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NCT ID: NCT06428877 Completed - Surgery Clinical Trials

Monocentric Retrospective Observational Study; Analysis of Gore Excluder ACS Device Using Numerical Simulation

ACSSim
Start date: June 15, 2023
Phase:
Study type: Observational

andated when the risk of rupture is low and interventional treatment is offered to patients at high risk of rupture. Rupture risk is driven by aneurysm diameter and growth rate. Aneurysms with diameter greater than 55 mm and/or growth rate greater than 1 cm per year are at high risk of rupture. Open surgery and endovascular treatment are the two types of interventions. Open repair consists in replacing the aneurysmal part of the aorta using a synthetic fabric prosthesis after the abdomen has been opened and the aorta clamped. This invasive procedure is associated with a 3-10% post-operative mortality. Endovascular repair (EVAR) consists in excluding the aneurysm sac by inserting a self-expanding prosthesis (called stent-graft) through very small groin incisions, without abdominal opening nor aortic clamping. This minimally invasive procedure is associated with a significantly reduced post-operative mortality (around 1%) . However, hostile proximal neck anatomy including high angulation is associated with higher rates of type IA endoleak, reintervention and long-term mortality . For this reason, a conformable design of the Excluder stent-graft has been engineered with initial satisfactory results in patients with highly angulated or short necks . However, these satisfactory results have been obtained in carefully selected patients from experienced centers and a tool demonstrating adequate apposition of the Gore ACS is lacking. Study Device Description Numerical simulation has been used successfully to predict stent-graft behavior during FEVAR . Preliminary studies have also demonstrated to applicability of the technology to standard infrarenal devices , including in the setting of very tortuous anatomies9 . The potential of numerical simulation to predict stent-graft apposition of Gore ACS in highly angulated necks appears very promising to enhance patient selection.

NCT ID: NCT06428864 Completed - Scoliosis Clinical Trials

Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis

GSSCAN
Start date: September 1, 2023
Phase:
Study type: Observational

Neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. Thoracic braces are necessary to slow down the deformation. In France, Garchois brace is largely used in this context because of a better pulmonary tolerance. Historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. He/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). The position during molding could be very uncomfortable and anxious. With the development of new technologies, a 3D scan application on smartphone to obtain the volume and deformations of the patient was developed. This tool enables digital acquisition of trunk and head volume while bypassing the seated patient. No plaster strips are used. The resulting negative is digitally filled to obtain a positive. The positive is then corrected before the corset is made, either digitally or after 3D scanning, in plaster or foam. This application was first used in our department in 2017. The aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding.

NCT ID: NCT06428279 Completed - Clinical trials for Integrative Oncology

Cross-sectional Survey of Sexual Health in Cancer Patients

S&C
Start date: April 19, 2024
Phase:
Study type: Observational

Sexual health, a vital aspect of the overall human health and a critical component of quality of life, can be negatively affected by cancer and cancer treatments. Although prevalence rates of sexual difficulties vary depending on several factors including primary diagnosis, treatment modality and methods of assessment, estimates rates are reported to range from 40% to 100%. Despite the abundant literature on sexuality and intimacy, communication about sexual health is often absent or inadequate between patients and health care providers. In this context, more research is needed to understand patients' priorities and needs for information about sexuality. The purpose of this study is to assess the main difficulties faced by patients in their sexual life and to evaluate patient's satisfaction after having followed sessions of psychosexual therapy proposed at Rafaël Institute, France. The survey will be conducted using questionnaires developed specifically for this study. All questions will be coded through a Likert scale from 1 (strongly disagree) to 7 (strongly agree). Responses to each question will be analyzed with higher mean scores (>4) indicating main difficulties faced by patients in their sexual life. Patients will also express their positive or negative state of agreement regarding questions evaluating their satisfaction after following a program of psychosexual therapy. Approximately 200 patients will be invite to participated in this survey after provided oral consent.

