Saarbruecken 66119, Germany
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
Phase
2Span
135 weeksSponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyMedellin
Recruiting
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Phase
3Span
258 weeksSponsor
Bristol-Myers SquibbMedellin
Recruiting
Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
Phase
N/ASpan
55 weeksSponsor
University of ChicagoMedellin, Antioquia
Recruiting
Healthy Volunteers
A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
Part 1 will enroll participants aged 6 months to <6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine. Part 2 will enroll participants aged 6 months to <6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series. Part 3 will enroll participants aged 6 months to <6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine. Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to <5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to <2 years enrolled in Cohort B (Part 4B).
Phase
3Span
175 weeksSponsor
ModernaTX, Inc.Medellin, Antioquia
Recruiting
Healthy Volunteers
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
A randomized, double-blind, placebo-controlled multicenter phase 3 study to evaluate efficacy, safety and tolerability of ianalumab on top of standard-of-care therapy in patients with systemic lupus erythematosus (SIRIUS-SLE 2)
Phase
3Span
301 weeksSponsor
Novartis PharmaceuticalsMedellin, Antioquia
Recruiting
Medellin
Recruiting
Screening Study for Participants With Malignant Tumors
Phase
2Span
544 weeksSponsor
Hoffmann-La RocheMedellin
Recruiting
Correlation Between Cycle Threshold (Ct) Values in COVID-19, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory.
After being informed about the study, all patients giving written informed consent will undergo a serial of test related to COVID-19. Rh and blood type will be obtained using the Colombian ID card or official document. All symptomatic and asymptomatic COVID19-positive patients will be evaluated for a period of 4 weeks at three different times of the study. In a single time, the mitochondrial DNA will be measured, and the variability in the CT value, hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, levels of dehydrogenase lactate, ferritin and D-dimer, antibodies IgG and IgM, will be measured on day 5, day 14 and day 28. In addition, spike S protein sequencing and growing the virus in cell culture that meet specific criteria will be performed. A physician will do clinical follow up through the period of the study for each patient.
Phase
N/ASpan
18 weeksSponsor
Universidad de AntioquiaMedellin, Antioquia
Recruiting
Abdominal Wall Closure After Laparotomy in Oncologic Surgery
REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.
Phase
N/ASpan
54 weeksSponsor
AbSolutions Med Inc.Medellin
Recruiting