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NCT06856902
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.
NCT06851858
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.
NCT07007416
This prospective observational study aimed to evaluate the effects of supraphysiological estradiol (E2) levels, induced by gonadotropin therapy during IVF, on cardiac electrophysiological parameters. Sixty-two women aged 18-40 undergoing IVF treatment at Konya City Hospital between December 2024 and January 2025 were included. ECG recordings were performed twice: once before gonadotropin stimulation and again on the day of hCG administration, when peak E2 levels were expected. Routine blood tests and hormone levels were also evaluated. Patients with obesity, cardiovascular disease, chronic illness, or medication use were excluded. After treatment, significant increases were observed in PR interval, J-Tpeak, QTc, and Tp-e values. E2 changes showed a moderate negative correlation with QTc and a low positive correlation with J-Tpeak. The results suggest that elevated E2 levels during IVF may affect cardiac electrophysiology, highlighting the need for careful monitoring in women with cardiac risk factors.
NCT06687252
Variations in genital development (VDG) account for 0.5% to 1% of births. Advances in ultrasound techniques, as well as in prenatal diagnosis techniques, particularly in genetics, have led to improvements in the prenatal diagnosis of these pathologies. However, to date, there is no consensus on etiological research and standardized management of these patients and their families, once VDG has been detected. The value of multidisciplinary management has already been demonstrated, but a number of grey areas remain: the frequency of false-positive ultrasound findings, the place of invasive antenatal diagnostic tests, the role left to parents during the diagnostic process, the frequency of associated malformations discovered post-natally, and how to prepare for immediate management at birth. The aim of this study is to improve the management of patients and their families as soon as a Disorders of Sexual Development is detected antenatally. The primary objective is to describe the management, particularly complementary investigations performed in the antenatal management of ultrasound diagnoses of Disorders of Sexual Development over the last 10 years. The secondary objectives are : * To determine the correlation between pre- and post-natal morphological phenotype and the proportion of false positives in antenatal ultrasound diagnosis. * To characterize prenatally diagnosed Disorders of Sexual Development * To determine the proportion of isolated prenatally-diagnosed Disorders of Sexual Development that turn out not to be isolated during postnatal follow-up. * The evaluation of the care pathway : * To establish the frequency of prenatal psychological support for parents * To establish the role of parents in prenatal diagnosis strategy decisions at our center