Clinical trials: Drug-Related Side Effects and Adverse Reactions
Drug/Agent Toxicity by Tissue/Organ, Leukemia
05-001: Treatment of Acute Lymphoblastic Leukemia in Children
RATIONALE: L-asparaginase is an important component of treatment for childhood acute lymphoblastic leukemia, but is also associated with notable side-effects, including hypersensitivity, pancreatitis, and thrombosis.
- Trial name
- NCT00400946
- Testing
- asparaginase, cyclophosphamide, cytarabine
- Where
- 8 sites in United States, Canada
- Volunteers
- 800 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Drug-Related Side Effects
Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib
Background: Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life.
- Conditions
- Breast Cancer, Drug-Related Side Effects, Diarrhea
- Trial name
- NCT07264985
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Hubei Cancer Hospital
Pain, Injection Site Reaction
Safety of Pediatric COVID-19 Vaccination
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to < 16) will be followed post administration of mRNA COVID-19 vaccines.
- Conditions
- Pain, Injection Site Reaction, Adverse Drug Event
- Trial name
- NCT05157191
- Testing
- Observational
- Where
- 5 sites in United States
- Volunteers
- 299 people, healthy volunteers welcome
- Sponsor
- Duke University
Morbid Obesity, Anorectal Diseases
GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity
Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients.
- Conditions
- Morbid Obesity, Anorectal Diseases, Drug-Related Side Effects and Adverse Reactions, Constipation
- Trial name
- GLP-PROCT (NCT07668765)
- Testing
- GLP-1 receptor agonist therapy
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people
- Sponsor
- Gazi University
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
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
Advanced Malignancy, Advanced Solid Cancers
ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers
The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors.
- Conditions
- Advanced Malignancy, Advanced Solid Cancers, Metastatic Solid Tumors
- Trial name
- NCT07238075
- Testing
- ADCX-020
- Where
- 9 sites in Australia, Spain
- Volunteers
- 290 people
- Sponsor
- Adcytherix SAS
Head and Neck Cancer, Hearing Loss
Maximizing Quality of Life After Cancer Through Rehabilitation
Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients.
- Conditions
- Head and Neck Cancer, Hearing Loss, Tinnitus, Dysphagia
- Trial name
- TIMELY REHAB (NCT07622407)
- Testing
- TIMELY REHAB
- Where
- 3 sites in United States
- Volunteers
- 74 people
- Sponsor
- VA Office of Research and Development
Acute Respiratory Distress Syndrome (ARDS)
Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN)
Randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy of intravenous metoprolol in patients with Acute Respiratory Respiratory Distress Syndrome (ARDS).
- Trial name
- MAIDEN (NCT05847517)
- Testing
- Metoprolol Injection, saline 0.9%
- Where
- 12 sites in Spain
- Volunteers
- 14 people
- Sponsor
- Consorcio Centro de Investigación Biomédica en Red (CIBER)
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.
Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions
Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation
This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft…
- Conditions
- Immune Checkpoint Inhibitor-Related Pneumonitis, Drug-Related Side Effects and Adverse Reactions, Neoplasms
- Trial name
- NCT07554885
- Testing
- Spirulina-Bifidobacterium capsule, Fish oil-grape seed-blueberry soft capsule, Ganoderma spore oil
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Guangzhou Institute of Respiratory Disease
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
Breast Cancer, Metastatic Breast Cancer
Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response
The metabolism of anticancer drugs is influenced by genetic variants that affect their bioavailability and toxicity. In the case of antibody-drug conjugates (ADCs), such as sacituzumab-govitecan (SG), trastuzumab-deruxtecan…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Drug-Related Side Effects and Adverse Reactions, Pharmacogenetic Variant
- Trial name
- NCT07582887
- Testing
- Sacituzumab Govitecan, Trastuzumab deruxtecan, Datopotamab Deruxtecan
- Where
- Spain
- Volunteers
- 70 people
- Sponsor
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Kidney Cancer, Renal Cell Carcinoma Metastatic
TDM for Optimized Outcome in Patients With mRCC.
The purpose of this observational study is to assess the role of plasma concentration monitoring of treatment drugs for patients with metastatic renal cell carcinoma (mRCC) in terms of efficacy and side effects.
- Conditions
- Kidney Cancer, Renal Cell Carcinoma Metastatic, Drug Toxicity, Drug Side Effect
- Trial name
- NCT04659343
- Testing
- Measurement of concentration of active metabolite in cancer treatment.
- Where
- Denmark
- Volunteers
- 200 people
- Sponsor
- Niels Fristrup
Adverse Drug Reaction (ADR)
National Active Surveillance Network and Pharmacogenomics of Adverse Drug Reactions in Children
The purpose of the study is (1) to identify and collect samples from children and adults who take drugs and have adverse drug reactions AND children and adults who take drugs and do not experience any adverse drug effects; (2) to…
- Trial name
- NCT00414115
- Where
- Canada
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Adverse Drug Reaction (ADR)
Integrating Pediatric Pharmacogenomic Testing Into the Canadian Health Care System
This project addresses the problem of adverse drug reactions in the three most frequently prescribed therapeutic classes of drugs in children: antibiotics, analgesics, and mental health medications.
- Trial name
- NCT04249375
- Where
- 2 sites in Canada
- Volunteers
- 150 people
- Sponsor
- University of British Columbia
Neoplasms, Chemotherapy-induced Nausea and Vomiting
Serious Gaming for Chemotherapy-induced Nausea and Vomiting
The purpose of this study is to examine the effectiveness of a technology-based intervention for managing nausea and vomiting in older adults with cancer.
- Trial name
- NCT05838638
- Testing
- eSSET-CINV
- Where
- 2 sites in United States
- Volunteers
- 610 people
- Sponsor
- University of Central Florida
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
Diabetes, Obesity
AIManage Using an AI-driven CDS and Chatbot
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations.
- Conditions
- Diabetes, Obesity, Medication Side Effects
- Trial name
- NCT07546357
- Testing
- AIManage
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- NYU Langone Health
Diarrhea, Drug/Agent Toxicity by Tissue/Organ
N2003-01: Irinotecan, Temozolomide, and Cefixime in Treating Young Patients With Recurrent or Resistant Neuroblastoma
RATIONALE: Drugs used in chemotherapy, such as irinotecan and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die.
- Conditions
- Diarrhea, Drug/Agent Toxicity by Tissue/Organ, Neuroblastoma
- Trial name
- NCT00093353
- Testing
- cefixime, irinotecan hydrochloride, temozolomide
- Where
- 13 sites in United States
- Volunteers
- 30 people
- Sponsor
- New Approaches to Neuroblastoma Therapy Consortium