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NCT ID: NCT04842305 Not yet recruiting - Covid19 Clinical Trials

Mucosal Immunity in Terms of SARS-CoV-2 Antibodies in Saliva After COVID-19 Infection and Vaccination

Start date: April 2021
Phase:
Study type: Observational

The Primary Objective of This Single-center Study is to Investigate the SARS-CoV-2 Spike Glycoprotein RBD Antibody Concentration in Saliva and Serum in Healthy Non Vaccinated and Non-SARS-CoV-2 Infected, COVID-19 Convalescents, Persons Vaccinated With Pfizer-BioNTech BNT162b2, Moderna mRNA-1273 or AstraZeneca ChAdOx1 nCov-19 AZD1222 Vaccines, and Convalescent COVID-19 Patients That Have Subsequently Been Vaccinated. A Potential Difference in the Immunoglobulin Concentrations of the Pfizer-BioNTech BNT162b2 Vaccine, Moderna mRNA-1273 vaccine and the AstraZeneca ChAdOx1-S Vaccine Will be Uncovered. This Knowledge About the Mucosal Immunity Will be Important for Further Designing of Vaccine Strategies.

NCT ID: NCT04843098 Not yet recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Start date: April 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetic and efficacy of TL117 plus paclitaxel in patients with recurrent or metastatic head and neck cancer.

NCT ID: NCT04847830 Not yet recruiting - Periodontitis Clinical Trials

Adjunctive Laser for Periodontal Intrabony Defects

Start date: April 2021
Phase: N/A
Study type: Interventional

Participants with periodontitis and presence of bilateral intrabony defect will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.

NCT ID: NCT04848649 Not yet recruiting - Psoriasis Clinical Trials

Shortening Treatments Of Chronic Inflammatory Conditions

STOIC
Start date: April 2021
Phase: N/A
Study type: Interventional

Background Psoriasis is a common disease which is a source of major distress for patients and costs for the society. Treatments are effective but temporary and relapses occur, preferentially at sites previously involved. Locally, tissue resident memory T cells (TRM) cells prone to produce pathogenic cytokines accumulate in the outer layers of the resolved skin of psoriasis patients under treatment, and can trigger strong inflammatory responses upon reactivation, thus starting the cascade of the relapse. We have recently shown that the skin transcriptional responses after TRM cell activation in healed skin biopsies of patients could predict the time until the disease relapse. How to modify the local pool of TRM cells in the human skin is not known, but several factors leading to the establishment and the persistence of the TRM cells in the skin are suggested. First, the skin microbiota has emerged as a potent actor of the skin immunity, with the capacity to shape the pool of skin T cells in mice. Second, after TRM cells are settled in the skin, their lipid intake will impact their local survival. Last, in addition to these local factors, the gut subclinical inflammation that lead to bacterial translocation can trigger a more global state of inflammation in the body and could drive the local survival of the TRM cells in the skin. Aims Our first aim in this project is to validate a tool to predict psoriasis relapse upon treatment withdrawal in a cohort of patients treated with systemic drugs- the STOPso cohort (Shortening Treatments Of Psoriasis). We will correlate the skin reaction to local TRM activation in resolved lesions to the time before relapse. In parallel, we will characterize several factors likely to participate to the establishment, function and survival of the TRM cells in the skin. We will decipher the skin microbiota and mycobiota; the lipid composition of the outer layer of the skin; the presence of lipopolysaccharide in the blood, in order to better understand what factors should be targeted to modify the skin populations of TRM cells. Methods Patients will be recruited through the Dermatology department of the university hospital of Besançon. We will use skin biopsies from resolved lesions to perform the characterization of the skin responses at the transcriptional level after local TRM activation with OKT-3 antibody compared to control. RNA will be analyzed with Nanostring technologies. For the microbiota analysis, we will use wet swabs and later DNA sequencing. The lipid composition and the circulating LPS will be analyzed after tape stripping, through the LabEx LipSTIC lipidomic platform of the region Bourgogne Franche-Comté. Patients will be followed up at Month 1, Month 6, Month 12 and Month 18 and at time of relapse if it occurs in between those intervals. Data about the disease activity (PASI, quality of life scores) and inter-current events will be registered at each time point. Expected results and Perspectives The final aim of this project is to validate a tool available to clinicians to guide them in their decision to withdraw an efficient treatment in psoriasis, based on the skin reactivity to the resident T cells left locally after resolution of the inflammation. This would help reduce treatment length, and thus toxicities and costs to the health care systems. To open future perspectives, we also want to better understand the reasons why TRM populations tend to be retained in the skin, in order to develop remodeling strategies of the skin TRM populations.

