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NCT ID: NCT03214380 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

PRONTO-T2D
Start date: July 14, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

NCT ID: NCT03214367 Completed - Clinical trials for Type 1 Diabetes Mellitus

A Study of LY900014 in Participants With Type 1 Diabetes

PRONTO-T1D
Start date: July 17, 2017
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug LY900014 compared to insulin lispro, both in combination with insulin glargine or insulin degludec, in adults with type 1 diabetes (T1D).

NCT ID: NCT03209466 Recruiting - Diabetic Foot Clinical Trials

Chlorhexidine Gluconate Solution at 0.125% vs Placebo for the Healing of Grade IIB Ulcers of Diabetic Foot

Start date: May 11, 2017
Phase: Phase 4
Study type: Interventional

There is controversy regarding the utility of antiseptics in wound management for diabetic foot ulcer syndrome. The aim of this study is to assess chlorhexidine gluconate at 0.125% vs. saline solution to reduce the ulcerated area in patients with diabetic ulcer syndrome. A clinical trial model to evaluate modifications in size and area is proposed. Patients to be included will be those with diabetic foot ulcers Graded II accordingly to the University of Texas wound classification system.

NCT ID: NCT03208946 Completed - Healthy Clinical Trials

Effects of a High-CML Diet on Absorption and Excretion Levels in Healthy Adults

Start date: July 6, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect of carboxymethyl-lysine (CML) on the levels of absorption and excretion of CML, and in the microbiota of healthy adults. To achieve the objective, a randomized clinical trial will be carried out. Before the intervention, subjects will have a washout period for seven days, then they will be randomly assigned to either a high-CML or to a low-CML diet for 5 days. Both groups will consume the foods provided by the researchers at the research center. Diets for this intervention will be based on an isocaloric diet that will include breakfast, lunch, snacks and dinner. Blood samples will be taken the first day, the second day of the intervention, and after the five days of the intervention. Urine and fecal samples will be taken the day before the intervention and after the intervention. CML levels will be measured by Liquid chromatography tandem-mass spectrometry in serum and urine samples to evaluate the levels of absorption and excretion. DNA extraction from the fecal sample will be carried out by a commercial kit. Bacterial log10 number of copies will be determined by using q-PCR.

NCT ID: NCT03208322 Withdrawn - Hepatitis C Clinical Trials

Early Post-marketing Study of Daclatasvir (Daklinza®) + Asunaprevir (Sunvepra®) in the Treatment of Chronic Hepatitis C (CHC) in Adults

Start date: November 30, 2018
Phase:
Study type: Observational

The primary objective of the study is to determine the number of adverse events (AEs) reported by chronic hepatitis C (CHC) patients receiving at least 1 dose of daclatasvir (DCV) and asunaprevir (ASV) at the 2 sentinel sites and that have been reported through the Mexican Health Authority's AE surveillance system during a specified 24-month study period. The secondary objective is to describe AEs reported by CHC patients receiving treatment with DCV and ASV treated by doctors at participating sentinel sites for the National Pharmacovigilance Center (CNFV) in Mexico during a specified 24-month study period.

NCT ID: NCT03207282 Completed - Clinical trials for Depressive Disorder, Treatment-Resistant

Treatment Resistant Depression in America Latina

TRAL
Start date: September 27, 2017
Phase:
Study type: Observational

The purpose of this study is to estimate the prevalence of Treatment Resistant Depression (TRD) among Major Depressive Disorder (MDD) participants being treated in a psychiatry reference site (example, clinic, ambulatory, hospital, day-hospital) in 4 Latin American countries: Argentina, Brazil, Colombia and Mexico; and to evaluate all and depression-related healthcare resource utilization in TRD participants.

NCT ID: NCT03207243 Completed - Asthma Clinical Trials

Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma

Start date: September 14, 2017
Phase: Phase 2
Study type: Interventional

GSK3772847, an anti-interleukin (IL)33 receptor monoclonal antibody, is a novel treatment for asthma. This is a phase 2a study which aims to evaluate efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of GSK3772847 in subjects with moderately severe asthma. The study will be conducted in 4 phases including screening, run-in phase, treatment phase and follow-up. In treatment phase, eligible subjects will be randomized to receive either GSK3772847 or placebo administered via intravenous (IV) route every 4 weeks in addition to open-label background therapy of fluticasone propionate/ salmeterol (FP/Sal) 500/50 micrograms (mcg) twice daily. During the treatment phase, the background therapy will be switched to FP 500 mcg for 2 weeks and the dose of FP will be reduced by approximately 50 percent at every 2 weeks until complete FP discontinuation. The total duration of study will be approximately 33 weeks and approximately 165 subjects with moderately severe asthma who are maintained on high-dose of inhaled corticosteroids/ Long-Acting Beta-2-Agonists (ICS/LABA) will be randomized.

NCT ID: NCT03206476 Completed - Food Habits Clinical Trials

Modifications in the Eating Habits of Adolescents of Secondary Education as a Result of a Nutritional Intervention

Start date: February 1, 2016
Phase: N/A
Study type: Interventional

The objective of the study was to demonstrate the efficacy of a nutritional intervention based on the Social Cognitive Theory and the Transtheoric Model in the favorable modification of eating habits in adolescents of secondary education. The hypothesis was that secondary school adolescents receiving a nutritional intervention based on Social Cognitive Theory and the Transtheoric Model presented more favorable modifications in their eating habits than adolescents who only received nutritional information. A community trial was conducted with pilot testing for the validation of the study instruments. Adolescents from the second grade of the afternoon shift of the Jalisco Technical High School Nº46 participated in the 2015-2016 cycle. Self-completed questionnaires evaluated socioeconomic variables, physical activity habits, stage of change (Transtheoric Model), constructs of the Social Cognitive Theory and five eating habits: consumption of fruits and vegetables, natural water, dairy products, sugary drinks and processed foods ; As well as anthropometric variables. The intervention group had twelve workshops on healthy eating habits and two sessions for parents. The control group received three sessions of nutritional information. All variables were measured again at the end of the intervention to evaluate results in the short term and three months later to know results in the medium term.

NCT ID: NCT03205371 Completed - Clinical trials for Meningitis, Meningococcal

Immunogenicity and Safety of a Meningococcal Conjugate Vaccine Given Concomitantly With Other Vaccines in Toddlers

Start date: November 7, 2016
Phase: Phase 3
Study type: Interventional

This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study was conducted to assess the immunogenicity and safety of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, Thailand, the Russian Federation, and Mexico. Primary Objective: - To describe the immunogenicity profile of MenACYW Conjugate vaccine administered alone or concomitantly with licensed pediatric vaccine(s) (measles-mumps-rubella vaccine [MMR] + Varicella, diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type-b Conjugate vaccine [DTaP-IPV-HB-Hib], or pneumococcal Conjugate vaccine [PCV13]). Secondary Objective: - To describe the immunogenicity profile of licensed pediatric vaccine(s) (MMR + Varicella, DTaP-IPV-HB-Hib, or PCV13) when administered alone or concomitantly with MenACYW Conjugate vaccine.

NCT ID: NCT03204838 Recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

IDH1/IDH2 Mutation Frequency in Acute Myeloblastic Patients

Start date: July 10, 2017
Phase: N/A
Study type: Observational [Patient Registry]

This leukemia is characterized by a poor prognosis for most patients, as they have a high relapse rate despite aggressive treatment with chemotherapy agents and allogeneic bone marrow transplantation. It has been proposed that relapse can be attributed to a leukemic cells population with quiescence properties that are resistant to chemotherapy, known as leukemic stem cells (LSCs). Clinical trials shown a major LSCs percentage than diagnosis correlated with worst prognosis or minimal residual disease with AML. AML is most common in adults and represents about 40% of all leukemia types in American Continent. In Mexican patients with AML age median is 32 years, lower than other international series. Genomic and functional studies have identified two classes of mutations, which cooperate during AML development. Somatic mutations have been identified recently that codify for isocitrate dehydrogenase (IDH). These genes codify key metabolic enzymes, which convert isocitrate into α-ketoglutarate (α-KG).15-16From which IDH1 and IDH2 genes presenta high frequency of mutations in AML and other types of tumors. IDH mutations affect mainly active site residues (for example, IDH1 R132, IDH2 R140 or IDH2 R172), resulting in the normal enzymatic function loss abnormally converting α-KG to 2-hydroxiglutarate (2-HG). "Oncometabolyte" 2-HG may competitively inhibit multiple α-KG depending dioxygenases, including key epigenetic regulators as histones demethylases and TET proteins. Consequently, IDH mutations are associated with chromatin alterations including global alteration of histones and NDA methylation. This is the reason of the need to identify such mutations of genes (IDH1/IDH2) in patients with SMD and AML entering Hematology service of the Hospital General de Mexico from 2017 to 2019, and determine clinical impact in prognosis and monitoring the response to therapy, as well as prognosis and survival.