Clinical trials: Adverse Drug Reaction (ADR)
Myeloma, Heart Failure
Cardiovascular Complications of Carfilzomib
Cardiovascular toxicity of carfilzomib, a last generation proteasome inhibitor, is highly incident according to retrospective data. Prospective cohort study of patients initiated on carfilzomib.
- Conditions
- Myeloma, Heart Failure, Hypertension
- Trial name
- ICARE (NCT04407858)
- Where
- France
- Volunteers
- 60 people
- Sponsor
- European Georges Pompidou Hospital
Hypoactive Sexual Desire Disorder, Sexual Dysfunctions, Psychological
Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction
The purpose of this study is to provide the first empirical examination of the effects of Ginkgo biloba (GBE), sex therapy, and a combination of the two on subjective and physiological measures of sexual function in women who are…
- Trial name
- NCT00034021
- Testing
- Ginkgo Biloba, Sex Therapy (genital focus)
- Where
- United States
- Sponsor
- National Center for Complementary and Integrative Health (NCCIH)
Cerebral Stroke, Thrombosis, Deep Vein
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Trial name
- NCT03804125
- Sponsor
- Pfizer
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
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
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
Depression, Adverse Reaction to Drug
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.
- Trial name
- NCT00817375
- Testing
- SSRI treated group, non-SSRI treated group
- Where
- South Korea
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Samsung Medical Center
Adverse Drug Reaction
Serious Adverse Drug Reaction and Their Preventability
Introduction: Elderly aged over 65 years accounted for around 17.5% of the French general population. Adverse drug reactions (ADR) are common in this population. In elderly subject, prevalence of ADRs ranged from 4.3% to 63.0%.
- Trial name
- SADR (NCT02888834)
- Testing
- Adverse drug reaction
- Where
- France
- Volunteers
- 100 people
- Sponsor
- CHU de Reims
Effect of Drug, Adverse Drug Event
Efficacy and Safety of Remimazolam Besylate for Sedation in Post-Non-Cardiac Surgery Patients Requiring Mechanical Ventilation
A multi-center, prospective, randomized, double-blind, active-controlled, no-inferiority clinical trial conducted across 5 tertiary medical centers in China.
- Conditions
- Effect of Drug, Adverse Drug Event, Mechanical Ventilation Complication, Critical Illness
- Trial name
- NCT06575530
- Testing
- Remimazolam Besylate, Dexmedetomidine Hydrochloride
- Where
- China
- Volunteers
- 306 people
- Sponsor
- Beijing Shijitan Hospital, Capital Medical University
Supraventricular Arrhythmia, Ventricular Arrythmia
Safety Assessment for Sotalol Protocol in Outpatient Unit
Sotalol is an antiarrhythmic medication with proven effects for the suppression and prevention of supraventricular and ventricular arrhythmias.
- Conditions
- Supraventricular Arrhythmia, Ventricular Arrythmia, Proarrhythmia, Antiarrhythmic Drug Adverse Reaction
- Trial name
- Sotalol (NCT05418036)
- Testing
- Sotalol Oral Tablet
- Where
- Brazil
- Volunteers
- 110 people
- Sponsor
- University of Sao Paulo General Hospital
Serious Adverse Events, Patient Safety
Chemokeyp: A Feasibility Study for Realtime Safety Data-Capture for Potential Serious Adverse Drug Events
Chemokeyp is a feasibility study testing a secure ED-Oncology interface for patients receiving chemotherapy who may present to unscheduled care with possible treatment-related complications.
- Conditions
- Serious Adverse Events, Patient Safety, Pharmacovigilance, Oncology
- Trial name
- NCT07592234
- Where
- Ireland
- Volunteers
- 100 people
- Sponsor
- St Vincent's University Hospital, Ireland
Tonsillectomy, Adenotonsillectomy
Celecoxib for Pediatric Adenotonsillectomy
The investigators' study will involve the administration of either placebo or celecoxib to children aged 2 to 18 years of age undergoing tonsillectomy and assessing pain relief, impact on quality of life and side effect profile.
- Conditions
- Tonsillectomy, Adenotonsillectomy, Pain, Postoperative
- Trial name
- NCT00849966
- Testing
- Celebrex suspension
- Where
- Canada
- Volunteers
- 282 people
- Sponsor
- Children's Hospital of Eastern Ontario
Adverse Drug Event
Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers
Limited large-scale studies have been conducted to investigate the adverse effects of COVID-19 vaccine in Latin America, particularly among the healthcare worker (HCW) population in Ecuador.
- Trial name
- NCT05113472
- Testing
- Pfizer-BioNTech COVID-19 vaccine
- Where
- Ecuador
- Volunteers
- 1,291 people, healthy volunteers welcome
- Sponsor
- Respiralab
Local Anaesthetic Drug Adverse Reaction
Computer - Controlled Intraligamentary Local Anaesthesia In Extraction of Primary Molars
Background: Exodontia poses a psychological threat for children, increasing the need for profound local anesthesia to assure painless extraction and maintain child cooperation on the dental chair.
- Trial name
- NCT04739735
- Testing
- Dental Local Anaesthesia
- Where
- Egypt
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Alexandria University
Latent Tuberculosis Infection
Adverse Drug Reactions to Anti-TB Drugs in the Treatment of Latent Tuberculosis Infection
The investigators aim to study the prevalence of adverse reactions of anti-tuberculosis (TB) drugs in latent tuberculosis infection (LTBI), and determine the risk factors of anti-TB drug-related toxicity in LTBI in Korean health…
- Trial name
- NCT03312647
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Hanyang University
Adverse Drug Event, Colon Cancer
Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
The purpose of this study is to examine the benefits of a clinical implementation of a DPYD-genotype test to patients starting treatment with fluoropyrimidines (Fluorouracil (5-FU), capecitabine, tegafur).
- Conditions
- Adverse Drug Event, Colon Cancer, Breast Cancer, Pancreas Cancer
- Trial name
- NCT05266300
- Testing
- DPYD genotype
- Where
- Denmark
- Volunteers
- 722 people
- Sponsor
- University of Southern Denmark
Older Adults (65 Years and Older)
Quantifying the Attentive Behaviors of Older Adults During Over-the-counter Drug Selection
Per-capita consumption of medication is higher in older adults than any other sector of the population. In fact, it has been estimated that although older adults comprise 13% of the population they take 34% of all prescriptions…
- Trial name
- NCT02188134
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Michigan State University
Adverse Drug Events
Reducing Adverse Drug Events in the Nursing Home
Medications are the single most common form of treatment in the long-term care setting, and often represent the most efficacious (and cost-effective) therapeutic modality used in this clinical setting.
- Trial name
- NCT00606606
- Testing
- Clinical Decision Support
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester