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NCT ID: NCT05633446 Not yet recruiting - COVID-19 Clinical Trials

Next Generation T-cell Vaccine Against Coronavirus Disease (COVID-19)

Start date: May 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The study aims to investigate the safety and immunogenicity of one dose vs two doses of a T-cell priming next-generation vaccine against Coronavirus disease.

NCT ID: NCT05633433 Recruiting - Clinical trials for SARS-CoV-2 Infection

Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19

Start date: December 29, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

NCT ID: NCT05630859 Active, not recruiting - Clinical trials for Sexually Transmitted Diseases

Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age.

Start date: November 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).

NCT ID: NCT05630820 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

B-Well 2
Start date: December 6, 2022
Phase: Phase 3
Study type: Interventional

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

NCT ID: NCT05629962 Active, not recruiting - COVID-19 Clinical Trials

SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

Start date: November 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.

NCT ID: NCT05624450 Recruiting - Clinical trials for Viral Lung Infection and Acute Respiratory Failure

Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen

TILIA
Start date: December 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of tozorakimab, as an add-on to SoC in patients with viral lung infection requiring supplemental oxygen, on the prevention of death or progression to IMV/ECMO.

NCT ID: NCT05622708 Recruiting - Clinical trials for Non-radiographic Axial Spondyloarthritis

A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission

Start date: March 28, 2023
Phase: Phase 4
Study type: Interventional

This study will establish whether prolonged chronic dosing with secukinumab is needed in participants with Non-radiographic axial spondyloarthritis, (nr-axSpA) who have achieved remission. Remission is defined as Ankylosing Spondylitis Disease Activity Score - C-reactive protein (ASDAS-CRP) Inactive Disease (ID) response (ASDAS-CRP < 1.3). Maintenance of remission on continued secukinumab treatment will be evaluated compared to placebo using a randomized withdrawal design. The primary outcome measure for this study is the proportion of participants remaining flare-free at Week 120.

NCT ID: NCT05621616 Recruiting - Clinical trials for Neurogenic Detrusor Overactivity

A Study of Mirabegron in Young Children With Neurogenic Detrusor Overactivity

Start date: February 28, 2024
Phase: Phase 3
Study type: Interventional

People with neurogenic detrusor overactivity have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder. It can also cause the bladder to leak by accident (incontinence). In this study, the researchers are studying whether a medicine, mirabegron, can help young children with neurogenic detrusor overactivity. The children will be from 6 months to under 3 years old. Mirabegron has already been approved for adults with bladder problems. The main aim of this study is to learn if mirabegron increases the maximum bladder capacity (to prevent high pressure in the bladder) in young children after 24 weeks of treatment. Maximum bladder capacity is the maximum amount of urine that the bladder can hold before it releases urine or starts to leak. There will be 2 groups in the study. Young children who are not taking certain medicines for their condition will be in group A. Young children who are already taking certain medicines for this condition will be in group B. Children in group B will stop taking these medicines before taking mirabegron. Their treatment will be delayed by 2 weeks to allow the other medicines to be cleared from the body before treatment. Both groups (A and B) will take the same treatment and have the same checks throughout the study. Children will have their vital signs checked (blood pressure, heart rate and body temperature). They will also have an ECG to check their heart rhythm and give urine samples for laboratory tests. Other tests will include checking how the bladder fills and empties plus an ultrasound of the bladder area. The caregivers will be shown how to check their child's blood pressure. They will be given an electronic diary to record the blood pressure, as well as any other medicines taken. They will do this every day for 7 days before each visit. Mirabegron will be stirred into water, making it easier for children to drink. Children will drink mirabegron once a day for up to 52 weeks. They will start on a low dose, adjusted for their weight. If children are taking other medicines for this condition, they will wait an extra 2 weeks before starting mirabegron. At weeks 2, 4 and 8, the dose may be increased once to a higher dose if the study doctor thinks the child will benefit from the higher dose. The children and their caregivers will visit the clinic at 2, 4, 8, 12, 24, 52, and 54 weeks. There will be fewer clinic visits if a child stays on the lower dose of mirabegron. In this case, the clinic will phone the caregiver instead to check the information in the diary. During each visit, the children will have their vital signs checked and have an ECG. The caregiver will be asked if their child has had any medical problems. At some visits, the children will give urine and blood samples for laboratory tests. Other tests will include checking how the bladder fills and empties. 36 weeks after treatment starts, the clinic will phone the caregiver to ask if their child has had any medical problems, and will check the information in the diary. The children and their caregivers will visit the clinic 52 weeks after treatment starts. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and have their vital signs checked. Also, they will have an ECG and have urine and blood samples taken for laboratory tests. Other tests will include an ultrasound of the bladder area. There will be a final clinic visit at 54 weeks. The caregiver will be asked if their child has had any medical problems. The children will have a physical exam and will have their vital signs checked. They will also have an ECG. The caregiver will be asked to complete a survey on their child's experience with taking mirabegron. They will do this at 4, 24 and 52 weeks after their child starts treatment. Finally, the clinic will phone the caregiver 30 days after the last dose of mirabegron to check if there were any further medical problems. No other visits are planned during this study.

NCT ID: NCT05616845 Completed - Jaundice, Neonatal Clinical Trials

A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application

NCT ID: NCT05609968 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare pembrolizumab (MK-3475) in combination with sacituzumab govitecan with pembrolizumab alone with respect to progression-free survival (PFS) and overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR) among adults with metastatic non-small cell lung cancer (NSCLC) with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%).