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.
Primary Objective: To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c). Secondary Objectives: To demonstrate the superiority of H0E901-U300 in comparison with Lantus in: - Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning - Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event - Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day - HbA1c change
This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.
Childhood obesity is one of the most serious global public health challenges of the 21st century (Daniels et al., 2009). Mexico has the highest prevalence of obesity, (Secretaría de Salud, 2009); 34.4% of children and 35% of adolescents are overweight or obese (ENSANUT 2012). Obesity has major health consequences for children and adolescents; On the other hand, undernutrition as well has important deleterious consequences on children's health. Anything that disrupts energy balance may cause individuals to be underweight, overweight or obese. Fat has been considered an endocrine organ for some time (Elizondo, 2011). Recently, skeletal muscle has been shown to function as a peripheral endocrine organ by releasing myokines, (Pedersen, 2012). Most recently, a new identified hormone secreted by muscle tissue in mouse, irisin, has been discovered. Irisin acts on white adipose cells in culture and in vivo to stimulate UCP1 expression and a broad program of brown-fat-like development. Irisin was induced with exercise in mice and humans which caused an increase in energy expenditure in mice with no changes in movement or food intake (Boström et al., 2012). Irisin was thus, promptly hypothesized as a hormone influencing body weight, obesity and type 2 diabetes mellitus, among other conditions (Sanchis-Gomar et al., 2012). Some studies have indicated that circulating levels of irisin in humans correlate positively with anthropometric parameters such as BMI, fat mass, fat free mass, and are higher in obese patients compared to lean ones (Stengel et al., 2013; Huh et al., 2012; Roca-Rivada et al., 2013; Crujeiras et al., 2014; Pardo, 2014). Studies have shown an association between irisin levels, insulin resistance and the metabolic syndrome (Park et al., 2013; de la Iglesia et al., 2014; Crujeiras et al., 2014; Pardo et al., 2014). However, some others have found a negative correlation with anthropometric parameters, finding lower irisin levels in obese patients (Moreno-Navarrete et al., 2013). Noteworthy, all these studies have been performed in adults. To date, there are only two studies evaluating irisin levels in children. One found that a 1-year long lifestyle intervention program was associated with an elevation in irisin levels in obese children, although no correlation was found between irisin levels and anthropometric markers (Blüher et al., 2014). The other study investigated normal weight Saudi children and found correlations between circulating irisin and glucose and HDLc, but a negative association with insulin resistance (Al-Daghri et al, 2014). Besides, associations between irisin levels and adiponectin, leptin and resistin in the set of obesity have been explored, the three of them are implicated in the physiopatology of obesity. As there are still conflicting data regarding the association of irisin with anthropometric parameters, obesity and the metabolic syndrome, as well as its 'association with other adiponectines, and most important, there is scarce data of these associations in children, the objective of this study will be to correlate the circulating irisin and adipokines levels across a broad spectrum of body mass index ranging from undernourished to obese as well as with insulin resistance and risk factors for the metabolic syndrome in Hispanic children. The sample size with statistical power for this study yielded a sample of 40 children. Frozen stored plasma (-80°C) will be taken from a previous study performed in children which has been published (Elizondo-Montemayor et al., 2014). The samples will be divided into five groups, 8 per group, according to the CDC and American Academy of Pediatrics body mass index percentile classification: 1.) underweight = <3 percentile; 2.) normal weight = >3 - < 85 percentile; 3.) Overweight = >85 - < 95 percentile, and 4.) obese = > 95 percentile. The fifth group will correspond to children with known metabolic syndrome according to the classification specified by Cooks et al (2008). Anthropometric measurements will include BMI, percentile BMI, waist circumference, % body fat, fat mass, fat free mass, and triceps skin fold. Biochemical measurements will include glucose, total cholesterol, low-density cholesterol (LDL), high-density cholesterol (HDL-c) and triglycerides. Clinical measurements will include blood pressure, physical activity records and dietary habits. All biochemical, anthropometric and clinical measurements were previously performed in a former published study (Elizondo-Montemayor et al., 2014). Irisin, adiponectin and leptin will be measured in plasma media using commercial ELISA kits.
To demonstrate non-inferiority of the efficacy of 200 mg mifepristone followed in 24 to 48 hours by 800 µg buccal misoprostol in outpatient medical abortion services among women 71-77 days' compared to women 64-70 days' LMP.
The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer.
This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.
The purpose of this study is to determine the effect of ixazomib maintenance therapy on progression free survival (PFS) compared with placebo, in participants with NDMM who have had a major response (complete response [CR], very good partial response [VGPR], or partial response [PR]) to initial therapy and who have not undergone SCT.
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
Preoperative dexamethasone reduces symptoms after different surgical procedures including mastectomy in breast cancer, but the effect in the postoperative respiratory function remains unknown. The aim of this protocol was to determine if the administration of a single dose of dexamethasone during the preoperative, could improve respiratory function and postoperative symptoms of patients undergoing mastectomy in breast cancer.