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Safety clinical trials

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NCT ID: NCT05913271 Recruiting - Heart Failure Clinical Trials

Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure

Start date: May 30, 2023
Phase:
Study type: Observational [Patient Registry]

1. To evaluate the efficacy and safety of levosimendan in the treatment of heart failure ; 2. Guide patients to apply levosimendan individually and establish a dose adjustment program.

NCT ID: NCT05911087 Not yet recruiting - Safety Clinical Trials

A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2

Start date: June 20, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Immunogenicity Objective:Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose. Primary Safety Objective:To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19. Secondary Immunogenicity Objectives:To describe the neutralizing antibody response at D29, D91 and D181.To describe binding antibody profile at D01, D15, D29, D91 and D181 of each study group. Secondary Safety Objective:To assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 COVID-19 vaccine doses. Exploratory Objective:1.Documented confirmed SARS-CoV-2 symptomatic infection;2.Todemonstrate the cellular immune response profile at study group (30 subjects per each group for cellular immune testing).

NCT ID: NCT05910918 Completed - Safety Clinical Trials

Intensive Care Nurses' Training Package on the Safety Culture of Geriatric Patients

Start date: November 30, 2022
Phase: N/A
Study type: Interventional

This study aims to determine the effect of intensive care nurses' training package on the safety culture of critically ill geriatric patients. Study hypothesis: Intensive care nurses who receive the proposed training package exhibit higher scores on critically ill geriatric patients' safety culture awareness than those who do not receive it.

NCT ID: NCT05847218 Completed - Pharmacokinetics Clinical Trials

Phase 1 Clinical Trial of RHN-001 in Healthy Adult Volunteers

Start date: March 9, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical Trial is to assess the safety, tolerability and Pharmacokinetic profile of 750 mg single oral dose of RHN-001 and 1500 mg of RHN-001 administered orally in fasted and fed conditions in healthy adult volunteers.

NCT ID: NCT05776550 Recruiting - Safety Clinical Trials

Safety and Efficacy of Distal Radial Approach (SAFE-BOX)

Start date: January 5, 2023
Phase:
Study type: Observational

A Prospective Registry to assess the Safety and Efficacy of Distal Radial Approach

NCT ID: NCT05774704 Recruiting - Safety Clinical Trials

Curcumin and Retinal Study

Start date: August 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance/composition of gut microbiota.

NCT ID: NCT05731258 Recruiting - Breast Cancer Clinical Trials

Observational of Adjuvant Treatment of Breast Cancer With Liposomal Doxorubicin Regimen

Start date: May 1, 2022
Phase:
Study type: Observational

The goal of this observational study aims to observe and evaluate the efficacy and safety of a liposomal doxorubicin containing regimen in the postoperative adjuvant treatment of breast cancer patients.

NCT ID: NCT05698095 Completed - Pharmacokinetics Clinical Trials

Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

Start date: December 27, 2022
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess the pharmacokinetics, safety, and tolerability of a single-dose and multiple-doses of 5-MeO-DMT administered by intramuscular (IM) injections in healthy subjects.

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: NCT05627518 Completed - Pharmacokinetics Clinical Trials

Relative Bioavailability of Linaprazan for the Test Formulation vs. Reference Formulation

BA
Start date: November 15, 2022
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, randomized, single dose, 3-way crossover study in healthy volunteers designed to evaluate the relative bioavailability of a new oral tablet formulation of linaprazan glurate in comparison to a previously studied oral tablet formulation under fasting conditions, and to assess the effect of a high fat, high calorie meal on the pharmacokinetics (PK) of linaprazan glurate and the active substance linaprazan after the administration of the new oral tablet formulation.