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NCT ID: NCT06438159 Not yet recruiting - Cardiac Disease Clinical Trials

Impact of Mindfulness-Based Stress Reduction Meditation Practice on Patients After Cardiac Rehabilitation.

CARDIO-MBSR
Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Cardiac rehabilitation is a major component of treatment for patients suffering from coronary pathology revealed by myocardial infarction or acute coronary syndrome warranting transluminal coronary angioplasty, as well as in the aftermath of cardiac surgery. A significant proportion of patients in this situation (40%) suffer from varying degrees of anxiety and depression, which are difficult to treat. These impair their quality of life and can make it more difficult for them to take part in the rehabilitation program, compromising the results that can be expected. Finally, they are often associated with lax compliance with medical treatment, less control of risk factors and less regular exercise. Cardiac rehabilitation teams are well aware of this anxiety-depressive picture, and various therapies such as sophrology, relaxation and yoga have been proposed as alternatives to conventional medical treatments to help patients through this period. Among these alternatives is the concept of "Mindfulness-Based Meditation", based on the Mindfulness-Based Stress Reduction (MBSR) protocol described by Dr. JKabat Zinn. It has been the subject of several prospective randomized studies, which have demonstrated that it is suitable for the management of patients in this situation, and that it has measurable beneficial effects on their sense of well-being. To our knowledge, the MBSR program used in cardiac rehabilitation has never been the subject of a randomized comparative study in France to assess its effectiveness on medium- and long-term anxiety-depressive disorders. This is the objective of this study.

NCT ID: NCT06438042 Recruiting - Pressure Ulcer Clinical Trials

Prevention of Pressure Ulcers in Patients at High Risk of Developping Pressure Ulcers Using the Low-pressure Motorized Air Support Mattress With XTECH®25 Control Unit

Start date: June 11, 2024
Phase:
Study type: Observational

The aim of the study is to determine the clinical value of using a a low air pressure motorised therapeutic mattress in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a high risk of PI, without PI, lying more than 20 hours a day on a XTECH®25 mattress will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the XTECH®25 mattress is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

NCT ID: NCT06437847 Not yet recruiting - Cognitive Disorder Clinical Trials

Assessment of the Need to Use Short Cognitive Tests for French General Practitioners/Family Doctors

Start date: June 2024
Phase:
Study type: Observational

The prevalence of cognitive disorders is constantly increasing, with 1.2 million patients affected in France in 2016. Dementia is currently the seventh leading cause of death. In the absence of available treatment, systematic screening is not recommended. However, cognitive evaluation is recommended to maintain a level of autonomy for the patient at home. Targeted screening is the responsibility of the general practitioner. The latest recommendations from the HAS (2011) highlight the use of the MMSE as a first-line approach, there are no recommendations regarding short tests. Early cognitive assessment is limited by the time required to perform the tests and the knowledge about the available tools. The Codex is a short test, its sensitivity (92%) and specificity (85%) place it among the most discriminatory scores. It is underutilized in France. The objective of this thesis is to assess the training needs of general practitioners in short tests.

NCT ID: NCT06436586 Completed - Clinical trials for Kidney Transplantation

Impact of HLA Evolutionary Divergence and HLA Donor-recipient Molecular Mismatches on Kidney Allograft Rejection

Start date: February 1, 2022
Phase:
Study type: Observational

The Human Leucocyte Antigen (HLA) system is pivotal in kidney transplant rejection. In-silico methods such as HLA eplet mismatches and PIRCHE-II scores have emerged to refine HLA immunogenicity assessment and stratify patients for immunological risk. However, large-scale studies in unselected large kidney transplant cohorts are lacking to support their broader clinical applicability. Additionally, recent studies on HLA evolutionary divergence (HED), quantifying HLA polymorphism, highlight its potential impact on rejection. Yet, the association of HED with kidney allograft rejection or de novo DSA occurrence remains unexplored in kidney transplantation. The complexity introduced by diverse in-silico methods for assessing HLA immunogenicity necessitates further research to comprehensively understand their role in relation to kidney allograft rejection. This project thus aims to investigate the association between various aspects of HLA immunogenicity, including HLA molecular mismatches and HLA evolutionary divergence, along with standard immunological and clinical parameters assessed at the time of transplantation, with the occurrence of antibody-mediated rejection and de novo DSA formation post-transplant in a large, comprehensively annotated kidney transplant cohort.

NCT ID: NCT06436118 Completed - Surgery Clinical Trials

Evaluation of the Use of the RELAX® Glasses on the Anxiety of Patients Undergoing Emergency Hand Surgery Under Locoregional Anesthesia

RELAX
Start date: May 2, 2022
Phase: N/A
Study type: Interventional

More than 90% of hand surgery is performed under local anesthesia and can be a source of anxiety, especially in an emergency context. The management of this intraoperative anxiety is essential for the comfort. The use of a virtual reality headset has shown its effectiveness in reducing anxiety in dental surgery or hand surgery under local anesthesia with the WALANT technique. On the other hand, virtual reality and the use of 3D can cause discomfort and side effects such as nausea and dizziness. It is known that audiovisual distraction also effectively reduces pain and anxiety in patients with fewer side effects. The investigators have therefore chosen to use the RELAX® glasses. There are no publications examining the effectiveness of positive distraction as a non-pharmacological agent to improve the patient experience during emergency management in the operating room in the context of hand surgery under locoregional anesthesia. The investigatos would like to study its action on the anxiety, pain and global satisfaction.

