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NCT ID: NCT04725331 Recruiting - Melanoma Clinical Trials

A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors

Start date: February 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/IIa, multicenter, open-label, consecutive cohorts, dose-escalation study of BT-001 with repeated IT administrations alone and in combination with IV infusions of pembrolizumab.

NCT ID: NCT04725188 Active, not recruiting - Clinical trials for Metastatic Non Small Cell Lung Cancer

Pembrolizumab/Vibostolimab Coformulation (MK-7684A) or Pembrolizumab/Vibostolimab Coformulation Plus Docetaxel Versus Docetaxel for Metastatic Non Small Cell Lung Cancer (NSCLC) With Progressive Disease After Platinum Doublet Chemotherapy and Immunotherapy (MK-7684A-002, KEYVIBE-002)

Start date: April 20, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to compare pembrolizumab/vibostolimab coformulation (MK-7684A) plus docetaxel or pembrolizumab/vibostolimab coformulation to normal saline placebo plus docetaxel. Participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti- programmed cell death 1 (PD-1)/ programmed cell death ligand 1(PD-L1) monoclonal antibody (mAb). MK-7684A is a coformulation product of pembrolizumab/vibostolimab. The dual primary hypotheses of the study are pembrolizumab/vibostolimab coformulation plus docetaxel and pembrolizumab/vibostolimab coformulation is superior to normal saline placebo plus docetaxel with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

NCT ID: NCT04725084 Completed - Clinical trials for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Comparison of Non-invasive Oxygenation Strategies in Patients Admitted for Covid-19 Acute Respiratory Distress Syndrome

SONIC-19
Start date: July 1, 2020
Phase:
Study type: Observational

Acute Respiratory Distress Syndrome (ARDS) is the main clinical presentation of SARS-CoV-2 (Covid-19) infected patients admitted in Intensive Care Unit (ICU). During the first phase of the outbreak (between February and May 2020), the use of invasive Mechanical Ventilation (MV) was largely required with 63% of ICU patients intubated in the first 24 hours after admission and up to 80% of patients during the overall ICU stay. Mortality was especially higher when using MV in the first 24 hours. In contrast, the use of non-invasive oxygenation strategies in the first 24 hours was only 19% for High Flow Nasal Cannula oxygen therapy (HFNC) and 6% for Non-Invasive Ventilation (NIV). Several non-invasive oxygenation strategies were proposed in order to delay or avoid MV in ICU patients suffering from Covid-19 ARDS. The use of HFNC became the recommended oxygenation strategy, based in particular on publications prior to the outbreak. The use of NIV or Continuous Positive Airway Pressure (CPAP) combined with HFNC have also been proposed. Although these non-invasive oxygenation strategies seem widely used in the second phase of the outbreak, they have not yet confirmed their clinical impact on MV requirement and patient's outcome. Moreover, no comparison has been made between these different non-invasive oxygenation strategies. The aim of this study is to compare different non-invasive oxygenation strategies (HFNC, NIV, CPAP) on MV requirement and outcome in ICU patients treated for ARDS related to Covid-19.

NCT ID: NCT04724863 Completed - Clinical trials for Complex Aortic Aneurysms

Analysis of Respiration-induced Deformities of the Visceral and Renal Arteries Before and After Stenting

Start date: April 28, 2020
Phase: N/A
Study type: Interventional

Fenestrated stents are used for the management of complex juxta-renal, para-renal or thoracoabdominal aneurysms in patients with high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term follow-up CT scans remain essential for the detection of complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The respiratory cycle might induce changes in the geometry and deformations of visceral and renal stents after complex aortic procedures. These could be detected by an adapted CT scan analysis by deep inhalation and deep exhalation acquisition carried out pre-operatively and post-operatively for monitoring of these same stents and screening for complications.

NCT ID: NCT04724603 Recruiting - Clinical trials for Prosthetic Joint Infection

Phage Safety Retrospective Cohort Study

PHASACO-retro
Start date: February 1, 2021
Phase:
Study type: Observational

The aim of this study is to determine the imputability of adverse events in patients who have had phage therapy for the treatment of their bone or joint or implant infection, in order to find out whether these adverse effects are related to surgery, antibiotic treatment or bacteriophages.

