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NCT ID: NCT04693923 Not yet recruiting - Septic Shock Clinical Trials

Capillary Refill Time Response to a Rapid Fluid Challenge in Septic Shock Patients

AUSTRALIS
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

In septic shock patients, the hemodynamic coherence between systemic, regional and microcirculatory blood flow can be tracked by "capillary refill time (CRT) response to an increase in stroke volume induced by a rapid fluid challenge". A parallel improvement in regional blood flow, microcirculation and hypoperfusion-related parameters should be expected in CRT-responders as reflection of preserved hemodynamic coherence. CRT non-response is associated with a more severe systemic inflammatory state, endothelial and microvascular dysfunction, and a higher adrenergic tone. The objective of this study is to determine if CRT response after a rapid fluid challenge signals a state of hemodynamic coherence as demonstrated by a parallel improvement in regional and microcirculatory blood flow in CRT-responders, and to explore the pathophysiological mechanisms associated to CRT non-response.

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: NCT04680637 Terminated - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

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: NCT04677569 Recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ENCORE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

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: NCT04669015 Recruiting - Covid19 Clinical Trials

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

NOVATION-1
Start date: June 10, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized, double-blind, multicenter, placebo-controlled trial to evaluate the safety and efficacy of a novel therapeutic agent, Novaferon, in hospitalized adult patients diagnosed with COVID-19. The study is comprised of two cohorts: - Cohort A: This is a blinded safety lead-in comprising two arms. 40 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus Standard of Care (SOC) - Cohort B: This is the main portion of the study, which comprises two arms. Up to 874 patients will be randomized on a 1:1 basis to receive either Novaferon or matched placebo via a commercial nebulizer, plus SOC

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: NCT04659603 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

CARMEN-BT01
Start date: March 29, 2021
Phase: Phase 2
Study type: Interventional

Primary Objective: - For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) - For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: - To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess the immunogenicity of tusamitamab ravtansine - To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination

NCT ID: NCT04654780 Recruiting - Clinical trials for Evaluate the Effectiveness Subsidies for Healthy Foods

Study of Purchasing Decisions and Food Consumption: Chile

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

Objective: To evaluate the effectiveness of taxes on unhealthy foods and subsidies for healthy foods in modifying the purchasing and consumption behavior of people in the Metropolitan Region, Chile. Research hypothesis: 1. The application of a tax that increases the price of "High in" foods by 20% will reduce the purchase and consumption of these foods by 24%. 2. The application of a subsidy that reduces the price of fruits and vegetables by 20% will increase the purchase and consumption of these foods by 17%. 3. People of lower socioeconomic status are more sensitive to price changes than people of higher socioeconomic status. Methodological design. The research proposal proposes an experimental design that will select the participants from a panel composed of people over 18 years of age, men and women, and of all socioeconomic levels. The methodological design considers a random assignment of the people eligible for the study into 3 groups: 1. First group of intervention (GI1): people who will make their purchases with taxes on food and beverages "High in"; 2. Second intervention group (GI2): people who will make their purchases with subsidies for fruits and vegetables; 4. Control group (CG) that will make the purchases with the market prices or currently applied by the supermarkets or purchase scenarios. Methodology. Participants will make a monthly simulated purchase through a simulated supermarket system with products similar to those found in real supermarkets, including "High in" products and fruits and vegetables. Different prices will be applied to each group depending on the type of food. With the data of simulated purchases, a variation of the demand and by socioeconomic subgroup will be calculated. The results will be compared with the control group. Expected results. GI1 participants are expected to modify their purchase intention with the "High in" food tax, decreasing the purchase of these products in their simulated purchases, compared to CG participants who will make their simulated purchases without taxes. Likewise, IG2 participants are expected to modify their purchase intention with the fruit and vegetable subsidy, increasing the purchase of these foods, compared to CG participants. Finally, it is assumed that the reduction in simulated purchases of "High in" foods and the increase in simulated purchases of fruits and vegetables vary according to socioeconomic level.