There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Given the current emerging epidemic of the MonkeyPox Virus (MPXV) and its route of transmission, the main objective of this pilot study is to characterize the presence of the MPXV in the semen of patients in the acute phase of infection and following this infection.
To date, many studies have focused on the characteristics of PID in children, allowing to highlight an entry into the disease in the context of more or less severe infections in all pediatric departments. However, only one study has so far studied the frequency of these PID in a pediatric resuscitation unit, which is why we propose this study to the Caen University Hospital. Investigtors propose a two-step study, both retrospective and prospective, in order to increase our cohort. The retrospective analysis of the data will be done over the period 2013-2016, the prospective analysis will be done from May 2017 to January 2018. The study will be monocentric, performed in the pediatric resuscitation department of the University Hospital of Caen to evaluate the prevalence of PIDs and describe their characteristics. The included patients will be aged 0 to 18 years, hospitalized in the pediatric intensive care unit for a serious infection and / or of an unfavorable evolution, or an opportunistic germ infection in the absence of a DIP or an immunodeficiency previously known. The inclusion will be proposed by the intensive care pediatricians. Authorization by the legal representative will be required in advance. The data will be collected during the systematic consultation in pediatric haemato-immuno-oncology within 3 months after their hospitalization in intensive care unit to detect a DIP by a thorough interrogation, a clinical examination and a first-line biological assessment. A second consultation will be scheduled in the 3 months following the 1st with announcement of the results of the first balance sheet and completion of a second complementary balance sheet if a suspicion of DIP persists at the end of the first balance sheet. The precise description of the incidence of these immunodeficiencies and their characteristics could lead to the development of recommendations on the routine screening of PID in pediatric resuscitation; an early diagnosis enabling preventive and curative management (vaccine, immunoglobulin, antibiotic prophylaxis, etc.) to be put in place in order to limit the risk of infectious recurrence and reduce the morbidity.
The rationale of the ROSY-T study is to continue to provide study treatment for patients who have participated in a parent study with osimertinib and who are continuing to derive clinical benefit from treatment at the end of such studies, as judged by the Investigator.
Hemophilia A (HA) is an X-linked bleeding disorder caused by mutations in the F8 gene. Bleeding in patients with moderate/mild HA can be treated with either FVIII concentrates or desmopressin (DDAVP). This drug acts as a vasopressin type 2-receptor agonist that causes endothelial cells to rapidly secrete von Willebrand factor (VWF) and factor VIII (FVIII) into the bloodstream. One advantage of DDAVP is that it increases the level of endogenous FVIII, thus avoiding the need for potentially immunogenic exogenous FVIII. It is also cheaper than FVIII concentrates. Finally, it is more widely available in pharmacies in all hospitals with emergency rooms and surgical facilities. DDAVP usually increases the basal FVIII (FVIII activity) level by 3- to 4-fold. Thus, complete correction of the FVIII level (>0.5 IU.mL-1) was achieved in different series as early as 1 hour after its administration in 50-60% of patients with mild HA. Since responses to DDAVP vary widely between individuals, it is recommended that each patient undergoes a therapeutic test before treatment. Several factors influence the FVIII response to DDAVP. The two most important are basal FVIII levels and the F8 gene defect. Rare studies related to the effect of genotype on DDAVP responses, but included relatively small patient groups (<100), with few patients sharing a similar genotype. As such, it has been difficult from a statistical point of view to formally demonstrate the influence of the F8 genotype on the DDAVP response. The objectives of the GIDEMHA study (Genetic Influence of Desmopressin Efficacy in Mild/moderate Hemophilia A) are: description of the post-DDAVP FVIII pharmacokinetics (PK) in a large retrospective cohort of patients with mild/moderate HA, research of patients-related factors influencing this FVIII PK, and building of predictive population- and Bayesian-based models. The study comprises 2 independent cohorts: - GIDEMHA-1 includes patients who had a DDAVP test from 2010 to 2020 in 4 centers. The influence of F8 variants on post-DDAVP FVIII PK is first analyzed then age, VWF level, blood group, weigh and DDAVP doses. - GIDEMHA-2 includes patients who had a DDAVP test from 2020 to 2023 in the previous 4 centers (Angers, Caen, Nantes and Rennes) plus patients who had a DDAVP test from 2010 to 2023 in 2 other centers (Brest and Tours). This is a replicative cohort allowing to build predictive models based on the above described influencing factors.
