Clinical trials: Adverse Reaction
Drug Related Side Effects and Adverse Reactions, Infusion Reactions
Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform
Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform.
- Trial name
- NCT07609069
- Testing
- PIV-850 (850-picometer Dual-NCE Acidic Matrix), Legacy Heterogeneous Payload (Micellar Vehicle)
- Where
- United States
- Volunteers
- 625 people
- Sponsor
- PICO IV, Inc.
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems.
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
- Trial name
- NCT02428660
- Testing
- Pharmacogenetic testing, Software-based drug & gene interaction risk analysis, MTM
- Where
- United States
- Volunteers
- 341 people
- Sponsor
- Genelex Corporation
Adverse Effect
Anti-staining Efficacy of Anti-Discoloration System (ADS) Added to Chlorhexidine (CHX)
Dental staining is the most common local side effect of chlorhexidine (CHX) mouthwashes. A prospective, cross-over, randomized clinical trial will be carried out in triple blind to compare the effect on dental staining of two…
- Trial name
- CHX+ADS (NCT02709824)
- Testing
- Chlorhexidine gluconate with ADS, Chlorhexidine gluconate without ADS
- Where
- Italy
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Milan
Drug-induced Liver Injury
Glucocorticosteroid Therapy on Drug-induced Liver Injury: a Prospective Non-randomized Concurrent Control Trial
The purpose of this study is to assess the safety and efficacy of glucocorticosteroid for treatment of drug-induced liver injury.
- Trial name
- NCT04553003
- Testing
- Glucocorticoids+hepatoprotectant, hepatoprotectant
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Li Yang
Polypharmacy, Deprescribing
Spread and Scale of a Polypharmacy App
Medication overload is an epidemic causing widespread harm, particularly to older Canadians. While most prescriptions are intended to help people live longer and healthier lives, taking multiple medications can increase frailty…
- Conditions
- Polypharmacy, Deprescribing, Adverse Drug Event
- Trial name
- NCT04762303
- Testing
- MedReviewRx
- Where
- 5 sites in Canada
- Volunteers
- 1,000 people
- Sponsor
- Centre for Innovation and Research in Aging, Canada
Cardiotoxicity, Gastrointestinal Neoplasms
Defining Robust Predictors of Chemotherapy Related Cardiotoxicity
Observational prospective cohort study designed for patients with gastrointestinal cancers receiving a fluoropyrimidine based chemotherapy regimen.
- Trial name
- NCT05159479
- Where
- United Kingdom
- Volunteers
- 600 people
- Sponsor
- University College, London
Cardiotoxicity., Anti Her2 Therapy.
Cardiotoxicity in Metastatic Her 2 Positive Patients Treated With Trastuzumab ,Pertuzumab and Taxanes
Approximately 15-25% of all breast cancers are human epidermal growth factor receptor 2 (HER2) positive and it has been well known that HER2 overexpression is associated with more aggressive phenotype and poor prognosis with…
- Conditions
- Cardiotoxicity., Anti Her2 Therapy., Metastatic Breast Cancer
- Trial name
- NCT02101879
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Rambam Health Care Campus
Acute Kidney Injury, Adverse Drug Event
Melatonin for Prevention of Kidney Injury
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
- Trial name
- NCT05084196
- Testing
- Melatonin
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Rutgers, The State University of New Jersey
Type 2 Diabetes Mellitus
Safety Evaluation of Adverse Reactions in Diabetes
The purpose of this study is to assess the effects of incretin-based antidiabetic therapies (DPP-4 inhibitors and GLP-1 agonists) on cardiovascular, gastrointestinal and renal system and to detail the mechanisms underlying their…
- Trial name
- SAFEGUARD (NCT02092597)
- Testing
- Exenatide, Linagliptin, Gliclazide
- Where
- Czechia
- Volunteers
- 42 people
- Sponsor
- Charles University, Czech Republic
Drug Induced Liver Injury, Tuberculosis (TB)
Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi
OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi.
