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NCT ID: NCT05461703 Recruiting - Pediatric Obesity Clinical Trials

Efficacy of a School-based Obesity Prevention Program in Mexican Schoolchildren: Cluster Randomized Controlled Trial

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

There is evidence that obesity prevention programs show positive effects on obesity and lifestyle parameters. However, the effect of the programs delivered by different implementers is unknown, and in Mexico, the available studies present methodological limitations. The aim of this study is to evaluate the feasibility and efficacy of a school-based obesity prevention program implemented by nutrition and physical activity advanced students compared to a control group and implemented by school teachers compared to a control group of Mexican schoolchildren. This is a cluster randomized controlled trial. Schoolchildren from different public schools in Hermosillo , Sonora will be invited to participate. The schools will be randomly assigned to one option:1) the Planet Nutrition Program (PPN) delivered by advanced students, 2) PPN by school teachers, or 3) a control group. A 6-month pilot study with a follow-up at 8 months (after the summer holidays), followed by a definitive study with a follow-up at 8 and 12 months will be conducted.The intervention will consist of nutrition education sessions, physical activity, and the provision of nutrition information for parents. The BMI Z-score, body fat, other obesity, and lifestyle parameters will be evaluated at baseline and at the end of the study. A mixed effects model will be used to evaluate the differences between the groups. The investigators expect that the program could be a model of obesity prevention with a high potential for dissemination in Mexican schools.

NCT ID: NCT05461365 Completed - COVID-19 Clinical Trials

Intranasal Insulin for COVID-19-related Smell Loss

Start date: January 4, 2021
Phase: Phase 3
Study type: Interventional

The aim of this study was to quantify the improvement in olfaction of 27 post-COVID-19 patients, after three intreventions of intranasal insulin during a four week period, with the help of the Threshold, Discrimination and Identification (TDI) score evaluated with Sniffin Sticks®.

NCT ID: NCT05460832 Completed - Clinical trials for Rheumatoid Arthritis

Phase 2b Study of MBS2320 in Participants With Methotrexate-Refractory RA

Start date: August 29, 2022
Phase: Phase 2
Study type: Interventional

Rheumatoid arthritis (RA) affects 1 percent of the population worldwide and up to 40 percent of patients don't respond to current treatments. MBS2320, the drug being tested in this trial, represents a new approach to treating RA, with the potential not only to reduce levels of inflammation but to also directly prevent bone damage. The aim of this project is to test the safety, tolerability and efficacy of MBS2320 in patients with RA in combination with an existing treatment, methotrexate. Approximately 224 participants with moderate to severe active RA who have not responded to treatment with Methotrexate will be enrolled from around 45 to 55 sites around the world. Participants will be randomly assigned to receive 1 of 3 doses of MBS2320 (5 mg, 20 mg, or 40 mg) or placebo (a "dummy" drug). The maximum duration of study participation for a participant will be 22 weeks, which consists of a Screening Period of up to 4 weeks, Treatment Period of 12 weeks, and a Follow-up Period of 6 weeks. Participants on the study will be asked to attend the hospital or clinic for regular visits during which they will have planned study assessments to evaluate the effectiveness, tolerability and safety of the study drug.

NCT ID: NCT05457608 Completed - Presbyopia Clinical Trials

Clinical Evaluation of Two Multifocal Contact Lenses

Start date: June 25, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the patient subjective experiences of the monthly multifocal lens when compared to the daily disposable multifocal lens after 15 minutes of daily wear.

NCT ID: NCT05457439 Active, not recruiting - Physical Activity Clinical Trials

Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

NCT ID: NCT05452499 Completed - Breast Cancer Clinical Trials

Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

Introduction: Breast cancer represents the most common type of malignant neoplasm worldwide. Advances in diagnosis and treatment have increased the life expectancy of patients. However, the sequelae associated with treatment and disease in survivors such as chronic pain, kinesiophobia and loss of physical function represent a long-term health problem. Physical therapy is a frequently used strategy for the treatment of sequelae in the acute stage of the disease, but there is a need to evaluate its effectiveness in cancer survivors with chronic sequelae. Therapeutic exercise and pain neuroscience education have been shown to be effective in the management of populations with chronic pain and loss of function; however, more evidence is needed in specific populations of cancer survivors. Objective:To evaluate the effectiveness of a physical therapy program based on pain neuroscience education and therapeutic exercise for the treatment of chronic pain, kinesiophobia and loss of physical function in breast cancer survivors. Methodology. Quasi-experimental study. The sample will consist of 40 female breast cancer survivors. The intervention will last 9 weeks, with 3 sessions of pain neuroscience education and 24 sessions of therapeutic exercise, 3 times per week (16 face-to-face sessions and 8 sessions at home). The intervention will be carried out in small groups of 8 to 12 people. The frequency and intensity of pain, the level of kinesiophobia and physical functionality and the range of of motion of the shoulder will be evaluated in 4 assessments, before the intervention (T0), 3rd (T1), 6th (T2) and 9th (T3) week of the intervention. Different validated measurement instruments will be used in this population such as self-report scales, questionnaires and the use of a goniometer.

