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NCT ID: NCT06335173 Recruiting - Alzheimer Disease Clinical Trials

A Study to Evaluate Efficacy and Safety of Intravenous ACU193 in Participants With Early Alzheimer's Disease (ALTITUDE-AD)

ALTITUDE-AD
Start date: February 29, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of ACU193 infusions administered once every four weeks (Q4W) in slowing cognitive and functional decline as compared to placebo in participants with early Alzheimer's disease.

NCT ID: NCT06334965 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Multi-modal Characterisation of Hepatocellular Carcinoma (HCC) Treated With Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

OPERANDI-HCC
Start date: March 2024
Phase: N/A
Study type: Interventional

OPERANDI project aims to address unmet clinical needs in the current management of advanced-stage HCC treated with TARE by exploring new opportunities provided by imaging-based artificial intelligence (AI) and data augmentation, simultaneous PET-MRI imaging, and novel approaches to increase patient selection and TARE efficacy (genomic profiling, radiopotentiators, and new radionuclides). The research aim to identify predictive and early markers indicative of TARE effectiveness based on a large prospective cohort of HCC patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 18F-Choline PET-MRI. Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic pretherapeutic and follow-up PET-MRI, in patients with HCC treated with TARE.

NCT ID: NCT06334952 Not yet recruiting - Epilepsy Clinical Trials

Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic

GALVANI GS-3
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to to obtain a significant decrease in seizure frequency in patients with refractory focal epilepsy after applying treatment of cathodal tDCS, compared to sham stimulation drug-resistant epileptic patient. The main questions it aims to answer are: - Changes in quality of life - Percent of newly reported side effects after the stimulation period - Scores in epilepsy severity. Participants will be randomized in a cross-over, and will receive 10 days of tDCS or Sham. Each day will allow 2 periods of 20 minutes stimulation separated by 20 minutes off (with 40 minutes of cathodal stimulation total).

NCT ID: NCT06334900 Recruiting - Clinical trials for GAD-receptor Antibodies-associated Encephalitis

Retrospective Analysis of the French National Cohort of Patients With GAD Antibodies and Cerebellar Ataxia

Ata-GAD
Start date: October 1, 2023
Phase:
Study type: Observational

Glutamic acid decarboxylase (GAD) is an enzyme whose function in the body is to decarboxylate glutamate to GABA. GAD65 antibodies (GAD65Ab) have been associated with type-1 diabetes (80% of new-onset patients) and various neurological conditions, mainly stiff-person syndrome (SPS/PERM), cerebellar ataxia (CA), limbic encephalitis (LE) and temporal lobe epilepsy. These syndromes all seem to result from a reduced transmission of GABA. These neurological conditions are rare and can cause symptoms like confusion, memory loss, muscle stiffness, muscle spasms, behavioural disorders, and pharmacoresistant epilepsy. When finding high levels of GAD65-Ab in the serum, a cerebrospinal fluid (CSF) sample should be taken to look for oligoclonal IgG bands and intrathecal GAD-Ab production to prove an auto-immune cause for the various neurological symptoms.

NCT ID: NCT06334705 Recruiting - Clinical trials for Healthy Volunteer EGEA4 Cohort

EGEA4 THE 30 YEAR FOLLOW UP OF THE EGEA STUDY

Start date: February 15, 2024
Phase: N/A
Study type: Interventional

Cardiovascular (CV) diseases affect 523 million people worldwide, and are the leading cause of death, accounting for over 18 million deaths (around 30% of all deaths) every year. CV diseases account for around 45% of all deaths in Europe, or around 140,000 deaths a year in France. Asthma is one of the main non-communicable diseases, with a significant societal and individual burden, particularly in subjects suffering from severe asthma. The prevalence of asthma worldwide has risen rapidly over the past five decades, and now affects 272 million people worldwide, representing a prevalence of around 3.6%. Asthma is often associated with multimorbidity. Allergic rhinitis, chronic sinusitis, sleep apnea syndrome, gastro-oesophageal reflux disease, obesity and hormonal disorders are among the most common conditions associated with asthma. More recently, other chronic conditions linked to asthma have been suggested, including CV diseases. Although data from the literature in recent years suggest that asthma is associated with an increased risk of major CV events, the underlying mechanisms remain poorly understood. In particular, it is not known whether asthma and CV disease share common etiological processes, such as anthropometric parameters, lifestyle, social, environmental and/or genetic factors, or whether CV disease is a direct consequence of certain features of asthma, such as systemic inflammation or asthma treatments. Our study is based on the hypothesis that the risk of CV events is increased in patients with asthma, which is supported by a growing body of scientific data.However, it remains to be determined to what extent this increased risk is a consequence of asthma or is linked to shared risk factors between asthma and CV health. We hypothesize that asthma, and more specifically adult and moderate-to-severe asthma, are associated with early markers of CV risk. Furthermore, by providing a better understanding of the mechanisms involved in this association, we hypothesize that EGEA_30years may help to disentangle and prioritize actionable levers of life-threatening cardiovascular comorbidities in asthma.

NCT ID: NCT06334588 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

Understanding the Mechanisms of Autism : an MRI and Social Cognition Study

ECLAT
Start date: April 2024
Phase: N/A
Study type: Interventional

The main goal of this study is to investigate anatomo-functional brain abnormalities associated with autism spectrum disorders using a multimodal brain imaging approach, as well as its links to social cognition difficulties measured using eye-tracking

NCT ID: NCT06334497 Not yet recruiting - Clinical trials for Cytomegalovirus Infection

Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections

LUCY-1
Start date: April 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment.

NCT ID: NCT06334458 Active, not recruiting - Pancreatic Cancer Clinical Trials

Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

IMAGene
Start date: February 3, 2023
Phase: N/A
Study type: Interventional

The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile. The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients.

NCT ID: NCT06333782 Not yet recruiting - Vulvar Atrophy Clinical Trials

Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation

Start date: March 31, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy/atrophy. The primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function & pain during injection). Participants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group. An ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection

NCT ID: NCT06333639 Not yet recruiting - General Surgery Clinical Trials

Implementing Virtual Reality in the Operating Room

IRVABO
Start date: April 1, 2024
Phase:
Study type: Observational

"Recently, virtual reality has become more accessible thanks to the use of smaller, more comfortable and easier-to-use devices. Its use in operating theatres is growing. However, despite the clinical effectiveness of virtual reality in reducing pain and anxiety, there are very few feedback studies from patients on their experience of surgery and their satisfaction, especially in orthopaedics. The aim of this study is to demonstrate the superiority, during long awake orthopaedic surgery, of equipping the patient with a virtual reality headset, on patient satisfaction, compared with the same surgery without a headset. The visual support offered will be appropriate to the duration of the surgery, i.e. more than 1 hour."