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.
The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.
The purpose of this study is to determine the safety and efficacy of combination therapy with pembrolizumab (MK-3475) and lenvatinib (E7080/MK-7902) in participants with triple negative breast cancer (TNBC), ovarian cancer, gastric cancer, colorectal cancer (CRC), glioblastoma (GBM), biliary tract cancers (BTC), or pancreatic cancer.
The primary objectives of this study are to evaluate the long-term safety and tolerability of AX 250 administered to subjects with MPS IIIB by an implanted ICV reservoir and catheter and to evaluate the impact of long-term AX 250 treatment on cognitive function in patients with MPS IIIB as assessed by developmental quotient (DQ).
This is a non-interventional, multi-country, multi-centre, multiple cohort prospective study, with retrospective collection of prior medical/treatment history data from medical records, designed to assess the real-world outcomes and safety of atezolizumab for indications in the existing label in the real world setting of routine clinical practice.
This is a randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.
This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which subjects receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.
Cable cars are means of transportation with urban mobility benefits for vulnerable populations living in areas with geographic barriers. Despite their popularity, there is no evidence of cable cars' potential health effects. TransMicable, located in "Ciudad Bolivar", Bogota, Colombia will open in late-2018 presenting an unprecedented opportunity to assess the health impacts and accessibility improvements. The investigators aim is to assess the effect of theTransMiCable implementation on social determinants of health (social capital, employment, crime, transport, microenvironment pollution, built environment), healthy behaviors (leisure and transport physical activity) and health outcomes (health-related quality of life, respiratory diseases and homicides). The investigators are conducting a controlled quasi-experimental pre-post study with six elements: 1) The co-construction of a conceptual framework using a causal loop diagram with stakeholders of multiple sectors. 2) A (non-intervention - intervention) quantitative study of social capital, community participation, travel time, costs, demand, modal choice, physical activity and health-related quality of life using repeated in-person questionnaire, anthropometric measurements and physical activity using accelerometers. 3) A transport trajectory study in a subsample of the population of the quantitative study using a mobile application to track journeys. 4) A subsample of environment evaluations 5) Our Voice in the Neighborhood qualitative study to address the potential change in perceptions of the neighborhood using Citizen Science "by the people" involving the community and local public and private stakeholders and 6) A Secondary-data analysis of Crime and Respiratory diseases using time trends from official surveillance systems for homicides and acute respiratory diseases. The investigators' main hypothesis are 1) There is an increase in the Social Capital and Quality of life indicators in the TransMicable target area after the implementation when compared to other neighborhoods without TransMiCable. 2) There is a significant decrease in travel time and cost for trips to downtown Bogota and an increase in the total number of trips for residents of "Ciudad Bolivar" neighborhoods with TransMiCable, after the implementation of TransMiCable when compared to other neighborhoods without TransMiCable in the locality of "San Cristobal". 3) There is a significant shift in modal choice for the resident of "Ciudad Bolivar" from informal transport service to the TransMiCable system with a positive association in terms of proximity to TransMiCable stations. 4) Most TransMiCable users are former informal bus transit and formal bus feeder users. While most users will access TransMiCable by walking, some living further from stations will take informal transport services to access to TransMiCable. 5) There is a reduction in the microenvironment pollution around the target area of TransMiCable when compared to the control area. 6) There is a change in the perception of the neighborhood for residents of the target area of TransMiCable when compared to the control area. 7) There is a significant decrease in the prevalence of homicides and acute respiratory diseases in the area of the TransMiCable implementation in comparison to the control area without TransMiCable. The results of this study will allow us to understand baseline dynamics, while, in the long-term, allowing us to assess the changes in travel and health behaviors.
The purpose of this study is to assess the efficacy and safety of treatment with carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal cancer. The primary study hypotheses are that the combination of pembrolizumab plus carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in participants with programmed death-ligand 1 (PD-L1)-positive tumors (Combined Positive Score [CPS]≥10) and in all participants, and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per RECIST 1.1 in participants with PD-L1-positive tumors (CPS≥10) and in all participants.
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
The purpose of this study is to evaluate the safety and efficacy of lenvatinib (E7080/MK-7902) in combination with pembrolizumab (MK-3745) versus lenvatinib in combination with placebo as first-line therapy for the treatment of advanced hepatocellular carcinoma in adult participants. The primary hypotheses of this study are that lenvatinib plus pembrolizumab is superior to lenvatinib plus placebo with respect to progression-free survival (PFS) and overall survival (OS).