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NCT ID: NCT04646590 Recruiting - Safety and Efficacy Clinical Trials

A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19

Start date: December 16, 2020
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled international multicenter clinical trial design will be adopted. A total of 29,000 subjects aged 18 years and above are planned to be recruited, including 750 subjects aged 18-59 years and 250 subjects aged 60 years and above in China; 21,000 subjects aged 18-59 years and 7,000 subjects aged 60 years and above will be recruited outside China. Safety and immunogenicity will be evaluated among the Chinese subjects, and efficacy, immunogenicity and safety will be evaluated among the subjects outside China. Among them, 750 subjects aged 18-59 and 250 subjects aged 60 and above from outside China and all subjects from China will be selected as the immunogenicity subgroup for immunogenicity bridging study. The IgG levels of SARS-COV-2 neutralizing antibody and RBD protein binding antibody will be detected by blood sampling before vaccination, 14 days and 6 months after full course of vaccination to evaluate the immunogenicity and immune persistence.

NCT ID: NCT04644055 Recruiting - Liver Cirrhosis Clinical Trials

EUS Share-wave in Patients With Liver Cirrhosis

Start date: November 1, 2020
Phase:
Study type: Observational

Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions. The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks. Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis. Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.

NCT ID: NCT04592263 Active, not recruiting - Clinical trials for Patient Satisfaction

Patient Centered Care in Diabetes in Ecuador

Start date: August 1, 2019
Phase:
Study type: Observational

Introduction: According to World Health Organization data, it is estimated that more than 422 million people have diabetes. In Ecuador, diabetes is the second cause of death, only after ischemic heart disease, and is the first chronic non-communicable disease. The complexity of the pathology, its difficult management and the patient's commitment and involvement in their own care has led health systems to seek mechanisms to activate patients. Currently, tools have been developed, Patient Reported Experience Measures (PREM) and Patient Reported Outcome Measures (PROM), which seek to reduce this gap between patient and health system. Objectives: To develop and validate PREM and PROM tools for diabetes in the Ecuadorian context. To achieve better clinical results and greater patient satisfaction with the system, thus adding value to the care process of patients with diabetes. Method: This is a study with two components. The first component will focus on the design and validation of PREM and PROM tools in Ecuador. A second component, consisting of a prospective cohort study for the corresponding implementation of the questionnaires obtained and their validation. Expected results: It is expected to involve patients in the care process, thus establishing a framework for achieving better clinical outcomes and greater patient satisfaction with the system.

NCT ID: NCT04576299 Active, not recruiting - Patient Safety Clinical Trials

Health Care Workers' Perception of Patient Safety During COVID-19 Pandemic

Start date: September 1, 2020
Phase:
Study type: Observational

Objective: Analyze health care workers' perception of patient safety during the COVID 19 pandemic. Methodology: Analytical cross-sectional observational study, with a quantitative focus on healthcare workers who are working on-site during the pandemic in the services of healthcare institutions that agree to participate in the countries where the study will be conducted, by applying a survey of patient safety perceptions in healthcare workers in times of pandemic. Analysis of the data will employ descriptive and inferential statistical techniques to meet the objectives of the study using IBM SPSS Statistics for Windows version 25.0 software. Expected results: The study seeks to generate evidence for the perception of patient safety in times of pandemic, for which it will generate the submission of an article with the results obtained to an indexed journal and presentation at a scientific event.

NCT ID: NCT04560062 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Contextualizing the Evidence for Action on Diabetes - Cohort

CEAD
Start date: October 13, 2020
Phase:
Study type: Observational

This protocol reflects the second part of a larger mixed-methods study aimed at exploring the process by which global recommendations can be translated into context-specific, evidence-informed action for diabetes prevention in low-resource settings. Firstly, a retrospective cohort study will assess the current level of implementation of comprehensive diabetes care over a 24-month period (2019-2020), by describing healthcare received and health outcomes of a representative sample of diabetes patients currently accessing care in the study region. Focus groups prompted by the findings of the retrospective study will be used to inspire local innovations which will be evaluated through a prospective follow-up of the cohort.

