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NCT ID: NCT05276934 Recruiting - Clinical trials for Intracranial Aneurysm

Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)

SAVEBRAINPWI
Start date: March 1, 2022
Phase:
Study type: Observational

The study is an observational prospective evaluation of an approved and unchanged clinical management, evaluating different diagnosis methods to assess brain perfusion in patients with an aneurysmal or AVM-related intracranial hemorrhage

NCT ID: NCT05276752 Recruiting - Nutrition Disorders Clinical Trials

Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People

Start date: October 12, 2021
Phase:
Study type: Observational

Malnutrition is associated with health adverse outcomes such as higher risk of mobility disability, falls and, fractures and higher mortality. Malnutrition had been defined as "a state resulting from lack of intake or uptake of nutrition that leads to altered body composition (decreased fat free mass) and body cell mass leading to diminished physical and mental function and impaired clinical outcome from disease". In 2018, the European Society for Clinical Nutrition and Metabolism (ESPEN) revisited nutrition and nutrition-related conditions definitions in the ESPEN guidelines on definitions and terminology of clinical nutrition based on the findings of the last decades. Nutrition disorders and nutrition related conditions were divided in 5 categories: Malnutrition/undernutrition, sarcopenia and frailty, overweight and obesity, micronutrients abnormalities, and refeeding syndrome. The definition of malnutrition based on the Global Leadership Initiative on Malnutrition (GLIM) criteria is globally accepted by de scientific community since this was launched in 2019. The presence of at least one phenotypic (i.e., nonintentional weight loss, low body mass index or low muscle mass) and one etiologic criterion (i.e., reduced food intake or inflammation) were required to define malnutrition. Malnutrition is a common pathological condition in older adults that can further influence and aggravate health-related muscle decline. Sarcopenia is known as a natural progressive decline in skeletal muscles occurring with age, with an age-related decline in muscle strength. According to the criteria published in 2019 by the European Working Group on Sarcopenia in Older People (EWGSOP2), this process is defined by the presence of low muscle strength and low muscle mass. Patients in acute care are likely to present higher stay and risk of mortality. However, the mortality have rarely been applied in acute care, due to difficulties to administer Dual X-ray Absorptiometry (DXA), the gold standard method for muscle mass in acute care. Pragmatic approaches to assess nutrition and nutrition-related condition are urgently needed to provide better quality of care in clinical practice in geriatric medicine. The primary objective of this study is to determine the impact of nutrition disorders and nutrition-related conditions at baseline (admission in hospitalization) on the all-causes mortality risk in hospitalized older people. Secondarily, this study evaluates their impact on other health adverse outcomes: falls, fractures, rehospitalization, institutionalization, all-cause admission in intensive care, length of hospital stay, length of ventilation and USI stay. Finally, the diagnostic performance indicators of the Mini Nutritional Assessment (MNA-SF) and the Geriatric Nutritional Risk Index (GNRI) for malnutrition assessment following the GLIM criteria were calculated.

NCT ID: NCT05276297 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.

NCT ID: NCT05276037 Recruiting - Clinical trials for Hepatocellular Carcinoma

Value of Negative 18FDG PET/CT in Milan Out, Up-to-seven in, HCC Transplant Candidates

Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

Hepatocellular carcinoma (HCC) is a rising public health concern with few curative options but liver transplantion (LT) in highly selected cases. LT could save many other HCC patients but organ shortage has lead to the necessity of selection of patients with the best survival chances, namely the Milan criteria. Hepatocellular carcinoma (HCC) is the fifth most common cancer, and the third cause of cancer related-death worldwide. HCC incidence is rising in Western countries including Belgium. There are more than 1,000 new HCC diagnoses in Belgium every year, but only 90 to 100 patients suffering from HCC are listed for liver transplantation (LT). In fact, the scarcity of organ donors has forced the development of strict criteria to limit LT to patients who are likely to have excellent outcomes. The universally accepted LT criteria for HCC are the Milan criteria (1 HCC nodule ≤5 cm or 3 nodules ≤3cm) that lead to a low rate of post-LT recurrence (>80% of disease free recurrence at 5 years). The majority of patients suffering from HCC outside the Milan criteria at the time of diagnosis is not eligible for LT and is therefore limited to palliative care. It is however considered that some of these patients with HCC outside the Milan criteria may benefit from LT with an acceptable risk of recurrence and chances of long-term disease-free survival (DFS). This fact has led to the extension of LT criteria for HCC in some centres in different countries, as for example the University of California San Francisco (UCSF) criteria, the up-to-seven criteria or the Asan criteria. The Belgian Liver-Intestine Allocation Committee (Be-LIAC) is a section of the Belgian Transplantation Society (BTS) composed of the 6 LT Belgian centres in charge of coordinating deceased LT activity in Belgium with the help of Eurotransplant. Be-LIAC has already built a retrospective HCC database that was successfully used for several scientific studies allowing international presentations and publications. Based on this successful experience, Be-LIAC is keen to continue with this national collaboration to initiate a prospective clinical observational database to better study the results of LT in Belgium and to evaluate potential of extension of LT criteria in HCC patients. Inclusion in this database will not change patient management or the allocation process of the liver grafts in Belgium. This project is financed by a 4-year (2019-2022) grant of the Belgian "Fondation contre le cancer" / "Stichting tegen Kanker".

NCT ID: NCT05274815 Active, not recruiting - Asthma Clinical Trials

Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

WAYFINDER
Start date: May 17, 2022
Phase: Phase 3
Study type: Interventional

This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.

NCT ID: NCT05274750 Active, not recruiting - Nasal Polyps Clinical Trials

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

ANCHOR-1
Start date: April 22, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.

NCT ID: NCT05274269 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

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.