- Trial name
- NCT07058090
- Testing
- Silymarin 420 mg, N Acetyl Cysteine, Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)
- Volunteers
- 410 people
- Sponsor
- Liaquat National Hospital & Medical College
Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug
The Thai Surgical Intensive Care Study (Thai-SICU Study)
The study observed the 28 days mortality of 9 participated University base surgical intensive care unit (SICU) as well as the occurrence of adverse events in SICU.
- Conditions
- Complications of Surgical and Medical Care: General Terms, Adverse Reaction to Drug, Sequelae of External Causes of Morbidity and Mortality, Critical Illness
- Trial name
- THAI-SICU (NCT01354197)
- Where
- 9 sites in Thailand
- Volunteers
- 4,652 people
- Sponsor
- Royal College of Anesthesiologists of Thailand
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
Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced
Analysis of Risk Factors for Hearing Loss in Survivors of Cancer Occurred During Childhood, Adolescence or Young Adulthood
This study is aimed at people treated for cancer before the age of 25, who have been followed for at least 5 years, and who are now aged between 18 and 50. It is a prospective, multicenter, non-randomized study.
- Conditions
- Ototoxicity, Drug-Induced, Ototoxicity, Radiation-Induced, Pediatric Cancer
- Trial name
- RISP-OTOTOX (NCT06957132)
- Testing
- Audiogram
- Where
- 3 sites in France
- Volunteers
- 500 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Child With Adverse Drug Reactions
Adverse Drug Reactions in Pediatrics: Experience of a Regional Pharmacovigilance Center
Aim. - To describe the adverse drug reactions (ADR) and the drugs involved in pediatrics. Methods. - An observational study on all ADR notifications recorded in the French pharmaco-vigilance database by the Regional…
- Trial name
- Pediatry ADR (NCT03316014)
- Testing
- Adverse drug reaction
- Volunteers
- 632 people
- Sponsor
- CHU de Reims
Postmenopausal Osteoporosis
Efficacy and Safety of Minodronate in Patients With Low Back Pain
This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol.
- Trial name
- NCT05645289
- Testing
- Minodronate, Alendronate
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Peking University Third Hospital
Chronic Hepatitis C, Medication Reaction
The Efficacy of Vosevi in Treating DAA-experienced Patients
Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015.
- Trial name
- NCT06180590
- Testing
- Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
Frailty in Older Adults, Functional Decline
Prevalence of Anticholinergics in Geriatric Patients With Acute Functional Deterioration
This study investigates the anticholinergic burden on patients seen in the Subacute mobile outpatient geriatric clinic in Aalborg, Denmark, between the years of 2024 and 2025.
- Conditions
- Frailty in Older Adults, Functional Decline, Anticholinergic Syndrome
- Trial name
- NCT07165574
- Testing
- No intervention as the study is observational
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- Aalborg University Hospital
Adverse Effect of Cardiovascular Medications (Diagnosis)
Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy
In patients with coronary heart disease who were treated with PCSK9 inhibitor evolocumab for intensive lipid-lowering therapy, the changes of retinal microvessels were measured with OCTA (Optical Coherence Tomography…
- Trial name
- NCT05802108
- Testing
- Evolocumab combined with statins, Statin
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Zibo Central Hospital
Drug Hypersensitivity, DRESS Syndrome
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
Drug Hypersensitivity Syndrome or DRESS for "Drug Reaction with Eosinophilia and Systemic Symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage.
- Trial name
- DRESSEO (NCT04330118)
- Where
- 11 sites in France
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Adverse Reaction to Drug, 3HP
Clinical Analysis of Safety in Latent Tuberculosis Infection Prophylaxis Treatment
The treatment of latent TB with 3HP is an important issue for the prevention of active TB. However, significant proportion of subjects receiving 3HP had adverse reaction.
- Trial name
- NCT04655794
- Testing
- 3HP
- Where
- Taiwan
- Volunteers
- 500 people
- Sponsor
- Chang Gung Memorial Hospital
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