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NCT ID: NCT04399655 Completed - Clinical trials for Renal Insufficiency, Chronic

Highlighting the Medico-economic Interest of an Adapted Physical Activity for Haemodialysis Patients

NEPHRACTIVE
Start date: November 12, 2020
Phase:
Study type: Observational

Chronic hemodialysis is often associated with a reduction in the quality of life of patients and a reduction in physical activity, due to the repeated frequency of sessions. Various studies conducted in hemodialysis patients have shown the beneficial effects of physical exercise during hemodialysis sessions on reducing cardiovascular risk, the number of hospitalizations and improving quality of life. It also contributes to improved patient adherence to care. Finally, it has been shown that exercise during the hemodialysis session is safe for the patient and does not disrupt dialysis parameters. Nevertheless, there are no data on the medico-economic impact of such a program. Based on the investigators' experience, the investigators have developed a specific protocol linking the different types of physical activity that have provided evidence of their efficiency and used in standard practice in the investigators' institutions. From tests and questionnaires assessing the physical abilities of patients have already validated for this population in this pathology. The objective of this project is to show the medico-economic interest of an adapted physical activity program for hemodialysis patients.

NCT ID: NCT04399551 Completed - HIV Infections Clinical Trials

A Study Evaluating Implementation Strategies for Cabotegravir (CAB)+ Rilpivirine (RPV) Long-acting (LA) Injectables for Human Immunodeficiency Virus (HIV)-1 Treatment in European Countries

Start date: September 28, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of the CAB LA + RPV LA clinical development program is to develop a highly effective, well-tolerated, two-drug, LA injectable regimen which has the potential to offer improved treatment convenience, compliance and improved quality of life for people living with HIV compared to current standard of care. This interventional study will examine different implementation strategies in different clinic settings across European countries to identify strategies which best meet the needs in each local context and involve both participants receiving study treatment CAB LA + RPV LA (patient study participants [PSP]) as well as the healthcare providers at the investigator site level (staff study participants [SSP]). SSPs consists of 2 groups: standard and enhanced arm.

NCT ID: NCT04399278 Completed - Surgery Clinical Trials

End-eXpiratory Occlusion Test to Predict fluId REsponsiveness in the Operating Room (EXPIRE)

EXPIRE
Start date: August 3, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to evaluate the influence of different durations of the end-expiratory occlusion test to predict fluid responsiveness in mechanically ventilated patients in the operating room.

NCT ID: NCT04399200 Recruiting - Stroke Clinical Trials

Apnea, Stroke and Incident Cardiovascular Events

ASCENT
Start date: July 13, 2020
Phase:
Study type: Observational

This prospective cohort study aims to compare the proportion of cardiac or cerebrovascular events after a first stroke, a first transient ischemic attack (TIA) or recurrent TIA, between sleep-disordered breathing (SDB) and non-SDB (control) patients, one year after SDB diagnosis, performed 3 months after stroke onset. The primary outcome is a composite endpoint composed of cardiac or cerebrovascular events regrouping: death from any cardiac or cerebrovascular cause, non-fatal stroke, and non-fatal acute coronary disease. 1620 patients, in the acute phase of a first stroke, TIA or recurrent TIA will be included in the cohort. Clinical, neuroimaging, sensorimotor, cognitive and biological parameters will be collected at inclusion. Three months after stroke or TIA onset, polysomnography will be performed for SDB diagnosis. Patients will be considered as having SDB for an Apnea-Hypopnea Index (AHI) > 15 events/hour, or to the control group otherwise. The same clinical, imaging, cognitive and biological assessments than during the first visit will be performed; incident (new) cardiovascular events will be collected. Three months later, and at 1, 2, 3, 4 and 5 years after SDB diagnosis, the same clinical, cognitive, sensorimotor, and sleep-related evaluations will be performed. In addition to the aforementioned parameters, incident cardiovascular outcomes will be collected, at the same time points. The primary study outcome will be retrieved one year after stroke onset.

NCT ID: NCT04399018 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Development and Prospective Validation of a Standardized Flow Cytometric Assay of Peripheral Blood Neutrophil Myeloperoxidase Expression for Ruling Out Myelodysplastic Syndromes.

