There are about 1933 clinical studies being (or have been) conducted in Colombia. 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.
Concurrent and aerobic physical exercise are recognized strategies for the treatment of overweight and obesity. The interventions of these modalities have been performed with cardiovascular machines or guided execution in their majority, making it possible to improve the health of this population; however, the studies have used high-cost equipment that is not very accessible to the general population. For this reason, we propose to compare the effects of two 12-week programs: concurrent vs. aerobic, using an innovative methodology with musicalized and outdoor activities, little approached by research. The polarized training intensity distribution model, usually used in sports and now applied to physical activity to improve VO2max, muscular strength, and body composition, will be used to determine which intervention is superior in improving these variables.
Selecting the right technique for lower limb soft tissue reconstruction is a therapeutic challenge. Despite having several reconstruction options, it's important to choose a technique that is effective and with the least possible donor site morbidity for the patient. Objective: demonstrate the therapeutic efficacy of the medial tab flap in soft tissue reconstruction on the leg, compared to conventional flaps. Materials and methods: Cohort study matched with Propensity Score Matching (PSM) by age. 64 patients with soft tissue defects were selected and followed up to one year postoperatively. Outcome variables: surgical time in minutes, healing, healing time in days, complications.
This study is a clinical trial will be carried out during academic term to assess the potential effects of the Daily Mile program on health-related physical fitness and sleep quality on overweight/obese schoolchildren.The trial will be taken place in Bucaramanga, Colombia
The goal of this randomized controlled trial is to test the effectiveness of an emotion regulation intervention called Jóvenes Capibara in a Venezuelan migrant and internally displaced population sample of youth between the ages of 18 through 30 delivered within a 10-day boot-camp entrepreneurship program. The main questions it aims to answer are: (a) Is Jóvenes Capibara feasible and acceptable among IDP and Venezuelan migrant youth aged 18-30 in Colombia?; (b) Is delivery of Jóvenes Capibara within entrepreneurship training feasible and acceptable among facilitators?; (c) Is Jóvenes Capibara associated with improved mental health, daily functioning, and labor market outcomes in Colombian and Venezuelan youth who receive the YRI compared with control youth? Participants will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. Measures will be taken at baseline, post-intervention, and at 6-month post-intervention follow-up. The comparison group will receive the intervention one year after youth in the experimental condition. The researchers will compare the experimental group and the waitlist control group to determine the effects of Jóvenes Capibara on mental health, daily functioning, and labor market outcomes.
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.
A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE
Total daily energy expenditure (TDEE) is known as the energy used by an organism during a day. The TDEE is divided into resting energy expenditure (REE), the thermic effect of food (TFE), and the energy expenditure of physical activity. There are multiple methods of measuring REE (e.g., estimating equations, direct and indirect calorimetry) among which there are significant discrepancies in its calculation in specific populations. Considering the lack of validation in the Colombian population to estimate the REE, the objective of the present research study is to compare the methods for estimating resting energy expenditure in the Colombian population with different levels of physical activity. This cross-sectional-observational study will be carried out through the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). The study population will be 130 adults from the city of Medellín, Bogotá and metropolitan areas with different levels of physical activity according to the results of the International Physical Activity Questionnaire (IPA-Q) where a high (athletes), moderate (physically active people) and low (sedentary) categorization will be made, then the indirect calorimetry tests will be applied. The development of the equation to estimate the REE will be carried out with multiple regression models under traditional and Bayesian approaches with three independent variables. It is expected to obtain a simple and valid equation to estimate the REE and contribute to the good practices of Colombian practitioners in health sciences, exercise, and sports.
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.