Clinical Trials Logo

Filter by:
NCT ID: NCT04586608 Completed - Premature Birth Clinical Trials

Investigation of Administration of MCT/ω-3 Fatty Acids is Towards Anti-inflammatory Related Fatty Acid Profile in Preterm Neonates.

MCT/?-3 FA
Start date: February 15, 2018
Phase: N/A
Study type: Interventional

Intravenous administration of pure soybean oil emulsions high in linoleic acid may lead to inflammation and lipid peroxidation in preterm neonates. The aim of the present study was to investigate the effects of a medium-chain triglyceride (MCT)/n-3 polyunsaturated fatty acid (PUFA)-enriched intravenous fat emulsion (IVFE) on plasma fatty acid (FA) profile in preterm neonates. Methods: In this double-blind randomized study, 92 preterm neonates (gestational age <32 weeks, birth weight <1500g) were assigned to receive either MCT/n-3 PUFA-enriched IVFE (Intervention Group) or soybean oil-based IVFE (Control Group). Neonates' parents gave their informed written consent for inclusion in the study. Levels of FAs were measured at baseline (day 0) and day 15 of parenteral nutrition with gas-chromatography mass-spectrometry.

NCT ID: NCT04577170 Completed - Fabry Disease Clinical Trials

Pulsatility Index, Vasomotor Reactivity and Leukoencephalopathy in Fabry Patients

Start date: November 20, 2020
Phase:
Study type: Observational

We hypothesize that Fabry disease - FD is associated with elevated vascular resistance induced by cerebral small-vessel disease, indicating increased distal resistance to blood flow. The findings of this study may be used as a precursor for neuroimaging manifestations related to stroke in FD patients.

NCT ID: NCT04570306 Completed - Clinical trials for Systemic Lupus Erythematosus

Transcriptional and Immune Parameters of Response to Belimumab

Start date: December 16, 2020
Phase:
Study type: Observational

The investigators propose to perform RNA-sequencing of the whole blood initially, in a cohort of 80 SLE patients who will receive belimumab as part of standard clinical practice, in order to assess intra-patient longitudinal (baseline, 1, 3 and 6 months) transcriptome changes and examine whether treatment can ameliorate the activity/flare, severity and major organ disease gene signatures. The investigators will also obtain preliminary information on molecular signatures predicting clinical responses and the impact of belimumab on gene signatures of host defense against viral and bacterial (including mycobacterial) pathogens. Using modules of cell type-specific genes and co-expression gene networks, The investigators will deconvolute our data to define pertinent molecular alterations in specific immune cell types. Results will be validated and functionally characterized by single-cell mass cytometry (performed at the aforementioned time points), which enables investigation of the cell identity (including subsets of B-cells and myeloid cells of particular relevance to the disease) and activation status at protein level (e.g. phosphorylation) through next-generation, high-dimensional flow cytometry. Through a focused analysis followed by targeted gene expression and function studies in purified monocytes, the investigators will determine whether belimumab can restore "SLE-primed" monocytes thus, alleviating their inflammatory and pro-atherogenic phenotype and enhancing their bactericidal activity. Collectively, these studies will provide novel mechanistic insights on the beneficial efficacy/toxicity ratio of belimumab therapy in SLE.

NCT ID: NCT04564456 Completed - Bioequivalence Clinical Trials

A Pivotal Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

Start date: September 22, 2020
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

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: NCT04549389 Completed - Clinical trials for Chronic Pelvic Pain Syndrome

The Ideal LiST Session Frequency Protocol for CPPS Treatment

Start date: March 2, 2020
Phase: N/A
Study type: Interventional

The study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups. Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week. Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week. National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit. Adverse events will be reported during the treatment and follow up period.

NCT ID: NCT04546581 Completed - COVID-19 Clinical Trials

Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)

Start date: October 8, 2020
Phase: Phase 3
Study type: Interventional

This protocol will serve as a platform for assessing treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials will involve sites around the world strategically chosen to ensure rapid enrollment. This trial will compare hyperimmune intravenous immunoglobulin (hIVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. SOC will include remdesivir unless it is contraindicated for an individual patient.

NCT ID: NCT04546256 Completed - Bioequivalence Clinical Trials

A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers

Start date: September 1, 2020
Phase: Phase 1
Study type: Interventional

ioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder

NCT ID: NCT04545554 Completed - Clinical trials for Osteogenesis Imperfecta

Study to Evaluate Romosozumab in Children and Adolescents With Osteogenesis Imperfecta

Start date: January 21, 2021
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetics (PK) profile following multiple subcutaneous (SC) doses of romosozumab in children and adolescents with Osteogenesis Imperfecta (OI).

NCT ID: NCT04537923 Completed - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

SURPASS-6
Start date: October 19, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.