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NCT ID: NCT03655912 Not yet recruiting - Amblyopia Clinical Trials

Binocular Visual Therapy and Video Games for Amblyopia Treatment.

Start date: September 2018
Phase: N/A
Study type: Interventional

Amblyopia, or lazy eye, is best defined by the American Academy of Ophthalmology as a unilateral or bilateral reduction of the best corrected visual acuity that occurs in the setting of an otherwise normal eye, or a structural abnormality involving the eye or visual pathway with reduction in visual acuity that cannot be attributed only to the effect of the structural abnormality. Which causes an abnormal visual experience early in life, with consequences such as deficiencies in the ability to perceive contrast and/or movement, visual acuity, accommodation and stereopsis. The treatment of choice consists in patching of the fellow eye 2 hours per day. The disadvantage of this treatment modality is that patients end up not complying and when treatment is interrupted, lazy eye reappears. Amblyopia was thought to be a monocular disease, now a days there are reports of cortical visual paths changes in both eyes (the fellow and amblyopia eye), believing that it might be a monocular consequence of a binocular disease. Following that statement new treatment studies have arisen, stimulating both eyes not only to improve visual acuity in the lazy eye, but to restore binocular function as well. These treatments use videogames in celular phones, computers, or tablets where the fellow eye is exposed to reduced contrast and the lazy eye is exposed to full-contrast. Although the evidence is promising, more studies are needed to establish effectivity and security of this treatment modality.

NCT ID: NCT03640104 Not yet recruiting - Clinical trials for Overweight and Obesity

Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

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

Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

NCT ID: NCT03633630 Not yet recruiting - Metabolic Syndrome Clinical Trials

Amla on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Start date: September 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Amla has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Amla has an excellent potential for the prevention and treatment of metabolic syndrome.

NCT ID: NCT03629301 Not yet recruiting - Clinical trials for Obesity or Overweight

Obesity Treatment Using an Internet-delivered Intervention Based on the Diabetes Prevention Program in Mexican Adults

DPPON-MEX
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

In Mexico, 7 out of 10 adults are overweight or obese. The diseases associated with these conditions (diabetes, cardiovascular disease and some cancers) are those that impact the most on the disability-adjusted life years of Mexicans and on their mortality rates. A reduction in body weight of 5-10% can reduce the incidence of obesity related diseases. The gold standard for treating obesity is an intensive lifestyle change program such as the Diabetes Prevention Program (DPP) whose effectiveness has been evaluated in various formats and populations with positive results, including in Mexico. However, the DPP is not accessible to all sectors of the population. To increase its dissemination, the implementation of online interventions based on the DPP (oi-DPP) has been proposed. A systematic review of oi-DPP showed promising results, however, the evidence is limited and the lack of studies of high methodological quality is highlighted. The main objective of this project is to evaluate the efficacy of an oi-DPP for weight loss in Mexican adults with overweight or obesity at 3 months. The study design is a randomized controlled trial with 2 arms: oi-DPP and wait-list control. A 3 months pilot study (n=30) will be conducted prior to the main study to estimate sample size, considering an alpha error of 0.05 and power of 80%. The primary outcome is the mean change in body weight from baseline to 3 months post-baseline between the 2 groups. Secondarily, differences in biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides and gamma glutamyl transferase) from baseline to 3 months will be evaluated, as well as mean changes from baseline to 3 and 6 months in body mass index, waist circumference, systolic and diastolic blood pressure, depression and quality of life scales and the number of participants achieving a weight loss greater than 5% of initial body weight. Body weight will be also evaluated at 6 months post-baseline. The previous measurements will apply both in the pilot study and the study except for the biochemical parameters that will only be included in the main study. The differences between the 2 groups for each variable will be analyzed using a t test for independent samples, in case of having a parametric sample. Otherwise, the Mann-Whitney U test will be used. Analysis will follow the intent-to-treat principle.

NCT ID: NCT03627481 Not yet recruiting - Sleep Clinical Trials

Sleep Quality After Nasosinusal Surgery in AERD Patients

Start date: August 13, 2018
Phase: N/A
Study type: Interventional

Aspirin exacerbated respiratory disease presents as a triad composed by asthma, eosinophilic rinosinusitis and intolerance to aspirin and NSAIDS. In subjects with chronic rhinosinusitis sleep alterations have been found, with important improvement after surgery, but those alterations and improvements have not been studied in patients diagnosed with AERD who, due to their comorbidities, may present more severe pre surgical symptoms and a more important post-surgical improvement. The investigators aim to study patients with AERD sleep, quality of life and symptoms before surgery, and one, three and six months post-surgery.