NCT ID: NCT04486404 Enrolling by invitation - Clinical trials for Acute Stress Disorder

Needs, Perceptions and Acute Stress of Healtcare Workers Caring for COVID-19 Patients in South America

Start date: April 1, 2020
Phase:
Study type: Observational

The pressure on care and the demand for critical decision-making generated by the current SARS-CoV-2 (COVID-19) pandemic, together with the situation of extreme social alarm and the adverse conditions in which care work must be promoted at this time, draw an extreme scenario in which action is urgently needed to alleviate emotional overload, acute stress reactions and other affective pathologies or psychosomatic reactions that may eventually lead to post-traumatic stress situations. This eventuality is being observed massively among professionals from different groups and levels of responsibility. In the case of healthcare personnel, it should be added that the care of non-COVID19 patients (of all pathologies and conditions) is clearly compromised and it is up to the professionals as a whole to make critical decisions and exercise a professional practice that is radically different from what has usually been done, which may require the application of undesirable triage criteria that are difficult for everyone to assume. Healthcare professionals and other essential personnel for healthcare and social-healthcare work (including personnel from external companies) are being subjected to emotional tensions and extraordinary, high-intensity work demands. Without professionals who feel supported and with moral strength, care will be even more compromised. The current scenario makes us think of many critical situations that are occurring as a result of the overload experienced. It is essential to act in order to counteract the devastating effect of this health crisis on health professionals and those who support them in their care work.

NCT ID: NCT04407182 Completed - Covid-19 Clinical Trials

Safety and Efficacy of Viusid and Asbrip in Hospitalized Patients Infected by SARS-Cov-2 With COVID-19

Start date: May 4, 2020
Phase: Phase 2
Study type: Interventional

This is a two-arm, open-label, randomized, phase 2, controlled center study to assess the safety and efficacy of Viusid and Asbrip in patients with mild to moderate symptoms of respiratory disease caused by 2019 coronavirus infection. Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours or standard care. Viusid and Asbrip will be administered orally. A total of 60 subjects will be randomized 2: 1 in this study. 40 patients will be assigned to Viusid plus Asbrip plus standard of care and 20 control patients with standard of care. Treatment duration: 21 days.

NCT ID: NCT04374123 Completed - COVID Clinical Trials

COVID-19 Serology Screening and Strict Protocol in the Endoscopy Unit

Start date: April 20, 2020
Phase:
Study type: Observational

The novel COronaVIrus Disease 19 (COVID-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. In Ecuador, the city of Guayaquil has nearly two-thirds of the COVID-positive patients in the country and nearly 40% of infected individuals are health-care related personnel. Nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the COVID-19 pandemic. Several experiences in the management of the endoscopic unit during the pandemic has been proposed. We aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of COVID-19.

NCT ID: NCT04362969 Not yet recruiting - COVID Clinical Trials

COVID-EC Study: Clinical Characteristics of Patients With COVID-19 in Guayaquil, Ecuador

Start date: May 2020
Phase:
Study type: Observational

In December 2019, an outbreak of pneumonia of initially unknown cause was detected in Wuhan (Hubei, China), and it was quickly determined that it was caused by a new coronavirus, that is, the SARS-CoV- 2 virus, causing the disease called COVID-19. Since then, the outbreak has spread to 5 continents, affecting 185 countries or regions, with more than 2,500,000 confirmed cases as of April 21, 2020. Ecuador, the 9th country according to territorial extension, and the 7th according to the number of inhabitants in South America, is the 4th country with the highest number of cases in that region of the world, only behind Brazil, Peru and Chile. According to data from the Ministry of Public Health (MSP) of Ecuador, as of April 20, 2020, the National Institute for Public Health Research (INSPI) has registered 33,279 samples, of which 10,128 are positive for SARS-CoV-2. By far, the province of Guayas where Guayaquil is located, the main city in terms of number of inhabitants of the country, is the region with the highest number of affected, with 6921 confirmed cases and 6274 with suspicion. Given the importance of this infection, the severity in some cases, its rapid distribution, and the differences in the Ecuadorian population with respect to the other countries where infected patients have been reported, the investigators consider that an updated analysis of cases, taking as a reference, patients seen in various hospitals of the city of Guayaquil can help identify the clinical characteristics and severity of the disease.

NCT ID: NCT04351932 Not yet recruiting - Clinical trials for Osteo Arthritis Knee

Bone Marrow Versus Adipose Autologous Mesenchymal Stem Cells for the Treatment of Knee Osteoarthritis

Start date: June 7, 2020
Phase: Phase 3
Study type: Interventional

Mesenchymal stem cells (MSC) are stromal cells that have the ability to self-renew and also exhibit multilineage differentiation. MSCs can be isolated from a variety of tissues, such as umbilical cord, bone marrow, and adipose tissue. The multipotent properties of MSCs make them a promising option for the treatment of osteoarthritis (OA). Bone marrow mesenchymal stem cells (BM-MSC) and adipose derived mesenchymal stem cells (AD-MSC) have been used separately to treat OA. The aim of the present study will be to compare in a randomized non blind controlled clinical trial 3 types of intra-articular injections containing MSC populations obtained from two clinically relevant sources: BM-MSC, AD-MSC and a combination of both BM-MSC and AD-MSC.