Oncology Group
Cisplatin Adverse Reaction
Evaluation of the Effect of Rosuvastatin on Cisplatin-induced Nephrotoxicity and Ototoxicity
Cisplatin is an effective anti-cancer drug for the treatment of many solid tumors in humans. Although the clinical response to cisplatin chemotherapy is encouraging, the nephrotoxicity and ototoxicity of the drug makes it…
- Trial name
- NCT04817904
- Testing
- Rosuvastatin 10mg
- Where
- Egypt
- Volunteers
- 65 people
- Sponsor
- Cairo University
Drug-induced Liver Injury
Impact of Silymarin Dosages to Decrease Drug-induced Elevated Liver Enzymes Compared to Placebo
In this clinical study silymarin will be administered in different dosages and compared to placebo in order to address if the liver protecting features of silymarin, measured by changes of liver enzyme concentration, can be…
- Trial name
- SILVER (NCT05144217)
- Testing
- 2x 140 mg per day, 3x 280 mg per day, 1x 1120 mg
- Where
- 2 sites in Germany
- Volunteers
- 19 people
- Sponsor
- Prof. Dr. Frank Behrens