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NCT ID: NCT04869007 Not yet recruiting - Clinical trials for Cesarean Section; Dehiscence

The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction

NICHE-ART
Start date: April 2021
Phase:
Study type: Observational

The prevalence of Caesarean sections continues to increase around the world. In France, the proportion of Caesarean sections has doubled from 11% in 1981 to 20,2% in 2016, bringing with it an increase in the risk of obstetrical complications. Uterine defects, or Isthomcele, first defined by Morris in 1995 as a scarring abnormality with a dehiscence of the hysterotomy following a caesarean section. This purely iatrogenic pathology can cause inter-menstrual bleeding or pelvic pain. Several definitions of isthmosceles exist in scientific literature with variations according to the nature of the reference examination chosen and the measurements made. However, for the majority of authors, isthmoceles are characterized by a residual myometrial thickness of less than 3 millimetres in the sagittal plane. The prevalence of isthmoceles amoung patients with a unicicatricial uterus is about 61%. Currently, the main diagnostic technique for isthmoceles are 2D or 3D ultrasound and hysterosonography. Small, non-controlled studies have found that surgical treatment of the isthmocele is effective in reducing metrorrhagia. In these studies, the authors noted that patients with metrorrhagia were also more frequently affected by secondary infertility. A small number of non-comparative studies with a low level of evidence have looked into the efficacy of surgical treatment of isthmoceles on related symptoms: metrorraghia, pelvic pain and/or secondary infertility. Their results show an idiopathic secondary infertility rate in the presence of isthmoceles prior to surgical treatment of approximately 66%. Significantly higher pregnancy rates after treatment suggest that the surgical management of isthmoceles is worthwhile. However, these data suffer from not negligible selection bias. The initial findings concerning fertility after surgical repair seem promising and some teams propose systematic surgical management of the isthmocele before a technique of assisted reproduction (ART) although without any evidence in literature. Isthmocele surgery can result in uterine perforations, adhesions and intrauterine synechia known to be detrimental to future fertility. The efficacy of surgical management of surgey must therefore be demonstrated prior to any attempts at treatment. This will require large prospective studies based on a consensual definition of isthmocele. The diagnosis using Hysterosonography is currently considered as the "gold standard" examination. The main hypothesis of our study is that a significant isthmocele, defined by a residual myometrial thickness of less than 3mm, measured in the sagittal plane by hysterosonography, could alter the results of ART.

NCT ID: NCT04865068 Not yet recruiting - Diagnosis Clinical Trials

Echocardiographic Standards and Sub-Saharian Africans (SSA) Migrants' in New Aquitaine Region

NEMANA
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

Standards Echocardiographic have been defined mainly on caucasian or Asian populations. In the EchoNoRMAL study the criteria for African populations were based solely on data from 198 subjects. This study suggests the presence of different standards depending on the ethnic origin of the subjects. The aims of this study is to describe the proportion of subjects reclassified (normal-pathological) according to the use of echocardiographic norm differences showed in TAHES population (Sub Saharian Africans) with those routinely used

NCT ID: NCT04858581 Not yet recruiting - Covid19 Clinical Trials

Prospective Clinical and Virological Analysis of Healthcare Workers Diagnosed Positive for Covid-19.

Pro-Co-HPA
Start date: December 2021
Phase: N/A
Study type: Interventional

Coronavirus disease 2019 (COVID-19) is an acute infection of the respiratory tract that emerged in late 2019. In several studies, the cardinal signs of COVID-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. In addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%). An increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the COVID-19. Mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of SARS-CoV-2 infection were identified. But, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. In this context of an emerging viral infection such as SARS-CoV-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.

NCT ID: NCT04852146 Not yet recruiting - Clinical trials for Acute Coronary Syndrome

Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.

