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.
B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
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.
The prevention of obesity and its main medical complications, such as hypertension, type 2 diabetes and cardiovascular diseases, have been become a health priority. One of the most frequent metabolic complications in obesity is the insulin resistance and is the most important risk factor for the development of coronary diseases. The weight loss induced by the restriction of dietary energy is the cornerstone of therapy for people with obesity, as it improves or even regularizes insulin sensitivity and related comorbidities. However, weight loss induced by diet also decreases lean tissue mass, which could result in adverse effects on physical function. Although, regularly recommended to increase protein intake during weight loss, there is evidence to suggest that high protein intake could have deleterious metabolic effects. On the other hand, there is an association between the type of protein consumption, mainly the concentration of branched-chain amino acids (BCAAs) and insulin resistance during the dietary energy restriction in the therapy of obesity. There are multiple factors that influence the concentration of BCAAs and insulin resistance, which can be by phenotypic or genetic modification. The phenotypic modification refers to race, sex and dietary pattern. Meanwhile, the genetic modification refers to the activity of the enzymes responsible for the catabolism of BCAAs and genetic variants, such as the polymorphisms of a single nucleotide of said enzymes. A randomized controlled trial will be conducted with 160 participants (80 women and 80 men) divided by a draw in 4 groups, each for 20 participants. A feeding plan will be assigned according to the distribution of proteins (standard or high) and type of protein (animal or vegetable). The main aim of this study is to evaluate the effect on the amount and type of dietary protein and energy restriction on insulin resistance in subjects with obesity in a period of 1 month, considering the main factors that influence the concentration of BCAAs. In this way, evidence will be provided on what type of dietary intervention is most convenient for weight loss in subjects with insulin resistance and obesity.
The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).
The aim of the study is to compare the effect of motor interference therapy (TIM) to reduce the intensity of discomfort (distress) generated by a traumatic memory compared to a relaxation control maneuver, immediately after the intervention, a week, a month and six months after intervention.
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
Systemic Arterial Hypertension (SAH) is a disease with a high prevalence in Mexico and worldwide. SAH is associated with an increase in cardiovascular morbidity and mortality, causing cardiovascular disease (CVD), heart failure (HF), as well as chronic kidney disease (CKD). Several of the physiopathological mechanisms observed are: the increase in cardiac output, central aortic pressure (CAP), pulse wave velocity (PWV) and peripheral vascular resistance (PVR), which leads to the generation of damage to the target organ. The identification not only of the peripheral arterial pressure, but also of these hemodynamic parameters and arterial stiffness would allow a better cardiovascular characterization of the patients. However, the measurements of hemodynamic parameters and arterial stiffness can vary during the 24 hours from individual to individual by all known mechanisms involved in the regulation of blood pressure such as cortisol, central nervous system, the peripheral nervous system, along with the renin angiotensin and aldosterone system, which are usually only measured in a single moment. Generally, the choice of drug in a patient with SAH is based only on the values of peripheral blood pressure at the time of the measurement. The use of oscillometric equipment such as the Mobil-O-Graph 24 allows to the investigators to know the hemodynamic and arterial stiffness behavior during 24 hours; therefore, this could favor the choice of the most appropriate antihypertensive drug, dose and administration time. The use of angiotensin II receptor antagonists (ARA II) At1 blockers such as losartan and calcium channel blockers (CCB) for instance amlodipine have shown a reduction in CAP and peripheral blood pressure respectively in patients with SAH. The most prescribed drugs in health units worldwide are enalapril, amlodipine, losartan and atenolol, of which the most used combination is losartan with amlodipine. There are no studies to date that allow investigators to identify the effect of the administration of losartan / amlodipine in a fixed combination form on the hemodynamic parameters and arterial stiffness of patients with SAH. Therefore, the objective of the present study is to evaluate the effect of this fixed combination versus losartan on hemodynamic and arterial stiffness parameters based on the behavior of these for 24 hours.
The aim of this study is to evaluate the effect of a 6-mo individualized and specialized food-based nutrition intervention program in breast cancer patients' body composition, metabolism and antioxidant activity associated with micronutrients, during antineoplastic treatment. It is a quasi-experimental prospective follow-up study of women with primary diagnosis of invasive breast cancer in Sonora, Mexico. Conducted between September 2015 through July 2018. The Ethics and Research Committees of The Oncology State Centre and the Food and Development Research Centre, have approved the study's protocol and procedures. At baseline, all participants must sign an informed consent form and answer an oral interview, including self-reported questionnaires, for their nutrition record. At the beginning and 6-mo after, participants will be weighed during the morning in a digital scale and height will be measured using a digital stadiometer. Body mass index (BMI) will be calculated and classified according to the World Health Organization criteria. Waist and hip circumferences will be measured with a metal tape, according to the protocol of the International Society for the Advancement of Kinanthropometry (ISAK), by a certified anthropometrist. Body composition components will be measured in a dual-energy x-ray absorptiometry (Hologic Corporation 4500 Waltham, MA) by total body, L1-L4, and femur neck scans. Blood samples will be drawn by a certified phlebotomist using sterile equipment and aseptic techniques. Breast cancer patients' total energy expenditure will be estimated using an algorithm for Mexican population. Diet plans and recommendations will be based on the individual's nutritional status, dietary habits, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein to avoid sarcopenic obesity and considering a caloric restriction (500-1000 kcal/d), when required. The individualized nutrition intervention program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. To guarantee that the obtained content for each macronutrient (g/day) meets the theoretical calculations, protein ±1g/d, total fat ±1g/d, carbohydrates ±2g/d and energy ±15 kcal/d variations will be accepted. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed, and initial measurements will be repeated. The differences in body composition determinants will be analyzed using paired Student's t-test analysis for each variable. A two-tailed P-value of 0.05 or less will be considered significant. Retinol, tocopherol and carotenoids determination will be performed using HPLC. Serum will be thawed and retinol will be extracted using chloroform:methanol (3:1) and hexane, extracted layers will be combined and then evaporated to dryness under a soft stream of nitrogen. Samples will be re-suspended in ethanol before injecting onto the HPLC using a YMC C-30 column (30 cm length, 4.6 mm internal diameter, 3 µm particle size and 100 mm pore size). The HPLC system is an Agilent 1200 with UV-Vis and PDA detectors. Commercial standards and internal standards will be used to assess concentration and extraction efficiency, respectively. Additionally, the investigators will use a standard NIST serum (National Institute of Standards and Technology; Gaithersburg, Maryland USA). The cut-off point for vitamin A deficient status will be set at < 1.05 μmol /L. The plasma antioxidant capacity will be determined by the trolox-equivalent antioxidant capacity test (TEAC) and oxygen radical absorbance capacity assay (ORAC). For both assays, results will be expressed as millimoles of Trolox equivalents per liter. The effect and their interaction on the response variables will be determined by ANOVA. Tukey's test will be used for the comparison of the means. Values of p<0.05 will be accepted as statistically significant. Human inflammatory cytokines and chemokines will be analyzed by using a panel of 12 pro-inflammatory cytokines as a conventional ELISA protocol all at once under uniform conditions. The cytokines and chemokines represented by this array will be IL1A, IL1B, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNg, TNFa, and GM-CSF. Plasma activities of both enzymes, glutathione peroxidase (GPx) and superoxide dismutase (SOD) will be determined in baseline samples and after 6-mo, by using an ELISA (enzyme-linked immunosorbent assay) based upon a sandwich assay principle and can be used to detect levels of SOD as low as 0.066 ng/mL and 1.56 ng/mL for GPx.
The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.
Diabetic nephropathy is one of the most feared complications of Diabetes Mellitus type 2, characterized mainly by the decrease in the glomerular filtration rate and an increase in protein secretion by the kidney, that results in proteinuria. This has led to the development of intensive treatment regimens for patients with diabetes and preventive measures since once the complications have already presented the improvement of glycemic control alone may not be enough, to prevent the progression of pathological processes. Currently, interventions to delay the progression of kidney damage, include changes in lifestyle, nutritional advice and regular exercise, achieve optimal levels in glycemic control and use of pharmacological therapies with nephroprotector, angiotensin II receptor blocker (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs). The most important biochemical mechanism proposed for this progression is the excessive binding of glucose to proteins, better described as the final products of advanced glycosylation (AGEs); the interaction of AGEs with its receptor (RAGE), participates in the metabolic and biochemical pathways in intracellular signaling, either by favoring or aggravating cell nephron damage. Recently, numerous RAGE isoforms have been described as: soluble RAGE, which are devoid of cytoplasmic domains, which bind to ligands that include AGEs and can antagonize intracellular signaling. Therefore, the need to seek for alternative therapies like nutraceuticals is arising, mainly due to its low toxicity and lower cost. Such is the case of green tea extract, which due to its chemical composition, especially of flavonoids that generate antioxidant and anti-inflammatory effects, In vivo and in clinical trials have shown that it could impact the progression of the diabetic neuropathy , through the modulation of the biological process, including molecular and biochemical pathways such as release of soluble RAGE.