NCT ID: NCT06416683 Completed - Clinical trials for Atezolizumab and Bevacizumab in Hepatocellular Carcinoma

Atezolizumab and Bevacizumab Combination Recommended in a Multidisciplinary Consultation Meeting in Caen for Hepatocellular Carcinoma (ABCHCaen)

ABCHCaen
Start date: January 1, 2021
Phase:
Study type: Observational

In France primary liver cancers (PLC) is the fourth leading cause of cancer-related death in men, and the seventh in women. The number of new cases per year is predicted to increase by 26.5% between 2020 and 2040. Hepatocellular carcinoma (HCC) account for 75% to 85% of PLC. It occurs mostly on cirrhotic livers. Diagnosis remains late in almost half of the patients so that a palliatif treatment is frequent. In advanced cases sorafenib has been so far the first line systemic therapy since 2008. In 2020 a phase 3 study has demonstrated a better overall survival in patients treated with bevacizumab associated with atezolizumab as compared to sorafenib (19.2 months vs 13.4 months) and a better quality of life. Noweday immunotherapy is recommended in first line in cases of ECOG 0/1 unresectable HCC without liver insufficiency. However the study included 70% of viral liver diseases while HCC are related to alcohol and steatohepatitis in 50% of cases in France. Moreover patients with high risk of oesophageal variceal bleeding were excluded. Recent real life data published worldwide confirm the bitherapy efficacy and good tolerability. By contrast french data are scarces, with a single serie of 43 patients in which median overall survival was estimated to 12 months. Our main aim is to determine the overall survival of HCC patients treated with atezolizumab and bevacizumab in Caen from april 2021.

NCT ID: NCT06415929 Completed - Melanoma Clinical Trials

Etude rétrospective Monocentrique MATRIX

Start date: March 20, 2024
Phase:
Study type: Observational

"Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. Monocentric retrospective study.Analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. Objective: To assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. "

NCT ID: NCT06408324 Completed - Clinical trials for Primary Immune Thrombocytopenia (ITP)

Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe

Start date: November 24, 2022
Phase:
Study type: Observational

The goal of this multicenter, observational, retrospective is to evaluate the standards of use of thrombopoietin receptor agonists (TPO-RA) in adult patients with primary immune thrombocytopenia (ITP), with a particular interest on phase of ITP (defined according to time when diagnosis of ITP is established in the medical records: newly diagnosed, 0-3 months; persistent, 3-12 months, and chronic, > 12 months), tolerability, safety, posology and remissions, outside controlled clinical trials. Secondary Objectives: To analyze the patient characteristics that could affect the choice of thrombopoietin receptor agonist for the treatment of ITP, considering specific clinical aspects (such as previous thromboembolic disease, bleeding, platelet count, surgical procedures, etc.). To evaluate the degree of adherence to international guidelines related to the use of thrombopoietin receptor agonists in regular clinical practice. Data will be collected through a retrospective chart review of patients with ITP who started TPO-RA treatment between January 2014 and December 2018.

NCT ID: NCT06408129 Completed - Latent Tuberculosis Clinical Trials

COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)

COMPASS-TB
Start date: January 31, 2017
Phase:
Study type: Observational

The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.

NCT ID: NCT06401902 Completed - Carotid Stenosis Clinical Trials

Diabetes and Risk of Ischemic Stroke.

Start date: January 1, 1990
Phase:
Study type: Observational

Diabetes in an independent risk factor for ischemic stroke, whose associated mortality rate is higher and sequelae more serious than for nondiabetics. Diabetes increases the risk of stroke or death after surgical carotid revascularization or endoluminal angioplasty. It is, with contralateral ICA occlusion, 1 of the 7 factors doubling the stroke risk after carotid endarterectomy. Diabetes also enhances the cerebral hemorrhage risk associated with carotid surgery, thrombectomy or thrombolysis revascularization of the cerebral arteries. This study was undertaken to examine whether the hemodynamic cerebral ischemia (HCI) frequency, which increases stroke severity, is higher in diabetics than nondiabetics and, if diabetes carries an excess HCI risk, whether it is independent of contralateral ICA occlusion.

NCT ID: NCT06400758 Completed - Public Health Clinical Trials

Impact/Interest of a Collective Prevention Intervention in Sexual and Emotional Health

Impex
Start date: March 14, 2024
Phase:
Study type: Observational

Main objective To measure the effects of a group prevention intervention on the sexual and affective knowledge of high school students in the Basse-Normandie region. Secondary objective Take stock of what is known about the sexual and emotional health of teenagers.

NCT ID: NCT06393491 Completed - Anorexia Nervosa Clinical Trials

Equine-assisted Therapy and Anorexia Nervosa

Start date: November 2, 2020
Phase:
Study type: Observational

Background: Severe anorexia nervosa is a complex psychiatric pathology with limited therapeutic tools to reduce morbidity and mortality. Equine-assisted therapy could provide additional therapeutic benefits. Objectives : The investigators aimed to explore the effects of equine assisted therapy on the experience of adolescents with severe anorexia nervosa. Méthods : Using a qualitative approach based on Interpretative Phenomenological Analysis, the investigators conducted semi-structured interviews with nine participants who had taken part in equine-assisted therapy sessions.