MPO-MDS-Develp
Start date: July 27, 2020
Phase:
Study type: Observational

Myelodysplastic syndromes (MDS) comprise a heterogeneous group of clonal bone marrow neoplasms that predominate in the elderly, with a median age at diagnosis of 70 years. The diagnosis of MDS relies on peripheral blood cytopenia and morphologic dysplasia for one or more hematopoietic cell lineage. Cytopenia is evidenced with hemogram while dysplasia requires bone marrow aspirate, which is an invasive procedure . Considering the low prevalence of disease among subjects referred for suspected MDS, many patients are exposed to unnecessary bone marrow aspiration-related discomfort and harms. Therefore, an objective assay based on a peripheral blood sample that accurately discriminates MDS from other cytopenia etiologies is highly desirable. We have previously developed and refined a flow cytometric analysis protocol for quantifying neutrophil MPO expression in peripheral blood at three university-affiliated hospitals (i.e., Clermont-Ferrand, Saint-Etienne, and Grenoble) (Raskovalova et al, Hematologica 2019). We found that the robust coefficient of variation (RCV, computed as the robust standard deviation divided by the median) within an individual subject was the best parameter in discriminating patients with versus without MDS. Although promising, flow cytometric analysis of neutrophil MPO expression in peripheral blood is technically complex, time consuming, and not standardized. Hence, its performance requires specific expertise and the results show substantial variability. A single ready-to-use tube with lyophilized antibodies would have the potential to standardize the measurement of neutrophil MPO expression in peripheral blood across laboratories, with results available within 30-60 min in routine practice. In this study, the investigators hypothesize that a standardized and semi-automatic flow cytometric assay of neutrophil MPO expression in peripheral blood could accurately rule out MDS and obviate the need for bone marrow aspiration and biopsy, with sensitivity and negative predictive value estimates approaching 100%. In this observational diagnostic accuracy study, burden will be null for recruited patients. No specific intervention is assigned to participants. All diagnostic testing, procedures, and medication ordering are performed at the discretion of attending physicians. A test result will have no impact on patient management. .Compliance with current guidelines disseminated by the French Haute Autorité de Santé (HAS) will be advocated for the diagnostic work-up of patients with suspected MDS. No follow-up visits are planned in this cross-sectional study.

NCT ID: NCT04398667 Terminated - Refractory Epilepsy Clinical Trials

European Non-interventional Study on Refractory Epilepsy With Developmental Delay

Start date: March 14, 2019
Phase:
Study type: Observational

This is a multinational, multicentre, non-interventional, retrospective data collection (manual Medical Chart Review).

NCT ID: NCT04398524 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma of the Oropharynx

A Phase II Study of Cemiplimab and ISA101b in Patients With Recurrent/Metastatic HPV16 Positive OPC

Start date: July 1, 2021
Phase: Phase 2
Study type: Interventional

This will be an open-label, phase 2 study in which subjects will receive ISA101b and cemiplimab.

NCT ID: NCT04398381 Completed - Intensive Care Unit Clinical Trials

Prognosis of SRD Patients in the ICU

ProSyDICU
Start date: March 1, 2017
Phase:
Study type: Observational

Critically ill systemic rheumatic disease (SRD) patients have benefited from better provision of rheumatic and critical care in recent years. Recent comprehensive data regarding in-hospital mortality and most importantly long-term outcome are scarce. The aim of this study is to assess short and long-term outcome of patients with SRD admitted to the ICU in a retrospective cohort study (2006 - 2016).

NCT ID: NCT04398017 Terminated - Cardiac Diseases Clinical Trials

MEOPA-coupled Hypnosis Versus MEOPA-standard Care in Transesophageal Echocardiography

HYPNETO
Start date: October 14, 2020
Phase: N/A
Study type: Interventional

The primary purpose is to evaluate the impact of hypnosis coupled with MEOPA (Equimolar Mix-ture of Nitrogen Protoxide and Oxygen) on patient comfort when performing transoesophageal echocardiographies. Further studies on the use of MEOPA alone or the technique of hypnosis alone in the context of an TEE, would not be innovative in any way in view of previous studies or already in progress. However, service has led to perform TEEs several times by combining MEOPA and hypnosis. Doctors noted a clear reduction in induction time for hypnosis and satisfaction of the patient and operators. This association technique is very often used in pediatrics. According to one study, it seems that MEOPA increases the threshold of suggestibility and imagination. However suggestion and imagination are two essential notions of the hypnotic technique. To date, doctors have not found any other studies combining MEOPA and hypnosis for adults patients in the context of TEE. This leads to the following hypothesis: Is there a difference for the patient in terms of for the global management of pain and anxiety between an TEE performed under MEOPA with a standard support and TEE under MEOPA coupled with hypnosis with support standard? Secondary purposes are: 1. Compare patients' feelings / opinions: patients who have benefited from hypnosis associated with MEOPA versus patients who have been treated with MEOPA alone. 2. Compare patient stress: patients who have benefited from hypnosis associated with MEOPA versus patients who have benefited from MEOPA alone. 3. Compare the operators' feelings / opinions: procedures that have been performed under hypno-analgesia and MEOPA versus standard procedures under MEOPA alone. 4. Failed the TEE procedure

NCT ID: NCT04397835 Completed - Depression Clinical Trials

Psychological Impact of COVID-19 Quarantine and Worsening of Cardiovascular Risk in the French General Population

PSYCOV-CV
Start date: April 17, 2020
Phase:
Study type: Observational

In response to the COVID-19 outbreak, the French government put in place home quarantine of the general population in order to limit the transmission of the virus. It is obvious that quarantine at home have a psychological impact which could worsened cardiovascular risk. Our aim is to assess risk factors for severe stress, anxiety or depression, during and after quarantine, as well as risk factors (including stress, anxiety or depression), in the worsening of cardiovascular risk.