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.
Well-differentiated neuroendocrine tumors (WDNETs) are uncommon neoplasms with an increasing number of new cases reported in the annual statistics of the Instituto Nacional de Cancerología (INC). The majority are advanced-stage presentations with limited chances of a complete surgical resection of the primary tumor, a clinical scenario where medical treatment options are also limited. In view of the characteristically defined expression of peptide receptors in WDNETs, radioactive molecular probes to target specific cellular receptors have been designed using radioisotopes with short range of penetration in tissues. We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET. Selected patients matching inclusion criteria will be enrolled at the INC's Section of Endocrinology. Tumor response, treatment safety (side effects) and survival will be appraised. Data from clinical, biochemical and imaging follow-up will be periodically registered during treatment and until two years after the last infusion of 177Lu- DOTATATE. This phase II trial is justified because despite the fact that many preclinical and clinical studies have showed the potential usefulness of this novel palliative approach to treat patients with advanced-stage WDNETs there is a paucity of vigorous results to establish its efficacy as first-line treatment.
Genital tract infections (GTIs) have increased in the past decade and there is an association between sexually transmitted infections (STIs) and other infections like bacterial vaginosis (BV), with the HIV transmission. BV and Candida are the most common causes of vaginal infections in symptomatic women, the prevalence of BV being 22-50% and the prevalence of Candida 17-39%. In an effort to reduce the transmission of GTIs, the World Health Organization (WHO) proposed a syndromic diagnostic approach as a low cost alternative in places with no access to laboratory diagnostic tests. Justification. In patients with syndrome of vaginal discharge, an effective treatment against Candida albicans, Trichomonas vaginalis, and bacterial vaginosis is adviced, therefore, for syndromic management of symptomatic vaginal discharge the combination of fluconazole and secnidazole could be used. No studies evaluating this combination were found in the literature reviewed. Objectives: To describe the safety and the clinical and microbiological efficacy of a single oral dose of a combined treatment with secnidazole + fluconazole for the syndromic management of symptomatic vaginal discharge. Methods: Design: open label, uncontrolled clinical trial to estimate clinical efficacy and safety of the combination of fluconazole and secnidazole for the treatment of symptomatic vaginal discharge. The participants will be sexually active women with lower genital tract symptoms (leukorrhea, itching, burning, pain, foul-smelling vaginal discharge, or urethral symptoms) compatible with symptomatic vaginal discharge syndrome. The study will be conducted in an outpatient service of a hospital in Bogota, Colombia. Given the descriptive character of the study, no a priori hypothesis is considered. A consecutive convenience sample size of 100 symptomatic patients is calculated. The statistical analysis will be performed with STATA 11.0 software (College Station, Texas, USA). Simple and relative frequencies and measures of central tendency and dispersion appropriate for the distribution of the variables will be calculated. The study has been submitted and approved by the Ethics Committee of the Faculty of Medicine of the National University of Colombia and the Institutional Review Board of the participating institution. All women must sign a written informed consent form agreeing to voluntarily participate in the study.
The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.
The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.
In accordance with the regulatory guidance this registry has been designed to collect information about the long-term safety of Adempas in real clinical practice outside the regulated environment of a controlled clinical study.
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Evaluate pro-BNP levels, oxygen consumption, functional class, and quality of life in patients with chronic heart failure after participating in an exercise program and compare them baseline and 2 months, with another group who underwent an educational program.
Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010). Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system. The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy. Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells. VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival. Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies. Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms. Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.
This is a randomized, double-blind, controlled, which seeks to compare two groups of volunteers (naive and previously exposed to malaria) who were made 3 immunizations with a synthetic derivative of the CS protein of Plasmodium vivax in order to determine their protective efficacy. Then volunteers will be subject to an infectious challenge to assess the infectivity of gametocytes in the blood early stage of P. vivax in Anopheles albimanus mosquitoes.