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NCT ID: NCT04328571 Completed - Healthy Subjects Clinical Trials

Effects of Enzymatic Digestion and Probiotic on Oleuropein Bioavailability

Start date: February 10, 2020
Phase: N/A
Study type: Interventional

This is a 3-arms randomized-controlled, parallel group, single center, double-blind study investigating the bioavailability of olive oil extract (OLE) in two different OLE formulations (enzymatically treated and co-administered with a probiotic) compared to original OLE formulation in healthy adult subjects.

NCT ID: NCT04327388 Completed - Clinical trials for Corona Virus Infection

Sarilumab COVID-19

Start date: March 28, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19). Secondary Objectives: - Evaluate the 28-day survival rate. - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity. - Evaluate changes in the National Early Warning Score 2. - Evaluate the duration of predefined symptoms and signs (if applicable). - Evaluate the duration of supplemental oxygen dependency (if applicable). - Evaluate the incidence of new mechanical ventilation use during the study. - Evaluate the duration of new mechanical ventilation use during the Study. - Evaluate the proportion of participants requiring rescue medication during the 28-day period. - Evaluate need for admission into intensive care unit. - Evaluate duration of hospitalization (days). - The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events. - Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia. - Grade greater than or equal to (>=) 2 infusion related reactions. - Grade >=2 hypersensitivity reactions. - Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline). - Major or opportunistic bacterial or fungal infections.

NCT ID: NCT04327336 Completed - Clinical trials for Obesity Hypoventilation Syndrome

Randomized Controlled Trial Between Auto-titration and Manual Titration of Non-invasive Ventilation in Obesity Hypoventilation Syndrome

TITRATION
Start date: April 1, 2020
Phase: N/A
Study type: Interventional

Primary Objectives: To evaluate the effectiveness in the obesity hypoventilation syndrome (OHS) treatment with non-invasive ventilation (NIV) set manually by polysomnography compared to the same treatment with a respirator with automatic NIV adjustment, analyzing as primary variable PaCO2 and as operational variables dropout rate for medical reasons and mortality. Secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. Other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, VNI compliance, quality of life and comorbidities; 2) To evaluate the profile of patients with poor adherence to NIV based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

NCT ID: NCT04327206 Completed - COVID-19 Clinical Trials

BCG Vaccination to Protect Healthcare Workers Against COVID-19

BRACE
Start date: March 30, 2020
Phase: Phase 3
Study type: Interventional

Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.

NCT ID: NCT04325750 Completed - Clinical trials for Sports Physical Therapy

Energy Transfer Therapy in Treatment of Medial Gastrocnemius

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.

NCT ID: NCT04324749 Completed - Cognitive Change Clinical Trials

Healthy Prebiotic and Postbiotic Effects of Peanuts and Peanut Butter: College Intervention Trial

ARISTOTLE
Start date: November 18, 2019
Phase: N/A
Study type: Interventional

Nuts have a prebiotic effect mainly due to their content of fiber and polyphenols, which provide substrates for the human gut microbiota. It is known that prebiotic substances are metabolized by microbiota generating postbiotics substances (products or metabolic by-products secreted by live bacteria or released after bacterial lysis). These products may improve host health and partly explain the health benefits of nut consumption. However, no study has been performed about the pre- and postbiotic effects of peanut and peanut butter consumption. Therefore, researchers propose a new interventional study to assess the impact of daily peanut and peanut butter intake on the organism, evaluating the pre- and postbiotic effects. The metabolome data generated will be correlated with the beneficial effects and cognitive skills. The final aim of this work is to spread a message of the health benefits of peanut consumption for the general population.

NCT ID: NCT04322214 Completed - HIV Clinical Trials

Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat

GHB_Cobi
Start date: January 30, 2020
Phase: Phase 1
Study type: Interventional

Gamma-hydroxybutyric acid (GHB) is a popular "party drug" because it is inexpensive and easy to ingest. The calming and euphoric effects of GHB in low doses have given the drug the nickname "liquid ecstasy". However, at doses >60 mg/kg coma, convulsions, and respiratory depression can occur. If the drug combinates with alcohol these effects intensify, especially respiratory depression and hypotension. Lately a phenomenon called Chemsex has been spreading across big European cities. This is a form of recreational drug use and it is believed that can be, in part, the cause of the increasing in consumption of GHB. Chemsex is especially common among men who have sex with other men (MSM) and in people living with HIV, with up to 50% of HIV-positive MSM reporting to be engaged in chemsex in recent months. This population is specially concerning since the combination of ART with the drug can cause pharmacological interactions leading to overdose. Specifically, this study intends to evaluate the drug interaction with low doses of cobicistat, an antiretroviral drug enhancer, since there are two case reports of life-threatening overdoses in patients on treatment with high doses of another enhancer that has a similar effect than cobicistat, but there are no studies about interactions with low doses.

NCT ID: NCT04321590 Completed - Clinical trials for Overweight and Obesity

Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against obesity_Pilot Study (OBHEALTH_PS)

OBHEALTH_PS
Start date: September 11, 2017
Phase: N/A
Study type: Interventional

Randomized, double blind, parallel study to assess the effect of a dietary supplement combining polyphenols (hydroxycinnamates from green coffee) and a soluble dietary fiber (oat beta-glucans) in obese/overweight subjects.

NCT ID: NCT04320615 Completed - COVID-19 Pneumonia Clinical Trials

A Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

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

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

NCT ID: NCT04320446 Completed - Clinical trials for Athletic Performance

Caffeine Increases Maximal Fat Oxidation During Exercise in Endurance-trained Men: is There a Diurnal Variation

Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fatmax) has been recognized as potential determinants of endurance performance. The purpose of this study was to determine the possible interaction between the effects of diurnal variation (morning vs. afternoon) and caffeine ingestion on MFO, Fatmax and VO2 max in endurance-trained men. Specifically, the investigators sought to elucidate whether the stimulant actions of caffeine could reverse the decrements of MFO and Fatmax observed in the morning.