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NCT ID: NCT05124171 Active, not recruiting - COVID-19 Clinical Trials

Immunogenicity and Reactogenicity Following a Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination

COVIBOOST
Start date: December 8, 2021
Phase: Phase 3
Study type: Interventional

The vaccination campaign in France began in early 2021 and was declared mandatory for all French people in July 2021. The efficacy of COVID-19 vaccines has since been widely demonstrated, as well as their safety, and now 60% of the adult population in France has received a first dose, most of them with Pfizer-BioNTech's mRNA vaccine. However, despite the increasing coverage, new data highlight the need for a booster dose for the most vulnerable people, including patients with immune deficiency. This makes it likely that a booster dose will also be needed in the general population, especially among healthcare workers, due to the active circulation of new variants since the beginning of summer 2021 and evidence of reduced protection against them. On the other hand, in addition to evaluating the potential benefit of a booster vaccination, it appears interesting to also evaluate a heterologous vaccination regimen, i.e. a booster with a different vaccine than the one used for the primary vaccination. Some studies have already evaluated a two-dose heterologous regimen and the results have shown stronger protection against SARS-CoV-2. In addition, this alternative could provide a real benefit in terms of accessibility, cost, and acceptability. The vaccine developed by Sanofi-Pasteur is based on a traditional recombinant protein approach using GSK's AS03 adjuvant. Two formulations of this vaccine are currently under development, the first targeting the S protein of the D614 strain (Wuhan strain), the second targeting the B.1.351 variant. Their value as a booster needs to be evaluated. The objective of this trial is therefore to evaluate the immunological response and safety induced by a homologous vaccine booster (Pfizer-BioNTech vaccine booster) and a heterologous vaccine booster (one of the two experimental Sanofi/GSK vaccines booster), on the D614 (Wuhan) strain and on the SARS-CoV-2 variants.

NCT ID: NCT05124145 Completed - COVID-19 Pandemic Clinical Trials

Primary Care in AURA for COVID-19

SOPRAC
Start date: April 1, 2020
Phase:
Study type: Observational

As few data are available on the epidemiology of the COVID-19 in primary care, the project aims to implement a practice-based surveillance network based on multiprofessional health homes in the French region Auvergne-Rhône-Alpes (Aura), able to monitor the evolution of the current epidemic.

NCT ID: NCT05123885 Completed - Clinical trials for Infarction, Myocardial

Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

WICD-MI
Start date: February 2, 2022
Phase:
Study type: Observational

Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia [VT] or ventricular fibrillation [VF]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.

NCT ID: NCT05123703 Recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Operetta 2
Start date: February 4, 2022
Phase: Phase 3
Study type: Interventional

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

NCT ID: NCT05123599 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

A Study of JNJ-73763989, JNJ-64300535, and Nucleos(t)Ide Analogs in Virologically Suppressed, Hepatitis B e Antigen (HBeAg)- Negative Participants With Chronic Hepatitis B Virus Infection

OSPREY
Start date: December 6, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the efficacy of the study intervention based on hepatitis B surface antigen (HBsAg) levels.

NCT ID: NCT05123586 Completed - Clinical trials for Systemic Lupus Erythematosus

A IMMA Master Protocol: A Study of LY3361237 in Participants With at Least Moderately Active Systemic Lupus Erythematosus

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

The main purpose of this study is to assess the efficacy and safety of LY3361237 in participants with at least moderately active systemic lupus erythematosus (SLE). Study will last up to 34 weeks and may include up to 15 visits.

NCT ID: NCT05123547 Completed - HIV Infections Clinical Trials

DENTAL CARE OF PATIENTS LIVING WITH HIV

DENTA-VIH
Start date: October 21, 2021
Phase:
Study type: Observational

This study is perform to identify oral diseases of people living with HIV (PLWHIV) or co-infected with HBV or HCV.

NCT ID: NCT05123456 Recruiting - Knee Injuries Clinical Trials

Risk of Osteoarthritis of the Knee at Least 5 Years After ACL Reconstruction: Comparative Study Between an Isolated ACL Reconstruction and a Reconstruction Combining ACL and ALL

Start date: April 15, 2020
Phase: N/A
Study type: Interventional

The main objective of this study is to compare, with a minimum follow-up of 5 years, the prevalence of femoro-tibial osteoarthritis after an isolated ACL ligamentoplasty or after an ACL ligamentoplasty combining ACL and ALL.

NCT ID: NCT05123430 Recruiting - Clinical trials for Mitral Insufficiency

Hemodynamic Estimation of the Result of the MitraClip Technique: Interest of the Ratio of Mean Arterial Pressure (MAP) to Pressure of the Mean Left Atrium (POG) (MitraPOG)

MitraPOG
Start date: March 23, 2021
Phase: N/A
Study type: Interventional

this research is based on the hypothesis that the measurement of the ratio of mean arterial pressure to mean left atrium pressure and of its evolution during the procedure, would make it possible to assess the immediate success of the procedure by supplementing the results of the ultrasound. The main objective of this research is to define the percentage of improvement in the mean arterial pressure / mean left atrium pressure ratio at the end of the procedure to validate the success of the MitraClip procedure.

NCT ID: NCT05123339 Completed - Marfan Syndrome Clinical Trials

Clinical Signs and Activity Limitations Associated With Dural Ectasia in Patients With Marfan Disease

MARFANLOMB
Start date: February 11, 2022
Phase:
Study type: Observational

Primary outcome is to compare the frequency and clinical features of spinal symptoms between Marfan patients with dural ectasia (cases) and those without (controls). 1. / Frequency of orthostatic headaches 2. / Frequency of low back pain due to orthostasis 3. / Frequency of low back pain during Vasalva maneuvers 4. / Frequency of lumbar claudication 5. / Frequency of root claudication Secondary outcomes are to compare activity limitations, quality of life and intensity of low back and radicular pain between Marfan patients with dural sac ectasia (cases) and those without (controls). 1. / Average intensity of back pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain) 2. / Average intensity of radicular pain measured on a self-administered digital scale (0 = no pain and 100 = maximum pain) 3. / Activity limitations specific to the lumbar spine measured using the self-administered Oswestry Disability Index questionnaire (ODI, 0 = no limitations and 100 = maximum limitations) 4. / Physical component of quality of life measured using the physical component of the self-administered questionnaire 12-Item Short Form Health Survey (SF-12, 9.95 = worst quality of life imaginable, 70.02 = worst quality of life imaginable ) 5. / Mental component of the quality of life measured using the mental component of the SF-12 self-administered questionnaire (5.89 = worst quality of life imaginable, 71.97 = worst quality of life imaginable)