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NCT ID: NCT06403189 Not yet recruiting - Metabolic Syndrome Clinical Trials

Choroid Plexus Dysfunction in Neurological Diseases

PLEXFOLD
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Cerebral folate deficiency (CFD), a partially treatable condition defined by a low folate cerebrospinal fluid (CSF) concentration, can be linked to genetic defects of folate metabolism or be secondary to various diseases without clear causal link. The team identified a neurological syndrome (named LHIPFOLFD) characterized by deep CFD and a specific leukoencephalopathy, related to several possible gene defects never involving folate metabolism. The team hypothesize that CFD in LHIPFOLD is due to a Choroid Plexus (CP) dysfunction, a brain organ that expresses transporters regulating flux between blood and CSF of numerous metabolites (including folate), and secretes CSF and specific proteins. Consequently, other potentially treatable biochemical abnormalities due to PC dysfunction may exist in LHIPFOLD, beyond CFD. Currently, there is no available clinical explorations to evaluate CP functions, whereas the team consider LHIPFOLD a very useful model to validate the capacity of some relevant diagnostic tools to do so. The objectives are to identify a CP-related MRI and biochemical signature in LHIPFOLD patients, using morphological and functional imaging (CP capillary permeability and CP macrovascular perfusion), and metabolomics/proteomics approaches (untargeted then targeted validation of candidate biomarkers related to CP physiology); and to set-up imaging and biochemical diagnostic tests for clinical practice. For this, brain MRI data and blood/CSF samples will be collected during 2 years from LHIPFOLD patients and controls. Some experimental data indicate that the innovative concept of generalized PC dysfunction as part of a more global pathophysiology has the potential to be applied to other neurological diseases like Alzheimer's disease. Therefore, efficient diagnostic tools exploring CP function will be of great utility not only in LHIPFOLD but also in more common neurological diseases, potentially leading to original therapeutic approaches.

NCT ID: NCT06401395 Not yet recruiting - Parkinson Disease Clinical Trials

Clinical Evaluation of A neW Management Strategy for Patients With pArKinson's disEase usiNg an Innovative telemonitorING (AWAKENING)

AWAKENING
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

Parkinson's disease (PD) ranks second among neurodegenerative diseases and is a major cause of neurological motor disability. The number of PD cases doubled between 1990 and 2016. The consequences of PD, including an increased risk of falls, loss of autonomy and reduced quality of life, contribute to increased morbidity and mortality. The costs associated with falls in the elderly (a fortiori those with PD) and their consequences represent between 0.85% and 1.5% of total healthcare expenditure. There is currently no cure for PD. Treatment is symptomatic and depends on the degree of functional impairment and the age of onset. After a period of stabilization (state phase) of varying length, the clinical situation worsens because of treatment-related motor complications (motor fluctuations, on/off phenomena, dyskinesias, under/overdosing) and the appearance or worsening of disease-specific signs linked to the pathogenic process. Treatment of motor complications involves constantly adjusting doses and dosing schedules to suit each individual case, and to take account of variations in the patient's motor status over the months. These adjustments must also take into account the non-motor signs of the disease, notably thymic fluctuations, treatment-related behavioral disorders, fatigue, sensory and pain disorders. Regular follow-up of patients is therefore essential to assess the evolution of their symptoms, adjust treatment, adapt therapeutic interventions and improve their quality of life. However, most consultations with the neurologist are bi-annual, and because of the long time lapse between two consultations, the practitioner often has only incomplete information on the evolution of symptoms. To help fill these gaps, advances in digital health technologies, with the development of telemonitoring solutions, enable patients to be monitored remotely and provide a potentially more robust amount of information relating to the severity of the disease and its evolution over time. In this sense, remote monitoring in PD would enable the neurologist to readjust treatment at the right time and in the most appropriate way. This will be done by means of a weekly questionnaire (adapted from the clinical examination via the MDS-UPDRS scale) completed by the patient via a mobile application. Remote monitoring of patients should improve their symptom management and quality of life, hence the interest in an intervention offering a remote monitoring service: DIGIPARK MONITOR.

NCT ID: NCT06400992 Not yet recruiting - Hearing Loss Clinical Trials

Investigation of Sky Automatic Technologies in Pediatrics

SKY-MARVEL
Start date: June 2024
Phase: N/A
Study type: Interventional

The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance

NCT ID: NCT06397846 Not yet recruiting - Clinical trials for Benign Pancreatic Lesion

Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.

PANORAMA
Start date: May 2024
Phase:
Study type: Observational

The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy. Today, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers. The aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily. The ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.

NCT ID: NCT06397417 Not yet recruiting - Clinical trials for Out-of-Hospital Cardiac Arrest

Refractory Cardiac Arrest Treated On Field By ECMO

ReCATOBE
Start date: May 2024
Phase:
Study type: Observational

Out-of-hospital cardiac arrest without resumption of spontaneous circulatory activity despite advanced medical resuscitation is considered refractory. Under certain well-defined conditions, today in many cities around the world and particularly in Paris, it benefits from resuscitation called ECPR (extracorporeal cardiopulmonary resuscitation). This technique consists of the installation of an extracorporeal membrane oxygenation (ECMO) device allowing organ perfusion while waiting for a resumption of cardiac activity. Since 2011, the Paris SAMU (SAMU 75) has set up a team capable of implementing ECPR for refractory out-of-hospital cardiac arrests. This team based within the SAMU of Paris at the Necker hospital (ECMO team) composed of an emergency doctor or anesthesiologist-resuscitator, a nurse anesthetist and an ambulance driver intervenes in Paris and its nearby region at the request of medical regulation. Given the growing development of this activity, it is essential to measure its effectiveness in real-life conditions.

