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NCT ID: NCT04033367 Completed - Atopic Dermatitis Clinical Trials

SAR231893-LPS15497- "Dupilumab Effect on Sleep in AD Patients"

Start date: August 22, 2019
Phase: Phase 4
Study type: Interventional

Primary Objective: To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD). Secondary Objectives: To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation. To continue to assess the safety and tolerability throughout the study.

NCT ID: NCT04033055 Completed - Inguinal Hernia Clinical Trials

Antalgic Efficacy of CycloMeshâ„¢ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia.

HENRI
Start date: October 31, 2019
Phase: N/A
Study type: Interventional

CycloMesh is a polyester visceral implant functionalized by drug delivery systems directly on its surface, targeting a unique intervention, a slow anesthetic release and an in situ activity. Based on the fact that cyclodextrins are capable of forming inclusion complexes with amino-amide anaesthetic agents, ropivacaine and cyclodextrins were combined on a commercial visceral mesh.This enables CycloMesh to release ropivacaine for a sustained period in order to improve patient's comfort after inguinal hernia surgery. The underlying hypothesis of this work is that clinical gain is achieved by adding a drug delivery system to visceral mesh for the local and prolonged delivery of ropivacaine. This should results in an improvement in quality of life, a reduction in pain and a faster returning to work following treatment of inguinal hernia by lichtenstein technique.

NCT ID: NCT04032769 Completed - Pulmonary Embolism Clinical Trials

Modified Strategy to Safely Rule Out Pulmonary Embolism in the Emergency Department

MODIGLIA-NI
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown. This is a non-inferiority, cluster cross-over randomized, international trial. Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods. All centers will recruit adult emergency patients with a suspicion of PE. In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA. In the intervention group (MODS) : All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule : - If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised. If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.

NCT ID: NCT04032509 Completed - Clinical trials for Mild Traumatic Brain Injury

A Study of Biomarkers of Mild Traumatic BRAIN Injury

BRAINI
Start date: August 10, 2019
Phase:
Study type: Observational

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

NCT ID: NCT04031937 Completed - Clinical trials for Major Depressive Disorder

Sensory and Psychomotor Profile in Depression

DEPCOR
Start date: October 23, 2018
Phase: N/A
Study type: Interventional

Despite a possible psychomotor retardation during a depressive episode, standardized psychomotor assessment is rare. So, other possible psychomotor disorders or neurological "soft signs" are not known in depression. The investigator propose in this study to explore the psychomotor characteristics of patients with a major depressive disorder from the realization of a psychomotor assessment in comparison with adult without depressive disorder (control). It will be specifically assess muscle tone, gross motor skills, praxis, body schema and the body image and the perceptions.

NCT ID: NCT04031690 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Health and Quality of Life Assessment Project for Caregivers of Idiopathic Pulmonary Fibrosis Patients

HELP-IPF
Start date: October 14, 2019
Phase:
Study type: Observational

Idiopathic pulmonary fibrosis (IPF) is a chronic, disabling disease characterized by a progressive and irreversible deterioration in respiratory function, resulting in impaired quality of life (QoL) and patient dependence. The factors involved in the alteration of QoL in these patients are the physical symptoms related to fibrosis (dyspnea, cough, fatigue) and psychological symptoms (anxiety and depression) as well as social, relational and financial factors, the experience of the disease and disability, the time required for diagnosis, the information received, and the initiation of a treatment such as oxygen therapy. Caregivers primarily in chronic diseases (so-called natural or informal caregivers) provide partial or total assistance to a dependent person for activities of daily living for care, social support and maintenance of autonomy, administrative procedures, psychological support, communication, domestic activities or even financial assistance, often despite their own exhaustion and health issues. Recent studies on the QoL of patient-caregiver dyads in IPF through semi-structured interviews highlight the role of previously identified factors in caregivers as well. Investigators want to confirm the data obtained in a large population of patients and their caregivers in order to evaluate the QoL of caregivers and confirm the impact of its various factors on it in order to suggest ways to improve the lives of both the caregiver and the patient. The hypothesis of investigators' work is that the QoL of caregivers of patients with IPF is altered, particularly by the patient's functional symptoms (cough, dyspnea, fatigue, anxiety and depression), the arrival of oxygen therapy in the home and the caregiver's social isolation. Investigators believe that there are links and interactions between the caregiver's and patient's quality of life and therefore have an impact on the patient's care.

NCT ID: NCT04030494 Completed - Hypertension Clinical Trials

Validation Study of an Advanced Blood Pressure Monitor

TALISMAN
Start date: March 13, 2019
Phase: N/A
Study type: Interventional

The proposed clinical study aims to validate the effectiveness of the WPM04 blood pressure monitor developed by Withings as a diagnostic tool for cardiovascular disorders. The detection of cardiovascular disorders is oriented along three axes, namely the measurement of blood pressure, the identification of rhythm disorders such as atrial fibrillation and the identification of heart murmur indicating valvular heart disease.

