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NCT ID: NCT04059120 Completed - Exercise Clinical Trials

Expression of BNDF Through Stretching and Recovery

BDNF&Exe
Start date: March 30, 2018
Phase: N/A
Study type: Interventional

The phenomena of biological adaptation and overtraining are closely related terms, that is why in sport it is possible to identify two types of overtraining. The first of these is known as short-term overtraining, which is required as a state of peripheral fatigue induced by repeated sessions of physical activity in short periods of time that are related to mechanisms of metabolic type, is considered desirable and normal, by allowing mechanisms of adaptation to be activated depending on the nature and administration of the loads, which allow reaching higher yield quotas. The second, long-term overtraining, is characterized by a series of signs and symptoms of exhaustion and persistent fatigue that take place at the level of the central nervous system and that are produced by the imbalance between demanding physical work and recovery periods.This type of condition is also known as, general syndrome of overtraining (GSO), unexplained low performance syndrome, staleness or burnout, which is propitiated by the need to achieve maximum physical performance and the performance of physical activities in a uncontrolled that cause an interruption to the processes of biological recovery that attenuate the obtaining of the physical form wished, reason why the sportsman experiences a decrease of the physical and mental performance, manifested in a clinical picture that reflects muscular inflammation, headache, elevation sudden blood pressure, loss of functional capacity, alterations of the central nervous system (CNS), metabolic, endocrine and immune systems. The stretching is commonly used as a method of physical rehabilitation. The actual information about how the GSO can reduce or prevent in the athlete are no cleared yet, that is the way the information regarding the relationship with the GSO, the stretching, the expression of BDNF and the effects can produce in the regenerative capacity in the over-trained subjects and their compensatory mechanisms during the different cycles of physical exercise, is null, making necessary the investigation of the effects that can produce in the decrease of factors that indicate GSO.

NCT ID: NCT04058158 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

Start date: August 7, 2019
Phase: Phase 3
Study type: Interventional

This is a randomised Phase III, double-blind, multicentre, cross-over study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB12 and Soliris® in subjects with PNH.

NCT ID: NCT04058028 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

Efficacy and Safety of AMG 570 in Subjects With Active Systemic Lupus Erythematosus (SLE)

Start date: February 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Rozibafusp Alfa could be a useful therapeutic agent in the current treatment landscape where subjects with SLE have ongoing disease activity despite treatment with standard of care therapies.

NCT ID: NCT04056039 Completed - Clinical trials for Cardiovascular Diseases

Atorvastatin vs Colchicine in Decrease of Troponin I of High Sensitivity in Patients With Rheumatoid Arthritis.

ACAR1
Start date: August 14, 2018
Phase: Phase 2
Study type: Interventional

Pilot study. The primary end point is the evaluation the efficacy of treatment with atorvastatin compared to colchicine for the decrease of high sensitivity troponin I levels in patients with rheumatoid arthritis with severe activity according of the Disease Activity Score 28 (DAS 28> 5.1), through a randomized controlled clinical trial blinded to the rheumatologist and the cardiologist who will carry out the evaluation of the patient.

NCT ID: NCT04053790 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)

Start date: January 15, 2019
Phase: Phase 4
Study type: Interventional

Background: The combination of Lactobacillus fermentum and Lactobacillus delbrueckii (Lactobacillus LB) has proven to be effective and safe for the treatment of acute diarrhea in children. Also, a clinical trial in adult patients with chronic diarrhea, showed a reduction in the number of daily stools. However, the evidence is not enough regarding the efficacy and safety of Lactobacillus LB for treatment of patients with irritable bowel syndrome with predominance of diarrhea (IBS-D). Justification for this study: Lactobacillus LB could be a promising treatment for patients with IBS-D; nevertheless, the scientific evidence in this context is limited and it is not recent. Therefore, is necessary to explore the efficacy and safety of Lactobacillus LB in patients with IBS-D according to Rome IV criteria. Hypothesis: Lactobacillus LB is useful to decrease the frequency and improve the stools consistency of patients diagnosed with IBS-D by Rome IV criteria. Primary Outcome: To compare the treatment with Lactobacillus LB at two different doses: a) 20,000 million / day, vs. b) 10,000 million / day; and to determine if one of them is better than c) placebo, to decrease the frequency (weekly average of the number of stools/day) in patients diagnosed with IBS-D by Rome IV criteria. Design of the study: Clinical trial, randomized, double-blind, placebo-controlled. Keywords: irritable bowel syndrome with diarrhea, Lactobacillus LB, treatment, efficacy, safety.

NCT ID: NCT04050605 Completed - Astigmatism Clinical Trials

Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear

Start date: June 4, 2019
Phase: N/A
Study type: Interventional

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.

NCT ID: NCT04048018 Completed - Clinical trials for Latent Tuberculosis Infection

Performance Evaluation of the VIDAS TB-IGRA Assay.

