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Tolerance clinical trials

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NCT ID: NCT05180201 Completed - Safety Issues Clinical Trials

SEPSIS: L. Plantarum Trial

Start date: January 7, 2022
Phase: Phase 2
Study type: Interventional

Sepsis is a life-threatening clinical syndrome and a leading cause of neonatal deaths worldwide. The burden of neonatal sepsis and severe infection (SI) is particularly high in areas of South Asia and other resource-limited settings. The goal of the Synbiotics for the Early Prevention of Severe Infections in Infants (SEPSIS) phase II L. plantarum trial is to generate knowledge on the safety, tolerability and effects on the microbiome of Lactiplantibacillus plantarum, with or without fructooligosaccharide, in infants (birth to 60 days of age) in Dhaka, Bangladesh. All data generated will support the design and implementation of a phase III trial to test the efficacy of the probiotic/synbiotic or other interventions for the prevention of SI, promotion of optimal growth and development, and effects on other health outcomes in early infancy.

NCT ID: NCT05150288 Completed - Growth Clinical Trials

Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)

NeHMO DACH
Start date: July 8, 2019
Phase: N/A
Study type: Interventional

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to monitor the safety & tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas and compare with breastfed infants data.

NCT ID: NCT05105243 Completed - Safety Issues Clinical Trials

Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers

Start date: January 17, 2022
Phase: Phase 1
Study type: Interventional

Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766 in Healthy Subjects

NCT ID: NCT05088694 Recruiting - Tolerance Clinical Trials

The Optimization and Evaluation of the Extremism and Intolerance Curriculum for the Kingdom of Bahrain.

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Researcher from UNC Greensboro have partnered with Prevention Strategies and key stakeholders from the Kingdom of Bahrain to conduct a study using the innovative, engineering-inspired methodological approach, the Multiphase Optimization Strategy (MOST), to optimize and evaluate the Peaceful Coexistence and Anti-Extremism middle and high school curricula. No other curriculum targeting tolerance and/or extremism has been optimized using the state-of-the-art MOST methodology. The overall goal of the project is that the optimized versions of Peaceful Coexistence and Anti-Extremism curricula will be used across the Kingdom of Bahrain and translated for use in other countries to combat the spread of extremism and intolerance. Additionally, the D.A.R.E. keepin' it REAL (kiR) and D.A.R.E. myPlaybook high school programs will be evaluated as part of the Peaceful Coexistence and Anti-Extremism evaluation.

NCT ID: NCT05076227 Completed - SARS-CoV2 Infection Clinical Trials

Effect of Different SARS-CoV-2 Vaccine Schedules and Vaccination Intervals on Reactogenicity and Humoral Immunogenicity

Start date: January 30, 2021
Phase:
Study type: Observational

Investigation of the reactogenicity and immunogenicity of homologous and heterologous vaccine combinations with regard to the formation of SARS-CoV-2 antispike antibodies in health care workers after basic immunization and boost vaccination

NCT ID: NCT05022420 Recruiting - Tolerance Clinical Trials

SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases

SATORI
Start date: August 19, 2021
Phase:
Study type: Observational

Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

NCT ID: NCT04820049 Completed - Tolerance Clinical Trials

F573 Ia Clinical Trial

Start date: February 8, 2021
Phase: Phase 1
Study type: Interventional

Tolerance and PK study of F573

NCT ID: NCT04707989 Completed - Tolerance Clinical Trials

Tolerance and Safety of a Ketone-Promoting Food Ingredient

Start date: December 11, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to capture information on tolerance and safety of a ketone-promoting food ingredient in healthy adults.

NCT ID: NCT04698694 Completed - Tolerance Clinical Trials

ElectroPoration In a Clinical Setting

EPIC
Start date: December 9, 2020
Phase: N/A
Study type: Interventional

This is a single-blind, single-center, randomized, study in healthy subjects in which the volunteer patients will remain blind with respect to the voltage strength received.

NCT ID: NCT04689035 Completed - Safety Issues Clinical Trials

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of AVLX-144

Start date: September 27, 2020
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, placebo-controlled, single ascending dose study in healthy volunteer subjects. Each dose level will be investigated with eight 20-50-year-old male subjects (6 on active drug and 2 on placebo). Additionally, eight healthy elderly subjects (65-80 years of age, males and females), 6 on active drug and 2 on placebo, will be included in the study at one dose level, once the safety and tolerability of AVLX-144 has been documented in younger subjects.