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.
Background: Mpox is a zoonotic disease caused by the mpox virus (MPXV). It has been endemic in West and Central African countries. However, the soaring number of those has been reported in non-endemic countries since May 2022, making World Health Organization (WHO) declare a global mpox Public Health Emergency of International Concern in July 2022. Those with mpox are primarily young men (96%, and median age of 34 [interquartile range (IQR):29-41 years]), and 84% are self-identified homosexual, bisexual, and men who have sex with men (MSM) . Furthermore, about half of these mpox cases with known human immunodeficiency virus 1(HIV-1, hereafter shown as HIV). WHO recommended prioritizing vaccinating those populations as high-risk populations, including those with HIV, since they will be severely ill if infected mpox virus (MPXV). The smallpox vaccine is expected to offer cross-immunity against MPXV. Under these circumstances, WHO included LC16m8 in the recommended vaccine lists for mpox as the product is expected to have cross-efficacy and immunogenicity against MPXV. Additionally, the safety profile was demonstrated in both adults and children, including infants who have low immuno-functions. Given that Colombia has the fifth highest mpox prevalence worldwide, WHO encouraged the authorities to implement vaccine programs while evaluating the safety and efficacy of LC16m8 as collaborative research. Following WHO initiative, this study is being conducted with the collaboration of various experts from Colombia and Japan on a large scale, with vaccine contributions and funding from Japan and Colombia However, the current infection situation differs from six months ago, and there have been few recent cases of MPXV infection in the country. Primary objective: To determine the efficacy of the replicating attenuated live vaccinia virus vaccine LC16m8 against laboratory-confirmed mpox and safety in a Colombian population with a high risk of being infected with MPXV(See the Inclusion Criteria), by comparing the immediate vaccination group and the delayed vaccination groups to assess safety and tolerability until 180 days after vaccination. Study design: An open randomized deployment study (1:1 Immediate and Delayed vaccination group). Study population: People at high risk of serious illness if infected with MPXV and those who engage in risk behaviors for acquiring MPXV infection.
This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.
The proposed study aims to assess the clinical outcomes of using ready-to-use parenteral nutrition, specifically Numeta G13E, compared to individualized parenteral nutrition in neonates with very low birth weight. Conducted in a level 4 neonatal intensive care unit from March 2017 to March 2023, the study focuses on growth parameters (weight, head circumference, height), growth velocity, and the incidence of complications. The retrospective open-cohort observational design involves a sample of 284 infants, 142 in each group, considering a 95% confidence level and 80% power. The study addresses the need for a local evaluation of the efficacy of ready-to-use parenteral nutrition in this vulnerable population.
Due to their genetic instability, breast tumors that do not express receptors for Estrogens, Progestagens or amplify the Her2 / neu oncogene [called triple-negative breast cancer (TNBC)] and other tumors such as melanoma, non-small cell lung cancer, accumulate numerous mutations that make them highly resistant to different regimens of chemo- or radiotherapy, thereby generating high morbidity and mortality. However, immunology can turn the genetic instability of tumors into the Achilles' tendon. Evidence of this has been revealed in Phase I clinical studies in patients with melanoma and lung cancer in an advanced stage of metastasis treated with Ipilimumab (anti-CTLA4) to decrease immunosuppression, in whom peptides containing mutations presented in Major Complex molecules Histocompatibility of Class I (MHC I) of the tumor itself results in their recognition as "foreign" neo-antigens leading to the efficient destruction of the tumor by anti-tumor CD8 + T lymphocytes that are amplified when they are vaccinated with these peptides. For this reason, the identification of non-synonymous mutations of single amino acid and vaccination with 25 amino acid peptides that incorporate these mutations (synthetic vaccines) is emerging today as an alternative for immunotherapy of cancers responsible for high mortality in humans. In an approach that takes 16 weeks, today, it is possible to go from the analysis of the tumor's transcriptome (which allows identifying the universe of tumor mutations) to the patient's vaccination with a personalized vaccine that contains neo-antigens of his tumor. TNBC is the most aggressive breast tumor, representing around 15% of breast cancers in our environment. While generally, at least 30% of women with other types of metastatic breast cancer survive 5 years after diagnosis, most patients diagnosed with metastatic TNBC die within this time. The lack of selective therapies and the poor prognosis of patients with TNBC make their therapeutic management difficult, so the