This study conducted in 90 adults living with type 1 diabetes is an interventional single-arm open-label before/after multicentric national study conducted as a clinical investigation according to the law EU 2017/745 art. 62. After a 14-day baseline period during which the patient will use a Dexcom G6 Continuous Glucose Monitoring (CGM) and his current therapy (multiple daily injection or open-loop pump), the patient will start a 42-day treatment period during which he will use the DBLG1 System, a closed loop system (including a DBLG1 handset, a TERUMO MEDISAFE WITH insulin pump, in addition to his Dexcom G6 CGM). An optional 6-week extension period with treatment will be proposed to patients agreeing to pursue the use of the DBLG1 system. The main objective is to evaluate the safety and efficacy of the DBLG1 System with a TERUMO MEDISAFE WITH insulin pump in closed-loop for 6 weeks in 90 adults with type 1 diabetes. Data related to their glycemia, complications, usability and quality of life will be collected. The study is completed when all patients have their "end of study" file completed in the electronic Case Report Form (eCRF).
Trauma patient care requires collaboration and interaction with close relationship between many stakeholders from different professions (senior doctor, intern, nurse, nurse helpers, surgeons, etc). This is a stressful situation where decision and action need to be quick, decisive and coordinate. In this situation, quality of care and patient safety depends on a good interprofessional communication. The acquisition of advanced communication skills, team management and leadership, stress management are essentials elements in the practice of Intensive and trauma care. However, advanced structured training or assessment of theses skills is lacking in medical education or Healthcare professionals training. The study therefore, aimed to develop a global and attractive training to help healthcare professionals to improve their skills. Captain SonarTM is a naval battle game where two teams each composed of four participants clash. Each player has a well-defined role and it is imperative to communicate in a closed loop to advance in the game. This game also includes components similar to support for shock management: stress, speed of action, central communication and teamwork of four protagonists (Team Leader-Captain, intern-Second, nurse-Mechanic, Nurse help-Detector). It may improve team building, team leadership, interprofessional work, communication, stress management. The study hypothesis is that this board game would have an impact on the performance of professionals when facing a multiple trauma simulated patient. (differences in terms of technical and non-technical performance. Different use of closed loop communication, Different stress management, different efficiency and interprofessional collaboration with potentially a reduction in the timing of treatment being delivered in trauma room)
The incidence of fall in older adults aged 65 and over is estimated at 30%, and 50% of the people aged 80 and over with at least one fall a year. Falls are associated with significant morbidity and mortality. The origin falls is often multifactorial, involving intrinsic and extrinsic factors. Few studies have investigated the association with all antidepressants. Potential adverse effects of antidepressants such as hyponatremia, sedation, orthostatic hypotension, extrapyramidal symptoms are known risk factors for falls. Due to multimorbidity, polypharmacy including interaction risks, and aging-related changes in pharmacokinetic and pharmacodynamic of drugs, antidepressants may further increase this risk in older patients. Based on the World Health Organization global database, the main objective of this study is to investigate the association between antidepressants classes and the occurrence of falls reported in the database. A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of falls. A mediation analysis will also be performed. It will aim to examine some of the mediators involved in the association between antidepressants classes and falls.
Exhibitionism is a paraphilia, which is defined according to the DSM 5. The estimated prevalence in men is between 2 to 4% (The prevalence of exhibitionistic disorder in females is even more uncertain but is generally believed to be much lower than in males). At judiciary level: approximately 30% of apprehended male sex offenders are exhibitionists. They have the highest recidivism rate of any sex offender; about 20-50% are arrested again. The studies are old and not very prolific on the subject of exhibition. The available data are lacking, there is no clinical evaluation scale for exhibitionism. The diagnosis is essentially based on facts with judicial characteristics "did patient show himself? ", "Does he enjoy showing off?". Investigators have no data on the cognitive distortions that support this particular acting out, the (specific) triggering factors and the potential psychological vulnerabilities of exhibitionists Some cognitive and sensory mechanisms may be involved in the origin and development of the processes underlying the act (Johnston and Ward 1996). The investigators will rely on the identification of anticipatory, relieving and permissive beliefs as a schema that can explain cognitive processes leading to acting out (Johnston and Ward, 1996). The goal is to apply this approach to exhibitionism. It should be noted that this model of thoughts (anticipatory, relieving and permissive) is taken up in the field of addiction. Exhibition is generally presented in the literature as a possible addictive disorder (Jon E. et al). The investigators will investigate whether there are specific factors precipitating exhibitionnism's acting out, other than the general precipitating factors or the recidivism risk factors known in sexual violence (SONAR, STATIC-99, PCL- R, SVR-20…). The investigators will also study the psychological vulnerabilies of these subjects.