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NCT ID: NCT04249635 Completed - Obesity Clinical Trials

Fetal Programming of Immune Response and Body Fat by Maternal Obesity

EpiFat
Start date: June 9, 2016
Phase:
Study type: Observational

According to the Chilean National Health Survey 2009-2010, 60% of woman in reproductive age are overweight or obese with detrimental consequences on women as well as offspring´s health at long term. New efforts are required to clarify how increased maternal body fat and obesity previous and during pregnancy impinge an increased cardiometabolic and obesity risk in the progeny. Nowadays it is clear that obesity in adults constitute a chronic state of sub-clinical inflammation characterized by an increased infiltration of monocytes in the adipose tissue as well as an imbalance between increased pro- (M1) and decreased anti- (M2) inflammatory macrophage polarization. Increased inflammatory markers have been found in obese children as young as 3 years of age, but if these markers are present at birth is completely unknown. Therefore, unveiling the mechanisms implicated in the capability of monocytes to differentiate into pro-inflammatory macrophages at birth would contribute to establish early markers of the potential risk to develop cardio-metabolic diseases. In this context, modulation of M1-M2 polarization seems to be crucial for the development of altered immune response, and this process would be tightly regulated by epigenetic mechanisms. On the other hand, long chain polyunsaturated fatty acids (LCPUFAs) play a role as precursors of cellular membrane components and modifiers, and as precursors of a plethora of signaling molecules that participates in cardiovascular, metabolic and immune functions. Additionally, DHA regulates gene expression in monocytes and macrophages altering the M1/M2 polarization. The supplementation with DHA in a high risk population of pregestational obese mothers, with known low n-3 intake, would have an important impact on newborn and infant % body fat. An improvement in the n-6/n-3 LCPUFA ratio during pregnancy in humans could represent a primary prevention strategy to revert fetal and neonatal high body fat and a healthy immune system maturation. The hypothesis of this proposal is that neonates born from obese mothers supplemented with DHA during pregnancy show a reduction in specific markers of high-risk of obesity. These markers would be evidenced as a lower percent of body fat at birth and at 4 months of age, as well as the reversion of functional and epigenetic changes in neonatal monocytes at birth, compared to neonates from obese mothers with low DHA intake.

NCT ID: NCT04249349 Completed - Stroke Clinical Trials

Preliminary Biomechanical and Usability Study of an Active Ankle-Foot Orthesis for Stroke Survivors

Start date: September 27, 2019
Phase: N/A
Study type: Interventional

This research will present the biomechanical assessment of a robotic device for ankle assistance during gait on stroke's survivors with hemiparesis. Gait pattern through an optoelectronic motion capture system will be analyzed. Additionally, ergonomic and comfort aspects will be measured by an adapted spanish version of Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

NCT ID: NCT04233216 Completed - HIV-1 Infection Clinical Trials

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Start date: March 18, 2020
Phase: Phase 3
Study type: Interventional

This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC) of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage of participants receiving DOR/ISL to achieve ≥0.5 log10 decrease in HIV-1 ribonucleic acid (RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination with failing antiretroviral therapy (ART).

NCT ID: NCT04230083 Completed - Bioequivalence Clinical Trials

Bioavailability of Dienogest 2.0 mg With Regards to Reference Product

Start date: December 7, 2019
Phase: Phase 1
Study type: Interventional

This Pivotal study will investigate the bioavailability in women of 1 tablet formulations containing Dienogest 2.0 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 1 tablet of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.

NCT ID: NCT04230070 Completed - Bioequivalence Clinical Trials

Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product

Start date: October 24, 2020
Phase: Phase 1
Study type: Interventional

This Pivotal study will investigate the bioavailability in women of 2 tablet formulations containing Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg. The Pivotal study will be performed at a single site with 30 subjects. Participants will take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.

NCT ID: NCT04228224 Completed - Stroke Clinical Trials

Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

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

This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

NCT ID: NCT04227457 Completed - Lung Cancer Clinical Trials

Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America

LATINO Lung
Start date: July 25, 2018
Phase:
Study type: Observational [Patient Registry]

To describe the overall survival of advanced NSCLC in Latin America.

NCT ID: NCT04214496 Completed - Clinical trials for Cognitive Dysfunction

Electroencephalographic Biomarker to Predict Acute Post-operatory Cognitive Dysfunction

Start date: January 4, 2021
Phase:
Study type: Observational

Acute post-operatory cognitive dysfunction states are one of the most important complications in older patients after surgery. Two acute cognitive dysfunctions have been described: postoperative delirium (PD) and postoperative subsyndromal delirium (PSSD). Patients who develop delirium, both as a complete or incomplete syndrome, have poor long-term outcomes, such as longer length of hospital stay, institutionalization at discharge, and even higher mortality, and consequently, the human and economic costs significantly increase for the health system. Here the research team will use an observational cohort, investigator blinded in two-center with a primary endpoint to validate the relative alpha power ratio as a predictive biomarker of postoperative cognitive dysfunctions.

NCT ID: NCT04202679 Completed - Neurodermatitis Clinical Trials

Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)

Start date: January 16, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapy or when those therapies are not advisable. Secondary Objectives: To demonstrate the efficacy of dupilumab on additional itch endpoints in participants with PN, inadequately controlled on topical prescription therapy or when those therapies are not advisable. To demonstrate efficacy of dupilumab on skin lesions of PN. To demonstrate the improvement in health-related quality of life. To evaluate safety outcome measures. To evaluate immunogenicity of dupilumab.

NCT ID: NCT04194905 Completed - Bioequivalence Clinical Trials

Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product

Start date: November 21, 2020
Phase: Phase 1
Study type: Interventional

This Pilot study will investigate the bioavailability in fasting women of 2 tablet formulations containing Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg. The Pilot study will be performed at a single site with 30 subjects. Participants will take 2 tablets of the test product and reference product in 2 periods and 2 sequences (either test after reference or reference after test). There will be a washout of at least 14 days between each study period.