Start date: December 5, 2019
Phase:
Study type: Observational

This study will evaluate the performance of the VIDAS® Interferon Gamma (IFN-γ) Release Assay (TB-IGRA) assay, which is intended for use as an aid in the diagnosis of tuberculosis infection. This study is designed to assess (1) the sensitivity of this assay, (2) its percent agreement with other diagnostic tests, (3) its measurement precision , and (4) any potential interference of the presence of other non-tuberculosis mycobacterial bacterial infections with this assay.

NCT ID: NCT04041492 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Vitamins D3 and K2 in uOc and Insulin Serum Levels in Patients With Diabetes Mellitus

Start date: February 14, 2017
Phase: N/A
Study type: Interventional

Introduction: Patients with DM2 have chronic hyperglycemia derived from a decrease in insulin sensitivity, cause of comorbidities such as bone demineralization, decreasing quality of life and increasing mortality. This could be related to changes in the serum levels of carboxylated Osteocalcin and Insulin, together with the deficit the daily consumption of vitamins D3 and K, which is crucial for the process of mineralization of the bone matrix. Research question: What is the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus? Hypothesis: Supplementation with Vitamins D3 and K2 modifies the serum levels of Carboxylated Osteocalcin and Insulin in patients with Type 2 Diabetes mellitus. General Objectives: To assess the effect of supplementation with Vitamins D3 and K2 on serum levels of Carboxylated and Non-Carboxylated Osteocalcin in patients with Type 2 Diabetes mellitus. Material and Methods: Clinical trial, double blind, randomization, 40 patients with DM2, 35-65 years, supplementation (3 months), clinical and laboratory determinations (uOC and Insulin). - Group 1: Vitamin D3 1000UI + Placebo - Group 2: Vitamin K2 100 mcg + Placebo - Group 3 (Positive Control): Vitamins D3 1000UI + K2 100 mcg

NCT ID: NCT04040881 Completed - Cancer Clinical Trials

Accuracy of a Mobile Sensor-Based System for the Detection of Chemotherapy Toxicity in Older Adults With Cancer in a Developing Country

Start date: August 14, 2019
Phase: N/A
Study type: Interventional

Patients with cancer in developing countries face considerable challenges in obtaining access to care due to a lack of human resources and infrastructure. This is particularly pressing for vulnerable populations such as older adults. In this setting, many patients receiving chemotherapy are unable to report the presence of toxicities, and adverse events can go unnoticed for considerable amounts of time. The goal of this study is to assess the accuracy of an objective patient-centered measure of physical function (the number of steps taken per day measured using an accelerometer-equipped smartphone) for the remote detection of chemotherapy toxicity in older adults. This study builds on a pilot trial showing that monitoring older patients remotely utilizing an accelerometer-equipped smartphone is feasible and acceptable, and that a decline in the number of steps detected using the device can be an early sign of chemotherapy toxicity. The hypothesis of this study is that a decline in the number daily steps from a prechemotherapy baseline, measured using an accelerometer-equipped smartphone, will be accurate for detecting chemotherapy toxicity in older adults with cancer. This study will evaluate the ability of a patient-centered measure (a decline in the number of daily steps compared with a pre-chemotherapy baseline) to identify the presence of clinically-significant chemotherapy-related toxicity in Mexican older adults with cancer starting first line chemotherapy. Patients will be provided with an accelerometer-equipped smartphone with an installed pedometer application. Baseline steps per day will be obtained and recorded before starting chemotherapy. The patients' steps will be monitored daily for the first three chemotherapy cycles and compared with baseline recordings. Patients will be contacted daily and chemotherapy toxicity will be assessed by a physician. If significant toxicities are identified, the patient will be prompted to seek medical attention. The optimal cutoff point for detecting chemotherapy toxicity utilizing a decline in the number of daily steps will be chosen and validated. The adherence and satisfaction with the intervention will also be evaluated. This study could improve current methods and transform the way in which cancer care is delivered by demonstrating that a simple patient-centered measure obtained using a commercially available smartphone can aid in the accurate identification of clinically significant toxicities among a vulnerable population such as older adults with cancer.

NCT ID: NCT04037826 Completed - Clinical trials for Irritable Bowel Syndrome

L. Reuteri DSM 17938 and L. Reuteri ATCC PTA 6475 in Moderate to Severe Irritable Bowel in Adults

reuteri-IBS
Start date: July 12, 2018
Phase: N/A
Study type: Interventional

Randomized, double blind, controlled clinical trial, to evaluate safety and efficacy of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475 as adjuvant to reduce the severity of symptoms in adults with moderate to severe irritable bowel syndrome (IBS). Primary outcome: Global clinical Improve assessed by the GSRS-IBS score. Adults 18-65 years, any gender, with ROME IV criteria for moderate to severe IBS and body max index <36 will be included. Prescreening will be run for 2 weeks, the intervention period will be 2/days for 14t weeks, follow by a 2 weeks period of observation with no intervention. Secondary outcomes include: a) Improvements in the stool patterns evaluated through Bristol Stool Form (BSF); b) Improvement of the quality of life (QoL) measured by Latin-American IBS-QoL questionnaire; c) Improvement of the depression and anxiety severity evaluated by the Goldberg Depression and Anxiety Scale; d) Frequency of rescue medication use and e) Frequency of Adverse Events (AEs)