NCT ID: NCT04029870 Completed - Clinical trials for Osteoporosis, Postmenopausal

Psychological Determinants of the Therapeutic Observance of Osteoporotic Patients

OSTEOPSY
Start date: June 17, 2019
Phase:
Study type: Observational

Osteoporosis is a skeletal pathology characterized by decreased bone mass and deterioration of bone tissue. This pathology affects predominantly women, which is estimated that 40% of them will suffer an osteoporotic fracture. The incidence of osteoporosis, thus representing a major public health problem where osteoporotic fractures have a higher incidence than those combined with cardiovascular disease and breast cancer (INSERM, 2016; WHO 2008). It causes traumatic fractures that have the effect of dependence and loss of functional autonomy associated, in terms, with the risk of a reduction in life expectancy. The management of osteoporosis therefore becomes an issue for rheumatologists. The latter involves both compliance with hygienic-Dietetic measures (such as calcium intake, physical activities, prevention of falls...) and medicated treatments whose action is intended, for some, to block bone destruction or, for others to stimulate bone formation. The efficacy of drug treatments is now proven, these treatments are however profitable only if the therapeutic adherence of the patients is maximal. However, rheumatologists and researchers generally find an average rate of 70% enrolment after 6 months of treatment, most often lowered to 50% after 12 months of treatment, thus increasing fractures. On the other hand, the literature informs the medical and educational aspects of the problem of non-observance in osteoporotic patients, but curiously, it does not say anything of the psychological aspects likely to be linked to these behaviors of non-adherence to therapy. The objective of this thesis work is to take an interest in the underlying psychological determinants that may explain the behaviour of adherence and/or non-adherence of osteoporotic patients.

NCT ID: NCT04029064 Completed - Clinical trials for Isolated Right Aortic Arch

Management of Prenatally Diagnosed Isolated Right Aortic Arch

ARCADE
Start date: April 1, 2019
Phase:
Study type: Observational

The existence of a right aortic arch integrates nosologically into the group of aortic vascular arch anomalies. In the majority of cases, a right aortic arch is associated with cono-truncal congenital heart diseases (CHD), such as tetralogy of Fallot, pulmonary atresia with ventricular septal defect, and truncus arteriosus. Sometimes, a right aortic arch can be isolated, with an incidence of 0.05% to 0.1 %. Therefore, an assessment of the anatomy is necessary because an isolated right aortic arch can be associated with an encircling aortic arch anomaly and may subsequently have a functional repercussion, creating a digestive obstacle (oesophageal compression) and/or a respiratory obstacle (tracheal compression). Furthermore, indications for surgery in this type of abnormalities are not well-established. The diagnosis of a vascular artery anomaly is currently mostly made prenatally, with increasing diagnostic accuracy. Indeed, the application of the "3VT view" (e.g. three vessels and tracheae view) in routine prenatal sonographic screening for CHD has contributed to a better identification of such anomalies. Prenatal diagnosis of an isolated right aortic arch involves the identification of the following aspects: the existence of a left ductus arteriosus may relate to an increased risk of an encircling aortic arch anomaly at birth; the analysis of the different vessels of the aortic arch, which can be difficult because of the fetal circulation and the maternal-fetal conditions of the examination; and the absence of a thymus, which suggests the existence of a genetic anomaly, such as DiGeorge syndrome. After birth, the evaluation of the functional repercussion of the anomaly remains complex. The incidence of secondary symptoms to encircling abnormalities is estimated at 25%, but varies according to the anomaly: it is very frequent in case of a double aortic arch, variable in case of a right aortic arch with left ductus arteriosus (from 9% to 47% in the literature), absent in case of right aortic arch with right ductus arteriosus. Postnatal echocardiography can only assess the existence of a right aortic arch and check ductus arteriosus closure. The complete anatomical diagnosis of a vascular artery anomaly can only be made by slice cardiac imaging (CT scan or MRI), but in practice these examinations are not routinely performed in the absence of neonatal symptoms. The aim of this study is to evaluate the accuracy of prenatally diagnosed isolated right aortic arch in terms of anatomy and functional prognosis. The secondary aims are : - to specify the association of an isolated right aortic arch with a genetic anomaly, - to define the role of CT scan in children prenatally diagnosed with right aortic arch, in terms of diagnosis, prognosis and follow-up, - to evaluate the incidence of respiratory and digestive complications in the first year of life, - to evaluate the indications for surgical management during the first year of life.

NCT ID: NCT04029051 Completed - Dyspnea Clinical Trials

Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the Emergency Department

echoelderly
Start date: January 1, 2016
Phase:
Study type: Observational

Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee