There are about 5012 clinical studies being (or have been) conducted in Mexico. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this trial is to evaluate the efficacy and safety of the implementation of an Algorithm for enteral nutrition support compared with usual standard practice in non-critical hospitalized patients: ASNET algorithm.
The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a maximally tolerated oral dose of statin of at least moderate-intensity.
Vitamin D as adjuvant to subcutaneous specific immunotherapy in patients with allergic rhinitis Specific allergen immunotherapy is the treatment of choice for patients with persistent allergic rhinitis. Some strategies to accelerate immunological and clinical changes to ensure an early response and improve adherence are needed. The administration of vitamin D along with conventional treatments in allergic patients with asthma or atopic dermatitis, pathophysiological entities like allergic rhinitis, reduces the severity of symptoms in less time. Primary endpoint. To evaluate the efficacy of vitamin D in terms of reducing the time of therapeutic response to subcutaneous specific allergen immunotherapy. Compare the time of clinical improvement and adherence to treatment among the group receiving vitamin D against the group receiving placebo Analyze the relationship between vitamin D values, total serum IgE, serum eosinophil and nasal cytology in both groups before and after treatment Assess the safety of vitamin D by serum calcium. TH17 and Treg quantify cells before and after treatment. MATERIAL AND METHODS This is a interventional, prospective clinical trial randomized placebo-controlled, double-blind study including paediatric patients (children 3-12 yr old) with allergic rhinitis, with parallel group: Immunotherapy + Placebo and Immunotherapy + Vitamin D. Patients prior informed consent include more patients being female and male of 3 to 12 years old. They will be randomized and in the same proportion. The sample was calculated using the G Power program to achieve an effect size of 0.65, with alpha = 0.05, statistical power = 80% and 20% losses to mean difference of 2 independent groups, the result was 80 patients, 40 per group. Monitoring will be conducted at 0, 3 and 6 months, assessing clinical and laboratory parameters with the questionnaire RQLQ, TNSS, CARACT KIDS, ARIA, GINA. ANALYSIS It will be analyzed in SPSS. The results are expressed by descriptive statistics. For comparison of means will be used t student. It will be analyzed with ANOVA, variance for repeated measures in time, general linear model, structural equations, multivariate analysis, analysis of the main components. P values <0.05 were considered statistically significant.
Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: - Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). - To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
Colorectal surgery is highly associated with septic complications, therefore, multiple approaches have been used to reduce this complications, one of the most used is mechanical bowel preparation. Lately multiple studies have suggested that mechanical bowel preparation might not be necessary.
The purpose of this study is to evaluate the efficacy and safety of oral administration of 24 ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
This multicenter study will be conducted to compare the effect of FF/UMEC/VI with FF/VI plus UMEC on lung function after 24 weeks of treatment. This is a phase IIIB, 24-week, randomized, double-blind, parallel group multicenter study. This study will test the hypothesis that the difference in trough forced expiratory volume in one second (FEV1) between treatment groups is less than or equal to a pre-specified non-inferiority margin. Alternatively, this study will also test the hypothesis that the difference between treatment groups is greater than the margin. The triple therapy of FF/UMEC/VI in a single inhaler is being developed with the aim of providing a new treatment option for the management of advanced Global Initiative for Chronic Obstructive Lung Disease (GOLD) Group D COPD which will reduce the exacerbation frequency, allow for a reduced burden of polypharmacy, convenience, and improve lung function, health related quality of life (HRQoL) and symptom control over established dual/monotherapies. This study has a 2 week run in period where subjects will continue to have their existing COPD medications. At randomization, subjects will discontinue all existing COPD medications and will be assigned to treatment of FF/UMEC/VI, 100 microgram (mcg)/62.5 mcg/25 mcg and placebo or FF/VI, 100 mcg/25 mcg and UMEC, 62.5 mcg in a 1:1 ratio for 24 weeks. Subjects will have clinical visits at Pre-Screening (Visit 0), Screening (Visit 1), Randomization (Week 0, Visit 2), Week 4 (Visit 3), Week 12 (Visit 4) and Week 24 (Visit 5). A follow-up visit will be conducted at 1 week after the end of treatment period or after early withdrawal visit. Approximately, 1020 subjects will be enrolled in this study. There will be two pharmacokinetic (PK) groups (subset A and subset B). Approximately 120 subjects will be assigned to subset A and approximately 60 subjects will be assigned to subset B. The total duration of subject participation will be approximately 27 weeks, consisting of a 2-week run-in period, 24-week treatment period and a 1-week follow-up period.
The aim of this non-dispensing study is to evaluate the clinical performance of different hydrogel contact lens designs.
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.