Clinical Research Directory

Efficacy, Safety and Tolerability of AZD6234 in Participants Living With Overweight or Obesity With Type 2 Diabetes Who Are on a Stable Dose of GLP-1 Receptor Agonist

This Phase II study is a randomized, parallel group, double blinded, placebo-controlled, multicenter to evaluate the efficacy, safety, and tolerability of AZD6234 in adults with overweight or obesity and type 2 diabetes on stable GLP-1 RA therapy.

Interest of FSL 2 in Recently Diagnosed Type 2 Diabetic Patients

Therapeutic patient education (TPE) is a key element in the management of people living with type 2 diabetes. The benefit of therapeutic education (TPE) has been clearly established on glycaemic control. Continuous interstitial glucose monitoring (CGM) can be considered as a TPE tool for people living with diabetes. A direct reading of the effects of diet and physical activity on glycaemic levels could have an impact on the initiation and maintenance of therapeutic lifestyle modifications. The investigators therefore propose a prospective randomised study in 2 arms : * a group of people living with diabetes receiving standard TPE vs * a group of people living with diabetes receiving standard TPE + FSL 28 days Ourmain objective is to determine the benefit of CGM on HbA1c at 3 months between 2 arms

Long-term Follow-up of Pituitary and Hypothalamic Dysfunction in Children Who Have Suffered Moderate to Severe Head Trauma Included in the ENDOC TC Cohort

The annual incidence of traumatic brain injury (TBI), all causes combined, varies between 180 and 300 per 100,000. TBI increases the risk of death or serious sequelae by a factor of 8. Studies conducted in adults have shown an anterior pituitary deficit in 28% to 68% of patients with TBI. The variability of these studies does not currently allow for standardization of the management of these children in either the acute or late phases. Several studies, including a Lyon-based study called Endoc TC (Ref. Clinical Trials: NCT01250132), have aimed to investigate the association between anterior pituitary deficits in the acute phase and those identified a few months after the trauma. Since then, few studies have been conducted more than five years after the trauma to study its pituitary consequences. To date, the investigators have sought to study the long-term prevalence of pituitary and hypothalamic dysfunction in patients who suffered moderate to severe head trauma during childhood, specifically patients included in the initial Endoc TC study in Lyon. To this end, the main objective is to determine the current height of these patients and whether there are any associated growth delays or other clinical signs that may suggest the presence of a pituitary or hypothalamic hormone deficiency. This study consists of a telephone questionnaire lasting approximately 15 minutes, with participants from Lyon who took part in ENDOC TC study, designed to determine the growth of these patients and the presence or absence of symptoms that may be related to post-traumatic damage to the hypothalamic-pituitary system linked to head trauma.

The Influence of Virtual Reality on Blood Parameters

The goal of this study is to learn what the impact of exposure to virtual reality content is on the levels of stress-related blood values in healthy volunteers. The main question it aims to answer is: * To compare the levels of stress-related biomarkers before and after relaxing VR-content (Relax Visit); * To compare the levels of stress-related biomarkers before and after stress-inducing VR-content (Rollercoaster Visit). Researchers will compare the Relax and Rollercoaster Visit to see if there is a relationship between the relaxing and stress-inducing VR content on stress-related blood values. Participants will be asked to watch relaxing or stress-inducing VR content for approximately five minutes. Blood will be withdrawn before and after intervention. After 3-5 weeks the study visit will be repeated using the other VR content.

BEhavioral and Adherence Model for Improving Quality, Health Outcomes and Cost-Effectiveness of healthcaRe

Lack of adherence to treatment is a widespread issue worldwide, which leads to higher healthcare utilisation rates and even premature death. While the level of adherence may differ based on the specific condition and treatment, studies estimate that approximately 50% of medications are not taken according to the prescribed instructions. In addition, adherence rates tend to decrease even further when the treatment requires a behavioural change. Literature reviews about factors that affect people's adherence show that it is challenging to predict whom can be considered to have adherent and non-adherent behaviours. In addition, the studies highlight that it is challenging to support a person to be adherent. Based on this knowledge the BEAMER project was established (Behavioural and Adherence Model for improving quality, health outcomes and cost-Effectiveness of healthcaRe). The overall goal of the project is to improve the quality of life of individuals, enhance healthcare accessibility and sustainability, thereby transforming the way healthcare stakeholders engage with patients to understand their condition and adherence levels throughout their healthcare journey. To address the overall goal, the BEAMER project has developed a disease agnostic model named "B-COMPASS: BEAMER-COmputational Model for Patient Adherence and Support Solutions". The aim of the B-COMPASS is to identify patients' needs and preferences which enables the creation of patient-specific supports, with the intention of improving their adherence to treatment within the heterogeneity of the different disease-areas and healthcare contexts. Based on the validated BEAMER questionnaire, the B-COMPASS predicts relative adherence and offers an elicitation process of patient needs and preferences to enable targeted supports to improve patient adherence. This results in an allocation of patients to different groups based on their needs and preferences. Overall, the B-COMPASS provides patient insights that will enable more effective design of patient support, most likely resulting in better patient experience, improved adherence and lower healthcare and societal costs. So far, several activities from a technical and user perspective have already been conducted in the project to refine the B-COMPASS. This has been done by applying an iterative mixed method approach were both stakeholders (regulator, pharma, academic/research and small and medium-sized enterprises) and end users (patients, health providers and health systems) have been involved. Despite the finetuning of the B-COMPASS, the effectiveness of the B-COMPASS hinges on empirical investigations into the structural elements that impact patient behaviour and the identification of predictive factors that can assist healthcare providers' (HCP) and Research Leads in designing more effective treatment plans (the term HCPs/Research Lead include both the individuals and the institutions where care is delivered). Therefore, validation studies will be conducted to assess the B-COMPASS's performance in six therapeutic areas (cardiovascular, endocrinology, immunology, neurology, oncology and rare diseases) with patients recruited in at least Italy (FISM), Portugal (APDP and MEDIDA) Norway (AHUS), Spain (FHUNJ and FIIBAP), The Netherlands (WDO), and Germany (UDUS). The collected data will be used to evaluate the B-COMPASS's capacity to attend to a variety of needs and challenges for adherence.

Retrospective Study of the Cohort of Transgender Patients Who Began Medical Support Before the Age of 18

Gender incongruence is characterized by a marked and persistent incongruity between the gender with which a person identifies and their assigned sex. Behaviors and preferences that vary by sex do not, in and of themselves, justify the assignment of diagnoses in this group.