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NCT ID: NCT05085873 Recruiting - Palliative Care Clinical Trials

Sodium Oxybate Versus Midazolam for Comfort Sedation

ONAMI
Start date: October 14, 2021
Phase: Phase 4
Study type: Interventional

The study aims at deepen the proof level of sodium oxybate use for comfort sedation at the end of life in a palliative care unit by comparing it to midazolam in a prospective randomized study with blinded efficacy evaluation. The study will be carried out for a period of 24 months with a recruitment objective of 22 patients with refractory suffering and with a short-term prognosis.

NCT ID: NCT05084950 Recruiting - COVID-19 Clinical Trials

Informing the Population of Their Level of Protection Against COVID-19 in Monaco: a Prospective Study (MonaVacc)

MonaVacc
Start date: July 1, 2021
Phase:
Study type: Observational

Vaccines against the coronavirus type 2 causing severe acute respiratory syndrome Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) have been created in a short period of time due to the rapid spread of the virus. These vaccines use different and sometimes innovative technologies, such as the use of ribonucleic acid (RNA), or a non-replicating viral vector. Efficacy ranging from 70-90% in the first weeks after the second injection of these vaccines has been reported, with side effects whose causality remains to be determined.

NCT ID: NCT05074745 Recruiting - COVID-19 Clinical Trials

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Buccal Screening Evaluation Using an RT-PCR Assay and a Rapid ELISA Test Among Symptomatic and Asymptomatic Patients

CORDAGES
Start date: February 18, 2021
Phase: N/A
Study type: Interventional

The main objective is to expand screening for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by evaluating the diagnostic accuracy of the RT-PCR test (Cobas® Roche, Switzerland) and the ELISA Point of Contact Testing (PORTABLE COVID-19 ANTIGEN LAB® Stark, Italy) on buccal swab compared to the reference test, the RT-PCR test (Cobas® Roche, Switzerland) on nasopharyngeal swab. Secondary objectives - To evaluate the diagnostic accuracy of oral swab RT-PCR and POCT relative to the quantitative amplification (Ct) values of the NP Swab RT-PCR assay. - Analyze RT-PCR amplification cycle thresholds (Ct) and POCT diagnostic accuracy as a function of the presence and timing of symptoms. - Among symptomatic participants, compare clinical presentations between positive and negative participants on the NP swab RT-PCR test. - The RT-PCR test may be imperfectly sensitive, ranging from 71 to 98%3. Using a Bayesian latent class model, the investigators will assess the true accuracy of POCT as it does not require the assumption that any one test or combination of tests is perfect14,15.

NCT ID: NCT05049551 Completed - Hyperthyroidism Clinical Trials

Thyroid Uptake Quantification on a New Generation of Gamma Camera

QUANTHYC
Start date: October 30, 2019
Phase:
Study type: Observational

The primary objective of this study is to evaluate the potential of a new large field CZT gamma camera to estimate the thyroid uptake (TU) on Single photon emission computed tomography (SPECT) and SPECT/CT images in comparison with standard planar scintigraphy. The secondary objective is to analyze the diagnostic contribution of SPECT/CT imaging.

NCT ID: NCT04990505 Not yet recruiting - Clinical trials for SARS-CoV-2 Infection

