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NCT ID: NCT04853758 Recruiting - Clinical trials for Chagas Cardiomyopathy

Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction: ANSWER-HF.

ANSWER-HF
Start date: May 6, 2021
Phase: Phase 3
Study type: Interventional

Chagas disease is considered by the World Health Organization (WHO) as one of the most neglected tropical diseases in the world, having relevance in many Latin America countries. In addition, it already affects North America, Europe, Asia and Oceania. Some studies suggest that chagasic heart failure has a worse prognosis, with up to 50% shorter survival than other etiologies. The PARADIGM-HF (Prospective Comparison of Angiotensin Receptor Blocker-Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) study showed 20% reduction in mortality comparing sacubitril/valsartan with the standard treatment with ACE (angiotensin converting enzyme) inhibitors. In the scenario of chagasic cardiomyopathy, a post hoc analysis of PARADGIM-HF was reported on 113 patients. Reduced risk of cardiovascular death or hospitalization for HF was noted in the group treated with sacubitril/valsartan. Attention was drawn the study's limitations that included the small number of patients and reduced statistical power. Therefore, the benefit of this new class remains uncertain in heart failure due to Chagas cardiomyopathy. The ANSWER-HF Trial will be a clinical, randomized, single-center, prospective, double-blind, controlled study. It will include 200 consecutive participants with Chagas cardiomyopathy and left ventricular ejection fraction less than 40% randomized independently. The objective of this study is to evaluate the benefit of sacubitril/valsartan compared with enalapril in patients with heart failure due to Chagas cardiomyopathy, with reduced ejection fraction. The primary endpoint of the study is the change of left ventricular ejection fraction determined by transthoracic echocardiography. Secondary endpoints include: assessment of ventricular arrhythmias; evaluation of functional class; assessment of functional capacity; assessment of ventricular remodeling; and evaluation of biomarkers. The patients will be followed for 6 months after treatment start. All patients will be undergone to Doppler Echocardiography, 24-hour Holter, 6-minute walk test, Biochemical and hematological exams and Biomarkers at the baseline and after 6 months.

NCT ID: NCT04853719 Completed - Clinical trials for Peripheral Artery Disease

Rivaroxaban 2.5 mg BID and Aspirin for Intermittent Claudication in PAD Patients

Start date: April 20, 2021
Phase: Phase 4
Study type: Interventional

This trial is evaluating if rivaroxaban 2.5 mg BID and aspirin 100 mg OD compared to aspirin alone improves on intermittent claudication distance in PAD patients.

NCT ID: NCT04853290 Completed - Pain Clinical Trials

Patient Experience in Peripheral Venipuncture With and Without Ultrasound

PERCEPT
Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Randomized clinical trial to compare the patient's experience after peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture. Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.

NCT ID: NCT04853264 Completed - Ultrasonography Clinical Trials

Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate

SPECTRA
Start date: September 23, 2021
Phase: N/A
Study type: Interventional

Randomized clinical trial to test the assertiveness on the peripheral vein puncture attempt by comparing two methods: peripheral venipuncture catheterization using the conventional technique (vein visualization and palpation) versus ultrasound-guided venous puncture. Patients with indication of peripheral venous puncture, admitted to the clinical inpatient units on the hospital where the study will be conducted (Hospital de Clinicas de Porto Alegre - HCPA) will be enrolled in this single-center trial and will be randomized to conventional peripheral venipuncture performed by a registered nurse; or ultrasound-guided peripheral venipuncture performed by a registered nurse with expertise in vascular access.

NCT ID: NCT04853134 Withdrawn - Covid19 Clinical Trials

Proxalutamide Treatment for COVID-19 Female Outpatients

Start date: November 1, 2020
Phase: Phase 3
Study type: Interventional

This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection

NCT ID: NCT04852770 Recruiting - Covid19 Clinical Trials

Efficacy of TBCT, MBHP and PPT for PTSD During the Covid-19 Pandemics

Start date: April 23, 2021
Phase: N/A
Study type: Interventional

The psychotherapies to be assessed in the present study, delivered on-line, are: trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT). Objectives: 1) to assess the efficacy of TBCT compared to MBHP and PPT in reducing the symptoms of PTSD during the COVID-19 pandemic.