implementation of new therapies for this type of tumor is the main focus of researchers who seek more effective and selective treatments to improve the life expectancy of patients without compromising their quality of life. The genetic instability and high rate of mutations of the TNBC most likely favor the generation of neo-epitopes. Still, due to the immunosuppressive environment of the tumor, it escapes the immunosurveillance of the immune system. Despite the high mortality induced by this tumor, a percentage of patients treated with neoadjuvant chemotherapy with agents such as Doxorubicin and Cyclophosphamide (AC) + Taxanes respond to this chemotherapy regimen. In particular, the anti-tumor effect of AC is attributed to two things: (i) the direct cytotoxic effect on the tumor cell, (ii) the immunostimulation of T lymphocytes promoted by Immunogenic Cell Death (ICD) selectively induced by these drugs. Therefore, in this project, we propose to carry out the first clinical study in Colombia of vaccination of patients with TNBC with synthetic peptides that contain mutations of their own tumor to evaluate the immunogenicity and safety of this type of personalized vaccine as a therapeutic alternative for this tumor. Achieving the specific objectives set out in this project would mean that we have been validated in Colombia the experimental design necessary to identify unique epitopes in tumors and demonstrate the safety and immunogenicity of these vaccines. We consider that having achieved the above; we will have taken an important step towards the implementation in our country of the use of this type of vaccine for immunotherapy not only of TNBC but of other tumors such as glioblastoma, gastric, esophagus, and pancreas, highly fatal due to its high mutation rate.
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).
This study aims to assess analytical performance of four BGMs and four HbA1c POC devices in comparison to suitable comparator or reference methods, with the view to evaluate performance in the hands of trained users, as well as intended users who are unfamiliar with the system (lay users, for BGMs only). System usability will also be assessed for all BGMs (including lancing devices) and HbA1c devices.
Observational and prospective cohort study that seek to evaluate the epidemiological characteristics and changes in the ocular surface of patients diagnosed with dry eye disease who are treated with preservative-free lubricating drops.
The purpose of this study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.
Objective: To determine the effect of strength training in inertial machines, on SJ CMJ and CMJ with arms; in youth volleyball players from the city of Cartago. Methodology: A quasi-experimental study of quantitative order was carried out and takes up an empirical-analytical approach, quasi-experimental with pre-test - post-test evaluation. 32 female volleyball players, belonging to the minor category of the Fénix G Club of the city of Cartago Valle Results: Both groups showed significant improvements in jump height, flight time, strength and power in the protocol that was carried out during the 12 weeks of intervention, but there was no statistically significant difference between the control groups (P = 0.356). , experimental (P = 0.984) Conclusions: Keywords: Inertial machines, Squat jump, Countermovent Jump, Abalakov
Introduction: Hepatitis C virus infection is a major cause of chronic hepatitis, cirrhosis, and liver cancer. The risk of developing cirrhosis for people with chronic infection with the virus ranges from 15% to 30% over a 20-year period. According to 2019 data from the World Health Organization there are 58 million people living with chronic hepatitis C infection. Three-quarters of those infected live in low- to middle-income countries, some of which lack budgets for screening, diagnosis and treatment campaigns. While good progress has been made in several countries, a significant gap in testing and treatment remains. Barriers to timely diagnosis include lack of awareness on the part of health professionals, availability and access to screening tests. Simplifying the cascade of care for this pathology would help ensure that more patients remain involved in the care pathway and ultimately achieve global goals. Objective: To estimate the prevalence of anti-HCV antibodies in patients with risk factors for hepatitis C virus captured by opportunity screening in the included hospital institutions. Methodology: Descriptive multicenter cross-sectional study. A total of 27160 participants among the seven institutions, 3880 per institution. Includes all persons over 18 years of age attended in the included health service provider institutions (IPS) who are users of hospitalization, emergency, outpatient and any other hospital care services. Application of a questionnaire to identify the inclusion criteria and data collection, signature of informed consent, sample collection by rapid test Abbott HCV rapid test - BIOLINE HCV and evaluation by tele-consultation by hepatologist principal investigator who will guide you to access the confirmatory test for HCV (viral load for Hepatitis C), the study will assume responsibility for its realization.