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NCT ID: NCT04535063 Completed - Covid19 Pneumonia Clinical Trials

Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia

Start date: April 18, 2020
Phase: Phase 3
Study type: Interventional

To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia

NCT ID: NCT04534647 Recruiting - Lupus Nephritis Clinical Trials

Serological and Urinary Biomarkers in Latin American Patients With Systemic Lupus Erythematosus: GLADEL 2.0 Cohort

Start date: June 1, 2019
Phase:
Study type: Observational

Lupus nephritis (LN) is one of the main manifestationsin SLE patients, having an important impact on morbidity and mortality. Renal biopsy is the "gold standard" for the diagnosis of LN, however, it is an invasive technique, not free of complications,which is not recommended to be performed serially as a follow-up tool for patients with LN. Searching for biomarkers in SLE has been the subject of interesting research, although results have not always been relevant. Multiple biomarkers have been studied in different locations (soluble markers in blood, urine and biological fluids),of different nature(autoantibodies, genetic markers of "kidney damage") looking atdiagnostic and/orprognostic features. In recent years, several biomarkers have been developed that seek to find an association with pathological patterns, with pathogenic mechanisms and with a non-invasive diagnosis of different glomerulopathies, allowing the identification of prognostic subgroups in each type of kidney disease, while predicting response to treatment and/or recurrence. To date, double-stranded anti-DNA antibodies (anti-dsDNA) and serum complement are the only non-invasive routine biomarkers for monitoring renal activity in patients with LN. However, these markers are only the reflection of the immune activity of the disease and they are not markers of renal damage or poor prognosis. For all the above, the purpose of this study is, in a case-control study, to evaluate simultaneously serum (ANA, anti-dsDNA, anti-C1q, anti-cardiolipin IgG and IgM, anti-ß2GPI IgG and IgM, anti-phosphatidylserine/prothrombin antibodies, and anti-DFS70 antibodies) and urinary biomarkers, and the presence of anti-DFS70 antibodies, in a multiethnic cohort of patients with SLE such as the cohort of GLADEL, and assess its possible correlation with various socio-demographic, clinical and serological manifestations of the disease. In subgroup of patients, transcriptome studies will be performed using RNA from blood and tissue to identify possible transcriptional signatures.

NCT ID: NCT04534205 Recruiting - Clinical trials for Recurrent Head and Neck Cancer

A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1

AHEAD-MERIT
Start date: January 7, 2021
Phase: Phase 2
Study type: Interventional

An open-label, controlled, multi-site, interventional, 2-arm, Phase II trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing programmed cell death ligand -1 (PD-L1) with combined positive score (CPS) ≥1. This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized part of the trial to generate pivotal efficacy and safety data of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. For Part B, an optional pre-screening phase is available for all patients where patients' tumor samples may be submitted for central HPV16 DNA and central PD-L1 expression testing prior to screening into the main trial.

NCT ID: NCT04532749 Terminated - Clinical trials for Depressive Disorder, Major

A Study of Seltorexant as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of Seltorexant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in participants with major depressive disorder with insomnia symptoms (MDDIS) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

NCT ID: NCT04531982 Active, not recruiting - Schizophrenia Clinical Trials

Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia

ADVANCE-2
Start date: August 5, 2020
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of adjunctive pimavanserin compared with adjunctive placebo in the treatment of negative symptoms of schizophrenia

NCT ID: NCT04530578 Recruiting - Covid19 Clinical Trials

Nebulized Heparin in Severe Acute Respiratory Syndrome COVID-19

NEBUHEPA
Start date: June 1, 2020
Phase: Phase 4
Study type: Interventional

To evaluate the safety and efficacy of the use of inhalational heparin in patients with pulmonary compromise / pneumonia / SARS associated with COVID-19, laboratory with marked inflammation parameters, and prothrombotic state secondary to it (Fibrinogen, Ferritin and / or elevated D-Dimer) , from admission to hospitalization. The combination of inhalation heparin combined with prophylactic doses of LMWH could reduce the progression to severe forms of the disease, and consequently the need for intensive care units and mechanical ventilation.

NCT ID: NCT04529525 Completed - Covid19 Clinical Trials

Ivermectin to Prevent Hospitalizations in COVID-19

IVERCORCOVID19
Start date: August 19, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

It is a single-center, prospective, randomized, double-blind, placebo-controlled study carried out by the Ministry of Public Health of the Province of Corrientes, Argentina, in coordination with the Corrientes Institute of Cardiology "Juana F. Cabral". Patients who meet all the inclusion criteria and none of the exclusion criteria are randomized via the web system to receive placebo or ivermectin. The need for hospitalization in patients with COVID-19 is assessed as the primary end point. As secondary end points are evaluated: time to hospitalization (in days); use of invasive mechanical ventilation; time to invasive mechanical ventilation (in days); dialysis; all-cause mortality; negative of the swab at 3 ± 1 days and 12 ± 2 days after entering the study and ivermectin safety. Intermediate internal analyzes of study objectives and serious adverse events will be performed, including 125; 250 and 375 patients in order to assess the possible need for early termination of the study. For these intermediate internal analyzes, the Haybittle-Peto rule will be followed, therefore a value of p <0.001 will be considered significant

NCT ID: NCT04529122 Recruiting - Solid Tumours Clinical Trials

A Worldwide Cancer Registry Enrolling Participants Profiled With a Next-Generation Sequencing Test

Start date: August 27, 2020
Phase:
Study type: Observational [Patient Registry]

WAYFIND-R is a registry that aims to capture high-quality real-world data linking next-generation sequencing, treatments and outcomes from cancer patients diagnosed with a solid tumour. The WAYFIND-R has three main overarching objectives: 1. To provide a platform to support the design and conduct of clinical and epidemiological research; 2. To develop an evidence-generation platform to better understand health outcomes and cancer care processes; and 3. To characterize the treatments and clinical course of solid tumor cancers in patients who have undergone NGS testing.

NCT ID: NCT04528706 Active, not recruiting - Clinical trials for Cerebral Adrenoleukodystrophy

A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT)

NEXUS
Start date: September 13, 2019
Phase: Phase 2
Study type: Interventional

An Open-Label, multicenter study in male pediatric patients with cerebral x-linked adrenoleukodystrophy (cald) to assess the effects of MIN-102 treatment on disease progression prior to human stem cell transplant (HSCT)

NCT ID: NCT04526990 Completed - COVID-19 Clinical Trials

Phase III Trial of A COVID-19 Vaccine of Adenovirus Vector in Adults 18 Years Old and Above

Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

This study is a global multicenter, randomized, double-blind, placebo -controlled, adaptive designed phase Ⅲ clinical trial, in order to evaluate the efficacy, safety and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in adults 18 years old and above.