There are about 1920 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.
Background: Neonatal sepsis is the leading cause of mortality in preterm newborns. The autonomic nervous system modulates the response to sepsis through the cholinergic anti-inflammatory reflex. However, premature neonates exhibit immaturity of the autonomic nervous system, which could increase the risk of sepsis. Kangaroo Care (skin-to-skin contact) may promote autonomic nervous system modulation and maturation in preterm newborns with sepsis. The objective of this study is to determine the effect of Kangaroo Care on heart rate variability in preterm newborns with late-onset clinical sepsis. Methods: A cross-over randomized clinical trial will be conducted, including 20 preterm infants with late-onset sepsis. The autonomic nervous system will be assessed using heart rate variability analysis. The study interventions consist of routine care in an incubator and Kangaroo Care. Randomization will be performed using a four-block permuted design for the two intervention sequences AB: Kangaroo Care - incubator care, or BA: incubator care - Kangaroo Care. Heart rate variability will be recorded using a Polar Rs800 monitor and analyzed with Kubios software. Discussion: This study will provide information on the relationship between Kangaroo Care and autonomic nervous system activity in preterm neonates with late-onset sepsis. These data will contribute to the understanding of the cholinergic anti-inflammatory reflex in neonates and the capacity of skin-to-skin contact to modulate autonomic activity in neonatal infection. Thus, the study seeks to provide initial evidence for the use of skin-to-skin contact as a non-pharmacological therapeutic intervention in neonatal sepsis.
The purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.
The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).
The purpose of this study is to assess the safety and tolerability and to confirm the dose of nemtabrutinib in combination with venetoclax in participants with R/R CLL/SLL. The primary study hypotheses are that the combination of nemtabrutinib plus venetoclax is superior to VR with respect to progression-free survival (PFS) per 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria as assessed by blinded independent central review (BICR).
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
Severe dengue is a cause of admission to critical care, especially in pediatric cases, and during epidemic outbreaks. Fluid support is basically the therapy offered, due to a scarcity of antiviral or immunological options to modulate the disease. Dengue is an endemic condition in tropical and subtropical regions as Villavicencio, and local ICUs provide care to the adult and pediatric population from the city and distant surrounding areas. National and international agencies' clinical guidelines have standard recommendations for the therapy of dengue shock syndrome (DSS), but data about performance is not available. Severity, organ dysfunction, hemorrhagic events, and capillary leak are predictors for decease. There are several epidemiological trials about dengue in the region, although publications about the characteristics of patients in ICU are nearly null. Currently, there is enough human resources and technology in ICU to provide an optimal care in cases of severe dengue. There is a need to recognize most appropriate strategies for the treatment of the disease, and their results, to adjust and provide better outcomes. The aim of the study is to analyze the characteristics of patients with severe dengue admitted to the intensive care unit, to contribute to knowledge and better understanding of the disease in a specific clinical environment. An observational retrospective study will be designed by the analysis of the ICU database of hospitals from Villavicencio, Colombia, since January to May 2023. The records of patients admitted with a diagnose of severe dengue will be exported to Excel for reviewing and debugging. Demographic information, laboratory results, severity scores, and outcomes will be examined. Categorical variables will be described by frequency and proportion; quantitative variables will be defined in a central and dispersion distribution. Chi-square and Mann-Whitney U test will be used to compare, according to the characteristics of the outcome. It will be a pioneer study at this region, and it is necessary to determine the characteristics of patients admitted to the intensive care unit, the care provided, and the results of the treatment.
The goal of this observational study is to know the prevalence of PCOS among economically productive and reproductive age women from Medellín and the Valle de Aburrá, Colombia. The main questions it aims to answer are: 1. What is the phenotypic distribution of PCOS detected in women seeking medical attention as a requirement for employment in Medellín and the Valle de Aburrá, Colombia? 2. What is the effect of environmental factors, such as geographical location and diet, and biological factors (such as obesity and ethnicity/race) on the prevalence and phenotype of PCOS in this populatión? Participants will undergo anthropometric measurements and physical examination for hirsutism, acne, alopecia, acanthosis nigricans, and thyroid enlargement. During the initial visit, a transvaginal or transabdominal pelvic ultrasonography will be performed. A sample of venous blood will be collected in plain tubes for serum cryopreservation and for immediate glucose estimation. Some participants will be rescheduled for a second evaluation visit for additional assessment when they have a possible PCOs.
The present study is a prospective multicenter study consisting of a cohort of patients with prenatal or intraoperative diagnosis of PAS, evaluating the clinical outcomes of the group of patients found in each category of the topographic classification. In addition, an approach to evaluate the acceptability of this classification among the obstetrician-gynecologists of the participating medical centers will be included.
The purpose of this international oncology research includes the following three aims: - Aim 1. Expand and strengthen the existing research partnership with investigators from Centro Javeriano de Oncología, Pontificia Universidad Javeriana, and Hospital Universitario San Ignacio in Bogotá, Colombia. - Aim 2. Evaluate the implementation feasibility and acceptability of the 9-week Spanish-translated mindfulness app, Wakeful, in a mixed Colombian young adult cancer patient sample. - Aim 3. Translate and record professional Spanish-language voice overs for all new STU00210628 content for future implementation.