FERVEUR
Start date: September 2022
Phase:
Study type: Observational

ST+ Acute Coronary Syndrome (ACS) is a major cause of mortality, morbidity and healthcare costs in Europe and France. Emergency trans-luminal angioplasty (TLA), the gold standard treatment, is the major determinant of vital prognosis and functional recovery of patients with ST+ ACS. However, data from surveys and French practice registers highlight frequent deviations from the recommendations at different stages of the procedure; in the pre-hospital phase these malfunctions result in longer delays. Improving the quality of care for patients with ST+ ACS, and in particular improving compliance with recommended delays in the acute phase, is a public health priority in France. Feedback has been identified as one of the most effective interventions to improve practices and organisations in healthcare institutions. Feedbacks are defined as "any summary of a care performance over a given period of time that can be transmitted a posteriori to the health professional in any form, whether written, oral or by computer (in this case called e-feedbacks)". Feedbacks, by objectifying the level of individual and collective performance, encourage recipients to modify their practices and organisations to improve their performance. It also acts as a social pressure mechanism. While the minimum elements of feedback have been identified in the literature, there is a lack of information about the optimal operational modalities for their deployment, which limits the system's capacity to implement them. To overcome this lack of information, there is a consensus in the scientific community that research on feedback should focus not only on analysing its effectiveness, but above all on the determinants of its effectiveness. With regard to the quality of management of patients with ST+ ACS, only four trials were found in the literature that studied the effectiveness of feedbacks; none of them defined the optimal intervention for deploying feedbacks in the emergency department setting. Practice registers, particularly in the cardiovascular field, have shown their effectiveness in improving practices, particularly through the implementation of feedback to practitioners, who produce data. In 2012, the ARS Aquitaine set up two regional cardiovascular registers constituting permanent, nominative, continuous and exhaustive records of the management of patients suffering from coronary pathologies: the Aquitaine Interventional Cardiology Register (ACIRA) and the Aquitaine Register of Initial Management of Myocardial Infarction (REANIM). The cross-referencing of the REANIM and ACIRA registers constitutes an exhaustive cohort of patients with ST+ ACS containing information on the management of the entire care pathway, from the onset of symptoms to the end of the hospitalization for the management of the acute episode. This cohort, which is unique in France in the field of coronary pathologies, makes it possible to produce unprecedented and highly accurate information, particularly concerning the time taken to provide care. Wishing to actively engage in a process of changing practices, the Aquitaine Cardiovascular Registries team has developed an e-feedback tool for emergency, EMS and cardiology teams. This tool alone cannot contribute to effectively improving patient care. It is necessary to build an intervention for the deployment of this tool that takes into account the scientific data and the organisational constraints of care. Secondly, the evaluation of the effectiveness and economic impact of this e-feedbacks tool deployment intervention will allow us to know its real added value on practices, organisations and health care expenditure.

NCT ID: NCT04852094 Not yet recruiting - Prematurity Clinical Trials

Family-centered Round in Neonatology

VINCI
Start date: September 1, 2021
Phase:
Study type: Observational

The family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. In a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. In France, parents are rarely actively involved in the medical round. The aim of this study is to plan the implantation of the Family-centered round in a neonatal department using the 6 steps of the "Intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; Curriculum development; 5- adoption and implementation; 6- evaluation and dissemination

NCT ID: NCT04851600 Not yet recruiting - Limb Deficiencies Clinical Trials

Early Prosthetics in Children With Upper Limb Deficiency

EARLIMB
Start date: May 2021
Phase:
Study type: Observational

For children with congenital upper limb deficiency, introduction of the prosthesis is guided by clinical experience rather than by Evidence Based Medicine. This study will assess early development in children with upper limb deficiency according to age at the introduction of the prosthesis. This study will give new keys in these specific prosthesis cares.

NCT ID: NCT04849585 Not yet recruiting - Covid19 Clinical Trials

Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection

POSTREACOVID
Start date: June 2022
Phase:
Study type: Observational

To evaluate the psychological, physical, social, professional and family impact of a hospitalization in intensive care for a covid 19 by analysis of the verbatim during a semi-structured interview.

NCT ID: NCT04841824 Not yet recruiting - Clinical trials for Critical Illness With or Without Sepsis

TRanscriptomic Analysis of Circulating Endothelial Cells During Sepsis - TRACES Study

TRACES
Start date: April 2021
Phase:
Study type: Observational

Vascular dysfunction is an important mechanism involved in organ failure, in the setting of sepsis condition, with different types of circulating endothelial cells.Transcriptom analysis via RNAseq in different types of circulating endothelial cells, comapring critically ill patients with or without sepsis will allow determining differential gene expression for signal pathways in endothelial alteration and restoration associated with sepsis.

NCT ID: NCT04834947 Not yet recruiting - Covid19 Clinical Trials

Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19

Start date: April 15, 2021
Phase:
Study type: Observational

Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position.

NCT ID: NCT04834596 Not yet recruiting - Clinical trials for Detection of Liver Metastases

Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma

OOPS
Start date: May 2, 2021
Phase:
Study type: Observational

Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer