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Safety clinical trials

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NCT ID: NCT06123832 Active, not recruiting - Safety Clinical Trials

Study of the Clinical Benefits of Different Formulations of Amphotericin B

Start date: January 1, 2020
Phase:
Study type: Observational

This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.

NCT ID: NCT05919355 Active, not recruiting - Quality of Life Clinical Trials

Effectiveness of a Communication Device in Home Care Services in Norway: Does Komp Make Older Adults Feel Happier, Safer and More Connected, and Able to Live Longer at Home.

BoVEL
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

This study is a field trial where "Komp" is implemented and tested as part of Oslo Municipality's home care services for older adults. Komp is a "one button" communication device designed specifically for older adults who are unfamiliar with or struggle to use conventional digital technologies such as smart phones, computers, or tablets. The aim of the trial is to study the effects of increased social contact with family and care services via Komp. In a randomized design, 300 Komp units will be offered to a sample of older municipal home care service recipients. By comparing the intervention group (who are offered to test Komp for free) with the control group (who receive services as usual), the study will uncover if, on average, users of Komp 1) can live longer at home than non-users, 2) have lesser need of home care services, and 3) are happier, safer, and more socially connected.

NCT ID: NCT05686161 Active, not recruiting - Safety Clinical Trials

mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs

Start date: October 19, 2022
Phase: Phase 3
Study type: Interventional

Primary#Objectives #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose. Secondary#Immunogenicity: 1. To describe binding antibody profile at D01, D29 and D181 of each study group. 2. To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group. Secondary#Safety: To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses. Exploratory#Cell-mediated immunity: To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group. Exploratory#Efficacy: To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.

NCT ID: NCT05388981 Active, not recruiting - Safety Clinical Trials

Study of Single Doses of SBT115301 in Healthy Participants

Start date: July 25, 2022
Phase: Phase 1
Study type: Interventional

This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.

NCT ID: NCT05173922 Active, not recruiting - Alzheimer Disease Clinical Trials

"Safety in Dementia": An Online Caregiver Intervention

Start date: May 22, 2022
Phase: N/A
Study type: Interventional

In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

NCT ID: NCT05032976 Active, not recruiting - COVID-19 Clinical Trials

Korea Comirnaty Post-marketing Surveillance

Start date: March 18, 2022
Phase:
Study type: Observational

This study will collect information on the safety of BNT162b2 products for at least 15,000 subjects who have been administered in a routine clinical practice from 05Mar2021 to 04Mar2027 in Korea, and will be conducted in accordance with the New Drug Re-Examination Guideline of the Ministry of Food and Drug Safety (MFDS).

NCT ID: NCT03806465 Active, not recruiting - Safety Clinical Trials

Malaria Vaccine Pilot Evaluation

MVPE
Start date: February 25, 2019
Phase:
Study type: Observational

The RTS,S/AS01 malaria vaccine is being introduced sub-nationally in phased pilot introductions through the EPI programmes in Malawi Ghana and Kenya. Vaccine introduction is by the respective MoH in selected areas randomly assigned to receive the vaccine at the beginning of the pilots. In the context of this programmatic activity, the Malaria Vaccine Pilot Evaluation (MVPE) registered here as observational evaluations during early vaccine introduction, include a series of 3 household surveys, and sentinel hospital and community mortality surveillance, building on routine systems. These observational evaluations will measure: 1. The programmatic feasibility of delivering a 4 dose schedule; 2. Safety in routine use, with focus on cerebral malaria and meningitis; 3. The impact of the malaria vaccine in routine use on severe malaria and all-cause mortality

NCT ID: NCT03315221 Active, not recruiting - Safety Clinical Trials

Renoir: A Randomised, Double-blind, Controlled Trial to Evaluate the Effects of a New Human Milk Fortifier on Growth and Tolerance in Preterm Infants.

Renoir
Start date: March 8, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Preterm birth (birth before start of the 37th week of gestation) is a major determinant of neonatal morbidity and mortality and has long-term adverse consequences for health and neurodevelopment. Preterm infants have much higher nutrient requirements than term infants. The preferred nutrition for all infants including preterm infants is human milk from the infant's own mother, or alternatively donor human milk, provided it is fortified with several nutrients as human milk alone does not sufficiently meet the nutritional needs of preterm infants. Human milk fortifiers (HMFs) are multicomponent enrichments that can be added to human milk (own mother´s milk or donor milk) to meet the increased nutritional needs of preterm infants. The current Nutricia HMF (control product) has been available in its current composition since 2010. It is a multicomponent HMF providing protein, energy, minerals, and vitamins in accordance with the ESPGHAN recommendations. Recent investigation suggests positive effects on growth and development of preterm infants when lipids are added to their nutrition. Therefore, Nutricia has added lipids to their HMF (test product) for a nutritionally more complete fortification of human milk aiming for optimal growth and optimal cognitive and brain development. The Renoir study will investigate the difference between both HMFs with regards to the growth velocity as well as the safety and tolerance of the new HMF.

NCT ID: NCT03308929 Active, not recruiting - Safety Clinical Trials

Prospective G7 Dual Mobility Total Hip PMCF

Start date: February 28, 2017
Phase:
Study type: Observational

This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

NCT ID: NCT02239172 Active, not recruiting - Safety Clinical Trials

A Phase 1 Study of the Safety and Immunogenicity of Plant-Derived Recombinant Protective Antigen (rPA) Anthrax Vaccine in Healthy Adults

Start date: August 2014
Phase: Phase 1
Study type: Interventional

The purposes of this study is to evaluate and compare the safety, reactogenicity, and tolerability of the PA83-FhCMB vaccine candidate delivered at 4 dose levels with Alhydrogel