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NCT ID: NCT04032509 Completed - Clinical trials for Mild Traumatic Brain Injury

A Study of Biomarkers of Mild Traumatic BRAIN Injury

BRAINI
Start date: August 10, 2019
Phase:
Study type: Observational

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.

NCT ID: NCT04031846 Completed - Clinical trials for Pneumococcal Infections

Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)

PNEU-PED-EU-1
Start date: September 4, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

NCT ID: NCT04031391 Completed - Fibromyalgia Clinical Trials

Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

Start date: July 22, 2017
Phase: N/A
Study type: Interventional

Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.

NCT ID: NCT04031248 Completed - Clinical trials for Patello Femoral Syndrome

Whole Body Vibration and Exercise in Knee Pain

Start date: September 2, 2019
Phase: N/A
Study type: Interventional

The present study will consist of evaluating the effect of applying an exercise protocol on a vibratory platform in order to provoke immediate influences in the affected systems and in the quality of life of the patients with patella-femoral pain.

NCT ID: NCT04029818 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of a Probiotic on LDL-cholesterol Levels

Start date: May 24, 2019
Phase: Phase 1
Study type: Interventional

The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.

NCT ID: NCT04029727 Completed - Clinical trials for Cardiovascular Disease

Effect of the Combination of Plant Extracts (BSL_EP025) in Cardiovascular Health

Start date: May 24, 2019
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the ability of a combination of plant extracts (BSL_EP025) to reduce the levels of LDL-cholesterol and oxidized LDL-cholesterol in individuals with LDL-cholesterol levels between 100 and 190 mg/dL.

NCT ID: NCT04029558 Completed - Immune Response Clinical Trials

Effect of a Combination of Plant Extracts (BSL_EP024) on the Immune Response

Start date: June 3, 2019
Phase: N/A
Study type: Interventional

The aim of the present trial is to study the effect of the combination of plant extracts (BSL_EP024) in the activation of the immune response.

NCT ID: NCT04028128 Completed - Healthy Subjects Clinical Trials

High Flavonols Cocoa Intake for the Improvement of Body Fat Composition in Athletes

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

The decrease in body fat percentage improves exercise performance, reducing race time. The intake of cocoa improves the body fat composition in obese and diabetic people by improving their cardiovascular disease risk factors. Although epidemiological studies indicate that healthy subjects who consume cocoa have lower body fat composition, there is no study indicating whether cocoa improves fat composition in athletes. The aim of the study was to determine if the intake of cocoa rich in flavonoids improves the fat composition of athletes, modifying the systemic levels of adipokines (folistatin, myostatin and leptin), resulting in an improvement of physical performance.

NCT ID: NCT04027218 Completed - Venipuncture Clinical Trials

Clinical Trial to Assess the Effectiveness of Applying Dry Local Heat and/ or High Tourniquet Pressure for Venipuncture.

ECYPVEN-H/17
Start date: July 9, 2017
Phase: N/A
Study type: Interventional

Low level intervention health products clinical trial, fourth phase, non-commercial research. Dissertation of COMPLUTENSE UNIVERSITY of Madrid. Principal Investigator of this clinical trial: Ms. LETICIA CARMEN SIMÓN LÓPEZ Collaborative investigators: Dr. DOLORES OCHOA-MAZARRO (principal investigator of bioequivalence clinical trial), and Sir. SERGIO LUQUERO-BUENO (collaborative researcher) The setting is Clinical trials Unit of Clinical Pharmacology Department. LA PRINCESA HOSPITAL of Madrid. Research Ethical Committee of LA PRINCESA HOSPITAL of Madrid. Any person will monitor this clinical trial because the sponsor and principal researcher are the same person. Nevertheless, an adherence to this protocol will ensure by principal researcher and co-researchers. The three interventions are: 1. To Apply local dry heat. 2. To apply high tourniquet pressure. 3. To apply both of them. (Dry heat and high pressure) The common comparator: Current Clinical practice for peripheral venous catheterization. The main hypothesis: The number of attempts of success venipuncture at first time are influenced by any of the interventions applied before. The main goal: To identify the most effective intervention of applying dry local heat and/or high tourniquet pressure in relation of number success venipuncture attempts, compared to current clinical practice. Design: An experimental, randomized study which is controlled with current clinical practice to insert a peripheral vein catheter. It is an incomplete cross-over clinical trial, with three arms which are involved interventions and a common comparator. Population: Adult healthy subjects. Sample size: It is required to enroll 54 subjects with a 95% of level of confidence and 80% level of power. Main variable: Succeed peripheral vein catheter insertion at first attempt. Effectiveness assessment: The optimal effectiveness is considered when vein cannulation success at first attempt exceeds 95% applying any of the interventions. Planned date to address: It is planned to carry out around June and/or July of 2017 for the main variable.

NCT ID: NCT04026113 Completed - Clinical trials for Functional Constipation

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

LINZESS
Start date: October 1, 2019
Phase: Phase 3
Study type: Interventional

The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria for Child/Adolescent Functional Constipation (FC). The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (145 μg or 290 μg daily) in pediatric participants, 7 to 17 years of age, who fulfill the Rome III criteria for child/adolescent Irritable Bowel Syndrome (IBS) and modified Rome III criteria for child/adolescent Functional Constipation (FC).