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NCT ID: NCT04699916 Completed - Covid19 Clinical Trials

EEG-based Sedation Protocol for Patients on Mechanical Ventilation Due to SARS-CoV-2 Pneumonia

Start date: January 4, 2021
Phase: N/A
Study type: Interventional

Deep sedation in patients with COVID-19 may be challenging in many aspects. The use of an EEG-based protocol to guide deep sedation may be useful in this particular population, considering their unusually high sedation requirements. In the present trial, we aim to evaluate an EEG-based protocol to guide deep sedation in patients with COVID19, using to EEG derived parameters that are displayed in the BIS monitor: Suppression Rate and Spectral Edge Frequency. The protocol is designed to both minimize the suppression rate along with maintaining a spectral edge frequency over 10 Hz. The use of this protocol may reduce the amount of sedatives administered and, therefore, diminish the time needed for the weaning process.

NCT ID: NCT04687072 Completed - Clinical trials for Primary Immune Thrombocytopenia

A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

ADVANCE SC
Start date: December 11, 2020
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

NCT ID: NCT04678856 Completed - Sinusitis Clinical Trials

Dupilumab in CRSsNP

Liberty CRSsNP
Start date: December 2, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: - To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on CT scan and sinus total symptom score (sTSS) compared to placebo - To evaluate the safety and tolerability of dupilumab in CRSsNP patients compared to placebo - To evaluate the pharmacokinetics (PK) of dupilumab in CRSsNP patients compared to placebo - Assessment of immunogenicity to dupilumab over time compared to placebo

NCT ID: NCT04677543 Completed - Clinical trials for Mycobacterium Infections, Nontuberculous

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ARISE
Start date: December 22, 2020
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the Patient-Reported Outcome (PRO) endpoints.

NCT ID: NCT04651790 Completed - Covid19 Clinical Trials

Efficacy, Safety, and Immunogenicity of Two Vaccination Schedules of an Inactivated Vaccine Against COVID-19 in Adults

CoronaVac3CL
Start date: November 27, 2020
Phase: Phase 3
Study type: Interventional

The study will evaluate the efficacy, safety, and immunogenicity of two vaccination schedules of an inactivated vaccine against SARS-CoV-2 infection in adults. Two doses of the vaccine will be administered in a 0,14 and a 0,28-day schedule. Follow-up of safety and efficacy will be assessed for 12 months after the first dose. Immunogenicity will be studied in a subgroup of participants.

NCT ID: NCT04641897 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Impact of Decreasing Respiratory Rate on Lung Injury Biomarkers in ARDS Patients

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

Acute respiratory distress syndrome (ARDS) is a form of acute lung injury of inflammatory origin, which represents a public health problem worldwide due to its prevalence, and its high mortality rate, close to 40%. Mechanical ventilation is a fundamental therapy to improve gas exchange, however, it can also induce further lung injury, a phenomenon known as ventilator induced lung injury (VILI). The limitation of tidal volume is the strategy that has shown the greatest decrease in mortality and is the cornerstone of protective ventilation. However, the respiratory rate, a fundamental parameter in the programming of the mechanical ventilator, has not been evaluated in most of the main clinical studies to date. Moreover, the natural clinical response to the use of a low tidal volume strategy is the increase in respiratory rate, which may harm the lung as it increases the energy applied to the lung parenchyma. The investigators hypothesize that the use of a lower respiratory rate, tolerating moderate hypercapnia, is associated with less VILI, measured by the release of proinflammatory mediators at the systemic level (biotrauma), compared to a conventional higher respiratory rate strategy in patients with moderate to severe ARDS. This effect is mediated by lower energy applied to the pulmonary parenchyma. To confirm this hypothesis the investigators propose a prospective cross-over clinical trial in 30 adult patients with ARDS in its acute phase, which will be randomized to two sequences of ventilation. Each period will last 12 hours, and respiratory rate (RR) will be set according to PaCO2 goal: 1) Low RR, PaCO2 60-70 mmHg; and 2) High RR, PaCO2 35-40 mmHg. Protective ventilation will be applied according to ICU standards under continuous sedation and neuromuscular blockade. Invasive systemic arterial pressure and extravascular lung water will be monitored through an arterial catheter (PICCO® system), and airway and esophageal pressures and hemodynamics continuously measured throughout the protocol. The main outcome will be Interleukin-6 in plasma. At baseline and at the end of each period blood samples will be taken for analysis, and electrical impedance tomography (EIT) and transthoracic echocardiography will be registered. After the protocol, patients will continue their management according to ICU standards.

NCT ID: NCT04641182 Completed - Covid19 Clinical Trials

Prone Position for Nonintubated Patients With COVID-19 and Hypoxemic Respiratory Failure

Start date: July 6, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to evaluate the physiological and clinical effects of prone position in awake patients with respiratory failure due to COVID-19.

NCT ID: NCT04635163 Completed - Mental Disorders Clinical Trials

Ideation Trajectories and Suicide Attempts in Adolescents With Psychiatric Disorders in Chile

Start date: March 19, 2018
Phase:
Study type: Observational

This project seeks to evaluate the trajectories of suicidal ideation and attempts in adolescent patients with psychiatric disorders in secondary care controls in the Maule region, in relation to clinical factors (depressive symptoms, anxiety, stress, psychiatric comorbidity, mistreatment or abuse, history of psychiatric disorders and pharmacological treatments); psychological (parenting styles, impulsivity, barriers in seeking help and emotional regulation), and neuropsychological (executive function-decision making).

NCT ID: NCT04628195 Completed - Covid19 Clinical Trials

Cardiac Performance in Mechanically Ventilated COVID-19 Patients

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

Although COVID-19 affects primarily the respiratory system, several studies have shown evidence of cardiovascular alterations. Increased troponin levels were observed in a significant proportion of patients and this alteration was associated with higher mortality. In addition, case reports of cardiogenic shock or fulminant myocarditis have been communicated. Likewise, pulmonary embolism (PE), right ventricle dilation, and acute cor pulmonale (ACP) have also been described. Therefore, investigating cardiac function in COVID-19 is highly relevant, particularly in critically ill patients who are usually under sedation and mechanical ventilation, which may further impair cardiovascular function. Thus the objective is to determine the prevalence of left ventricle dysfunction and acute cor pulmonale, and its association with respiratory mechanics, in 100 consecutive critically ill COVID-19 patients, who were assessed with critical care echocardiography (CCE) within the first 24 hours of mechanical ventilation.

NCT ID: NCT04620733 Completed - Clinical trials for Primary Biliary Cholangitis

RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: April 21, 2021
Phase: Phase 3
Study type: Interventional

To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo