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NCT ID: NCT05272202 Recruiting - Clinical trials for Accidental Awareness During General Anesthesia

Investigation of Cerebral Motor Activity Modulations Following Median Nerve Stimulation During General Anaesthesia

Start date: January 15, 2023
Phase: Early Phase 1
Study type: Interventional

Accidental Awareness during General Anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). Actually, no monitoring techniques can accurately predict or detect an AAGA. Since the first reflex for a patient during an AAGA is to move, a brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. The investigators previously showed that median nerve stimulation (MNS) could be the keystone of a BCI specialized in the detection of movement intention. Indeed, based on these previous results, the investigators can envisage a routine system where the patient would be stimulated at the median nerve position, while a BCI device would analyze the event-related desynchronization (ERD) and event-related synchronization (ERS) modulations in the motor cortex to check whether the patient is intending to move or not. According to the investigator's knowledge, no published studies have investigated the detection of EEG patterns in relation to peripheral nerve stimulation over the sensorimotor cortex during general anesthesia. The main objective of this study is to describe the changes in terms of ERD and ERS modulations, in the EEG signal over the motor cortex, during general anesthesia with propofol, while a median nerve stimulation is performed. STIM-MOTANA is an interventional and prospective study conducted in patients scheduled for surgery under general anesthesia, involving EEG measurements and median nerve stimulation. In this study, 30 patients will undergo surgery under total intravenous anesthesia using a propofol target-controlled infusion pump. The rest of the anesthetic protocol will be at the discretion of the anesthesiologist in charge. Changes in ERD and ERS during median nerve stimulation according to the various propofol concentrations will be continuously monitored by an EEG amplifier. Pre- and post-injection comparisons of propofol will be performed by paired series tests. After surgery, patients will have a gradual decrease of propofol at different effect-site concentrations (from 4.0 μg/ml to 2.0 μg/ml, in increments of 0.5 μg/ml).

NCT ID: NCT05272020 Recruiting - Clinical trials for Aortic Valve Stenosis

Outcome, Recuperation and Hemodynamics in Aortic Stenosis

PROCARE-AS
Start date: March 22, 2021
Phase: N/A
Study type: Interventional

Indication for aortic valve replacement (AVR) in aortic stenosis (AS) is currently based on the classical triad of clinical AS symptoms, estimation of AS severity, and cardiac repercussion at rest. However, presence of symptoms in elderly is often subjective and underreported, and cardiac function analysis at rest underestimates the true impact of the chronic afterload increase. This complicates the diagnosis and hampers timely aortic valve replacement therapy with an impact on prognosis and cardiac function recovery. Exercise imaging in AS may reveal underlying cardiac repercussion and symptoms at an earlier stage and therefore impact prognosis and cardiac function recovery after AVR. Therefore the principal objective of this study is to reveal the factors that determine clinical outcome and hemodynamic function recovery after AVR in AS.

NCT ID: NCT05271344 Recruiting - Pancreatic Cancer Clinical Trials

Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

SIO3D
Start date: April 8, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.

NCT ID: NCT05270668 Recruiting - Clinical trials for Interstitial Lung Disease

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

ATHENA-SSc-ILD
Start date: July 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

NCT ID: NCT05269264 Recruiting - Clinical trials for Lower Limb Lymphedema

Development of a Clinical Screening, Diagnostic and Evaluation Tool for Patients With Lower Limb Lymphedema: Aim 1

EvaLymph-Leg1
Start date: February 7, 2022
Phase:
Study type: Observational

Of all of the different measurement methods that are currently available for use in clinical practice for assessing the same lymphedema characteristic (for example water displacement versus perimetry, both assessing swelling) or different lymphedema characteristics (for example water content in the skin versus hardness of the skin versus thickness of the skin), a clear overview about the reliability, concurrent validity (if applicable) and clinical feasibility is missing for the assessment of lower limb lymphedema (LLL). The objective of this observational cross-sectional study is to investigate the (day-to-day) reliability and clinical feasibility of currently applied measurement tools in patients with LLL.

NCT ID: NCT05269212 Recruiting - Clinical trials for Failed Back Surgery Syndrome

Return to Work for Persistent Spinal Pain Syndrome Type II Patients

OPERA
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.

NCT ID: NCT05268952 Recruiting - Clinical trials for Neuroendocrine Tumors

A Study to Evaluate the Value of Circulating Tumour DNA in Follow-up of Patients With an Advanced Gastroenteropancreatic or Lung Neuroendocrine Tumour Under Everolimus +- SSA Treatment (Liquid-NET 2.0)

Start date: May 27, 2019
Phase: N/A
Study type: Interventional

Prospective, multicentric, single arm, POC study to evaluate the value of CtDNA in follow-up of patients treated with everolimus, with or without somatostatin analogues for advanced gastroenteropancreatic or lung neuroendocrine tumours.

NCT ID: NCT05268783 Recruiting - Quality of Life Clinical Trials

Patient-reported Outcomes in Neuroendocrine Neoplasms: a Prospective Quality of Life and Quality of Care Study Within NETwerk

Quali-NET
Start date: November 5, 2018
Phase: N/A
Study type: Interventional

Neuroendocrine tumors (NET) are rare tumors that require specific diagnosis and treatment. Therefore, this poses a challenge for clinical practice. Diagnosis and treatment can be optimized when physician specialists and other healthcare providers, across various hospitals, join forces to provide patients the best care. Based on this idea, a hospital network called NETwerk was set up. The following hospitals are part of this network: University Hospital Antwerp, VITAZ, AZ Monica, AZ Voorkempen, AZ Klina, Gasthuiszusters Antwerpen, Ziekenhuis Netwerk Antwerpen and AZ Rivierenland. In this NETwerk, patients with a neuroendocrine tumor or patients suspected with a neuroendocrine tumor are discussed with the specialists and treated.The aim of this study is to map the quality of life of NET patients within NETwerk in order to optimize the quality of care. Throughout the diagnosis, the treatment process and the follow-up, the patient will be asked to fill out three questionnaires (QLQ-C30, QLQ-GI.NET21 and a satisfaction survey). These questionnaires will be filled out every six months at home. Patients will be asked to complete these questionnaires over a period of five years.

NCT ID: NCT05267808 Recruiting - Clinical trials for Obstructive Sleep Apnea

Pathophysiological Endotyping Using Baseline Polysomnography Data

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

The study is designed to develop models to predict site of collapse information using routine polysomnography. In an observational study, the investigators will study 1000 patients with obstructive sleep apnea (OSA) who have had a recent polysomnographic study and will undergo drug-induced sleep endoscopy (DISE) as part of their standard clinical care. Flow shape information from the polysomnographic study will be associated with the DISE results, and a set of prediction models will be developed and validated to detect the site, pattern and degree of upper airway collapse as seen during DISE.

NCT ID: NCT05267613 Recruiting - Erosive Esophagitis Clinical Trials

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

EE
Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.