Clinical trials: Safety Issues
Safety Issues
NOPARK Open Label Extension Study
This protocol describes the NOPARK Open Label Extension Study. The NOPARK Open Label Extension study is an optional extension of the clinical phase II NOPARK study.
- Trial name
- NCT05546567
- Testing
- Nicotinamide Riboside
- Where
- Norway
- Volunteers
- 400 people
- Sponsor
- Haukeland University Hospital
Scoliosis Idiopathic, Navigation, Spatial
Preoperative and Peroperative Comparison Between 3D Spine Reconstructions
The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed…
- Conditions
- Scoliosis Idiopathic, Navigation, Spatial, Fusion of Spine, Safety Issues
- Trial name
- Spine-PDCA-OR (NCT04611490)
- Testing
- Spine Fusion
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Grenoble
Safety Issues, Infant Nutrition Disorders
Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT
This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.
- Trial name
- NCT03035721
- Testing
- Low protein formula, Standard protein formula
- Where
- Italy
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Safety Issues, Chronic Kidney Diseases
Sick-Day Protocol to Improve Outcomes in Chronic Kidney Disease
The benefits of renin angiotensin system (RAS) blockers and diuretics for blood pressure control are well-established in chronic kidney diseases (CKD) patients; however, these agents may become hazardous on "sick-days" that lead…
- Trial name
- NCT03141905
- Testing
- Sick-Day Protocol, Usual Care
- Where
- United States
- Volunteers
- 342 people
- Sponsor
- University of Maryland, Baltimore
Safety Issues
Study to Assess the Impact of Medication Reconciliation at Hospital Admission on Healthcare Outcomes
Medication reconciliation is a systematic process by which health care professionals obtain the most complete and accurate information about the drugs regularly taken by patients.
- Trial name
- MedRec (NCT03654963)
- Testing
- Medication reconciliation
- Where
- 2 sites in Switzerland
- Volunteers
- 1,702 people
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
Safety Issues
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
Late-preterm neonates are born between 34 and 36 weeks 7 days gestational age (GA). Neonates born less than 34 weeks GA are at increased risk for morbidity and directly admitted to the Neonatal Intensive Care Unit (NICU).
- Trial name
- NCT03585192
- Testing
- Skin Group, Warmer Group
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Safety Issues, Immunogenicity
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
to assess safety and immunogenicity of measles-rubella (MR) routine immunization in Indonesian Children and Infants
- Trial name
- NCT03680417
- Testing
- Measles-Rubella (MR) Vaccine
- Where
- Indonesia
- Volunteers
- 590 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Immunogenicity
Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants
This study is to assess the safety and immunogenicity of Vi-DT vaccine in adults, adolescent, children and infants.
- Trial name
- NCT03460405
- Testing
- Vi-DT Vaccine, Vi Polysaccharide Vaccine, IPV Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, Immunogenicity
Immunogenicity and Safety of Vi-DT (Diphtheria Toxoid) Typhoid Conjugate Vaccine (Phase III)
Phase III study, Randomized, observer blind, lot to lot consistency, non inferiority to PQed typhoid conjugate vaccine and Typhoid Vi polysaccharide vaccine.
- Trial name
- NCT04051268
- Testing
- Vi-DT Typhoid Conjugate Vaccine, PQed Typhoid Conjugate Vaccine, Vi Polysaccharide Vaccine
- Where
- Indonesia
- Volunteers
- 3,071 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues, BPD - Bronchopulmonary Dysplasia
Autologous Cord Blood Cells for Prevention of BPD in Preterm
To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
- Conditions
- Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death
- Trial name
- NCT04311476
- Testing
- Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy, 0.9% Sodiun Chloride
- Where
- China
- Volunteers
- 62 people
- Sponsor
- yangjie
Safety Issues
Post Marketing Surveillance of Diphtheria Antitoxin (DAT)
The aim of this study is to evaluate the safety profile of Diphtheria Antitoxin
- Trial name
- NCT06053853
- Testing
- Diphtheria Antitoxin
- Where
- Indonesia
- Volunteers
- 68 people
- Sponsor
- PT Bio Farma
Safety Issues
Dexmedetomidine for Sedation Undergoing Bronchoscopy
Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression.