NCT ID: NCT05450458 Recruiting - Overuse Injury Clinical Trials

Hyaluronic Acid in Overuse Knee Pain

Start date: July 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Sports activity represents part of day living people, a knee pain originated by high demand joint activity could represent a limitation to continue sports. The aim of this clinical trial is demonstrate the effects of hyaluronic acid in sportsmen with knee pain.

NCT ID: NCT05445791 Recruiting - Clinical trials for Non Small Cell Lung Cancer

Metformin Plus Tyrosine Kinase Inhibitors for Treatment of Patients With Non-small Cell Lung Cancer With EGFR Mutations

METLUNG
Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

Lung cancer represents the most frequent neoplastic disease worldwide, with an annual incidence of over 2 million cases, which represents 11.6% of all cancer diagnoses. Further, it constitutes the main cause of cancer-related deaths. Among the lung cancer types, non-small cell lung cancer represents 80-85% of cases, and the majority of patients are diagnosed with locally advanced or metastatic disease, and 5-year survival rates remain discouraging in most world regions, ranging from 8-18%. Advances in molecular biology have led to the discovery of several molecular targets and development of targeted therapy for patients with specific molecular subtypes of NSCLC. One of the most widely studied is the epidermic growth factor receptor (EGFR), which has been long recognized as a key modulator for specific tumor cell functions, and thus it has been used in drug development strategies. Mutations in the EGFR gene are reported in 15% of all NSCLC cases, though incidence varies widely and in Mexico up to 34% of patients present with tumors with EGFR mutations. Treatment of patients with tumors with these characteristics is based on specific tyrosine kinase inhibitors (TKIs), achieving higher objective response rates and improved progression-free survival (PFS) compared with chemotherapy-based schemes. Nonetheless, despite the initial response, most patients treated with TKIs will eventually develop resistance mechanisms and present progressive disease. Consequently, the development of novel strategies to overcome TKI resistance and improve PFS of patients with NSCLC with epidermic growth factor receptor mutations (EGFRm) is priority. Up to 30% of patients with NSCLC present with somatic mutations in the liver kinase B1 (LKB1) gene, which acts as a tumor suppressor through inhibition of mammilian target of rapamycin (mTOR). In a study which included 24 patients with LKB1 expression who received treatment with metformin + TKIs, overall survival was improved significantly, and therefore it is important to evaluate LKB1 expression in addition to mutations which could be related with treatment response in patients given metformin plus antineoplastic agents. LKB1 can activate AMP-activated protein kinase (AMPK) signaling through specific phosphorylations at aminoacid residues. AMPK can regulate cell cycle, cell proliferation and cell survival in NSCLC. Recently, the loss of expression of LKB1 has been associated with a reduced activation in AMPK using in vivo models, and increase in tumor necrosis after treatment with bevacizumab. The expression of AMPK has also been evaluated in NSCLC, a study which included 99 samples concluded that increased AMPK expression was associated with worse overall survival. Nonetheless, the association between AMPK expression and metformin treatment has not been ascertained. Metformin is a biguanide used as treatment for type 2 diabetes. Additionally, several studies have identified a reduced incidence and mortality from diverse neoplasms in patients treated with metformin. In vitro studies have shown that metformin is cytotoxic in lung adenocarcinoma cells, producing a cell cycle arrest at G0 and G1, and it inhibits resistance to TKIs induced by Epithelial-Mesenchymal transition (EMT). Retrospective trials have also provided evidence as to the benefit of metformin in patients undergoing treatment for NSCLC. Several prospective trials have evaluated the concurrent use of metformin plus TKIs for patients with lung adenocarcinoma, though results have been controversial. This randomized, phase 3 study will evaluate the PFS in patients with NSCLC with EGFR mutations undergoing treatment with TKIs plus placebo vs. TKIs plus metformin.

NCT ID: NCT05444972 Completed - Myelofibrosis Clinical Trials

A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review

METER
Start date: August 23, 2022
Phase:
Study type: Observational

Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis. Data from approximately 1000 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks. There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.

NCT ID: NCT05443139 Recruiting - Depression Clinical Trials

Online Multi-component Psychological Intervention for Depression, Anxiety and Well-being in 7 Countries

Start date: December 23, 2022
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.