Microvascular Injury and Distal Thrombosis in COVID-19

MIND
Start date: August 2021
Phase:
Study type: Observational

Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement

NCT ID: NCT04870203 Recruiting - Clinical trials for Rheumatoid Arthritis

Combination of Baricitinib and Adalimumab in Rheumatoid Arthritis

CRI-RA
Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

As stated by the European League Against Rheumatism (EULAR) and the Société Française de Rhumatologie (SFR), treatment of patients with rheumatoid arthritis (RA) should target sustained remission or at least low disease activity. However, despite significant advances based on various combinations of conventional synthetic disease-modifying antirheumatic drugs (DMARDs) and biologic DMARDs, RA therapies meet treatment goals only in some patients: - 40 to 50% of patients with early RA, treated with methotrexate (MTX) monotherapy as first-line therapy, - 20 to 30% of patients treated with a combination of MTX and biologic as second-line therapy. - Less than 10% of patients treated with a combination of MTX and another targeted DMARD, such as baricitinib, as third-line therapy. Therefore, new strategies targeted at achieving a higher percentage of remission are needed, that do not require waiting for multiple failed therapies. Combinations of biologics have shown synergistic improvement of symptoms in murine models of RA relative to the improvement observed with either agent alone. However, in RA patients, only five randomised clinical trials (RCTs) have explored the efficacy and safety of combining tumour necrosis factor (TNF) inhibitor with another biologic (anakinra, abatacept, rituximab or bimekizumab). Baricitinib is a selective, reversible and competitive inhibitor of Janus kinases (Jaki). This treatment is efficient in a number of therapeutic scenarios in RA and showed a clinical superiority over adalimumab in one RCT (RA-BEAM study in MTX inadequate responders). Of note, baricitinib inhibits many of the pro-inflammatory cytokines involved in the pathogenesis of RA but does not block signalling downstream of TNF. Owing to the interest in combining different mechanisms of action, the investigators plan to assess the efficacy and safety of combination therapy with baricitinib and a TNF inhibitor (adalimumab). The investigators are aware that combining targeted therapies is not recommended due to a potential increase in the frequency of serious adverse events. However, several case series on patients treated with a combination of targeted therapies have been published, suggesting a certain efficacy in patients with refractory RA. The first ones focused on inflammatory bowel diseases and psoriasis, but more recently, combination of tofacitinib (which belongs to the same Jaki family as baricitinib) with various biologics has been reported in a sample of RA patients. No serious adverse effects were reported over a mean of approximately 11 months of therapy. The clinical improvement was mild but noticeable in these refractory RA cases. Recently, data of interest from the RA-BEAM study have been reported. Patients who switched from adalimumab to baricitinib showed improvements in disease control. Because the switch from adalimumab to baricitinib occurred without a washout period, and because adalimumab has a mean circulating half-life of approximately 14 days, patients would have received several weeks of dual TNF and Jak1/Jak2 inhibition in the course of the change of treatment. The observation of increased efficacy, with no apparent acute safety issues during the weeks when patients were exposed to both adalimumab and baricitinib, is of interest, and supports our strategy to combine the two treatments for patients with refractory RA. The investigators consider that there is a need for investigation into the addition of adalimumab to baricitinib in patients suffering of refractory RA (inadequate response to TNF inhibitors). The investigators hypothesize that in this population, based on ACR50 score, this combination therapy will decrease disease activity more efficiently than a switch to another targeted DMARD, such as baricitinib.

NCT ID: NCT04731246 Recruiting - Clinical trials for Parkinson Disease, Idiopathic

Video-oculography and Parkinson's Disease

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015): - the evolution of oculomotricity markers over time. - the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years. - the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography. - the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.

NCT ID: NCT04730167 Recruiting - Brain Injuries Clinical Trials

The Monaco Initiative for Concussion in Motorsport Pilots

Start date: October 5, 2021
Phase:
Study type: Observational

The study aims: - to observe a population particularly exposed by the past to brain trauma and concussion: Motorsport Pilots who are retired from a professional practice of motor sport; - to report results of their neuro-cognitive evaluations, - to determine if specific profiles emerge. - to evaluate potential consequences of these traumas' history at a cerebral, physical and psychological level. - to evaluate the contribution of the various examinations performed as part of a concussion assessment in routine care (eye-tracking, brain imaging, Neuropsychological Assessment).

NCT ID: NCT04705610 Completed - Healthy Clinical Trials

Social Cognition in Multiple Sclerosis, From a Study of Eye Movement and Gaze Strategies Using Video-oculography

EYE-SEP
Start date: May 23, 2017
Phase: N/A
Study type: Interventional

This study aims to: - analyze prospectively the prevalence of subclinical oculomotor disorders (OMDs) in different phenotypes of Multiple Sclerosis (MS) and to study correlations with brain MRI T2 data. - highlight link between modification of visual exploration strategies to decode emotions, and social behavioral disorders, in patients with demyelinating disease, from early to clinically definite stages.

NCT ID: NCT04702763 Recruiting - Multiple Sclerosis Clinical Trials

Eye Movements Recording Using a Smartphone: Comparison to Standard Video-oculography in Patients With Multiple Sclerosis

Start date: October 8, 2020
Phase:
Study type: Observational

This study aims to compare measurements obtained through the e-VOG application (mobile application, usable on mobile phones or tablets, to measure eye movements) with measurements from the standard video-oculography device (Eye-Tracker®T2), in patient with Multiple Sclerosis.