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NCT ID: NCT05558813 Not yet recruiting - Clinical trials for Duchenne Muscular Dystrophy

Natural History of Duchenne Muscular Dystrophy Cardiomyopathy (DMD-CMP)

DMD-CMP
Start date: November 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

NCT ID: NCT05558709 Not yet recruiting - Clinical trials for Alzheimer's Disease (AD)

Social-cognitive Functioning: Validation of a New Neuropsychological Test

REALSOCOG
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).

NCT ID: NCT05557201 Not yet recruiting - Miscarriage Clinical Trials

Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

FALCO
Start date: October 2022
Phase:
Study type: Observational

About 1 to 3% of women of childbearing age have repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be related to parental chromosomal abnormalities, congenital or acquired uterine abnormalities, hormonal causes (e.g. type 1 and 2 diabetes, ovarian failure), infectious etiology, constitutional or acquired thrombophilia or sickle cell disease. The presence of antiphospholipid antibodies, antithyroid and anti-transglutaminase antibodies in approximately 10% of cases suggests an autoimmune origin for these fetal losses. The role of other antibodies, in particular unconventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases would be due to an immunological dysregulation of the mother leading to a decrease in tolerance to the fetus. Several studies have shown immune abnormalities, such as an imbalance of pro and anti-inflammatory cytokines, an increase in cytotoxic cells and a defect in regulatory cells in the blood of patients. The assessment of these immune abnormalities is not currently carried out routinely in France in women with recurrent early miscarriages. When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. In these women with unexplained RCF, slightly more than half could be linked to aneuploidies and primary recurrent spontaneous abortions. The evaluation of the degree of aneuploidy and the genetic origin of fetal losses remains difficult, the examination of the sample of tissue from the miscarriage being rarely available, due to the spontaneous nature of the loss. The constitution of a prospective cohort of patients with RCF is an essential step in exploring the factors associated with the success of treatment.

NCT ID: NCT05554055 Not yet recruiting - Thrombosis Clinical Trials

Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)

AXAES
Start date: November 2022
Phase:
Study type: Observational

Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated. Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre. In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.

NCT ID: NCT05552105 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis (OPERA)

OPERA
Start date: September 2022
Phase: N/A
Study type: Interventional

OPERA aims to better understand and predict the responsiveness of rheumatoid arthrits (RA) patients to biological disease modifying anti-rheumatic drugs (bDMARDs). Our objectives will be (i) to determine, at baseline, the differences of oxylipin response between responders vs non-responders to Anti-Tumor necrosis factor (Anti TNF) and (ii) to investigate the relationships between the oxylipin response, the polyunsatured fatty acid (PUFA) content of immune cells and the cytokine response.

NCT ID: NCT05551572 Not yet recruiting - Clinical trials for Prosthetic-joint Infection

Physiopathology of Prosthetic Joint Infections

PROTHEE-PILOTE
Start date: October 2022
Phase:
Study type: Observational

This study aim to explore cellular responses of bone and immune cells to bacterial infections observed in patients with prosthetic joint infections. The investigators will analyze clinical data and tissue samples collected from patients undergoing surgery as part of their usual care for prosthetic joint infections. These research will be conducted on three different hospitals in Paris: Lariboisière (AP-HP), Cochin (AP-HP) and Croix Saint-Simon.

NCT ID: NCT05551234 Not yet recruiting - Isolation, Social Clinical Trials

Reciprocal Benefit by Intergenerational Meetings

Part'Ages
Start date: September 2022
Phase:
Study type: Observational

The investigators want to set up an experiment that allows a reciprocal benefit to 2 fragile populations: isolated seniors and disadvantaged children. The main hypothesis is that regular exchanges between these two populations reduce the feeling of social isolation of seniors and improve the school behavior of childrens. Therefore the investigators propose the following study design. The seniors and childrens will meet once a week, for 7 months, in a defined location in the city of Vallauris, over a period of one and a half hours, outside school hours (4:30 p.m. to 6:00 p.m.) and school holidays. During the school holidays the group will meet 3 times for day-long activities in the presence of at least one of the parents and possibly brothers and sisters. At the end of the project, a convivial evening will be organized in the presence of the families. The group will meet in a room in the city center and in the presence of a facilitator so that an adult will never be alone with a child. The formed pair will follow a defined schedule where will alternate activities proposed by the senior, sessions proposed by the facilitator and convivial moments in the presence of families . During the sessions proposed by the senior, he will offered the child a leisure activity that he likes and masters (eg gardening, DIY, sewing, etc.). All the proposed activities will be validated upstream by the project managers. The sessions proposed by the facilitator (e.g. games, walks) could be done with the participation of an outside speaker (e.g. for writing a gazette). A new evaluation session will be offered to all participants at the end of the meeting period, then at the end of the project, 1 month after the end of the meeting period.