NCT ID: NCT06436027 Completed - Clinical trials for Heart Transplant Rejection

Molecular Diagnosis of Heart Allograft Rejection Using Intra-Graft Targeted Gene Expression Profiling.

Nano-Heart
Start date: November 10, 2021
Phase:
Study type: Observational

The goal of this observational study is to develop and validate a molecular heart rejection diagnostic system based on targeted transcriptome as a novel monitoring companion tool for heart allograft precision diagnostics applicable to formalin-fixed paraffin-embedded endomyocardial biopsies. The primary outcome will be the biopsy-proven rejection, that will be predicted with molecular classifiers (cellular and antibody-mediated rejection scores).

NCT ID: NCT06435689 Not yet recruiting - Colon Cancer Clinical Trials

Study and Modulation of Immune Responses in Primary and Metastatic Colon Cancers

I-COMET
Start date: June 15, 2024
Phase:
Study type: Observational

Colorectal cancer (CRC) is the 3rd most common cancer in France. Treatment of CRC relies primarily on surgical removal of the primary tumor and chemotherapy is the current standard of care for synchronous metastatic disease. Overall survival remains strongly correlated with the tumor stage at the time of surgery, from 90% at five years for localized disease (stages 1 and 2), to around 20% for metastatic forms of the disease (stage 4). Recent research in cancer highlights the role of the immune system in the development, evolution and fate of tumors. Understanding the nature of interactions between different immune cells infiltrating the tumor is important for the development of innovative therapies. Recently, the consensus molecular classification of CRC confirmed the importance of the immune response in CRC by showing that a "high immune response" is a good prognostic indicator for patients with this pathology. However, immunotherapies are effective for only a minority of patients with metastatic CRC. Indeed, anti Programmed cell Death 1 (anti-PD-1), -PD-L1 immune checkpoint blocking antibodies have only shown effectiveness in patients with microsatellite instability (MSI), which only represents 5% of metastatic CRCs. Thus, the aim of this study is to better understand the role of the immune system on the development of CRC and its possible modulation to treat or prevent metastatic recurrences.

NCT ID: NCT06435546 Recruiting - Breast Cancer Clinical Trials

Adherence to Oral Therapies in Advanced Breast and Prostate Cancers

AdOTAC
Start date: June 4, 2024
Phase: N/A
Study type: Interventional

AdOTAC is a pilot study, open, prospective, single-center, one-arm. The 200 patients will be included. Patient is included at Day 0. The included patient will have the opportunity to complete the self-questionnaires either at the ICL on Day 0, or at home up to 10 days after the date of inclusion in the study. Blood samples are collected the day of enrolment (Day 0) in order to measure the following biological markers: ferritin, serum iron, TSAT, albumin, and haemoglobin, except if performed as part of routine care in the previous 6 weeks.

NCT ID: NCT06435468 Not yet recruiting - Autoimmune Diseases Clinical Trials

Biocollection of Rare Pediatric-onset of Autoimmune and Autoinflammatory Diseases

GENIALII
Start date: July 2024
Phase: N/A
Study type: Interventional

Rare diseases are defined as those that affect one person in 2,000, or around three million people in France. The majority of rare diseases are caused by genetics and tend to be severe when they begin in childhood. Autoimmune and autoinflammatory diseases, such as systemic lupus, juvenile dermatomyositis, and juvenile idiopathic arthritis, are examples of rare pediatric diseases. While autoimmune diseases are characterized by an inappropriate adaptive immune response, autoinflammatory diseases involve an excess of the innate immune response. The precise mechanisms of these diseases are not yet fully understood, but recent research has led to advances in their diagnosis and identification, particularly in early onset and familial forms. However, the rarity of these diseases and limited availability of biological samples pose significant challenges. This study aims to create a biological collection, which includes primary cells (PBMC), DNA, RNA, lymphoblastic lines, and serum, that will help identify genetic and immunological abnormalities in rare autoimmune and autoinflammatory diseases through various research projects.

NCT ID: NCT06434506 Completed - Orthodontic Wires Clinical Trials

Prevalence of the Wire Syndrome

Start date: July 2, 2022
Phase:
Study type: Observational

The Wire Syndrome problem referred to dental displacements that can be described as aberrant, inaccurate, unexplained, or excessive on teeth still contained by an intact orthodontic wire, without detachment or fracture, leading to evolving dental and periodontal, aesthetic and/or functional consequences. The objective of this study was to define the prevalence of mandibular wire syndrome and the associated risk factors.