NCT ID: NCT04724395 Recruiting - COVID-19 Clinical Trials

Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19

DisCOVID
Start date: March 31, 2021
Phase:
Study type: Observational

The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.

NCT ID: NCT04724265 Recruiting - Clinical trials for Hearing Loss, Cochlear

Cytomegalovirus (CMV) Perilymphatic Fluid

CMVP
Start date: December 10, 2020
Phase: N/A
Study type: Interventional

In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%. Most of the remaining cases of CI in children are caused by congenital CMV infection. The proportion of CMV inducing SNHL with a CI in children is not clearly defined. During CI, we aim to collect a very small sample of perilymphatic fluid and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in SNHL.

NCT ID: NCT04723407 Not yet recruiting - Rheumatism Clinical Trials

Assessment of the Psychological Impact of the COVID19 (SARS-CoV-2) Pandemic on Patients With Chronic Inflammatory Rheumatism

RICOVID19
Start date: February 1, 2021
Phase:
Study type: Observational

Patients with chronic inflammatory rheumatism (RIC) or autoimmune diseases, rheumatoid arthritis and spondyloarthritis, are regularly monitored in consultation as part of a "treat to target" strategy with rapid adaptation of treatments to the activity of their disease. according to French recommendations. They are treated with immunosuppressive drugs: disease-modifying treatments with very often methotrexate, associated with biotherapies or targeted therapies (JAK inhibitors) They can also be treated transiently or over the long term with corticosteroids. These treatments expose them to greater infectious risks, especially with regard to COVID19. The objective is on the one hand to assess the impact of the Covid 19 pandemic on general state of health of these patients and the evolution of their disease and on the other hand to prioritize the optimal care of these patients by including in the context of maintaining the pandemic reduction rules, modern telemedicine technologies.

NCT ID: NCT04722926 Recruiting - Clinical trials for Bone and Joint Infection

Lyon PJI Retrospective Cohort Study

Start date: January 10, 2022
Phase:
Study type: Observational

Bone and joint infections (BJI), although infrequent (prevalence of 70 per 100,000 in France), have a significant economic and clinical impact. Between 2008 and 2013, the prevalence of BJI increased and infections involving joint prosthesis (PJI) represent a third of BJI in France. They are most often post-operative and more expensive than native IOAs. This study aims to describe PJI and understand the failure mechanisms of PJI in order to improve their management.

NCT ID: NCT04722809 Recruiting - Bruxism Clinical Trials

Efficacy of Botulinum Toxin A in the Treatment of Bruxism-related Symptomatology

Botox
Start date: May 25, 2022
Phase: Phase 3
Study type: Interventional

Bruxism is defined as a parafunction that consists of a clenching of the jaw and/or grinding of the teeth. It can occur when an individual is sleeping or awake or it can be mixed. Most often, it is primary or idiopathic bruxism, however when it is related to a cause it is qualified as secondary. Primary bruxism is a condition that is not well known to the general public, but I is very widespread (12% of the adult population). In addition, it can alter quality of life, as a result of associated sleep disorders, concentration disorders, daytime fatigue, chronic pain, etc. The current treatment for this condition is only symptomatic. Currently, one of the most effective treatments is the intramuscular injection of botulinum toxin A in the muscles of mastication. The progressive anticholinergic action results in a reduction of functional signs (dental pain, periodontal pain, temporomandibular joint pain, tension headaches, neck pain) and physical signs (reduction of the mass of the injected muscles, alba linea, tongue scalloping, limitation or stability of dental damage). However, these clinical data are practically not objectified in daily practice. Objective criteria would make it possible to measure the effectiveness of the treatment, to follow the patient, and to identify the early symptoms in order to prevent a recurrence. The aim of the prospective study is to concretely measure the strength and electromyographic activity of the muscles of mastication before and after botulinum toxin injection.