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NCT ID: NCT04251533 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

EPIK-B3
Start date: June 8, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

NCT ID: NCT04250896 Completed - Clinical trials for Overweight and Obesity

mHealth for Prevention of Childhood Obesity in Mexico

mHealth
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Background: The sending of text messages (short messaging service, SMS) has been proven as an effective strategy in behavior change. In Mexico, the Strategy of Comprehensive Care for the Nutrition (EsIAN for its acronym in Spanish ) focuses on improving access to information for the main caregivers of child beneficiaries on the practice of infant feeding and healthy physical activity. Objective: To assess whether the mHealth (or mobile health) strategy or the sending of SMS has an effect on knowledge, attitudes, intentionality, perceived control and practices to prevent childhood malnutrition in a population living in poverty. Design: Randomized effectiveness trial by conglomerates. Participants: 400 primary caregivers of children <59 months and health personnel working in the health units included in the study. Control group: Healthy child care in standard health units plus exposure to EsIAN. Intervention group: In addition to the control group, the SMS are sent through a cell pone through the RapidPro platform on practices related to prevention of child malnutrition (in primary caregivers) and the reinforcement of counseling for the prevention of infant malnutrition (with health personnel). Randomization: The first level health units were stratified by state (Morelos or Yucatan); rural and urban area and affiliation institution (Secretary of Health or Mexican Institute of Social Security); and randomized to be assigned to the control or intervention group; 400 primary caregivers of children <59 months in total will be included for the study. Main measures of interest: State of nutrition and knowledge, attitudes or practices on breastfeeding, physical activity, adoption and preparation of healthy foods and beverages in primary caregivers of children<5 years old; and advice on the key messages of EsIAN by health providers.

NCT ID: NCT04247087 Completed - Clinical trials for Coronary Calcification

Effects of Fhytomenadione on Coronary Artery Calcification of Hemodialysis Patients

Start date: September 7, 2017
Phase: N/A
Study type: Interventional

Until 2013 the reported incidence of chronic kidney disease varied widely between countries, reporting the highest prevalence Taiwan, the region of Jalisco in Mexico and United States, with 458, 421 and 363 individuals per million inhabitants respectively. Mexico has around 52,000 patients in replacement therapies, of which 80% of patients are treated in the Instituto Mexicano del Seguro Social (IMSS). In each stage of renal disease the principal cause of mortality is cardiovascular disease. The risk of cardiovascular mortality is greater than the general population. Arterial calcification, a marker of atherosclerosis and cardiovascular mortality predictor is common in chronic kidney disease. The presence of arterial calcification leads to an increase in arterial stiffness and to a decrease in coronary perfusion resulting in cardiac hypertrophy and myocardial ischemia. The presence of traditional cardiovascular risk factors like diabetes, hypertension, hyperlipidemia and old age cannot fully explain the high prevalence of atherosclerosis and arterial calcification in chronic kidney disease. Another specific factors related to chronic kidney disease, like hyperphosphatemia, high calcium concentration in dialysis solutions, use of high doses of vitamin D for the management of hyperparathyroidism has been shown to positively influence development of arterial calcification. Invitro studies show that in presence of hyperphosphatemia smooth muscle cells are transformed into osteoblast-like cells that can express proteins that regulate mineralization. Two of this proteins, the matrix Gla protein (MGP) and osteocalcin (OC) are regulators of tissue mineralization in arterial walls and bones respectively. Vitamin K is required as cofactor in the gamma-carboxylation process of several extracellular matrix proteins, converting inactive carboxylated proteins to carboxylated active proteins. Prothrombin and coagulation factors 7,9 y 10 require vitamin K2 for its carboxylation process, while osteocalcin and the matrix Gal protein require vitamin K1. Matrix Gla protein is a calcification inhibitor that plays an important role in the prevention of arterial calcification. For carboxylation and correct function of the MGP is necessary an enzymatic cofactor, vitamin K; this is corroborated in the fact that the antagonism of vitamin K with warfarin antagonizes the carboxylation of MGP and produces rapid arterial calcification. There are currently no studies evaluating vitamin K in the prevention of vascular calcification in patients with chronic kidney disease, therefore, the role of vitamin K in the patient with kidney disease needs to be clarified with randomized controlled studies, in which the target will be this population of patients at high risk. The aim of this study is evaluate the effect of phytomenadione on coronary artery calcification of patients on hemodialysis compared to placebo, our research hypothesis is that phytomenadione slows the progression and favors the regression of coronary arterial calcification in patients on hemodialysis compared to placebo, evaluating the coronary calcium score by coronary tomography. As secondary objectives was determine changes in the baseline coronary calcium score and at 12 months of use of phytomenadione and presence of cardiovascular events like acute myocardial infarction, unstable angina and death of cardiac cause. The intervention group received phytomenadione 10 mg (1 vial in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months and the control group 1 vial of placebo solution (solution for injection in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months. The follow-up of the patients was for 12 months, at the end of the follow-up, a coronary control tomography was performed by the Radiology Department to assess the final calcium score. Relative risk measurement (RR), absolute risk reduction (ARR) and number to be treated (NTT) were performed.

NCT ID: NCT04245462 Completed - Aging Clinical Trials

Adequate Protein Intake Per Meal and Physical Disability in Mexican Adults Aged 60 Years and Older

Start date: January 2017
Phase:
Study type: Observational

This study sought to determine if the number of meals per day with an adequate protein content (defined as eating >30 g protein or >0.4 g protein/kg body mass each) is associated with presenting physical disability in Mexican adults aged 60 years and older. Physical disability was evaluated with self-reported questionnaires for different activities of daily living.

NCT ID: NCT04245267 Recruiting - Type 2 Diabetes Clinical Trials

Multicomponent Integrated Intervention on Metabolic Control and Quality of Life in Type 2 Diabetes: DIABEMPIC Program

DIABEMPIC
Start date: January 7, 2017
Phase: N/A
Study type: Interventional

Type 2 diabetes is one of the leading causes of morbidity and mortality rate in Mexico. Although important advances in treatment strategies have been developed in type 2 diabetes mellitus, large gaps exist in achieving quality of care. Few studies have determined the effect of multicomponent interventions in low and middle income countries. The DIABEMPIC program is a quality of care initiative developed by primary care public health services of the Mexico City Government to propitiate diabetes empowerment in people living with type 2 diabetes through an intervention comprised by an interdisciplinary team care, shared medical appointment scheme, patient-centered care approach, structured diabetes education program, promotion of self-management, audit, and guaranteed supply of anti-diabetic medication. The DIABEMPIC program target population consists of patients with type 2 diabetes, without advanced chronic complications, who have regular care in the public primary care services in Mexico city.

NCT ID: NCT04240600 Recruiting - Clinical trials for Acute Myeloid Leukemia, Adult

Effect of a Hyperproteic Hyperenergetic Enteral Formula on Body Composition and VEGF in AML During Hospital Stay

HEMVEF
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

A randomized controlled clinical trial in two groups of supplementation with high protein enteral formula and a normocaloric enteral formula in two groups of 37 patients .

NCT ID: NCT04238026 Completed - Clinical trials for Radial Artery Occlusion

Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)

DAPRAO
Start date: May 2, 2019
Phase: N/A
Study type: Interventional

The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence. The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.

NCT ID: NCT04237220 Completed - Clinical trials for Helicobacter Pylori Infection

Endoscopic Biopsy to Detect Helicobacter Pylori

Start date: January 25, 2020
Phase:
Study type: Observational

Helicobacter pylori (H. pylori) infection represents one of the most common chronic infections that affect humans.Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with alarm symptoms. The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. This is a prospective uncontrolled cross-sectional clinical trial. Endoscopy must be performed to take biopsies for detection of Helicobacter pylori in patients with epigastric pain, weight loss, iron-deficiency anemia, individuals with dyspepsia over 60 years of age or younger with alarm symptoms (weight loss, dysphagia, vomiting, gastrointestinal bleeding, among others). The Sydney Protocol is the recommended strategy that guarantees maximum diagnostic yield. Histology is expensive since it requires time for biopsy processing and trained personnel for staining and interpretation but it provides additional information on the degree of inflammation and complications such as atrophic gastritis, intestinal metaplasia, and malignancy. The modified Sydney protocol includes two biopsies from the antrum, two from the body, and one form the incisura.

NCT ID: NCT04236609 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

ABILITY
Start date: June 15, 2020
Phase: N/A
Study type: Interventional

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

NCT ID: NCT04232553 Recruiting - Crohn's Disease Clinical Trials

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-2
Start date: June 22, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.