Clinical trials: Drug-Related Side Effects and Adverse Reactions
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
Pain, Quality of Life
Simultaneous RZV and aIIV4 Vaccination
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine…
- Conditions
- Pain, Quality of Life, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05007041
- Testing
- FLUAD® Quadrivalent, Fluzone® High-Dose Quadrivalent, SHINGRIX®
- Where
- 2 sites in United States
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Duke University
Adverse Drug Reactions
Collection, Evaluation and Assessment of Adverse Drug Reactions on the Oncology Ward
The proposed cohort study collected within a 5-month observation period adverse drug reaction (Adverse Drug Events - ADE) in patients at the Department of Oncology at the University of Zurich.
- Trial name
- NCT01058122
- Testing
- Collection of adverse drug events
- Where
- Switzerland
- Volunteers
- 129 people
- Sponsor
- University of Zurich
Coronary Microvascular Dysfunction, Cardiotoxicity
Effects of Immune Checkpoint Inhibitors on Coronary Microvasculature
This is an observational study that includes patients with breast cancer or non-small cell lung cancer who will be treated with immune checkpoint inhibitor (ICI) therapy.
- Conditions
- Coronary Microvascular Dysfunction, Cardiotoxicity, Breast Cancer, Lung Cancer (NSCLC)
- Trial name
- NCT06332131
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Drug Allergy
In Search of the Correct Diagnosis of Beta-lactam Allergy: From the Validation of a Risk Stratification Tool to Accurate Endotyping
Testing a clinical decision tool (BL-Predictor)
- Trial name
- Allergy (NCT07011212)
- Testing
- BL-Predicter
- Volunteers
- 332 people
- Sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Poly Pharmacy, Frail Elderly
Applying a Multidisciplinary Intervention for Drug Adequacy in an Intermediate Care Hospital (AMIDA-ICH)
The goal of this clinical trial is to learn if a multi-professional (conducted by geriatricians, clinical pharmacists, nurses) medication revision, centered on patients' goals and characteristics, can improve treatment adequacy…
- Trial name
- AMIDA-ICH (NCT07015112)
- Testing
- Patient-centered multidisciplinary treatment review
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Parc Sanitari Pere Virgili
Breast Cancer, HER2-positive Breast Cancer
Investigating the Long-term Cardiac Sequelae of Trastuzumab Therapy
The introduction of trastuzumab for the treatment of patients with human epidermal growth factor receptor 2 (HER2) positive breast cancer has had a major impact upon cancer outcomes.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Cardiotoxicity
- Trial name
- NCT05019365
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Glasgow
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
Breast Cancer
Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity
Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab.
- Trial name
- NCT00459771
- Testing
- AT1 blocker candesartan
- Where
- 19 sites in Netherlands
- Volunteers
- 210 people
- Sponsor
- The Netherlands Cancer Institute
Antifungal Drug Adverse Reaction
An Open-label Study to Evaluate the Effects of Concurrent Administration of Vaginal Antimycotic Medication Miconazole Nitrate on the Pharmacokinetics of Nestorone and Ethinyl Estradiol Delivered by a Contraceptive Vaginal Ring in Normal Ovulating Women
To evaluate the pharmacokinetics (PK) of EE and NES released from the CVR in the presence of a single dose and multiple doses of antimycotic co-medication (miconazole nitrate suppository or cream).
- Trial name
- NCT02215395
- Testing
- NES/EE CVR
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Population Council
Hypertension
Lacidipine in Medical Practice in Patients With Mild to Moderate Essential Hypertension
In order to confirm the proposed metabolic effect of lacidipine these follow-up study was to provide long-term data on its impact on liver function, glucose homoeostasis and lipid metabolism.
- Trial name
- NCT02177331
- Testing
- Lacidipine
- Volunteers
- 53 people
- Sponsor
- Boehringer Ingelheim
Adverse Drug Event
Improving Wisely - Polypharmacy
This is a randomized controlled trial that uses an audit and feedback intervention to alert primary care physicians who are outliers in one or more metrics related to high risk prescribing of participants' outlier status.
- Trial name
- NCT03857100
- Testing
- Audit and feedback - letter and report
- Where
- United States
- Volunteers
- 11,000 people
- Sponsor
- Johns Hopkins University
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
Breast Cancer
Potential Protective Role of SGLT-2 Inhibitors for Chemotherapy-induced Cardiotoxicity
The purpose of this study is to evaluate whether dapagliflozin reduces chemotherapy-induced cardiotoxicity in participants with breast cancer treated with (neo-)adjuvant Anthracycline-based chemotherapy +/- trastuzumab.
- Trial name
- PROTECT (NCT06341842)
- Testing
- Dapagliflozin 10mg Tab
- Where
- Italy
- Volunteers
- 316 people
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
Pancreatic Neoplasms, Pancreatic Cancer
Baduanjin for Quality of Life in Pancreatic Cancer Chemotherapy
Baduanjin is a traditional Chinese mind-body exercise originating from the Song Dynasty, integrating body adjustment, breathing regulation, and mental focus.
- Conditions
- Pancreatic Neoplasms, Pancreatic Cancer, Drug-Related Side Effects and Adverse Reactions (MeSH Term)
- Trial name
- BDJ-PC (NCT07791550)
- Testing
- Baduanjin Exercise
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Pharmacogenetics, Drug-Related Side Effects and Adverse Reactions
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
The research is planned as a prospective nested case-control study. The plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years.
- Conditions
- Pharmacogenetics, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Drugs
- Trial name
- NCT05307718
- Testing
- Oral Anticoagulant, Direct-Acting
- Where
- Croatia
- Volunteers
- 1,200 people
- Sponsor
- Clinical Hospital Centre Zagreb
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
Adverse Drug Event, Readmission
The Effect of a Pharmacist Home Visit on Drug-related Problems Post-discharge.
the purpose of this study is to determine the the effect of a home-based medication management program on drug-related problems post-discharge.
- Conditions
- Adverse Drug Event, Readmission, Patient Compliance
- Trial name
- HomeCoMe (NCT01897870)
- Testing
- HomeCoMe-program
- Where
- Netherlands
- Volunteers
- 150 people
- Sponsor
- H.T. Ensing, PharmD, MSc
Mycoses
Therapeutic Drug Monitoring of Voriconazole
The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.
- Trial name
- NCT00890708
- Testing
- Voriconazole (therapeutic drug monitoring)
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- Seoul National University Hospital
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