NCT ID: NCT04856020 Not yet recruiting - Pediatric Tumor Clinical Trials

Role of Gray Scale and Color Doppler Ultrasound in Diagnosis of Pediatric Neck Masses

Start date: April 2021
Phase:
Study type: Observational

Our aim is to assess the role of the gray scale and color Doppler ultrasound in diagnosis of the different pediatric neck masses .

NCT ID: NCT04856371 Not yet recruiting - Clinical trials for Advanced Breast Cancer

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

Start date: April 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.

NCT ID: NCT04859413 Not yet recruiting - Clinical trials for Rotator Cuff Injuries

Frequency Analysis of the Ultrasound Images in Rotator Cuff Tendon

Start date: April 2021
Phase:
Study type: Observational

Previous studies used spatial frequency analysis of tendon ultrasound images and considered that the parameters can reflect the micro-structure of the tendon. In this study, we try to recruit and analysis the rotator cuff tendon in healthy adults with different ages and different equipment to explore the the normal range and differences of spatial frequency parameters. The hypotheses of this study are (1) the young and the elderly would have significantly different spatial frequency value; and (2) there would be significant different results between different equipment.

NCT ID: NCT04860063 Not yet recruiting - Metabolic Syndrome Clinical Trials

Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

BERMESyH
Start date: April 2021
Phase: Phase 3
Study type: Interventional

With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance. Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.

NCT ID: NCT04866381 Not yet recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

An Exploratory Clinical Study of SHR6390 and SHR1020 in the Treatment of Esophageal Squamous Cell Carcinoma After Progression on PD-1 Antibody

Start date: April 2021
Phase: Phase 2
Study type: Interventional

This study is being conducted to explore the efficacy of SHR-6390 and SHR-1020 in the treatment of esophageal squamous cell carcinoma after progression on PD-1 Antibody.

NCT ID: NCT04866940 Not yet recruiting - Clinical trials for Magnetic Resonance Imaging

Validation and Implementation of 3T MRI Research Protocols

VALIDIRM
Start date: April 2021
Phase: N/A
Study type: Interventional

The Philips 3T imager installed on the Pavillon Baudot site is an imager dedicated solely to research. It is not located in hospital premises but in INSERM premises for which an authorization for biomedical research has been granted. This equipment is part of the Technical Platform of the UMR 1214 ToNIC whose main objective is the study of the human brain and the main pathologies that affect it. MRI is an evolving technique, which is used in many research projects. Our technical platform must follow these developments and remain at the cutting edge. One of the essential services of our technical platform is to help set up research protocols and validate acquisition sequences. This development activity is therefore located upstream of research projects involving clinical or fundamental applications. The fact that we can provide our users with a regulatory framework to carry out these development tests for their Research Involving Human Subjects project is a necessity for our research support activity. This study aims to provide a generic framework to test the feasibility of MRI sequences requested within the framework of protocols, but also to optimize MRI acquisition sequences already in place, to improve image quality and reduce artifacts that can degrade the quality of the images obtained. In France, there are just over 35 centers with MRI dedicated to research and therefore with a validation protocol allowing them to validate their sequences.