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NCT ID: NCT05611437 Recruiting - Laryngeal Edema Clinical Trials

Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation

REVEAL
Start date: December 1, 2022
Phase:
Study type: Observational

In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%. Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality. Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.

NCT ID: NCT05611255 Recruiting - Urinary Retention Clinical Trials

Comparison of Two Bladder Catheterization Strategies in Thoracic Surgery Patients With an Enhanced Recovery After Surgery (ERAS)

URICATHOR
Start date: December 8, 2022
Phase: N/A
Study type: Interventional

General anesthesia, thoracic epidural, and morphine inhibit the urination process and promote postoperative Acute Urinary Retention (AUR) after thoracic surgery. Indwelling bladder catheterization prevents this risk, but is associated with other complications (urinary tract infection, delayed mobilization). With the rise of enhanced recovery after surgery (ERAS) protocols, bladder catheterization is being questioned. The current protocol in the department is to catheterize only patients with a high bladder volume in the post anesthesia care unit (defined as a bladder volume > 400 ml on bladder scan). Preliminary results from the "AirLeaks" study show a high rate of early postoperative AUR (approximately 50%). The investigators believe that a "systematic intermittent catheterization" (SIC) strategy is superior to the current "bladder scan-guided catheterization in the post anesthesia care unit" (BSGC) strategy in preventing the risk of postoperative AUR. To their knowledge, no study has compared these two bladder catheterization strategies in a thoracic accelerated rehabilitation protocol.

NCT ID: NCT05611047 Recruiting - Multiple Sclerosis Clinical Trials

Telerehabilitation of Multidomain Cognitive Impairment in Multiple Sclerosis

TELECOG-MS
Start date: February 21, 2023
Phase: N/A
Study type: Interventional

Treating cognitive impairment (CI) in multiple sclerosis (MS), the leading cause of disability due to nontraumatic neurological disease in young adults, is an important challenge. The contribution of CI to disability in MS has been increasingly recognized, and CI has been shown to decrease health-related quality of life (HR-QOL), even in the early stages of the disease. CI negatively impacts daily activities such as driving, vocational status, absenteeism, and instrumental activities in persons living with MS (PwMS). No medication has proven to have a consistent symptomatic effect on CI in MS, and disease-modifying therapies only have a small impact on CI progression. CI in MS is dominated by a slowdown in information processing speed (IPS), as well as by disturbances of more specific cognitive functions such as attention, episodic memory (EM), working memory (WM) and executive function (EF). The alteration of IPS has consequences for WM, attention, EF and EM. IPS impairment predicts subsequent disability and vocational status and changes in quality of life (QOL). Cognitive rehabilitation (CR) is the most promising approach for treating MS-related CI, as concluded by recent reviews and meta-analyses, despite important methodological shortcomings. Methodological limitations in early studies have led to disappointing results, and well-designed studies are still scarce. As noted recently, many studies lack a randomized controlled design that includes passive or active control conditions, primary neuropsychological end-points identified a priori, evidence of the sustainability of CR and the inclusion of near and far transfer outcomes. Tertiary outcomes of QOL, metacognition, or other patient-reported outcomes (PROs) are rarely used. In view of the results of these different studies, the investigators propose a single-blind randomized controlled trial of a telerehabilitation program for MS associated CI, based on Rehacom software, using appropriates modules according to specific CI, but complemented by individual remote online rehabilitation sessions allowing a better adaptation of the program to the patient's deficit, a more efficient supervision and meta-cognitive work. This program will be evaluated in terms of effectiveness on neuropsychological tests, effectiveness on specific cognitive domains re-educated according to the impairments detected in the baseline, an ecological evaluation and the impact on daily cognitive functioning. Specific active rehabilitation will be compared to a placebo intervention of the same duration and intensity. Only a multi-center study will make it possible to achieve sufficient number of patients to meet these objectives.

NCT ID: NCT05610995 Recruiting - Clinical trials for Premature Exit After Colorectal Surgery

Feasibility Study of Early Return-home After Colorectal Surgery Using a SENSIUM® Vital Parameter Monitoring Device

Colo-SENSIUM
Start date: July 22, 2023
Phase: N/A
Study type: Interventional

The principal aim of this study is to evaluate the impact on length of stay of a return-to-home monitoring device versus enhanced rehabilitation after bowel resection surgery with anastomosis. The device SENSIUM is a tool to monitor vital signs (respiratory rate, heart rate and temperature) by applying a connected skin patch in order to detect complications early.

NCT ID: NCT05610930 Completed - Clinical trials for Objective Understanding of Nutritional Label

Is a Front-of-package Label Contaning Information on Both Nutrient Profile and Ultra-processing Well Understood?

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

A modified version of the Nutri-Score (Nutri-Score 2.0), containing an additional graphic mention when the product is ultra-processed, has been proposed. The investigators aim to study, in a randomised controlled trial design nested in the NutriNet-Santé cohort, the impact of this modified version on the objective understanding of foods' nutritional quality, and on the identification of UPFs as primary outcomes. They also aim to study as secondary outcomes the impact of this label on purchasing intentions and the product perceived as the healthiest.

