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NCT ID: NCT04756908 Recruiting - Cataract Clinical Trials

Safety and Effectiveness of the Opira AIOL in Comparison to Commercial IOLs in Patients Undergoing Cataract Surgery

Start date: October 8, 2020
Phase: N/A
Study type: Interventional

This is a clinical trial comparing an investigative accommodative IOL and two commercial IOLs in patients with cataracts undergoing primary cataract surgery.

NCT ID: NCT04742192 Completed - Clinical trials for Non-small Cell Lung Cancer

Non-interventional, Prospective Study to Determine Prevalence of EGFR Mutations in Non-small Cell Lung Cancer

EARLY-EGFR
Start date: March 4, 2021
Phase:
Study type: Observational

This prospective, multicountry, multicentre, non-interventional study plans to include patients who have undergone surgery for early-stage (IA to IIIB on the basis of pathologic criteria) non-squamous NSCLC up to 6 weeks prior to enrolment into the study. The main objective of this study is to determine the prevalence of EGFRm in patients with surgically resected early-stage (IA to IIIB) non-squamous NSCLC as there are limited data on its prevalence in this patient population.

NCT ID: NCT04662710 Active, not recruiting - Clinical trials for Advanced/Metastatic Gastroesophageal Adenocarcinoma

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

LEAP-015
Start date: December 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

NCT ID: NCT04610502 Completed - Covid19 Clinical Trials

Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients

SECR-01
Start date: September 6, 2020
Phase: Phase 2
Study type: Interventional

Reports of the use of plasma from convalescent patients and purified immunoglobulin preparations in respiratory infections by various viral agents and SARS-CoV-2 in severely ill patients suggest that specific neutralizing antibodies may benefit their clinical course. During the previous SARS-CoV epidemic in 2003, preparations of hyperimmune equine serum were produced and demonstrated in vitro viral neutralization. These preparations were also successful in several animal models. Taking advantage of the important trajectory of our country in the study and use of equine hyperimmune serums with neutralizing antibodies for snake venom, preparations of hyperimmune serums against recombinant proteins of SARS-CoV-2 were produced through repeated immunization of horses, a first group of animals was inoculated with the "S" (Spike) protein of the virus and the second group with a mixture "M" of the S1 (Spike) proteins, the N (Nucleoprotein) protein and a construct with epitopes of the S1, E (Envelope) and M (Membrane) proteins, generating two different pharmaceutical preparations. Objective: Evaluate the efficacy and safety of two hyperimmune equine serum anti-Sars-CoV-2 ("S" and "M") formulations as an addition to the standard therapeutic approach for hospitalized patients with COVID-19 over 18 years of age with the presence of at least 2 risk factors and a symptom onset period not exceeding 10 days. A total of 52 patients will be included and randomly divided into two balanced groups. On day 1, all participants from each group will receive an intravenous infusion containing 10ml (one vial) of hyperimmune equine anti-Sars-CoV-2 serum labeled as A or B. Patients will be evaluated clinically, general laboratory, SARS-CoV-2 serologies, SARS-CoV-2 viral load and cytokines level as well as pulmonary ultrasound. Data will be collected for both groups on Days 0 to 7, 10 and 14 or discharge after completion of treatment. The study will end for each participant on the day of discharge from the hospital.

NCT ID: NCT04609904 Recruiting - Asthma Clinical Trials

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

LOGOS
Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

NCT ID: NCT04574115 Active, not recruiting - Cataract Clinical Trials

Clinical Investigation of Omega Refractive Capsule, Model VI

ORCVI
Start date: February 6, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)

NCT ID: NCT04574102 Completed - Cataract Clinical Trials

Clinical Investigation of Omega Refractive Capsule Model V With Use of an FDA Approved IOL

ORCV
Start date: December 9, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model V)

NCT ID: NCT04566484 Active, not recruiting - Chikungunya Clinical Trials

Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia

IVICHIK001
Start date: August 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of the selected dose (part C) based on the accumulation of subjects' data within the entire study period as shown below. Part C will be randomized for immunogenicity subset and will be open label for safety cohort. The participants assigned to the control group from all parts (i.e, Part A, B and C) will be continuously followed up from the enrollment until the end of the study.

NCT ID: NCT04497610 Withdrawn - COVID19 Clinical Trials

SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

Start date: November 2022
Phase:
Study type: Observational [Patient Registry]

The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.

NCT ID: NCT04352634 Recruiting - Depression Clinical Trials

The Covid-19 HEalth caRe wOrkErS (HEROES) Study

HEROES
Start date: April 26, 2020
Phase:
Study type: Observational

Since December 2019 the world has been shaken with an enormous global threat: the Covid-19 pandemic. This new kind of coronavirus is generating an unprecedented impact both on the general population and on the healthcare systems in most countries. Health services are trying to expand their capacity to respond to the pandemic, taking actions such as increasing the number of beds; acquiring necessary equipment to provide intensive therapy (ventilators), and calling retired health professionals and health students so they can assist the overwhelmed health care workforce. Unfortunately, these organizational changes at health facilities, along with the fears and concerns of becoming ill with the virus or infecting their families, put an enormous emotional burden on workers in health services which may lead to negative outcomes on mental health in this population. Recent cross-sectional studies in China indicate that health service workers exposed to people with Covid-19 reported higher rates of depressive and anxious symptoms. This negative impact on mental health among health workers in China has also been informally reported in other countries where the Covid-19 pandemic has been devastating in its effects (such as Spain and Italy), as well as in countries where the pandemic is becoming a growing public health problem. This is particularly relevant in regions with fewer resources (Latin America, North Africa), where there are limited means and the response from the health system is usually insufficient. Moreover, it is necessary to study these negative effects longitudinally considering that some effects will appear over time (post-traumatic stress). The COVID-19 HEalth caRe wOrkErS (HEROES) study is a large, bottom-up, South-North initiative aimed to evaluate the impact of the COVID-19 pandemic on the mental health of health care workers (HCWs). HEROES encompasses a wide variety of academic institutions in 19 LMICs and 8 HICs, in partnership with the Pan American Health Organization (PAHO) and with support from the World Health Organization (WHO). The HEROES study is led by Dr. Rubén Alvarado at University of Chile, and Dr. Ezra Susser and Franco Mascayano at Columbia U Mailman School of Public Health.