Clinical trials: Adverse Drug Event
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
Drug-Related Side Effects and Adverse Reactions
Impact of Clinical Pharmacist on Adverse Drug Events in Older Adults
Adverse drug events (ADE) are one of the major problems affecting quality of care and achievement of therapeutic goals in older adults (OA), increasing re-admissions, hospital stays, resource use, and problems on patient safety.
- Trial name
- NCT03156348
- Testing
- Clinical Pharmacist Care
- Where
- Chile
- Volunteers
- 611 people
- Sponsor
- University of Chile
Respiratory Depression, Hypoxemia
Dexmedetomidine vs Propofol in High-Risk ERCP Patients
ERCP requires deep sedation due to pain and discomfort, but propofol-commonly used with opioids-often causes respiratory and cardiovascular complications, especially in elderly or high-risk patients.
- Conditions
- Respiratory Depression, Hypoxemia, Hypotension Drug-Induced, Bradycardia
- Trial name
- NCT07166614
- Testing
- dexmedetomidin, Propofol
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
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
Contraception
A Prospective Observational Study of the Clinical Performance of Femplant in Pakistan
This will be a non-comparative prospective observational study of women using Femplant as a primary method of contraception in Pakistan.
- Trial name
- NCT01463254
- Where
- Pakistan
- Volunteers
- 724 people, healthy volunteers welcome
- Sponsor
- FHI 360
HIV Infections, Gonorrhea
Cellulose Sulfate (CS) Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
- Conditions
- HIV Infections, Gonorrhea, Chlamydia Infections
- Trial name
- NCT00120770
- Testing
- Cellulose Sulfate Vaginal Gel (Microbicide)
- Where
- 2 sites in Nigeria
- Volunteers
- 2,160 people, healthy volunteers welcome
- Sponsor
- FHI 360
Best Possible Medication History
Best Possible Medication History at USB
This pilot project investigates the use of a structured medication history (Best Possible Medication History, BPMH) in patients (primarily admitted at the emergency department of University Hospital Basel) after transfer to a…
- Trial name
- bpmh@USB (NCT03851328)
- Testing
- BPMH structured interview
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- University Hospital, Basel, Switzerland
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
Tumor Associated Lymph Node T Cell, Advanced Solid Tumor
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical…
- Conditions
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab Injection
- Trial name
- NCT06716619
- Testing
- Tumor Associated Lymph node T cell, Serplulimab Injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
Resistant Hypertension, Urinary Incontinence
An Educational Intervention on Medication Adverse Effects in Patients With Resistant Hypertension (HTAR-CSI)
This randomized, single-blind controlled trial evaluates the effectiveness of a nurse-led educational intervention focused on the adverse effects of antihypertensive drugs-specifically sexual dysfunction and urinary…
- Conditions
- Resistant Hypertension, Urinary Incontinence, Sexual Disfunction
- Trial name
- HTAR-CSI (NCT07589881)
- Testing
- Educational Intervention for Adverse Drug Effects, routine care
- Where
- Spain
- Volunteers
- 46 people
- Sponsor
- Consorci Sanitari Integral
Adverse Drug Event, Effect of Drug
Research on Human Insulin rDNA Safety and Efficacy in Patients With Type 2 Diabetes Mellitus
Objective: To evaluate the safety and efficacy of Human Insulin rDNA (Insuget) in patients with Type II Diabetes Mellitus. Study Design: Open-label, prospective, observational, single arm, multi-center, post-marketing…
- Conditions
- Adverse Drug Event, Effect of Drug, Type 2 Diabetes Treated With Insulin
- Trial name
- RISE (NCT05161741)
- Testing
- Insulin
- Where
- Pakistan
- Volunteers
- 238 people
- Sponsor
- Getz Pharma
ALL, Childhood, Pediatric Cancer
Pharmacogenomic Association Study in Indian Children With Acute Lymphoblastic Leukemia
A five-year prospective observational cohort study. The study is focused on observing the relation between static germline variants and therapeutic response in Indian children with acute lymphoblastic leukemia (ALL).
- Conditions
- ALL, Childhood, Pediatric Cancer, Toxicity, Drug, Adverse Drug Event
- Trial name
- MPGx-INDALL (NCT05512169)
- Where
- 2 sites in India
- Volunteers
- 556 people
- Sponsor
- University of Geneva, Switzerland
Fall, Fall Accident
The Geriatric Emergency Department Pharmacologic Harm Prevention Project
The goal of this project is to determine whether pharmacogenomic testing (using participants' DNA) can help optimize medication prescribing and reduce side effects in older adults taking five or more medications.
- Conditions
- Fall, Fall Accident, Poly Pharmacy, Adverse Drug Events
- Trial name
- GREAT PHARM (NCT07216846)
- Testing
- DNA care pathway
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Florida Atlantic University
The Study Goal is to Assess the Introduction of Sustainable Family Planning/Reproductive Health Information and Services Through, Land O' Lakes-supported Dairy Cooperatives
Family Planning Through Dairy Cooperatives
This observational study will assess a model for providing family planning through quarterly events organized by dairy cooperatives supported by Land O'Lakes in Kenya.
- Trial name
- NCT01226433
- Where
- Kenya
- Volunteers
- 319 people, healthy volunteers welcome
- Sponsor
- FHI 360
Recurrent Drug-induced Liver Injury
Clinicopathological Features and Genetic Susceptibility Screening of Recurrent Drug-induced Liver Injury
The goal of this observational study is to screening for clinical, pathological and HLA features in patients with recurrent drug-induced liver injury.
- Trial name
- RDILI-GS (NCT06547229)
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Friendship Hospital
Acquired Long QT, Ventricular Arrhythmias
Do QT-Prolonging Drugs Cause Major Adverse Cardiac Events in Hospitalized Adults?
There are 28 non-cardiology medications from multiple families costing more than $13 billion annually in Canada, categorized as 'Known' QT-prolonging medications (QTPmeds) based on very low levels of evidence.
- Conditions
- Acquired Long QT, Ventricular Arrhythmias, Torsades de Pointes, Syncope
- Trial name
- QTP-MACE (NCT07374263)
- Where
- 2 sites in Canada
- Volunteers
- 990,000 people
- Sponsor
- St. Joseph's Healthcare Hamilton
Enalapril Adverse Reaction, Pharmacogenomics
A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.
Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese…
- Conditions
- Enalapril Adverse Reaction, Pharmacogenomics, Stroke
- Trial name
- NCT03259399
- Testing
- detection of genotype
- Where
- China
- Volunteers
- 2,200 people
- Sponsor
- Cui Yimin
Omeprazole
Evaluation of the Prophylactic Use of Omeprazole in Patients Admitted to the State Hospital of Américo Brasiliense
Introduction. The prevalence of the use of drugs that act on the gastric system has increased in the population. Omeprazole is an inhibitor of the protons pump and has a widespread use, mainly as a prophylactic to prevent reflux…
- Trial name
- NCT02278432
- Volunteers
- 427 people
- Sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
Cancer, Drug Toxicity
Atrial Fibrillation in Active Cancer Patients
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines.
- Conditions
- Cancer, Drug Toxicity, Atrial Fibrillation, Cardiovascular Complication
- Trial name
- AFIB-CANCER (NCT04696081)
- Testing
- occurence of atrial fibrillation
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Caen
Emergencies
International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments.
Morphine is the gold standard for treatment of severe acute pain but it has a number of adverse effects. No study has so far managed to identify the morphine-induced adverse drug reactions.
- Trial name
- EI-Morphinique (NCT01654055)
- Where
- France
- Volunteers
- 1,128 people
- Sponsor
- University Hospital, Toulouse