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NCT ID: NCT03950752 Completed - Hyperlipemia Clinical Trials

Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia

PALMFREE
Start date: June 19, 2019
Phase: N/A
Study type: Interventional

Postprandial lipemia produced by fat intake is a major risk factor for the development of cardiovascular diseases (CVD), the most important cause of disease and death in the Western world. Scientific evidence shows that the consumption of saturated fatty acids has a potential harmful effect on postprandial lipemia compared to the intake of monounsaturated fatty acids. The magnitude of postprandial lipemia is also determined by the health status of individuals, being altered in individuals with metabolic disorders associated with the development of CVD, such as hypertriglyceridemia. Palm oil is widely used in bakery products because it is more economical compared to other fats and oils of other origin and for its stability properties that contribute to this type of food. This oil has a profile of fatty acids, rich in saturated fatty acids, mainly palmitic acid, which as mentioned above, is associated with health alterations. In addition, the investigators must add the environmental problems that are generated by the massive cultivation of the plant from which palm oil is extracted (oil palm Elaeis guineensis), including the loss of thousands of hectares of tropical forest and endangering to dozens of animal species from deforested areas. The proliferation of all these arguments associated with the effect on the health and environment of the consumption of palm oil has given way to a paradigm shift in the use of palm oil in the food sector. The hypothesis of the study is that consumption of bagels with a composition optimized in fatty acids, eliminating the content of palm oil and replacing it with high oleic sunflower oil and stearic acid completely hydrogenated without trans fatty acids, so that the same amount of fat is maintained, will decrease the postprandial lipemia, compared to the consumption of bagels with a more conventional composition in fatty acids, in healthy and / or with mild-moderate hypertriglyceridemia individuals. The main objective of this study was to evaluate the effect of acute consumption of bagels without palm oil in its formulation and with an optimized fatty acid composition on postprandial lipemia measuring the evolution of plasma triglyceride levels in healthy and/or with mild-moderated hypertriglyceridemia individuals.

NCT ID: NCT03950622 Completed - Clinical trials for Pneumococcal Infections

Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

PNEU-AGE
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

NCT ID: NCT03946800 Completed - Cancer Clinical Trials

A Study of MEDI1191 in Sequential and Concurrent Combination With Durvalumab in Subjects With Advanced Solid Tumors

Start date: May 8, 2019
Phase: Phase 1
Study type: Interventional

To evaluate MEDI1191 administered intratumorally in sequential and concurrent combination with intravenous durvalumab in patients with solid tumors.

NCT ID: NCT03946553 Completed - Allergic Rhinitis Clinical Trials

The Dysbiosis of the Intestinal Microbiota in Individuals With Allergic Rhinitis (MICRORIN)

MICRORIN
Start date: May 17, 2019
Phase:
Study type: Observational [Patient Registry]

Allergic rhinitis (AR) is triggered by environmental allergens such as pollen and mites, and is associated with several symptoms such as itching and nasal congestion, sneezing or tearing and redness of the eyes. RA can affect patients life quality who suffer it, reducing the quality of sleep and cognitive function, causing irritability and fatigue and, consequently a decrease in work performance. Because the existing pharmacological treatments for RA are not entirely effective, it is of interest to find other means to enhance the effects of these drugs and decrease more effectively the signs and symptoms associated with RA. In this context, RA has been related to an alteration of the intestinal microbiota (MI).However, there is a need to characterize in detail the MI of individuals who suffer RA. The main objective of the present study is to characterize the MI of individuals with RA, compared with people without RA. In addition, the secondary objective is to study the association between characteristics of the MI of individuals with RA and different immunological markers.

NCT ID: NCT03945292 Completed - Clinical trials for Alpha 1-Antitrypsin Deficiency

Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)

SEQUOIA
Start date: August 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of AROAAT2001 (SEQUOIA) is to evaluate the safety, efficacy and tolerability of multiple doses of the investigational product, Fazirsiran Injection, administered subcutaneously to participants with alpha-1 antitrypsin deficiency (AATD).

NCT ID: NCT03945188 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 52
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.

NCT ID: NCT03945019 Completed - Crohn's Disease Clinical Trials

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease

NCT ID: NCT03944642 Completed - Breastfeeding Clinical Trials

Design and Piloting of a Complex Intervention to Support Breastfeeding Self-efficacy (CRIAA Program)

CRIAA
Start date: August 9, 2019
Phase: N/A
Study type: Interventional

The aim of the study is to design and pilot the effect of a complex intervention to support mothers' breastfeeding self-efficacy and professional self-efficacy to support breastfeeding families, considering breastfeeding as a health promoting behavior. Specific objectives are the evaluation of feasibility and acceptability of the intervention, and estimate the preliminary effect on maternal and professional self-efficacy.

NCT ID: NCT03944135 Completed - Clinical trials for Indication for Modification of Patient Cognitive Status

Cognitive Rehabilitation in Older Adults With Neuron-up (CROAN)

Start date: February 15, 2019
Phase: N/A
Study type: Interventional

Introduction. The application of new technologies for cognitive rehabilitation has increased over the last years and has enabled occupational therapists to work more efficiently, minimizing costs and time for analysis, management, and design of activities. Objective. The purpose of the present study was to assess the effect of cognitive intervention using the web platform Neuronup in a group of elderly subjects; the study is based on the dependent variables (memory, attention, and language) analyzed with the abbreviated Barcelona Test. Subjects and Methods. Aquasi-experimental design was carried out with subjects assigned to two groups: a control group (20 subjects) and an experimental group (20 subjects). The abbreviated Barcelona Test was administered to assess patients before and after the intervention with this software to draw conclusions.

NCT ID: NCT03942744 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

The Effect of High-flux Hemodialysis and On-line Hemodiafiltration on Endothelial Function.

Start date: November 8, 2018
Phase: N/A
Study type: Interventional

The main aim of this project is to evaluate, in patients with chronic kidney disease (CKD5D), the role of adhesion molecules in leukocyte adhesion and transendothelial migration involved in atherogenesis. This trial is a prospective randomized crossover study in CKD5D hemodialysis patients followed in the Nephrology Unit of the Reina Sofia University Hospital (Cordoba, Spain). The estimated inclusion period is two years, with a follow-up of 24 months. Patients will be randomized to high-flux hemodialysis versus online hemodiafiltration with high convective transport (above 21 liters); after 6 months in each dialysis modality they will be switched the other technique for another 6 months. Then, patients will be maintained during 4 weeks in conventional hemodialysis "wash out period", before being started in the other dialysis modality.