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NCT ID: NCT06102473 Not yet recruiting - Clinical trials for Overweight and Obesity

Effect of an Educational Intervention About Front of Package Labeling in Children and Caregivers.

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the effect of a digital educational intervention of front-of-package warning labeling on the selection and purchase of food in elementary school children and their caregivers. The main question it aims to answer is: - What is the effect of a digital educational intervention on front-of-package warning labeling on food selection in children from primary schools in Mexico City, compared to a control group? Participants will be randomized into two groups. - The control group, the dyads (caregiver-schoolchildren), will receive general nutritional education. - The intervention group, will also receive guidance on reading labels and raise awareness about the impact of consuming processed or ultra-processed foods on health. The intervention will be carried out through a web page with audiovisual material and all participants also will be asked to complete: - Multiple-choice evaluation (5 questions) to ensure theoretical understanding of the topics - Lunch register - 24-hour dietary recall - Survey of food habits and consumption - Validated food preference questionnaire - Anthropometric measurements (Weight, height, waist circumference, body mass index) - Socioeconomic survey - Participate in a simulated online selection and shopping of food and beverages. To see if the digital educational intervention in the front of package warning labeling in children and caregivers will improve the selection and purchase of foods.

NCT ID: NCT06104839 Not yet recruiting - Alopecia Areata Clinical Trials

Safety and Efficacy of Oral NXC-736 in Adult Participants With Severe Alopecia Areata

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of NXC-736 monotherapy in participants with severe alopecia areata (AA).

NCT ID: NCT06108089 Not yet recruiting - Clinical trials for Head and Neck Cancer

Novel Hypoxia Imaging for Head and Neck Cancer: Imaging Phenotype for Personalized Treatment

Start date: April 1, 2024
Phase:
Study type: Observational

Tumor hypoxia is one of the physiological factors for treatment resistance and likely contributes to poor overall survival among patients with head and neck cancer (HNC). Identifying hypoxic features of HNC may allow the personalizing treatment plan. The investigators propose multiparametric Hypoxia MR (HMR) imaging using diffusion, perfusion, and oxygenation as non-invasive, in-vivo imaging components of a hypoxia phenotype. Assessing the hypoxia phenotypes' expression will be critically important for characterizing and predicting CRT response among patients with advanced HNC. A prospective cohort study will be conducted used multiparametric MR (MPMR) imaging correlated with treatment response assessed by 3 months fluorodeoxyglucose-positron emission tomography (FDG-PET). The image analysis approach will be developed to incorporate FDG-PET and quantitative MRI characteristics of tumor (ADC, oxygen-enhanced T1 and T2* maps, and volume transfer constant (Ktrans) to facilitate 3D visualization of multiparametric information. This proposed study's overarching goal is to develop and validate multiparametric HMR imaging using 18F - (fluoromisonidazole) FMISO-PET and immunohistochemistry (IHC) as the standard of references.

NCT ID: NCT06109142 Not yet recruiting - Clinical trials for Critically Ill Patients

Clearance of Vasoactive Metabolites With Blood Purification

VITAL
Start date: April 1, 2024
Phase:
Study type: Observational

Extracorporeal blood purification is a supportive therapy in the management of patients with sepsis or vasoplegic shock. The pathophysiology of sepsis is based on an inappropriate host response to infection. Certain medical devices with higher adsorption capacity make it possible to limit this inappropriate response and could thus improve the hemodynamics of patients in septic or vasoplegic shock. The preliminary experience of the investigators from clinical data of vasopressor withdrawal in pediatric patients treated with oXiris shows a 50% reduction in the vasopressor score, Vaso Inotropic Score (VIS), for 40% of patients within 24 hours following the start of treatment. Similar results were found in adult patients treated for severe COVID-19 or vasoplegic shock by the other centers participating in the study. Cytokine purification is an important physiological effect of purification membranes. However, this may not fully explain the rapid hemodynamic improvement of patients treated with an oXiris membrane. The role of angiotensin metabolites (Ang 1-5, 1-7, 1-9) in the systemic vascular tone of patients has been recently discussed. The administration of angiotensin 2 in vasoplegic shock in adults helps correct hypotension. In the group of patients with increased renin, this treatment was associated with a reduction in mortality. Indeed, increased renin associated with dysfunction of Angiotensin Converting Enzyme (ACE) leads to an accumulation of Angiotensin 1 which degrades to Ang 1-7. The hypothesis f the investigators is that the concentration of Ang 1 and Ang 1-7 is elevated in cases of vasoplegic shock and that the clearance of these vasodilator peptides by blood purification is associated with clinical improvement.

NCT ID: NCT06111417 Not yet recruiting - Breast Cancer Clinical Trials

Use of an Ultra-rapid BRCA1/2 Status Screening Test in Theranostic Indication: Performance and Interest for Patients and Practitioners

TURBO
Start date: April 1, 2024
Phase:
Study type: Observational

The time taken to obtain the results of germline mutations in BRCA1 and BRCA2 has become a major issue in adapting the therapeutic management of patients, particularly those with breast cancer. The time taken to obtain the results of BRCA1/2 tests in routine laboratories with a view to personalised treatment can range from a few weeks to a few months. The waiting time required to obtain results is likely to cause stress and anxiety in cancer patients. The investigators hypothesise that ultra-rapid testing can reduce anxiety about patients' genetic status and improve their mental well-being. The main objective of this project is to compare the results obtained with an ultra-fast kit developed by O.N.T with those obtained with the current gold standard, NGS sequencing.