NCT ID: NCT05610683 Completed - Clinical trials for End Stage Renal Disease (ESRD)

Comparison of the Removal of Uremic Toxins With Medium Cut-off and Super High-flux Vitamin E-coated Dialyzers

E-FLUX
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

End-stage renal disease (ESRD) induces an accumulation of uremic toxins responsible for increased morbidity and mortality. These toxins cover a wide range of molecules, classified according to their molecular weight as small-size (< 500 Da), middle-size (500 Da-60 kDa), and protein-bound toxins. Specific complications have been associated with the accumulation of middle-size toxins, including beta2-microglobulin (12 kDa), myoglobin (17 kDa), prolactin (23 kDa), alpha1-microglobulin (33 kDa), alpha1-glycoprotein (44 kDa), kappa (22 kDa) and lambda (45 kDa) free light chains (FLC). Moreover, mediators of oxidative stress such as asymmetric dimethylarginine, malondialdehyde, oxidative-LDL and inflammatory cytokines such as Interleukin-6 (IL)-6, IL1-β, TNF-α have been involved in atherosclerosis, malnutrition, cardiovascular events and mortality. Hemodialysis (HD) remains the main standard modality of renal replacement therapy in ESRD. In the past decade, low-flux hemodialysis was most commonly used, providing effective clearance of small solutes through diffusion, but negligible clearance of middle molecules. This limitation was insufficiently improved by the development of high-flux (HF) dialyzers due to their cut-off pores size values of approximately 15-20 kDa. In fact, most of middle molecules cannot be efficiently removed by HF-HD because of their molecular radii larger than that of membrane pores. Thus, HF dialyzers were used in post dilution on-line hemodiafiltration (OL-HDF) mode with high convection volumes and achieved greatest clearance of middle molecules. However, OL-HDF is generally not available in most HD centers and needs additional hardware technology. Therefore, several super high-flux (SHF) dialyzers integrating higher cut-off size pore value and achieving Beta2-microglobulin clearance > 70 ml/min were developed for HD mode. These SHF dialyzers used in HD (SHF-HD) provides similar middle molecules depuration compared to OL-HDF. The recently developed medium cut-off (MCO) dialyzer (Theranova 500™, Baxter healthcare Corporation Deerfield, USA; surface area 2 m², ultrafiltration coefficient: 59 ml/h/mmHg) differs from conventional HF membranes by higher and controlled porosity resulting in a steep sieving curve with a cut-off value approaching that of albumin. MCO-HD has demonstrated efficient depuration of middle uremic toxins as compared to HF-HD, similar to that of OL-HDF. MCO-HD and SHF-HD are two new large pore size dialyzers currently used nowadays in HD. In addition, the interaction between blood and membrane surface play a key role in generating oxidative stress and inflammation. Antioxidants such as vitamin E work by inhibiting LDL oxidation and by limiting cellular response to oxidized LDL. In HD patients, vitamin E may be integrated as a part of the HD procedure in the form of bioreactive dialysis membranes, in which the blood surface has been modified with alpha-tocopherol. Dialysis with vitamin E-coated membranes has been associated with an improvement in biocompatibility including circulating lipid peroxidation biomarkers and cytokine induction. In small studies, vitamin E coated dialyzers have been associated with reduced red blood count fragility and improvements in erythropoietin resistance index and erythropoietin requirements in HD. VieX (Polysulfone, surface area: 2.1 m², sterilization gamma, ultrafiltration coefficient: 104.3 ml/h/mmHg, Asahi Kasei Medical, Japan), a novel SHF vitamin E-coated (SHVE) dialyzer, which has larger pore size than HF dialyzer, might provide higher middle molecules removal and biocompatibility improvement. The aim of the present study was to compare the efficiency of the SHFVE dialyzer (VieX™) versus the MCO dialyzer (Theranova 500™) on the removal of beta2-microglobulin and other middle molecules in a non-inferiority fashion, and their respective effects on inflammation, oxidative stress and biocompatibility parameters.

NCT ID: NCT05610670 Recruiting - Parenthood Status Clinical Trials

Access to Parenthood and Gynecological Follow-up After Organ Transplantation

FerGyTransplan
Start date: October 10, 2022
Phase: N/A
Study type: Interventional

Solid organ transplants affect subjects of all ages, including young women of childbearing age. The improvement in the management of young female transplant patients makes it possible to consider pregnancies, about which the literature reports reassuring data on small series. The question of gynecological follow-up, access to parenthood, as well as the information and experience of patients regarding these issues after transplantation have thus become topical issues.

NCT ID: NCT05610618 Recruiting - Clinical trials for Physiological Reactivity to Cues

Study of Brain Activity Underlying Predictive Mechanisms During the Perception of Visual Scenes

PREPER
Start date: March 20, 2023
Phase: N/A
Study type: Interventional

This study aims to clarify the mechanisms by which the predictions we have about our visual environment influence the processing of expected or unexpected visual stimuli at the cerebral level.

NCT ID: NCT05610436 Recruiting - Long COVID Clinical Trials

Post-Covid Condition Cohort: Evolution of Symptomatology, Patient Profile and Associated Prognostic Factors

SYNPOCov
Start date: January 7, 2022
Phase:
Study type: Observational

The aim of our cohort is to collect prospectively, in a standardized and exhaustive manner, the health data of patients referred to the CAPCoV, our holistic referal post covid clinics for post-covid condition in order to be able to identify typical profiles of patients suffering from post covid syndrome and to follow the evolution of their disease over time.

NCT ID: NCT05610280 Active, not recruiting - Clinical trials for Cardiovascular Diseases

A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.