Clinical trials: Side Effect of Drug
Sepsis, Critical Illness
Optimizing Vancomycin Therapy in Children
The purpose of Opt Vanc is to evaluate the feasibility of Bayesian dose adaptation, based on a previously-developed population pharmacokinetic (PK) model and a single optimally timed PK sample, to predict vancomycin area under…
- Conditions
- Sepsis, Critical Illness, Infections, Drug Toxicity
- Trial name
- Opt Vanc (NCT05691309)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Children's Hospital of Philadelphia
Drug Toxicity
GHB Poisoning and Poisoning Induced by Others
Patients with suspected GHB poisoning presenting to Oslo Accident and Emergency Outpatient Clinic (Oslo Legevakt) or a hospital in Oslo (Oslo University Hospital Ullevål, Diakonhjemmet, Lovisenberg) will be included.
- Trial name
- NCT03651778
- Where
- Norway
- Volunteers
- 250 people
- Sponsor
- Odd Martin Vallersnes
Adverse Drug Event
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the…
- Trial name
- IMPACTO (NCT05402254)
- Testing
- Pharmacovigilance Program
- Where
- Spain
- Volunteers
- 395 people, healthy volunteers welcome
- Sponsor
- Natalia Rodriguez Galan
COVID-19 Vaccine Adverse Reaction
Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)
Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes. The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.
- Trial name
- PEDIVACOV-HCSC (NCT06646744)
- Testing
- mRNA COVID-19 vaccine
- Where
- Spain
- Volunteers
- 2,100 people, healthy volunteers welcome
- Sponsor
- Ana Belen Rivas Paterna
Tonsillectomy, Adenoidectomy
Effect of Intranasal Midazolam Versus Ketamine Midazolam Combination as a Premedication on the Occurrence of Postoperative Respiratory Adverse Events
The aim of this study is to investigate the effect of addition of intranasal ketamine to midazolam compared to midazolam alone as a premedication on the occurrence of PRAEs
- Conditions
- Tonsillectomy, Adenoidectomy, Drug-Related Side Effects and Adverse Reaction
- Trial name
- NCT06122948
- Testing
- The midazolam group, The midazolam ketamine group
- Where
- Egypt
- Volunteers
- 200 people
- Sponsor
- Kasr El Aini Hospital
Adverse Drug Event
Evaluation of the Implementation of the Pharmacogenetics and Personalized Medicine Program "MedeA" in the Extremadura Health Service.
An open longitudinal observational study, non-randomized, which will include the adult population, attended by the SES, in which preference will be given to those patients under treatment with drugs that can produce relevant…
- Trial name
- MedeA (NCT06607445)
- Where
- Spain
- Volunteers
- 6,445 people, healthy volunteers welcome
- Sponsor
- Complejo Hospitalario Universitario de Badajoz
Adverse Reaction to Drug, Neonatal Disorder
Exploratory Propofol Dose Finding Study In Neonates
The aim of the study is to explore the optimal propofol dose in neonates receiving a single intravenous propofol bolus for endotracheal intubation during (semi-)elective INSURE (intubation-surfactant-extubation) procedure…
- Trial name
- NEOPROP (NCT01621373)
- Testing
- propofol administration
- Where
- Belgium
- Volunteers
- 50 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Cancer, Side Effect of Drug
Radiopharmaceuticals Analysis for Detailed Insights And INternational Tracking of Safety
Little is known about cancer therapy-related radiopharmaceuticals drugs safety. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to…
- Trial name
- RADIANTS (NCT06483685)
- Testing
- Radiopharmaceuticals drugs
- Where
- France
- Volunteers
- 500,000 people
- Sponsor
- University Hospital, Caen
Effect of Drug, Toxicity, Drug
Apatinib Plus IE Chemotherapy (Ifosfamide and Etoposide) for Relapsed or Refractory Osteosarcoma
Apatinib has led to positive responses in the treatment of osteosarcoma refractory to first-line chemotherapy. However, apatinib demonstrates only short-lived activity, and the disease control of musculoskeletal lesions is worse…
- Trial name
- AIEO (NCT04824352)
- Testing
- apatinib
- Where
- 2 sites in China
- Volunteers
- 44 people
- Sponsor
- Peking University People's Hospital
Acute Kidney Injury, Drug Toxicity
Retrospective Registry Study of Patients With Cancer Treated With High-dose Methotrexate
This retrospective observational study will evaluate high-dose methotrexate patterns of use, supportive care measures used during high-dose methotrexate chemotherapy, along with the incidence of delayed elimination of…
- Trial name
- NCT05899751
- Testing
- High-dose methotrexate, Glucarpidase
- Where
- 5 sites in France, Italy and 1 more
- Volunteers
- 1,000 people
- Sponsor
- Protherics Medicines Development Limited
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
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
Oncolytic Virus, Diffuse Intrinsic Pontine Glioma
Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
This is a 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 primary DIPG patients…
- Conditions
- Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
- Trial name
- NCT05717712
- Testing
- Ad-TD-nsIL12
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Capital Medical University
Lymphoma, T-cell, Peripheral, Lymphoma, T-cell, Cutaneous
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic…
- Trial name
- NCT05137847
- Testing
- Remitoro
- Where
- 3 sites in Japan
- Volunteers
- 118 people
- Sponsor
- Eisai Inc.
Adverse Drug Events
Improving Safety by Basic Computerizing Outpatient Prescribing
The study will measure the effect of basic clinical decision support on medical errors and adverse drug events in the ambulatory setting.
- Trial name
- NCT01091038
- Testing
- Basic Clinical Decision Support, Routine Care
- Where
- 2 sites in United States
- Volunteers
- 228 people
- Sponsor
- Indiana University
Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ
Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
- Conditions
- Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Thrombocytopenia
- Trial name
- NCT00074165
- Testing
- Rituxan, Cyclophosphamide, Etoposide
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- OHSU Knight Cancer Institute
Drug-Related Side Effects and Adverse Reactions
Investigation of Serious Adverse Events Following Vaccination Against Yellow Fever: Emphasis on Genetic Basis and Biological Markers
It concerns an investigation aiming to investigate genetic biological(s) marker(s) which allow to identify individuals who have risk of serious adverse events to the yellow fever vaccine.
- Trial name
- NCT03938597
- Where
- Brazil
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Acute Kidney Injury, Drug Use
A Big Data Approach to Predict NEOnatal Acute Kidney Injury in Newborns expoSed to nephroTOxic Drugs (NeoAKI STOP)
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach.
- Conditions
- Acute Kidney Injury, Drug Use, Drug Interaction, Drug Toxicity
- Trial name
- NeoAKISTOP (NCT05851222)
- Where
- Italy
- Volunteers
- 4,200 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Adverse Drug Reactions, Cancer
Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
CAR-T cells and cellular therapies may lead to various adverse reactions. This study investigates reports of different toxicities for cellular therapies in the World Health Organization's (WHO) global database of individual…
- Trial name
- CARTABLE (NCT04279470)
- Testing
- CAR T-cell and Cellular Therapies
- Where
- France
- Volunteers
- 100,000 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Poison;Medicinal, Extracorporeal Membrane Oxygenation
Treatment of Extracorporeal Membrane Oxygenation in Severe Poisoning
This is a prospective, multicentre clinical study to determine the value of the Extracorporeal Membrane Oxygenation in the treatment of critically ill poisoning patients and whether there are significant differences in the…
- Trial name
- NCT05762029
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Affiliated Hospital of Nantong University