Clinical trials: Adverse Reaction
Linezolid, Tuberculosis Multi Drug Resistant Active
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment
Multidrug-resistant tuberculosis (MDR-TB) poses a significant challenge to global public health. Globally, the World Health Organization (WHO) estimates the number at 400,000 patients with MDR-TB for 2023.
- Conditions
- Linezolid, Tuberculosis Multi Drug Resistant Active, Therapeutic Drug Monitoring (TDM)
- Trial name
- PLOT-TB (NCT07477119)
- Testing
- Linezolid dose personalization based on TDM
- Where
- Guinea
- Volunteers
- 150 people
- Sponsor
- Marco Schiuma
Self Efficacy, Drug Toxicity
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs
the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor…
- Trial name
- NCT01965275
- Testing
- Erlotinib or Gefitinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Anhui Medical University
DLBCL - Diffuse Large B Cell Lymphoma
Prevention of Anthracycline-Induced Cardiac Dysfunction With Dexrazoxane in Patients With Diffuse Large-B Cell Lymphoma
Patients treated for DLBCL are at high risk of developing AICD. This adverse event is characterized by irreversible damage to the heart muscle with a loss of cardiomyocytes and subsequent decline in cardiac pumping capacity.
- Trial name
- HO170DLBCL (NCT06220032)
- Testing
- Dexrazoxane, Rituximab, Cyclophosphamide
- Where
- 25 sites in Netherlands
- Volunteers
- 324 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
Adverse Reaction
Knowledge and Practices of ADR Reporting in LMICs
The reported literature suggests that knowledge about pharmacovigilance is on a lower side and ADR reporting is not common in developing countries.
- Trial name
- NCT04301219
- Where
- Pakistan
- Volunteers
- 1,500 people
- Sponsor
- Getz Pharma
POCD - Postoperative Cognitive Dysfunction
Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients
Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery.
- Trial name
- NCT05555693
- Testing
- Collecting clinical data, EGG，Brain Metabolomic Characteristics(with Magnetic Resonance Spectroscopy), blood gas data and blood sample
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Adverse Drug Events
Response to Medication Registry
To create a registry/database of patients who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication.
- Trial name
- NCT02593916
- Where
- United States
- Volunteers
- 196 people
- Sponsor
- Intermountain Health Care, Inc.
Occult Hepatitis B, Biological Substance; Adverse Effect
Risk of Hepatitis Flare in Patients With Previous Hepatitis B Virus Exposure Amongst Patients
The purpose of this study is to study the risk of hepatitis flare in patients with previous hepatitis B virus exposure amongst patients on immunosuppressive and biological modifier therapies
- Conditions
- Occult Hepatitis B, Biological Substance; Adverse Effect, Immunosuppression
- Trial name
- NCT04356404
- Where
- Hong Kong
- Volunteers
- 68 people
- Sponsor
- Chinese University of Hong Kong
Crohn's Disease Relapse, Biological Substance; Adverse Effect
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
This is a randomized placebo-controlled trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy…
- Trial name
- AZITRATIM (NCT05599347)
- Testing
- Azithromycin Pill
- Where
- 9 sites in Israel
- Volunteers
- 180 people
- Sponsor
- Rambam Health Care Campus
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.
Cardiovascular Diseases, Dyslipidemias
Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins
This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is…
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Statin Adverse Reaction, Pharmacogenic Myopathy
- Trial name
- PREVESTATGx (NCT06262685)
- Testing
- Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines
- Where
- Spain
- Volunteers
- 216 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz
Drug-Induced Liver Injury
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Granule
This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Granule (XLGB Granule) through a non-intervention observational way.
- Trial name
- NCT03091608
- Where
- China
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beijing 302 Hospital
Adverse Drug Reaction
Personalised Therapeutics @LUMC
In PT@LUMC 2000 patients will be randomized between a PGx-guided dosing group and a standard of care group. The patients will be followed for one year in which they will be asked to report adverse drug reactions at one, three…
- Trial name
- PT@LUMC (NCT05508763)
- Testing
- Genetic test for 14 pharmacogenes
- Where
- Netherlands
- Volunteers
- 2,000 people
- Sponsor
- Leiden University Medical Center
Drug/Agent Toxicity by Tissue/Organ, Leukemia
Growth Factor to Prevent Oral Mucositis in Patients With Hematologic Cancer
RATIONALE: Keratinocyte growth factor may prevent symptoms of mucositis in patients receiving radiation therapy and chemotherapy.
- Conditions
- Drug/Agent Toxicity by Tissue/Organ, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm
- Trial name
- NCT00004132
- Testing
- filgrastim, palifermin, cyclophosphamide
- Where
- United States
- Sponsor
- Jonsson Comprehensive Cancer Center
Drug-Related Side Effects and Adverse Reactions, Treatment Adherence and Compliance
Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and…
- Trial name
- OTABIO (NCT05202964)
- Testing
- Tolerance and adherence to oral antibiotics in patients managed for BJI
- Where
- France
- Volunteers
- 60 people
- Sponsor
- Hospices Civils de Lyon
Hypertension, Pulmonary
Multidisciplinary Collaboration Care in Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a severe pulmonary vascular affection, which treatment has evolved in the last few years, improving quality of life. However, adherence to treatment has not been assessed in such patients.
- Trial name
- ETHAP (NCT01038284)
- Testing
- Patient education, Data collection
- Where
- 11 sites in France
- Volunteers
- 101 people
- Sponsor
- University Hospital, Grenoble
Ischemic Stroke, Alteplase Adverse Reaction
Predictors of AIS Unfavorable Outcomes
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
- Trial name
- NCT06058884
- Testing
- Alteplase
- Where
- Egypt
- Volunteers
- 592 people
- Sponsor
- Kafrelsheikh University
Cardiotoxicity
Cardiotoxicity Monitoring With Single-lead Electrocardiogram
This research is a multi-center prospective cohort interventional study aimed to determinate the capabilities of remote 1-minute single-lead electrocardiogram monitoring for cardiotoxicity detection, during two- three weeks…
- Trial name
- NCT05676606
- Testing
- Remote 1-minute single-lead electrocardiogram (ECG) monitoring in cancer patients after the first polychemotherapy cycle.
- Where
- Russia
- Volunteers
- 120 people
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Multiparametric Magnetic Resonance Imaging, Propofol Adverse Reaction
Safety Evaluation of Propofol Sedation for Magnetic Resonance Imaging in Pediatric Patients
Propofol is often used for sedation in children undergoing magnetic resonance imaging. The investigators will perform a chart review of 4 month of activity (about 100 cases) and review the incidence and severity of adverse events…
- Conditions
- Multiparametric Magnetic Resonance Imaging, Propofol Adverse Reaction, Sedation Complication, Anesthesia; Adverse Effect
- Trial name
- NCT04455776
- Testing
- Propofol
- Where
- Belgium
- Volunteers
- 99 people
- Sponsor
- Brugmann University Hospital
Aplastic Anaemia
Adverse Effects of ATG/ALG Therapy in Aplastic Anemia
This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin)…
- Trial name
- NCT07461116
- Testing
- ATG/ALG
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Cisplatin Ototoxicity
Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone Treatment
Cisplatin is a widely used chemotherapeutic agent for the treatment of various malignant neoplasms, including testicular, ovarian, bladder, cervix uteri, head and neck and lung cancers.
- Trial name
- NCT01372904
- Testing
- Dexamethasone Phosphate
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Meir Medical Center
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