- Trial name
- NCT04169685
- Testing
- bronchoscopy
- Where
- Taiwan
- Volunteers
- 80 people
- Sponsor
- Kaohsiung Medical University
Defibrillators, Implantable, Cardiac Arrest
Electrical Safety of Implantable Cardioverter Defibrillators
Patients at risk of developing life-threatening heart rhythms may require the implantation of a small device called a cardioverter-defibrillator (ICD), which constantly monitors the heart rhythm and delivers an electrical shock…
- Trial name
- NCT03271619
- Testing
- Surface current measurement
- Where
- United Kingdom
- Volunteers
- 25 people
- Sponsor
- University Hospital Southampton NHS Foundation Trust
Safety Issues, Injuries
An Interactive Web Platform to Teach Children Hunting, Shooting and Firearms Safety
Firearms injuries present a major pediatric public health challenge, killing >800 children ages 0-15 annually and leading to lifelong disability among >1000 survivors.
- Conditions
- Safety Issues, Injuries, Firearm Injury
- Trial name
- NCT04622943
- Testing
- firearms safety, nutrition
- Where
- United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Health Knowledge, Attitudes, Practice, Safety Issues
The Inspection Campaign of French Phase I/II Research Sites Following the BIA 10-2474 Accident
Following the serious adverse events that occurred in January 2016 during the BIA 10 2474 First-in-Human study, the French Ministry of Health asked the Regional Health Agencies to inspect operations at all Authorized Research…
- Conditions
- Health Knowledge, Attitudes, Practice, Safety Issues, Health, Subjective
- Trial name
- HARMONY (NCT03943017)
- Testing
- Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Groupe Hospitalier Pitie-Salpetriere
Noise Exposure, Intensive Care Unit
Effective Strategies to Reduce Noise and Related Distractions
Patients admitted to the intensive care unit (ICU) undergo complex critical care treatment and are consequently surrounded by equipment and monitors contributing to high sound pressure levels.
- Conditions
- Noise Exposure, Intensive Care Unit, Safety Issues
- Trial name
- NOISY (NCT04643652)
- Testing
- Noise Reduction Bundle
- Where
- Netherlands
- Volunteers
- 250 people
- Sponsor
- Radboud University Medical Center
Safety Issues, Anticoagulant Toxicity
Clinical Pharmacist Anticoagulant Stewardship
Initiative to improve direct anticoagulant utilization involving programmatic review by clinical pharmacists in collaboration with multidisciplinary team.
- Trial name
- NCT03527615
- Testing
- Clinical Pharmacist Medication Review
- Where
- Israel
- Volunteers
- 4,000 people
- Sponsor
- Hadassah Medical Organization
Safety Issues, Emergencies
Automated Early Warning Scoring on Surgical Normal Wards
Establishment of early warning systems in hospitals was strongly recommended in recent guidelines to detect deteriorating patients early and direct them to adequate care.
- Trial name
- NCT03461133
- Testing
- Intervention
- Where
- Germany
- Volunteers
- 3,827 people
- Sponsor
- University Hospital Carl Gustav Carus
Safety Issues
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children & Neonates
This study is to assess the safety of Rotavirus (Bio Farma) vaccine in adults, children and neonates.
- Trial name
- NCT03462108
- Testing
- Rotavirus (Bio Farma) Vaccine
- Where
- 4 sites in Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Safety Issues
Tolerability and Modulatory Action of the Butyrate Releaser N-(1-carbamoyl-2-phenyl-ethyl) Butyramide
Accumulating evidence is showing that gut microbiota could play a key role in gastrointestinal tract and immune system development and function. Many beneficial effects elicited by gut microbiota are mediated its metabolites.
- Trial name
- NCT04491266
- Testing
- FBA
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Federico II University