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NCT ID: NCT04568863 Completed - COVID-19 Clinical Trials

Efficacy of Intravenous Melatonin on Mortality in Adult Patients Admitted to the Intensive Care Unit With COVID-19

MELCOVID
Start date: June 20, 2020
Phase: Phase 2
Study type: Interventional

There is an urgent need to evaluate effective treatments for COVID-19 patients. Melatonin has significant anti-inflammatory and antioxidant properties and it lacks of side-effects. This randomized controlled trial seeks to evaluate the efficacy of intravenous melatonin in reducing mortality in Covid-19 patients in the ICUs.

NCT ID: NCT04568785 Completed - Health Education Clinical Trials

Effectiveness of a Brief Intervention for Acceptance of Influenza Vaccine in the Primary Care Setting

Start date: October 1, 2017
Phase: N/A
Study type: Interventional

Influenza virus has high morbidity rates during annual epidemics, with certain high-risk groups being particularly susceptible to complications and mortality. Vaccination is the main prevention measure, alongside with hygiene measures. Nevertheless, vaccine coverage remains low. Some studies suggest that short, standardized interventions can improve coverage of several vaccines. Hypothesis: Brief Intervention is an effective tool in improving vaccination coverage in people who have initially rejected it. Objective: To determine the effectiveness of a Brief Intervention in increasing influenza vaccination (IIV) coverage compared with the usual advice in people who refuse it. Method: cluster randomized clinical trial. The study population was individuals with high risk factors who initially refused the influenza vaccine. Professionals participants (doctors and nurses) were assigned randomly to the intervention group (brief intervention) and the control group (usual advice).

NCT ID: NCT04568434 Completed - Clinical trials for Familial Chylomicronemia Syndrome

A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS)

BALANCE
Start date: November 16, 2020
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of Olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT04568408 Completed - Sleep Disorder Clinical Trials

Validation of the Quality of Sleep Data for Xiaomi Domestic Wristbands

Start date: August 4, 2020
Phase:
Study type: Observational [Patient Registry]

Introduction: Polysomnography (PSG) is currently the accepted Gold Standard for sleep studies as it measures multiple variables that lead to a clear diagnosis of any sleep disorder. However, it has some clear drawbacks as it can only be performed by qualified technicians, has a high cost and complexity and is very invasive. In the last years, Actigraphy has been used along with PSG for sleep studies. In this study, the investigators intend to assess the capability of the new Xiaomi Mi Band 5 to be used as a sleep self-assessment tool for patients. Objective: Determine whether sleep stages recorded by the new Xiaomi Mi Band 5 can effectively replace PSG sleep stages classification in patients that undergo a sleep study. Methods and analysis: the study will be carried out with patients in a hospital from A Coruña (Galicia, Spain) that are > 18 years old. Patients who are performed a polysomnography test will be given the wearables so the investigators can record sleep stages with both techniques in order to compare both recordings afterwards. This is an observational, analytic and longitudinal study. In other words, in this study different variables from the population of interest will be observed and recorded without any direct intervention, so as to establish causality associations between these variables. It is considered as longitudinal since a six-months tracking of the variables will be performed, continually (and sometimes occasionally) recording and monitoring sleep quality (wearable wristbands). The data obtained from PSG and Xiaomi Mi Band 5 will be preprocessed and explored before extracting the features of interest for the study. Then, Paired sample T-Test will be performed to compare the means among the different variables, Bland-Altman plots will be used to assess the concordance between both techniques and, finally, Epoch by Epoch analysis will be performed to compare the classification of the sleep stages carried out by both PSG and Xiaomi.

NCT ID: NCT04567940 Completed - Social Isolation Clinical Trials

ENRED@TE. Social Support in Southern Spain. Interventional Study

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).

NCT ID: NCT04566653 Completed - Clinical trials for Chronic Kidney Disease + Hyperkalaemia +/- Heart Failure

Patient Palatability and Preference of 3 Potassium Binders in Patients With Chronic Kidney Disease and Hyperkalaemia

APPETIZE
Start date: October 23, 2020
Phase:
Study type: Observational

This non-interventional, Phase IV, exploratory, cross-over, randomised, single-blind, active comparator-controlled study has been designed to measure the palatability and preference of Lokelma® versus Veltassa® versus S/CPS in patients with dialysis and non-dialysis chronic kidney disease (CKD) and hyperkalaemia (HK). The sponsor hypothesizes that palatability, in terms of taste, texture, smell, and mouthfeel, will score higher (better) for Lokelma when compared with Veltassa and S/CPS.

NCT ID: NCT04566601 Completed - Clinical trials for Borderline Personality Disorder

A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

Start date: November 13, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups and the placebo group are then compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04564664 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

High-flow Oxygen Therapy During Exercise in Idiopathic Pulmonary Fibrosis

Start date: March 1, 2019
Phase: N/A
Study type: Interventional

Objectives: 1. To evaluate endurance time during cardiopulmonary exercise test (CPET) performance comparing standard oxygen therapy to high-flow nasal cannula (HFNC) oxygen therapy in subjects with idiopathic pulmonary fibrosis (IPF) with exertional desaturation. 2. To assess oxygenation level (peripheral and muscular) as well as dyspnea and fatigue during exercise in IPF subjects with exertional desaturation using oxygen supplementation with HFNC compared with standard oxygen supplementation. Method: multicenter crossover clinical trial. Patients with IPF presenting oxygen desaturation during the six-minute walking test (6MWT) (SpO2 mean ≤ 85%) will be included consecutively . Each subject evaluated will perform initially an incremental CPET to evaluate the patient's maximum exercise capacity. Supplemental oxygen will be applied to maintain SpO2 >85% with a Venturi mask. Maximum exercise capacity and the appropriate final oxygen inspiratory fraction (FiO2) needed for the following tests will be determined. Posteriorly each patient will perform two constant load CPET (at 75% of the maximum workload achieved with the incremental CPET); one with standard oxygen therapy and the other one with HFNC oxygen therapy. Endurance time, dyspnea and leg fatigue and oxygen saturation (peripheral and muscular) will be recorded. Evaluation measures: Endurance time, dyspnea and leg fatigue (Borg scale), and oxygen saturation.

NCT ID: NCT04563663 Completed - Aging Problems Clinical Trials

Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion

ANKLE_WBROM
Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult.

NCT ID: NCT04562168 Completed - Skin Diseases Clinical Trials

Using AI as a Diagnostic Decision Support Tool to Help the Diagnosis of Skin Disease in Primary Healthcare in Catalonia

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

Background: Dermatological conditions are a relevant health problem. Machine learning models are increasingly being applied to dermatology as a diagnostic decision support tool using image analysis, specially for skin cancer detection and classification. Objective: The objective of this study is to perform a prospective validation of an image analysis ML model, which is capable of screening 44 different skin disease types, comparing its diagnostic capacity with that of General Practitioners (GPs) and dermatologists. Methods: In this prospective study 100 consecutive patients who visit a participant GP with a skin problem in central Catalonia will be recruited, data collection is planned to last 7 months. Skin diseases anonymized pictures will be taken and introduced in the ML model interface, which will return top 5 accuracy diagnosis. The same image will be also sent as a teledermatology consultation, following the current workflow. GP, ML model and dermatologist/s assessments will be compared to calculate the precision, sensitivity, specificity and accuracy of the ML model.