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NCT ID: NCT06042972 Recruiting - Clinical trials for Post Partum Depression

Risk of Maternal Depression From 1 Year to 4 Years Postpartum in Yvelines

DeTaPoP
Start date: September 30, 2023
Phase:
Study type: Observational

This observational study aims to estimate the prevalence of women from 1 to 4 years postpartum in Yvelines, who are suspected to suffer from postpartum depression, using the Edinburg Post natal Depression Scale (EPDS) and the Patient Heath Questionnaire 2 (PHQ2) and evaluate the factors that could be linked to it.

NCT ID: NCT06042478 Recruiting - Clinical trials for Chronic Spontaneous Urticaria

A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.

Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH).

NCT ID: NCT06042075 Not yet recruiting - Feelings Clinical Trials

Representation of Congenital Birthmarks

ReCONNAISSANCE
Start date: October 2023
Phase:
Study type: Observational

This descriptive cross-sectional single center study will be conducted at Angers Maternity Unit. It pertains to the ways in which healthcare professionals represent congenital birthmarks found in newborns. It is our assumption that health professionals may have a tendency to engage in inappropriate behavior when dealing with congenital birthmarks due to lack of knowledge. We make the presumption that insufficient knowledge causes difficulties in managing these birthmarks. Data as to representation of birthmarks in newborns by health professionals will be collected using a semi-quantitative questionnaire. This study constitutes preliminary research work, with a view to creating a professional development plan if necessary.

NCT ID: NCT06041906 Enrolling by invitation - Clinical trials for Congenital Porto-Systemic Shunt (CPSS)

International Registry of Congenital Portosystemic Shunt (IRCPSS)

IRCPSS
Start date: April 26, 2018
Phase:
Study type: Observational [Patient Registry]

Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.

NCT ID: NCT06041841 Not yet recruiting - Clinical trials for PCSK1 Deficiency Obesity

A Phase 2 Study to Assess Efficacy and Safety of LB54640 in Patients With Genetic Obesity

Start date: December 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study was to assess the efficacy of LB54640 in participants with rare genetic disorders of obesity

NCT ID: NCT06041737 Completed - Renal Failure Clinical Trials

Determination of a Profile of Patients With Renal Failure to be Supported as a Priority in the Care Pathway in Order to Avoid Emergency Hospitalizations.

DETERPROFIPA
Start date: October 9, 2023
Phase:
Study type: Observational

The purpose of this study is to map the population of stage 4 and 5 kidney failure patients followed in consultation by the CHSF nephrology team and to determine the factors associated with recurrent hospitalizations.

NCT ID: NCT06041607 Recruiting - Clinical trials for Patients With Cancer

Shared Meditation Involving People With Cancer, Carers and Third Parties

IMPLIC2
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Although the benefits of meditation are increasingly well documented, few hospitals offer this integrative approach in their supportive cancer care. Meditation is sometimes provided, but its potential benefits remain insufficiently evaluated. This project is based on the hypothesis that there could be a benefit in meditating together.

NCT ID: NCT06041555 Recruiting - Prostate Cancer Clinical Trials

MRI Guided Radiotherapy and Radiobiological Data: the ISRAR Database (Irm Sequences for Radiobiological Adaptative Radiotherapy)

ISRAR
Start date: January 8, 2024
Phase:
Study type: Observational

The MRI linac Unity is a major technological evolution in radiotherapy combining a linear accelerator with a 1.5T MRI (radiological quality). It allows to target the target volume more precisely and to adapt the daily dose distribution according to variations in the position and volume of the tumor, critical organs and the tumor response. In many studies conducted in radiology, the analysis of specific MRI sequences, particularly in radiomics, aims to characterize tumors and their sensitivity to treatment. Initial data show that in radiotherapy, it would eventually be possible to characterize the radiosensitivity of healthy and tumorous tissues. With linac 1.5T MRI, the performance of selected MRI sequences, at each session, could make it possible to identify different levels of radiosensitivity within the tumour. The reproduction of these sequences on a daily basis could make it possible to follow the variations in radiosensitivity during the treatment. The final objectives would be: 1- to adapt the doses of radiotherapy to each session with a modulation of the dose according to the daily level of intra-tumor radiosensitivity, 2- to develop Artificial Intelligence (AI) tools allowing an analysis sequences and the generation of 3D maps of intra-tumor radiosensitivity, fast and suitable for carrying out a radiotherapy session. A first work carried out in collaboration with the CREATIS lab of the University Claude Bernard Lyon 1 (UCBL1) made it possible to generate maps of tissue oxygenation from sequences produced on the MRI linac Unity of the Hospices Civils de Lyon (T2* , IVIM, Carto T2 Multi Echo-Gradient). Hypoxia is known to be the first factor of tumor resistance to irradiation. A research program is structured in collaboration with UCBL1 in order to develop radiobiological adaptive radiotherapy approaches, based on 3D maps of intra-tumoral hypoxia and their variation during treatment. Several tumor locations were selected because of the preponderant place of MRI in tumor characterization: prostate, cervix, kidney, ENT and glioblastoma. Hypoxia is not the only factor of radioresistance. Changes in the microenvironment could also impact the sensitivity of tumor cells. The program will therefore also aim to optimize the maps initially based on hypoxia, by identifying other relevant factors to be taken into account to define intra-tumor sensitivity.

NCT ID: NCT06041334 Recruiting - Spina Bifida Clinical Trials

Evaluation of muLtimodal and Non-invasive SPINa Bifida Neurovessels During Prospective Follow-up

SPINLESS
Start date: January 18, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to investigate known urinary biomarkers in order to determine whether they can be predictive of a risk of damage to the upper urinary tract and therefore the kidneys in patients with spina bifida. The risk of damage to the upper urinary tract can be calculated using the Galloway score, based on the results of the urodynamic study and retrograde urethrocystography, which all patients with spina bifida have regularly. The urinary biomarkers studied TIMP-2 (Tissue inhibitor of metalloproteinases 2) and MMP-2 (matrix metalloproteinase-2) are potentially associated with renal degradation, but this has not yet been demonstrated. Volunteers to take part in the study will have their biomarkers measured at the time of their urodynamic assessment.

NCT ID: NCT06040892 Recruiting - Clinical trials for Cochlear Implantation

Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children

KidTrain
Start date: March 27, 2024
Phase: N/A
Study type: Interventional

In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life. The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI. The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training. The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations. Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening). Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie & Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.