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NCT ID: NCT04557345 Completed - Clinical trials for Aortic Valve Stenosis

Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.

Start date: January 1, 1990
Phase:
Study type: Observational

Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America. Previous evidence shows that aortic valve calcification is an active biological process associated with inflammation. The only actual treatment for severe aortic stenosis is surgical aortic valve replacement (AVR). The materials with which the different types of prostheses are manufactured could induce inflammation per se. Biological prostheses, an incomplete cell removal process and therefore, the presence of residual proteins of animal origin, could induce the immune system's response. In the manufacturing bioprosthesis at the "Ignacio Chávez" National Institute of Cardiology (INC), an evaluation was carried out in the early, and late post-surgical period, it was shown that the inflammatory response after six months is similar to that produced by mechanical prosthesis. This study's main objective is to evaluate the inflammatory response in patients with post-operated AVR due to biological or mechanical prosthetic valve through different plasma biomarkers in long-term follow-up. Research question What is the inflammatory response and calcification in patients who undergo aortic valve replacement for a manufactured prosthesis at the "Ignacio Chávez" National Institute of Cardiology in the long-term follow-up? Hypothesis Manufactured bioprostheses at the "Ignacio Chávez" National Institute of Cardiology show a similar or lower inflammatory response to imported bioprostheses or mechanical prostheses associated with less valve dysfunction and more outstanding durability.

NCT ID: NCT04557059 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

PRIMORDIUM
Start date: November 12, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

NCT ID: NCT04556773 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

DB-08
Start date: December 17, 2020
Phase: Phase 1
Study type: Interventional

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

NCT ID: NCT04555447 Completed - Healthy Clinical Trials

Gastrointestinal Tolerability to Agavins and Impact on Host-gut Microbiota-metabolism Interactions Modulation

Start date: March 22, 2019
Phase: N/A
Study type: Interventional

Agavins are branched neo-fructans and prebiotic fiber found in Agave plants. In preclinical studies, agavins have demonstrated an effect in reversing metabolic disorders associated to overweight and obesity through the modulation of gut microbiota activity and composition, showing their interesting potential in the context of high obesity and cardiovascular diseases prevalence in Mexican population. However, current information about gastrointestinal adaptation and effects of agavins intake in humans is scarce. We hypothesized that increasing amounts of agavins up to 12 g/day, will be well tolerated by healthy and obese adult participants, but with differences between these groups, modulating gut microbiota activity and structure differentially, as well as the metabolic status after a 5-week dose-escalation intervention.

NCT ID: NCT04553133 Active, not recruiting - Breast Cancer Clinical Trials

PF-07104091 as a Single Agent and in Combination Therapy

Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

NCT ID: NCT04552899 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04552028 Recruiting - Acute Pancreatitis Clinical Trials

Respiratory Dysfunction in Acute Pancreatitis (SAFI)

SAFI
Start date: December 15, 2019
Phase:
Study type: Observational [Patient Registry]

Acute pancreatitis (AP) is an inflammatory process of the pancreas and is one of the main causes of hospital admission of gastrointestinal origin. The annual incidence is between 13 to 45 per 100,000 habitants. The etiology may correspond to vesicular gallstones, excessive alcohol consumption, drugs, among others. Risk factors such as smoking and type 2 diabetes mellitus have been found to increase the risk of pancreatitis by 1.86 to 2.89 times. Pulmonary complications are the most frequent in this group of patients, approximately in 75% of cases, they vary from hypoxemia to acute respiratory distress syndrome (ARDS). In the first 2 days of hospital admission, tachypnea, mild respiratory alkalosis and hypoxemia may occur, usually without radiological manifestations, however 33% of patients with AP have pulmonary complications with symtoms and radiological signs, some of them are atelectasis (15%), small pleural effusion (4-17%) mainly of right lung and pulmonary edema (8-50%). Non-invasive methods would allow faster identification of patients with hypoxemia or patients who have pulmonary organ failure. (6) There is no evidence on the usefulness of SpO2 / FiO2 (SF) as a predictor of hypoxemia and its correlation with PaO2 / FiO2 in acute pancreatitis, however its continuous calculation can greatly reduce arterial gas intake and decrease adverse events and costs.

NCT ID: NCT04551898 Completed - Covid19 Clinical Trials

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)

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

The primary objective of this study is to evaluate the efficacy of BGB-DXP593 administered intravenously as a single dose in participants with mild to moderate COVID-19

NCT ID: NCT04551768 Completed - COVID19 Clinical Trials

Study to Evaluate the Safety and Efficacy of VIRAZOLE® in Hospitalized Adult Participants With Respiratory Distress Due to COVID-19

Start date: February 10, 2021
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, open label, non-randomized, two-arm interventional clinical trial to evaluate the safety and efficacy of Virazole® in hospitalized adult patients who have tested positive for COVID-19 and, as a result, have significant respiratory distress (PaO2/FiO2 ratio <300 mmHg).

NCT ID: NCT04550962 Active, not recruiting - Asthma Clinical Trials

Description of Characteristics, Such as Age, Previous and Concurrent Treatments, Associated Diseases, of Patients With Asthma Treated With Dupilumab (DUPIXENT)

REVEAL
Start date: November 2, 2020
Phase:
Study type: Observational [Patient Registry]

Primary Objective: The primary objective of the study is to characterize patients initiating DUPIXENT for asthma in a real-world setting, with respect to their medical history, including asthma history and asthma treatment history, socio-demographic, biomarkers (including Fractional exhaled nitric oxide [FeNO]), and concomitant treatments for asthma. Secondary Objectives: The secondary objectives of the study are: - To characterize real-world use patterns of DUPIXENT for asthma (eg, most commonly used regimens, reason for initiation of new asthma treatments, concomitant therapies, treatment durations, and reasons for discontinuation and/or switching) - To assess the effectiveness of DUPIXENT in asthma patients in a real world setting (lung function improvement, exacerbation rate, asthma control) - To assess comorbid type 2 conditions (atopic/allergic) and patterns of use and effects of treatment in comorbid conditions in asthma patients treated with Dupixent - To collect data on HealthCare Resource Utilization (HCRU) - To collect safety data on study participants in the real-world setting.