Clinical trials: Adverse Drug Related Events, active
Opioid-induced Constipation
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced…
- Trial name
- NCT03720613
- Testing
- Naldemedine, Lubiprostone, Naloxegol
- Where
- United States
- Volunteers
- 34,532 people
- Sponsor
- BioDelivery Sciences International
Breast Cancer, Drug-Related Side Effects and Adverse Reactions
Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients
This study is a multicenter randomized controlled trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer receiving cyclin-dependent kinase (CDK) inhibitor therapy.
- Conditions
- Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Chemotherapy Toxicity, Treatment Adherence
- Trial name
- NCT07524829
- Testing
- Structured Telenursing Follow-up, Standard Nursing Care
- Where
- Italy
- Volunteers
- 124 people
- Sponsor
- Azienda Sanitaria Locale di Asti
X-linked Hypophosphatemia (XLH)
Effective Dosing of Burosumab in XLH
X-linked hypophosphataemia (XLH) is a rare, hereditary condition. The genetic defect leads to low blood phosphate levels and vitamin D suppression. Phosphate is required for strong bones and teeth and to store energy in cells.
- Trial name
- NCT07183579
- Where
- United Kingdom
- Volunteers
- 120 people
- Sponsor
- University of Nottingham
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
Blood Coagulation Disorder, Postoperative Blood Loss
Comparative Study of Tranexamic Acid Dosing in Cardiac Surgery
Tranexamic axid is routinely used as an antifibrinolytic agent in cardiac surgery to reduce the risk of blood loss and transfusion.
- Conditions
- Blood Coagulation Disorder, Postoperative Blood Loss, Adverse Drug Event, Fibrinolysis; Hemorrhage
- Trial name
- NCT07164300
- Testing
- Tranexamic acid at a dose of 10 mg/kg followed by 1 mg/kg/h, Tranexamic acid at a dose of 20 mg/kg, Tranexamic acid at a dose of 30 mg/kg
- Where
- Greece
- Volunteers
- 150 people
- Sponsor
- University of Ioannina
Neoplasms, Immunotherapy
IMMUNO-FIT Observational Study
This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers.
- Conditions
- Neoplasms, Immunotherapy, Physical Fitness, Quality of Life
- Trial name
- NCT07354971
- Testing
- Observational Study - No Study Intervention
- Where
- United Kingdom
- Volunteers
- 67 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Chronic Kidney Disease (CKD), Elderly
Escitalopram and the Risk of Serious Adverse Events
The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 10mg/day of Escitalopram (higher dose) compared to 5 mg/day (lower dose) in adults over the age of 65 with low…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07274241
- Testing
- Escitalopram
- Where
- Canada
- Volunteers
- 12,145 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Cancer
Predictive Markers of Immune-related Adverse Events in Patients Treated With Immune Stimulatory Drugs
The prospect of effective immunotherapies for the treatment of patients with cancer is now a clinical reality thanks to the approval of monoclonal antibodies (mAbs) specifically blocking immune checkpoints or ligands such as…
- Trial name
- PREMIS (NCT03984318)
- Testing
- Blood sample
- Where
- 5 sites in France
- Volunteers
- 1,240 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Drug-induced Liver Injury
A Prognostic Model for Drug-induced Liver Injury in China
A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and…
- Trial name
- DILI-PM (NCT05060289)
- Where
- 13 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Beijing Friendship Hospital
Chronic Kidney Disease (CKD), Elderly
Citalopram and the Risk of Serious Adverse Events
This population-based cohort study aims to evaluate the safety of initiating a new outpatient prescription of citalopram at 20 mg/day (higher dose) compared to 10 mg/day (lower dose) in adults aged 65 years and older with reduced…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07399795
- Testing
- Citalopram 10 MG, Citalopram 20 MG
- Where
- Canada
- Volunteers
- 7,110 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Endometrial Cancer Stage I, Mmr Deficiency
SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)
The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of…
- Conditions
- Endometrial Cancer Stage I, Mmr Deficiency, Endometrioid Endometrial Adenocarcinoma, Immune-related Adverse Event
- Trial name
- SATELLITE (NCT06278857)
- Testing
- Dostarlimab-Gxly 50 MG/1 ML Intravenous Solution [JEMPERLI]
- Where
- 3 sites in Australia
- Volunteers
- 10 people
- Sponsor
- Queensland Centre for Gynaecological Cancer
Oncolytic Virus, Diffuse Intrinsic Pontine Glioma
Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma
This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in…
- Conditions
- Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
- Trial name
- NCT05717699
- Testing
- Ad-TD-nsIL12
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Capital Medical University
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
Chronic Kidney Disease (CKD), Elderly
Sertraline and the Risk of Serious Adverse Events
The goal of this population-based cohort study is to assess the safety of initiating a new outpatient prescription of 50 mg/day of Sertraline, a higher dose, compared to 25 mg/day, a lower dose, in adults aged 65+ with low kidney…
- Conditions
- Chronic Kidney Disease (CKD), Elderly, Outpatient
- Trial name
- NCT07387120
- Testing
- Sertraline 50 mg, Sertraline 25 mg
- Where
- Canada
- Volunteers
- 6,893 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
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
Esophageal Neoplasms, Adverse Drug Event
Effect of NST Whole-course Nutritional Management on Nutritional Status and Adverse Reactions in Esophageal Cancer
This study is a randomized, open, parallel controlled clinical trial. The main purpose of this study was to compare the changes in body weight/body mass index (BMI) before and after treatment between the two groups of patients…
- Trial name
- NCT05800054
- Testing
- Nutritional Support Team, Docetaxel, cisplatin
- Where
- China
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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
Immune Checkpoint Inhibitor-related Rash, Immune-related Adverse Events
Wucao Anfu Formula as Adjunctive Treatment for Immune Checkpoint Inhibitor-Related Rash
Immune checkpoint inhibitors have improved outcomes for patients with cancer, but immune checkpoint inhibitor-related skin rash is a common adverse event that may affect quality of life and continuation of anticancer therapy.
- Trial name
- NCT07821424
- Testing
- Wucao Anfu Formula, Standard management
- Volunteers
- 72 people
- Sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
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
Drug Abuse, Harm Reduction
Harm Reduction Intervention for Anabolic-androgenic Steroids Users: a Randomized Controlled Trial
This clinical trial aims to investigate the short and long-term efficacy of a harm reduction intervention in reducing the use of non-clinical anabolic-androgenic steroids (AAS) in abusive users of AAS.
- Conditions
- Drug Abuse, Harm Reduction, Minimization, Harm, Anabolic Steroids Adverse Events
- Trial name
- SOS-RCT-HR (NCT07039539)
- Testing
- harm reduction intervention in non-clinical anabolic-androgenic steroids users
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo