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NCT ID: NCT05501886 Recruiting - Breast Cancer Clinical Trials

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

VIKTORIA-1
Start date: September 30, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

NCT ID: NCT05497310 Recruiting - Clinical trials for Promyelocytic Leukemia

Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL

Start date: July 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.

NCT ID: NCT05495074 Active, not recruiting - Metabolic Syndrome Clinical Trials

Design of a Genetic Score to Predict the Response to a Dietary Intervention in Adults With Metabolic Syndrome

Start date: September 2, 2021
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate whether a genetic score based on genetic variants related to amino acid metabolism could predict the response to a dietary intervention in adults with metabolic syndrome.

NCT ID: NCT05492877 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

An Efficacy and Safety Study of Mitiperstat (AZD4831) (MPO Inhibitor) vs Placebo in the Treatment of Moderate to Severe COPD.

CRESCENDO
Start date: November 14, 2022
Phase: Phase 2
Study type: Interventional

This is a research study to evaluate the efficacy and safety of the investigational drug Mitiperstat (AZD4831) in adult patients with chronic obstructive pulmonary disease.

NCT ID: NCT05490953 Recruiting - Hodgkin Lymphoma Clinical Trials

Enhancing Effect on Tumour Apoptosis With the Use of Pentoxifylline in Patients With Hodgkin Lymphoma

Start date: July 11, 2022
Phase: Phase 4
Study type: Interventional

Hodgkin's Lymphoma (HL) is a neoplasm that affects the lymph nodes and the lymphatic system. In Mexico, HL is the seventh most incident cancer and the ninth with the highest mortality. It is characterized by the presence of Reed-Sternberg (HRS) cells derived from B cells of the germinal center. They harbor mutations that activate the NF-κB pathway, favoring cell survival and their reprogramming. Currently, the available therapeutic options are chemotherapy and radiotherapy, achieving cure rates of 75% in patients in advanced stages, in which 70% of these are found at the time of diagnosis. The investigators proposed the use of pentoxifylline (PTX) as a therapeutic option to enhance the antitumor effect generated by the treatment since it can increase the efficacy of apoptosis, in vitro and in vivo, induced by doxorubicin, cisplatin, and adriamycin in human leukemic and cervical cancer cells, through inhibition of NF-κB by preventing phosphorylation of serine 32 of the inhibitor κB; it also decreases the expression of Bcl-2 and Bcl-XL, induces the releasement of cytochrome c and caspases 3, 9, and cleavage of caspase 8. The investigators evaluated the effects of PTX during the steroid window phase at induction to remission in pediatric patients with LLA of a recent diagnosis, where it was shown that the combined treatment of prednisone (PRD) with PTX achieves greater percentages of apoptosis compared to individual treatment. In addition, the effect of PTX on the expression of genes associated with apoptosis was evaluated; where it was shown that it activates the intrinsic and extrinsic pathways of apoptosis. Fortilin is a protein whose serum levels increase 2.4 times more after treatment with chemotherapy or radiotherapy in patients with malignancies, so it is considered a specific and sensitive biomarker of early apoptosis in vivo. The present protocol will evaluate the enhancing effect of PTX on tumor apoptosis in combination with chemotherapeutical agents in pediatric and AYA patients with HL. Apoptosis will be measured in vivo by quantifying serum levels of fortilin and cytochrome c in participants before and after treatment by ELISA; as well as an evaluation of the clinical response based on the results of the PET-Scan, overall and event-free survival according to the Kaplan-Meier curves, and the adverse effects associated with the use of PTX according to the common terminology criteria for adverse events and causality algorithms.

NCT ID: NCT05488223 Completed - Insulin Resistance Clinical Trials

Supplementation With PUFA´s in Obese Children

PUFA
Start date: February 17, 2014
Phase: N/A
Study type: Interventional

Introduction. Insulin resistance (IR) accompanies practically half of children with obesity. This alteration is the border between what can be reversible or permanent. Among the comorbidities associated with IR are T2D and cardio and cerebrovascular diseases, which are the leading causes of death in Mexico. It has been said that the prevention of obesity rather than its treatment is the way to contain this problem. It has been proposed to supplement obese children with IR with ω-3 polyunsaturated fatty acids (PUFA) or ω-9 monounsaturated fatty acids (MUFA) to determine their ability to reverse these alterations. Objetive. To evaluate the effect of supplementing PUFA ω-3, PUFA ω-9 or both, on the change in anthropometric and metabolic parameters in obese children with IR. Methods. Clinical trial, randomized triple-blind, in which obese children with IR participated. Intervention. Three groups were integrated that received one of the following treatments for three months: Group 1: PUFA ω-3 1.8 g/day; Group 2: PUFA ω-3 0.9 g/day + PUFA ω-9 0.9 g/day (avocado oil). Group 3: MUFA ω-9 1.8 g/day. Tracing. For 2 more months he continued his clinical surveillance. Anthropometric and metabolic profile measurements were made at baseline, 3 and 5 months. Throughout the study, all three child groups received nutritional counseling, but no calorie-restricted diets or exercise programs were used.

NCT ID: NCT05487781 Enrolling by invitation - Healthy Clinical Trials

Phase 1 Clinical Study to Describe Biological Safety and Pharmacokinetics of Tyrphostin

Start date: May 24, 2022
Phase: Early Phase 1
Study type: Interventional

Evaluate the biological safety and pharmacokinetics of tyrphostin AG-17 present in the solid oral formulations of the fixed-dose combination, in three different concentrations of the compound tyrphostin AG-17 contained 10 mg, 3.3 mg and 1 mg, respectively, with 700 mg of L-Carnitine tartrate each presentation, in a single dose in healthy research subjects of Mexican nationality.

NCT ID: NCT05483205 Completed - Acne, Adult Clinical Trials

Normaderm Phytosolution Global Observational Study

Start date: July 1, 2019
Phase:
Study type: Observational

The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

NCT ID: NCT05482178 Recruiting - Obesity Clinical Trials

The Association of Resistance Exercise With the Inflammasome Activation in Obesity Subjects

Start date: May 31, 2022
Phase: N/A
Study type: Interventional

The intervention study consist in 3 months of follow up to evaluate the effect of resistance exercise on NLRP3 and interleukin-18 (IL-18) gene expression, and IL-18 and IL-1b cytokines levels in obese subjects, due to, the current evidence has been suggested that aerobic physical exercise could reduce the low-grade chronic inflammation through the downregulation of the NLRP3 inflammasome in obesity subjects, however, there are not enough evidence with resistance protocol. The investigator randomized into two intervention groups: a) group with resistance exercise training plus hypocaloric diet, and b) group with hypocaloric diet. The blood sample was taken fasting at baseline and final intervention (3rd month). The serum was separated for biochemical analyzes and the quantification of cytokines levels. The RNA was obtained from leukocytes to expression assay.

NCT ID: NCT05475691 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Longitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin America

RegistrAME
Start date: August 17, 2022
Phase:
Study type: Observational [Patient Registry]

The natural history of SMA patients has changed, due to the improvements in treatment and technological advances. The systematic collection of data from routine clinical practice in multiple Latin American countries, harmonized to an internationally aligned core data set, is important to advancing the understanding the natural history of disease in the region and the influence of different drug treatments on patient outcomes. These data are critical to improving the care of these patients. So far, clinical trials regarding therapeutic approaches for SMA patients only cover a subgroup of the broad spectrum of severity of SMA. Thus, there is a strong need to monitor the full range of treated and untreated SMA patients in a real-world context.The aim of this study is to set up a regional healthcare provider (HCP) entered registry. The planned SMA registry will provide an online platform to collect longitudinal data on SMA patients across Latin America to achieve a better understanding of the clinical characteristics of SMA patients, the natural history of the disease, the use of DMTs and patients' outcomes, as well as to support further research projects and regional data generation.