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NCT ID: NCT06085950 Recruiting - Clinical trials for Treatment Resistant Depression

Transcranial Ultrasonic Stimulation in Treatment-resistant Depression : an Open-label Pilot Trial

StimulUS
Start date: May 9, 2023
Phase: N/A
Study type: Interventional

The primary objective of this study is to optimize the protocol for the TUS administration in patients with TRD while gaining an initial impression of treatment efficacy.

NCT ID: NCT06085118 Not yet recruiting - Food Allergy Clinical Trials

Observatory on Cow's Milk Protein Allergy

OLAF
Start date: November 2023
Phase:
Study type: Observational

The purpose of this study is to describe the symptoms and their evolution up to the age of 5 years in a population of newly diagnosed infants with a suspected or confirmed allergy to cow proteins, for whom the doctor prescribed the Pepticate® Syneo® replacement formula as soon as they were diagnosed. The Pepticate® Syneo® product is an advanced protein hydrolyzate, food type intended for special medical purposes. This is a product already available on the market.

NCT ID: NCT06085040 Not yet recruiting - Pediatric Obesity Clinical Trials

Pedicatric Obesity - Weight - Energy - Loss - Load

POWELL-2
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain. Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences. Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".

NCT ID: NCT06084936 Recruiting - Lymphoma Clinical Trials

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

GLOBRYTE
Start date: October 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

NCT ID: NCT06084832 Recruiting - Alcohol Drinking Clinical Trials

Smartphone Application for University Students With Binge Drinking Behavior

SmartBinge
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Alcohol use is a causal factor in more than 200 diseases and injury conditions (see ICD-10) and in France, alcohol is the first cause of hospitalization. Binge drinking (BD) has emerged as a major public health issue among student populations and is associated with negative consequences and social, cognitive and brain alterations. More than half of French university students have reported BD in the past month and are at increased risk of several alcohol-related consequences such as memory and sleep impairments, and reduced quality of life. BD is also a major risk factor in the development of alcohol addiction, with individual and environmental factors playing a role that is still poorly understood. Moreover, most students and young adults are reluctant to seek interventions when it is provided by health care professionals (only 4-5%) and have poor insight with regard to their alcohol use patterns / habits. Thus, there is an urgent need for developing effective prevention and intervention programs to reduce alcohol drinking in students. Recent studies have demonstrated that new types of technology-delivered interventions are promising tools for addressing unhealthy alcohol use. For example, an uncontrolled trial pilot study using a smartphone application-delivered intervention produced a reduction in both number of drinks per week and BD from baseline to 3-month follow-up. A recent review also showed significant outcomes of a mobile health intervention for self-control of unhealthy alcohol use. The investigators hypothesize that a timeline follow-back and personalized feedback based on the use of a mobile application can reduce excessive alcohol intake at 3-months. This study will provide scientific knowledge about BD in students, but also regarding a new type of intervention that could be effective for prevention in non-treatment seeking individuals and reducing the severity of health problems associated with excessive alcohol intake.

NCT ID: NCT06084689 Not yet recruiting - Colorectal Cancer Clinical Trials

Targeting MDMD and PD1 in Tumors With Tertiary Lymphoid Structures

EMPIRE
Start date: January 1, 2024
Phase: Phase 2
Study type: Interventional

Phase II, multicenter, open-label, multi-cohort proof-of-concept study designed to evaluate the safety and efficacy of Ezabenlimab combined with BI 907828 in patients with unresectable, locally advanced or metastatic solid tumors.

NCT ID: NCT06084195 Recruiting - Clinical trials for High Grade Serous Ovarian Cancer

Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging

MR-O-MICS
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance

NCT ID: NCT06084143 Recruiting - COVID-19 Clinical Trials

Analysis of Suicide Dynamics in Link to the COVID-19 Pandemic

DSL-Covid-19
Start date: July 21, 2023
Phase:
Study type: Observational

Covid is a virus that first appeared in China in 2019 and was quickly described as a pandemic virus by its globalized nature. The unprecedented occurrence of the virus has led to several health and restrictive government measures. The Covid-19 pandemic and health measures have been able to contribute to the deterioration of the mental health of citizens as it has already been observed during the former pandemic context (Sars covid in 2003 in China or the Spanish flu). Among the consequences of a negative impact on mental health, investigators assume that there is an increase in transitions to the completed suicidal act. However, current studies and observations tend to note that there has been no major change in the dynamics of successful suicides during the Covid period. However, there are biases in the studies conducted: some suicide deaths may have been hidden and not reported as such, due to several factors. For example, the measure of the evolution of suicide attempts that was most often made by the measure of the evolution of the number of hospitalizations for this reason can be a source ofestimate whether people who did this gesture were not hospitalized after a visit to the emergency room or if they gave up attending because of the pandemic. Moreover, suicide deaths are more difficult to report as such when they occur at home than after hospitalization. It is therefore interesting to study the dynamics of suicide during this health crisis retrospectively based on data from the Strasbourg Institute of Forensic Medicine containing the census of the Alsace region, which was hit hard by the pandemic.

NCT ID: NCT06083584 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis

ROSA
Start date: November 22, 2023
Phase:
Study type: Observational

Genetic diagnosis of Amyotrophic Lateral Sclerosis (ALS) could identify the origin of the disease, potentially allowing the patient to pursue targeted/gene therapy. However, many familial forms of ALS are genetically undiagnosed, either because no variant has been detected in the genes of interest, or because the detected variant(s) have uncertain significance. Currently, molecular diagnosis takes place in two stages: 1) Search for the GGGGCC expansion in the C9ORF72 gene by RP-PCR; 2) Analysis of the coding regions by high-throughput sequencing of a panel of 30 genes involved in ALS. Many of these variants of uncertain significance affect splicing. Their impact can be predicted using in silico tools, but only an analysis of the patient's RNA can confirm their pathogenic nature. Currently, the analysis of transcripts is only done a posteriori, when a variant predicted to impact splicing is detected on the patient's DNA. RT-PCR followed by Sanger sequencing then verifies the impact of the splice variants. This method confirmed the impact of certain splice variants in patients. However, this method is time-consuming and requires custom development, and is mutation/gene/patient-dependent. In contrast, high-throughput RNA sequencing (RNA-Seq) simultaneously analyzes the splicing of numerous genes, with a global approach, applicable to all patients. This approach avoids the custom design of primers, which can be biased by the interpretation of splicing predictions, while RNA-Seq systematically captures and sequences all the transcripts. Finally, RNA-Seq provides additional information compared to DNA sequencing such as the detection of exon skipping, intron inclusion, and the creation of fusion transcripts. In the GTEx project (GTEx Consortium, 2013), expression levels of human genome transcripts were quantified by RNA-Seq. Using these results, the study investigators measured expression of transcripts of known ALS genes in whole blood. Applying a threshold value of 0.5 transcripts per million reads (TPM), 25 of the 30 ALS genes currently analyzed by NGS in routine diagnostics at Nîmes University Hospital could be eligible for a complete analysis by RNA-Seq. None of the French laboratories carrying out genetic analyzes of ALS has yet developed RNA-Seq as a routine diagnostic tool. The study laboratory receives more than 600 requests for genetic diagnosis of ALS patients per year. The aim of this study is therefore to develop a global method for analyzing RNA transcripts of ALS genes to categorize the mutations to improve the diagnostic management of patients.

NCT ID: NCT06083415 Recruiting - Clinical trials for Environmental Exposure

Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context

PENELOPE
Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved. Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome. The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters. The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.