NCT ID: NCT03617965 Not yet recruiting - Septic Shock Clinical Trials

Mortality Due to Septic Shock Associated With Thrombocytopenia

Start date: August 15, 2018
Phase:
Study type: Observational

A prospective longitudinal study similar to the one performed by Claushuis and colleagues (2016) will be performed in order to further understand the epidemiology and clinical relationship between platelet levels and mortality secondary to septic shock in a different population. The primary objective is to compare the mortality due to septic shock between patients with thrombocytopenia and patients with normal platelet levels in the ICU of the General Hospital of León, Gto. The secondary objectives are to identify the association between mortality due to septic shock and mild, moderate and severe thrombocytopenia in patients admitted to the ICU at 30, 60 and 90 days. Research questions Is there an association between thrombocytopenia and mortality due to septic shock in patients admitted to the critical medicine service? Our hypotheses are that: 1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with thrombocytopenia than in patients normal platelet counts. Is there an association between the degree of thrombocytopenia and mortality from septic shock in patients admitted to the critical medicine service? Our hypotheses are that: 1. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with mild thrombocytopenia than in patients without thrombocytopenia. 2. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with moderate thrombocytopenia than in patients without thrombocytopenia. 3. Mortality from septic shock and thrombocytopenia at 30, 60 and 90 days will be higher in patients with severe thrombocytopenia than in patients without thrombocytopenia.

NCT ID: NCT03617263 Not yet recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease in Women With PCOS

Saroglitazar Magnesium 4 mg in the Treatment of NAFLD in Women With PCOS (EVIDENCES VII)

Start date: September 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS. The study will be conducted over a period of up to 34 weeks and will include Screening (Days -28 to -7) Phase, a 24-week Treatment Phase following randomization on Day 1.The primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF.

NCT ID: NCT03613740 Not yet recruiting - Metabolic Syndrome Clinical Trials

Effect of Fucoxanthin on the Components of the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

Start date: October 2018
Phase: Phase 2
Study type: Interventional

The Metabolic Syndrome (MS) is a cluster of cardiometabolic risk factors, which include abdominal obesity, hyperglycemia, dyslipidemia, and high blood pressure. MS is considered a serious problem to health systems due to a current inability on implementing an effective prevention and treatment program. In Mexico 73% of adult population suffers obesity or overweight, this condition triggers the best studied pathophysiological mechanism; insulin resistance, which in turn precedes the diagnosis of diabetes and cardiovascular disease, that are the main cause of general mortality in Mexico, thus the prevention and timely treatment of this condition are now a priority. Actual pharmacological therapy is designed to control its components individually, however, there are great interest in developing new therapeutic lines that improve more than one component simultaneously and thereby increase the cost-benefit and effectiveness of the therapy. Fucoxanthin is a functional element present in seaweed species. Several studies have offered certain perspectives on its action mechanism and safety. The information available is favorable for weight control in overweight subjects, but its activity in glucose levels, lipid metabolism and blood pressure is inconsistent. It represents a natural option with great interest in this research, since it could be a new, safe and effective therapy in the MS. The aim of this study is to evaluate the effect of fucoxanthin on the components of the MS, insulin sensitivity and insulin secretion. The investigators hypothesis is that Fucoxanthin modifies the components of the MS, insulin sensitivity and insulin secretion

NCT ID: NCT03608176 Not yet recruiting - Obesity Clinical Trials

Evaluation of the Plant-based Approaches to Stop Obesity Diet for the Treatment of Obesity

PASO diet
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

Obesity is one of the most important problems worldwide, thus effective and accessible treatments are required. Some authors highlighted that treatment is focused solely on lifestyle (diet, physical activity, behavioral therapy) has a limited effect on body weight because it does not consider the biological mechanisms linked to weight loss in patients with obesity. On the other hand, drugs and bariatric surgery consider these biological approaches; however, its costs, safety and effectiveness limits its use on a large scale. Research studies support the existence of compounds in plants (such as epigallocatechin gallate, caffeine, cinnamaldehyde, fiber), and water with biological properties that would contribute to the treatment of obesity. However, at the moment, these compounds have only been evaluated individually and their effects have been significant but limited clinically, therefore, more research studies are needed to evaluate whether several of these compounds contained in common plants synergistically have a clinical impact on the management of obesity. The present work integrates diverse plant-based approaches to stop obesity and it is compared with a control group and a waiting list group. The main aim is to evaluate the efficacy of the Plant-based Approaches to Stop Obesity diet (PASO diet) compared with a control group on body weight at 4 months in Mexican adults with obesity. The study design is a randomized controlled trial. A pilot study will be conducted prior to the main study with a (n=36). The primary outcome is the change in body weight from baseline to 4 months. Secondary outcomes will be the changes from baseline to 4 months in body mass index, waist circumference, systolic and diastolic blood pressure, depression, quality of life scales and biochemical parameters (fasting glucose, total cholesterol, LDL cholesterol, HDL-cholesterol, triglycerides and gamma glutamyl transferase). The previous measurements will apply both in the pilot study and in the study except for the biochemical parameters that will only be included in the main study. 24-hour dietary recall will be measured at baseline and 4 months to evaluate adherence to the intervention. Sample size calculation of the main study will be estimated based on data from the pilot study considering an alpha error of 0.05 and power of 80%.

NCT ID: NCT03606694 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Effect of Dihydromirycetin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Type 2 Diabetes Mellitus

Start date: October 1, 2018
Phase: Phase 2
Study type: Interventional

Dihydromyricetin has demonstrated promising effects in glycemic control, insulin sensitivity and insulin secretion, that above mentioned findings show that dihydromyricetin has an excellent potential effect in the treatment of type 2 diabetes mellitus patients.