NCT ID: NCT06117449 Not yet recruiting - Diabete Type 2 Clinical Trials

Insulin Therapy in Type 2 Diabetic Patients: Real-life Study on Effectiveness and Satisfaction

Start date: April 1, 2024
Phase:
Study type: Observational

Diabetes mellitus is an endocrine disorder with heterogeneous etiologies, which is characterized by raised levels of glucose in a person's blood and disturbances of macromolecules such as carbohydrate, fat, and protein metabolism resulting from defects in insulin secretion, insulin action, or both. A lack of insulin, or the inability of cells to respond to it, leads to high levels of blood glucose (hyperglycemia), which is the clinical indicator of diabetes. Type 1 DM is characterized by insulin deficiency and a tendency to develop diabetic ketoacidosis, whereas type 2 DM is characterized by variable degrees of insulin resistance, impaired insulin secretion, and excessive hepatic glucose produc Tion. Diabetes is one of the most rapidly increasing chronic diseases and an important public health problem all over the world. The global burden of diabetes is rising dramatically worldwide. Type 2 diabetes is the most common type of diabetes, accounting for around 90% of all diabetes worldwide (IDF). The prevalence of type 2 diabetes is high and rising across all regions. This rise is driven by increasing life expectancy, economic development, and increasing urbanization leading to more sedentary lifestyles and greater consumption of unhealthy foods linked with obesity. Type 2 diabetes prevalence has increased in Egypt during the past few years. Egypt is one of the top ten nations with the greatest proportion of adults with diabetes, according to the International Diabetes Federation. In Egypt, the prevalence of diabetes was projected to be 9.6 million, with type 2 diabetes making up the bulk of cases .

NCT ID: NCT06119906 Not yet recruiting - Endoscopy Clinical Trials

Hyper-Spectral Endoscopy for Detection of Early Neoplasia in Barrett's Oesophagus

HySE
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the efficacy of hyperspectral endoscopic imaging to distinguish neoplasia from non-dysplastic Barrett's oesophagus in vivo. The main outcome measures are: 1) Classification of spectral patterns corresponding to neoplastic vs non-neoplastic Barrett's; 2) Image quality assessed by the endoscopist by VAS rating the level of confidence in delineating the area of interest; 3) Time to perform hyperspectral imaging; 4) Quantification of molecular biomarkers in endoscopic areas with neoplastic spectral patterns. Participants will firstly undergo a standard endoscopy, followed by another endoscopy using the experimental HySe device. Subsequently, patients will receive biopsies according to Seattle protocol, and up to 6 additional (optional) snap frozen research biopsies.

NCT ID: NCT06121921 Not yet recruiting - Frailty Clinical Trials

RESTORE-TAVI Pilot

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.

NCT ID: NCT06123767 Not yet recruiting - Stroke Clinical Trials

Innovative Application of Pressure Gradient Measurement in Internal Carotid Stenosis in Patients Undergoing CAS

NOTICE-CAS
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

About 20% of stroke causes are atherosclerotic strokes caused by carotid artery stenosis. In 2005, 92% of carotid artery interventions in the USA were performed in asymptomatic patients. It should be noted that screening in the general population for carotid artery disease is unwarranted, due to uncertain eligibility criteria for interventional treatment of asymptomatic patients. On the other hand, 10-15% of all patients with a first-ever stroke will experience an ischemic stroke as a result of previously untreated, asymptomatic, significant carotid artery stenosis. Carotid artery angioplasty with stent placement (CAS) has become the second method of revascularization. ed, however, there is a great deal of ambiguity in the application of these criteria, which stems from the ratio of the risk to the possible benefit to the patient of performing the procedure, as well as the cost-effectiveness for health care systems. OBJECTIVES The overall goal is (following the model of measuring fractional flow reserve - FFR) to try to establish a new parameter that could prove helpful in qualifying patients for percutaneous internal carotid artery angioplasty with stent implantation (CAS). Determining whether measuring the pressure gradient across the stenosis will determine which patients will benefit from the CAS procedure. In the absence of convincing evidence on the effects of CAS, especially for so-called asymptomatic patients, it is advisable to establish a parameter that would complement the eligibility criteria that, on the one hand, could prevent strokes in the population of patients with silent internal carotid artery stenosis and, on the other hand, avoid performing the procedure in the absence of benefit. PRIMARY ENDPOINTS: 1. Assessment of cerebral perfusion by magnetic resonanse before and after CAS 2. Assessment of cognitive symptoms using before and after CAS 3. Assessment of neurological symptoms before and after CAS 4. Assessment of otolaryngological symptoms before and after CAS SECONDARY ENDPOINTS: Creation of a non-invasive computed tomography protocol with pressure gradient assessment in patients with carotid artery stenosis. A final version of the algorithm based on a new diagnostic measurement (concentration gradient) ready to be used in the diagnosis of CAS-eligible patients with an implemented function for automatic classification of measurement results that will indicate the group of patients who will benefit from the CAS procedure.

NCT ID: NCT06125821 Not yet recruiting - Headache Clinical Trials

Arabic Version Of Henry Ford Hospital Headache Disability Inventory Questionnaire : Validity, And Reliability

Start date: April 1, 2024
Phase:
Study type: Observational

ARABIC VERSION OF HENRY FORD HOSPITAL HEADACHE DISABILITY INVENTORY QUESTIONNAIRE: CROSS-CULTURAL ADAPTATION, VALIDITY, AND RELIABILITY