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NCT ID: NCT05286632 Recruiting - Diabetes Clinical Trials

KidneYou - Innovative Digital Therapy

Start date: July 18, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness program (MP), when they are conveyed to the patient by means of digital technologies or not. In the present study, non-pharmacological interventions conveyed by a digital technology (investigational arm) will be compared to a standard, paper-based approach (control arm).

NCT ID: NCT05286138 Recruiting - Clinical trials for Malignacy, Hemoglobinopathie

STUDY INCIDENCE AND CHARACTERISTICS OF MALIGNANT NEOPLASIES IN PATIENTS WITH HEMOGLOBINOPATHY FOLLOWED IN ITALY

Tum001
Start date: February 1, 2022
Phase:
Study type: Observational

The Trial aims to increase the information available on the relevance of tumor pathology in hemoglobinopathies, updating the data relating to hepatocarcinoma and investigating which other tumors are more frequent in patients with hemoglobinopathies. Still, in relation to tumor pathology, the study will evaluate any differences between the different types of hemoglobinopathy and will investigate the association between the appearance of neoplasms and risk factors such as age, sex, iron accumulation markers, history of bone marrow transplant, and others.

NCT ID: NCT05285982 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

NCT ID: NCT05284487 Recruiting - Clinical trials for Radiation-induced Dermatitis

Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.

JALOSOME-01
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Primary objective - To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT. Secondary objectives: - To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo. - To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life. - To investigate safety and tolerability of Jalosome®. - To investigate patient's compliance to Jalosome® treatment. - To investigate patient's global satisfaction with Jalosome® treatment.

NCT ID: NCT05284305 Recruiting - Clinical trials for Pregnancy Complications

Desmoid Tumor and Pregnancy: Effect of Pregnancy on Disease Control and Effect of Diagnosis on Pregnancy History.

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

Desmoid tumors (DT) are rare disease of intermediate malignancy with variable and often unpredictable clinical course. There is a growing interest in defining potential risk of recurrence or progression during or after pregnancy and in identifying potential obstetrical risks and infertility rate of desmoid patients. Aim of the study: - to define the impact of pregnancy on diagnosis, progression and recurrence of DT; - to define the risks related to DT of obstetrical risks and decisions to interrupt or avoid pregnancy after the diagnosis of DT.

NCT ID: NCT05284292 Completed - Caregiver Clinical Trials

GUARDIAN: The Social Robot Companion to Support Homecare Nurses

GUARDIAN
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

The primary objective of this study is to verify the acceptability of the GUARDIAN system by the elderly, detected through the scale Unified Theory of Acceptance and Use of Technology (UTAUT). The GUARDIAN platform consists of two connected apps: one dedicated to the caregiver and one dedicated to the older people, plus a robot (Misty II). Misty II will live with the elderly, it will have the task of detecting his presence inside the house, reminding him of appointments, assisting him in his daily activities and diminishing the sense of loneliness. The application dedicated to the caregiver receives the data and self reports of the elderly from the robot, in order to constantly offer an updated picture of the condition of the elderly and to keep them informed about their condition and well-being.

NCT ID: NCT05283642 Completed - Clinical trials for Endometrial Diseases

D-chiro-inositol and Endometrial Thickness

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

Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.

NCT ID: NCT05283603 Recruiting - Clinical trials for Left Bundle Branch Block (LBBB) on ECG

Clinical Observational Registry of Patients With Left Bundle Branch Block

RECOrd-LBBB
Start date: July 31, 2019
Phase:
Study type: Observational [Patient Registry]

The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure. Aims 1. To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG. 2. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population. 3. To derive data which may have an impact on therapeutic management.