NCT ID: NCT05550155 Not yet recruiting - Clinical trials for Schizophrenia; Psychosis

Efficacy of Maintenance Repetitive Transcranial Magnetic Stimulation (rTMS) in Auditory Verbal Hallucinations

MAINSTIM
Start date: November 3, 2022
Phase: N/A
Study type: Interventional

Repetitive transcranial magnetic stimulation (rTMS) can alleviate persistent auditory verbal hallucinations (AVH) in schizophrenic patients, but the classical procedure with low-frequency stimulation for several weeks upon the left temporoparietal junction have shown modest therapeutic effects, and there is currently no robust predictive factor to the response of the treatment. In a previous multicentric, randomized, and double-blind controlled study, it has been demonstrated that a high-frequency rTMS over an anatomical target can rapidly affect AVHs. Moreover, an intensification of the classical procedure delivering 20-Hz rTMS over a 2-day period was used in addition to a personalized anatomical stimulation target and neuronavigation guidance. Besides the significant efficacy of the procedure, the efficacy was maximal at two weeks after the end of the treatment. In this project, the hypothesis is that the two-day cure could benefit from maintenance rTMS sessions every week for one month and then every two weeks for 3 months to provide an optimal strategy for a long-lasting AVH reduction. This has for now never been tested. Predictive factors to the response of the treatment are also investigated.

NCT ID: NCT05548322 Not yet recruiting - Aging Clinical Trials

Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses

TACTHUM
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Our sense of touch is essential to explore our environment and experience life and is based on signals from receptors in the body that are sensitive to different types of stimulation. The TACTHUM projects aims to investigate the fundamental firing of mechanoreceptors in the body to various external stimuli, with an end-aim to better understand the human somatosensory system and to apply this knowledge to provide comprehensive sensory feedback in prosthetics. We have a vast system of peripheral receptors in the skin and muscles that provide us with exquisitely detailed information about our everyday interactions. When there is injury to a body part, such as in amputation, there is a significant loss of somatosensory input. Prosthetic devices have greatly developmed in the past few years, especially with the introduction of useful sensory feedback. However, there is a lot to discover both about the workings of the somatosensory system and how to recreate this to give feedback in a prosthetic device. The main objective of the TACTHUM project is to understand how to recover and apply useful somatosensory feedback in prostheses for amputees. There are a number of other sub-objectives, to: 1. Determine how tactile mechanoreceptors encode the texture of natural surfaces during passive and active exploration. 2. Investigate how our sense of touch varies with emotional state. 3. Explore what happens to our sense of touch when we explore surfaces at different temperatures. 4. Understand the origin of our perception of humidity. 5. Investigate differences in the encoding of tactile information with age. 6. Determine the perceptions generated by the stimulation of single tactile afferents. 7. Study changes in spontaneous activity and responses to tactile stimulation on the residual limb of amputees. To accomplish these objectives, we will primarily use the technique of microneurography, in vivo recordings from peripheral nerves, to gain direct information about the firing of peripheral neurons in humans. In conjunction with this, we will use a variety of mechanical and thermal stimuli to excite somatosensory fibers and register the activity of other physiological and perceptual measures. This will allow us to gain a fuller understanding of how the incoming somatosensory signals are interpreted and processed. Overall, we aim to explore how more naturalistic tactile interactions are encoded and how these can be translated to provide realistic prosthetic feedback.

NCT ID: NCT05545410 Not yet recruiting - Healthy Volunteers Clinical Trials

Optimization of Thoracic Aortic MRI Acquisition Sequences for the Quantification of Diagnostic-assisting Biomarkers

SEQUOIA
Start date: October 2022
Phase: N/A
Study type: Interventional

The main objective is to optimize MRI acquisition and image post-processing protocols in order to define the best compromise between short scan time and image quality (contrast between different tissues, spatial and temporal resolutions) high enough to accurately measure morphologic, hemodynamic and structural aortic biomarkers.