NCT ID: NCT04852536 Not yet recruiting - Chronic Pain Clinical Trials

Electroencephalographia as Predictor of Effectiveness HD-tDCS in Neuropathic Pain: Machine Learning Approach

Start date: June 15, 2021
Phase:
Study type: Observational

Contextualization: Neuropathic pain is a complication present in the clinical picture of patients with traumatic Brachial Plexus injury (BPI). It is characterized by high intensity, severity and refractoriness to clinical treatments, resulting in high disability and loss of quality of life. Due to loss of afferent entry, it causes cortical and subcortical alterations and changes in somatotopic representation, from inadequate plastic adaptations in the Central and Peripheral Nervous System, one of the therapies with potential benefit in this population is the Transcranial High Definition Continuous Current Stimulation (HD-tDCS). Thus, by using connectivity-based response prediction and machine learning, it will allow greater assurance of efficiency and optimization of the application of this therapy, being directed to patients with greater potential to benefit from the application of this approach. Objective: Using connectivity-based prediction and machine learning, this study aims to assess whether baseline EEG related characteristics predict the response of patients with neuropathic pain after BPI to the effectiveness of HD-tDCS treatment. Materials and methods: A quantitative, applied, exploratory, open-label response prediction study will be conducted from data acquired from a pilot, triple-blind, cross-over, placebo-controlled, randomized clinical trial investigating the efficacy of applying HD-tDCS to patients with neuropathic brachial plexus trauma pain. Participants will be evaluated for eligibility and then randomly allocated into two groups to receive the active HD-tDCS or simulated HD-tDCS. The primary outcome will be pain intensity as measured by the numerical pain scale. Participants will be invited to participate in an EEG study before starting treatment. Clinical improvement labels used for machine learning classification will be determined based on data obtained from the clinical trial (baseline and post-treatment evaluations). The hypothesis adopted in this study is that the response prediction model constructed from EEG frequency band pattern data collected at baseline will be able to identify responders and non-responders to HD-tDCS treatment.

NCT ID: NCT04850963 Recruiting - Stroke, Chronic Clinical Trials

Effects of Dualsite Anodic tDCS on Lower Limbs Function in Patients After Stroke: Randomized, Double-blind, Placebo-controlled, Crossover Trial

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

It is currently known that Transcranial Direct Current Stimulation (tDCS) can modulate cortical activity, being considered an important resource in the treatment of sequelae resulting from stroke. However, evidence of the effects of tDCS on lower limb motor recovery after stroke remains scarce and inconclusive. Furthermore, little is known about the effects of dualsite tDCS in chronic patients. Therefore, the present study seeks to compare the effects of conventional anodic tDCS (M1) with double-site/dualsite anodic tDCS (M1 + DLPFC) and simulated tDCS on lower limb motor function in patients after ischemic stroke in a chronic stage. The study is a randomized, double-blind, placebo-controlled, crossover clinical trial with subjects after stroke. After recruitment and initial screening, participants will be randomized into three groups: G1: anodic tDCS - participants who will receive real current over the primary motor area; G2: dualsite tDCS - participants who will receive real current over the primary motor area and dorsolateral prefrontal area (DLPFC) and G3: simulated tDCS - participants who will receive simulated stimulation. Participants will receive 10 tDCS sessions, for 20 minutes, associated with a physical therapy protocol based on a dual motor and cognitive task, on alternate days (3 times a week). In each phase of the study, pre- and post-intervention evaluations will be carried out, the evaluated outcomes will be: motor function (Fugl-Meyer Scale), functional connectivity (EEG), quality of life (EQ-5D), level of functional disability ( Rankin Scale), static balance (Biodex Balance System) and cognitive function (MoCA). Statistical analyzes will be performed using SPSS software (Version 20.0) and MATLAB 9.2.0 with a significance level of p <0.05.

NCT ID: NCT04849728 Recruiting - Clinical trials for NASH - Nonalcoholic Steatohepatitis

A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )

NATiV3
Start date: August 19, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

NCT ID: NCT04847557 Active, not recruiting - Obesity Clinical Trials

A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

Start date: April 20, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.