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NCT ID: NCT03954574 Recruiting - Clinical trials for Pulmonary Circulation Diseases

Pulmonary Hemodynamics During Exercise - Research Network

PEX-NET
Start date: December 1, 2018
Phase:
Study type: Observational [Patient Registry]

The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.

NCT ID: NCT03954041 Not yet recruiting - Brain Contusion Clinical Trials

A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

Start date: August 31, 2019
Phase: Phase 2
Study type: Interventional

The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo. The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

NCT ID: NCT03953807 Not yet recruiting - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

Start date: May 27, 2019
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.

NCT ID: NCT03953560 Recruiting - Pulmonary Embolism Clinical Trials

Symptom-related Screening for Early Detection of CTEPH.

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

Routine screening for Chronic thromboembolic pulmonary hypertension (CTEPH) i after PE is not supported by current evidence and guidelines. This study aims to evaluate if a screening program for patients with acute PE based on telephone monitoring of symptoms and further examination if only symptomatic patients could help an early detection of CTEPH.

NCT ID: NCT03952897 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

Quality of Life Related to Health in Spa Users

Start date: May 1, 2018
Phase:
Study type: Observational

Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis. Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain). Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days. Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis. Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment. Follow-up duration: 9 months.

NCT ID: NCT03952559 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study of Baricitinib (LY3009104) in Children and Adolescents With Atopic Dermatitis

BREEZE-AD-PEDS
Start date: May 10, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug called baricitinib works and is safe in children and teenage participants with atopic dermatitis.

NCT ID: NCT03951376 Recruiting - Depressive Symptoms Clinical Trials

Universal Preventive Resilience Intervention to Improve and Promote Mental Health for Teenagers

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

Adolescence is a period of many physical, mental, emotional, and social changes. It is also associated with risk behaviour conducts. Nonetheless, not all youths under disadvantage, adversity, or exposure to risk factors experience negative mental health outcomes. The concept of RESILIENCE provides one possible explanation for the ability of some individuals to maintain positive mental health. Resilience is thus the ability of an individual or community to adapt to life challenges or adversities while maintaining mental health and well-being. The increasing prevalence of mental disorders amongst children (around 10-20% of young people) makes positive mental health promotion in schools necessary through intervention programmes. UPRIGHT (Universal Preventive Resilience Intervention Globally implemented in schools to improve and promote mental Health for Teenagers) is a research and innovation project funded by the European Union´s Horizon 2020 programme (No. 754919). UPRIGHT general aim is to promote mental well-being and prevent mental disorders in youth by enhancing resilience capacities. It has been designed as a whole school approach addressing early adolescents, their families and the school community to finally create a real mental well-being culture at schools.

NCT ID: NCT03951025 Not yet recruiting - Clinical trials for Biological Availability

Study of the Bioavailability of a Food Supplement Rich in Melatonin Administered Sublingually and Orally (MELATONIN)

MELATONIN
Start date: May 2019
Phase: Phase 2
Study type: Interventional

Sleep disorders represent an important public health problem that cause important personal problems, absenteeism and considerable health costs. Although the main drugs used for the treatment of insomnia are still Benzodiazepines and Z-drugs (Zolpidem, Zopiclone, Zaleplon), these are not entirely effective and have numerous side effects that lead to poor compliance with therapy . For the treatment of sleep disorders, alternative non-pharmacological therapies have also been implemented, such as cognitive therapy, relaxation therapy, and the introduction of new agents, including the use of melatonin as a human endogenous molecule with low or zero toxicity. In Europe, the European Food Safety Authority (EFSA) has stated that "A cause and effect relationship is established between the consumption of melatonin and the alleviation of subjective feelings of jet lag. In order to present the declaration of health, the dose of melatonin should be between 0.5 and 5 mg and should be taken close to bedtime on the first day (and subsequent days) of the trip and the following days after arrival at destination.The target population is the general population ". On the other hand, the EFSA states that "A cause and effect relationship is established between the consumption of melatonin and the reduction of sleep onset latency. The Panel considers that to obtain the declared effect, 1 mg of melatonin should be consumed near bedtime. The target population is the general population." The results of several studies in humans show that melatonin administered orally has a low bioavailability (approximately percentage) and a very short half-life. Therefore, it has been suggested that the sublingual route represents an attractive alternative for the administration of compounds that have a low bioavailability, since through this route, the substances are distributed throughout the body avoiding the loss of the compounds by their first-pass metabolism by the liver, as well as the loss by the process of absorption by the digestive system. On this basis the present hypothesis is posed: the administration of melatonin sublingually will have a greater bioavailability than the administration of melatonin orally. The main objective of this study was to quantify the bioavailability of 1 mg of melatonin when administered sublingually and orally.

NCT ID: NCT03950752 Not yet recruiting - Hyperlipemia Clinical Trials

Effect of Consumption of Bagel Without Palm Oil on Postprandial Lipidemia

PALMFREE
Start date: May 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: NCT03950466 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Real Life Pediatric Obstructive Sleep Apnea

RELIPOSA
Start date: January 1, 2018
Phase:
Study type: Observational

OBJECTIVES: PRIMARY: To analyze the cognitive alterations in children with Obstructive Sleep Apnea OSA in different age groups and changes at 12 months after treatment with a protocol based on usual clinical practice. DESIGN: Observational, longitudinal, prospective, and multicenter study.