NCT ID: NCT05282316 Recruiting - Metabolic Syndrome Clinical Trials

Impact of Extra Virgin Olive Oil (EVOO) With Health Properties in Metabolic Syndrome

Start date: March 9, 2022
Phase: N/A
Study type: Interventional

Metabolic syndrome (MS), defined according to the revised Adult Treatment Panel III - National Cholesterol Education Program (ATP III - NCEP) criteria, represents a widespread condition in Western populations (prevalence ranging from 22% to about 33%) and with a trend that increases with time and age. MS, not differently from each of the components that characterize it, is a known risk factor for cardiovascular and metabolic diseases. To date, national and international panels indicate lifestyle modification as the only indication for treating MS and reducing the risk of cardiovascular and metabolic diseases. The increase in daily physical activity and the modification of the diet are therefore the cornerstones of the treatment. The Mediterranean Diet (MD) represents a traditional value of the Italian population which has shown in several studies a protective effect on mortality and survival free from cardiovascular events. The added value of MD is the presence of extra virgin olive oil (EVOO), a healthy food with high content of monounsaturated fatty acids, especially oleic acid, and variable concentrations (range 50-800 mg/kg) of phenols (oleuropein, ligstroside, and oleocanthal, and their derivatives phenolic alcohols, such as hydroxytyrosol and tyrosol). Olive oil is defined as healthy according to EC Reg. 432/2012. A good EVOO contains about 75% of oleic acid although a variability between 55% and 83% of all fatty acids is expected according to the World Health Organization. The polyphenols content plays a key role in the choice of the type and quantity of oil with health objectives, with particular reference to the unsaturated and polyunsaturated component (oleic acid, linoleic acid, alpha linolenic acid). Phenolic compounds not only determine EVOO main organoleptic qualities (oxidative stability and specific flavor and taste features) but, theoretically, make it a substance with antioxidant, antiinflammatory, insulin-sensitizing, cardioprotective, antiatherogenic, neuroprotective, immunomodulatory and anticancer activity. The study aims to use a polyphenols enriched EVOO with health properties, derived from different cultivation variants of olives (cultivars), chosen on the basis of preliminary research, coming from Sicilian harvesting campaigns, to evaluate its potential to modify 'in vivo', in subjects with MS, some clinical and laboratory parameters inferring cardiovascular risk, metabolism and inflammation.

NCT ID: NCT05282238 Not yet recruiting - Respiratory Failure Clinical Trials

Quantification of Inspiratory Effort Through Nasal Pressure in Patients Undergoing Weaning From Invasive Mechanical Ventilation and Correlation With Clinical Outcomes

NAIVE
Start date: May 1, 2022
Phase:
Study type: Observational

Weaning from invasive mechanical ventilation (MV) constitutes a fundamental procedure in intensive care, covering up to 50% of time spent on ventilation (1). Endotracheal tube (ETT) removal might be an important but delicate step in intensive care setting. Failure and subsequent need for re-intubation can occur in up to 20% of cases leading to a significant increase in mortality rates (24%), longer hospital stay and prolonged need for ventilation. Comorbidities such as obesity, COPD and cardiac related diseases might further increase this risk reaching up to 60% of failure in extubation. In this scenario, accurate predictors of weaning failure are far welcomed. The recurrence of respiratory failure after extubation might considerably raise rates of failure, probably due to increased work of breathing in patients after ETT removal. Most recent guidelines on the use of non-invasive ventilation (NIV) suggest using NIV after ETT removal in subjects with high risk of failure. NIV could contribute to reduce work of breathing hence preventing the onset of respiratory failure after extubation. Therefore, measuring inspiratory effort and its variation in weaned patients might help in identifying patients with significant risk of failing extubation. Esophageal pressure swings (DeltaPES) can be measured through a nasogastric tube with a pressure transducer located in the inferior part of the esophagus. DeltaPES is an extremely precise and accurate method to quantify inspiratory effort, however its use in daily clinical practice is limited due to the invasive nature of the maneuver, elevated costs and need for considerable clinical training of operators. Physiological studies have shown a correlation between nasal pressure measured at nostril entrance and esophageal pressure (which in turn is a measure of respiratory effort . Therefore, measuring nasal pressure could represent a method to quantify inspiratory effort non-invasively, proving to be useful in daily clinical practice.