NCT ID: NCT06397391 Not yet recruiting - Essential Tremor Clinical Trials

Nonlinear Absorber in Essential Tremor Treatment

TREM-AB
Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this study is to develop a non linear absorber for patients with essential tremor (ET). It 's an extern passive medical device which should improve patients tremor. Investigators will evaluate the impact of this medical device through one clinical scale (Fahn-Tolosa-Marin) and accelerometry record. Investigators focus on motor improvement.

NCT ID: NCT06396377 Not yet recruiting - Dementia Alzheimers Clinical Trials

Interest of the Reborn® Doll as a TO in the Care of Residents With Alzheimer's Disease or a Related Disorder

PROTMA
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the benefits of the Reborn®doll as an OT for the care of residents with Alzheimer's disease or related disorders, by assessing the frequency of resident agitation. The secondary objectives are to study the frequency of treatments, evaluate the average time of exposure to the Reborn® doll, study the behavior of the residents, study the interest of this therapeutic workshop, thanks to an evaluation grid and finally study the repercussions of this OT on the nursing staff.

NCT ID: NCT06396338 Not yet recruiting - Clinical trials for Voluntary Termination of Pregnancy

Voluntary Surgical Terminations of Pregnancy: Comparison of the Hemorrhagic Risk Depending on the Term

HEMOVG
Start date: September 2024
Phase:
Study type: Observational

Voluntary termination of pregnancy (abortion) is a major current societal issue. This is a very common situation, around 225,000 abortions are carried out every year in France. The legislation has recently been amended, with the law of March 2, 2022 aimed at strengthening the right to abortion (no. 2022-295) which extended the legal period for voluntary termination of pregnancy from 14 to 16 weeks amenorrhea (AS). The National College of French Obstetrician Gynecologists (CNGOF), in a press release published on October 12, 2020 in response to the proposed law adopted by the National Assembly, wishes to draw attention to the fact that the procedure of surgical abortion between 14 and 16 SA changes nature. He states that additional procedures are necessary beyond 14 weeks, which could be a source of complications. In addition, the practice recommendations have not been updated following this extension of time, the centers performing abortions are therefore free regarding the protocol for carrying out these so-called late abortions (between 14 and 16 weeks). There are two pregnancy termination techniques practiced in France: medical or surgical. Due to the recent nature of these late abortions, practitioners still have little experience of the consequences of these procedures and this compromises the quality of the information provided to patients. It is necessary to have quality studies to improve knowledge about late-term abortions, in order to be able to correctly inform patients and allow them to make an informed choice regarding the method used. This study follows the modification of the legislation extending the legal period for abortion, with the aim of providing arguments regarding the safety of carrying out surgical abortions at these more advanced stages of pregnancy. In addition, abortion often generates anxiety, the term at which it is carried out could influence the experience of patients. This study would therefore also improve knowledge about the experience of abortion, in order to better support patients throughout their journey.

NCT ID: NCT06395714 Not yet recruiting - Ankle Injuries Clinical Trials

Does Performing a Composite Test 3 Months Post-operatively Reduce the Risk of Failure to Return to Sport After Lateral Ankle Ligamentoplasty?

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

Ankle sprain is one of the most common pathologies in the general population (between 2.1 and 3.2 per 1000 patients per year). Nearly 40% of patients will develop chronic instability in the year following the sprain. We also know that a premature return to sport is a risk factor for developing chronic instability. However, despite the consensus of experts on the subject which have shown the key physiological elements to evaluate before resuming sport, no test or cohort of tests are proposed to allow a safe return to sport by reducing the risks of relapse. Some very recent studies have appeared on non-operated subjects but this remains a subject that is still too little studied, where the lack of consensus and objective criteria increases the risk of instability. Surgical treatment remains an effective option to reduce the risk of recurrence but failure of the latter can occur in approximately 13-37% of patients depending on the population, due to a relapse or a return to sport which does not correspond to expectations. of the patient. The objective of the study is therefore to evaluate the predictive nature of a composite test (ANKLE-GO) regarding the return to sport at the same level and the risks of recurrence.

NCT ID: NCT06395662 Not yet recruiting - Multiple Sclerosis Clinical Trials

Stratification of Risks of Conversion of Radiologically Isolated Syndromes (RIS) by Identifying Biomarkers in Serum and Cerebrospinal Fluid.

ProBioRIS
Start date: July 2024
Phase:
Study type: Observational

Radiologically isolated syndrome (RIS) often precedes Multiple Sclerosis (MS) but some patients have no symptoms. This study aims to use biological samples and magnetic resonance imaging (MRI) data from four large cohorts of patients with MS in the United States, Europe and France, to stratify the chances of RIS developing into MS. Identifying early biomarkers to predict greater disease severity would have a significant impact, not only on RIS but also on the entire clinical spectrum of multiple sclerosis.