Clinical trials: in Guatemala
Chagas Disease
An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About the Risk of Pregnancy Complications and About the Mother's and Baby's Health
This is an observational study in which data from women with Chagas disease who will take or have already taken nifurtimox during pregnancy and the impact on their babies are studied.
- Trial name
- NCT05477953
- Testing
- Nifurtimox (BAYA2502)
- Where
- 12 sites in United States, Argentina and 10 more
- Volunteers
- 50 people
- Sponsor
- Bayer
Postpartum Anemia
Prevention of Iron Deficiency Anemia Post-delivery
PRIORITY is designed as a 2-arm, randomized-controlled trial focused on postpartum women. The trial will recruit women who are diagnosed with moderate anemia based on a blood sample taken 6-48 hours after childbirth.
- Trial name
- PRIORITY (NCT05590260)
- Testing
- Ferric carboxymaltose (FCM) and folic acid tablets, Oral iron tablets and folic acid tablets
- Where
- 8 sites in Bangladesh, Democratic Republic of the Congo and 5 more
- Volunteers
- 4,857 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Hypoxic Ischemic Encephalopathy (HIE)
Caffeine for Hypoxic Ischemic Encephalopathy
CHIME is a randomized, parallel-arm, double-blind, placebo-controlled trial focused on infants with hypoxic ischemic encephalopathy (HIE).
- Trial name
- CHIME (NCT06855108)
- Testing
- Caffeine citrate oral solution
- Where
- 7 sites in Bangladesh, Democratic Republic of the Congo and 4 more
- Volunteers
- 830 people
- Sponsor
- NICHD Global Network for Women's and Children's Health
Zinc Deficiency, Mother and Child Malnutrition
Multi-Omic Profiling of a Zinc-Biofortified Maize Intervention in Guatemalan Mothers and Children
A trial evaluating the systemic and ecological impact of zinc-biofortified maize consumption on cellular zinc status, inflammatory biomarkers, and gut microbiota composition in a cohort of Guatemalan mothers and children.
- Trial name
- NCT07585318
- Testing
- F3 Biofortified Maize, Conventional Maize
- Where
- Guatemala
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Institute of Nutrition of Central America and Panama
COVID-19
Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years
This is a Phase 2/3 randomized, observer-blinded, placebo-controlled, age de-escalation trial to evaluate the safety and immunogenicity of 2 primary doses of SARS-CoV-2 rS with Matrix-M™ adjuvant (NVX-CoV2373) given 21 days apart…
- Trial name
- COVID-19 (NCT05468736)
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)
- Where
- 94 sites in United States, Colombia and 8 more
- Volunteers
- 3,600 people, healthy volunteers welcome
- Sponsor
- Novavax
Maternal Obesity Complicating Pregnancy, Birth,or Puerperium, Child Malnutrition
Addressing the Double Burden of Malnutrition in Guatemala
Globally, populations are experiencing increases in the double burden of malnutrition, commonly defined as maternal overweight/obesity and child stunting in the same household.
- Trial name
- NCT06750120
- Testing
- Family food ration, Optimal weight counseling, Enhanced Usual Care
- Where
- Guatemala
- Volunteers
- 1,532 people
- Sponsor
- Brigham and Women's Hospital
Multiple Sclerosis (MS)
Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
- Trial name
- NEOS (NCT04926818)
- Testing
- Fingolimod, Ofatumumab, Siponimod
- Where
- 51 sites in United States, Argentina and 23 more
- Volunteers
- 129 people
- Sponsor
- Novartis Pharmaceuticals
Zinc Absorption, Iron Absorption
Guatemala Biofortified Maize Study
Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to…
- Trial name
- NCT06650397
- Testing
- Biofortified maize
- Where
- Guatemala
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Stigma
RESPECT: (REsearching Stigma in PEdiatric Cancer Tool)
Researchers want to learn more about the way stigma affects children with cancer and their caregivers. They want to develop two clinical tools to identify and measure stigma in the pediatric cancer population within culturally…
- Trial name
- NCT06470230
- Where
- 4 sites in United States, Guatemala and 1 more
- Volunteers
- 633 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Growth, Development; Delayed
Effects of Complementary Feeding of Eggs on Infant Development and Growth in Guatemala: The Saqmolo Study
The specific aims of this study are: In a randomized controlled trial, the investigators will evaluate the impact of daily egg consumption during the complementary feeding period in addition to the local standard of nutrition…
- Trial name
- Saqmolo (NCT04316221)
- Testing
- Eggs plus standard of care, Standar of care
- Where
- Guatemala
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- Academy of Nutrition and Dietetics
Pregnancy Outcome Trends in Low-resource Geographic Areas
Maternal Newborn Health Registry
The primary purpose of this population-based study is to quantify and understand the trends in pregnancy outcomes in defined low-resource geographic areas over time, in order to provide population-based data on stillbirths…
- Trial name
- MNH (NCT01073475)
- Testing
- There is no intervention associated with the parent MNHR study. For the MNHR COVID sub-study, participants will be asked to provide a blood specimen at or near delivery.
- Where
- 15 sites in United States, Bangladesh and 5 more
- Volunteers
- 950,000 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Systemic Lupus Erythematosus
A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.
- Trial name
- NCT05306574
- Testing
- Telitacicept
- Where
- 78 sites in United States, Argentina and 13 more
- Volunteers
- 91 people
- Sponsor
- Vor Biopharma
Type 2 Diabetes Mellitus
Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)
This study evaluated the safety and efficacy of ertugliflozin (MK-8835) in pediatric participants with T2DM on metformin with/without insulin.
- Trial name
- NCT04029480
- Testing
- Ertugliflozin 5 mg, Ertugliflozin 15 mg, Insulin
- Where
- 104 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Merck Sharp & Dohme LLC
Relapsed or Refractory Solid Tumors
A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080)
The main purpose of this study is to evaluate the antitumor activity and safety of lenvatinib (MK-7902/E7080) in children, adolescents, and young adults with relapsed or refractory solid malignancies after administration.
- Trial name
- E7080-G000-231 (NCT04447755)
- Testing
- Lenvatinib
- Where
- 49 sites in United States, Argentina and 18 more
- Volunteers
- 127 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Bacterial Skin and Skin Structure Infections
A Study of Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator in Participants From Birth to Less Than 12 Years of Age With Acute Bacterial Skin and Skin Structure Infections (MK-1986-018)
This study will evaluate the safety, tolerability, and efficacy of tedizolid phosphate (MK-1986) compared with comparator antibacterial agent in participants from birth to less than 12 years of age with acute bacterial skin and…
- Trial name
- NCT03176134
- Testing
- Tedizolid phosphate, Comparator
- Where
- 58 sites in United States, Brazil and 12 more
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Neuromuscular Blockade
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years.
- Trial name
- NCT03909165
- Testing
- Sugammadex 2 mg/kg, Sugammadex 4 mg/kg, Neostigmine + Glycopyrrolate
- Where
- 39 sites in United States, Australia and 12 more
- Volunteers
- 145 people
- Sponsor
- Merck Sharp & Dohme LLC
Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer
InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort
Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to…
- Conditions
- Acute Lymphoblastic Leukemia, Nutrition Aspect of Cancer, Microtia, Genetic Predisposition
- Trial name
- NICHE (NCT05929976)
- Testing
- No intervention
- Where
- 8 sites in United States, Brazil and 4 more
- Volunteers
- 4,900 people
- Sponsor
- Columbia University
Severe Traumatic Brain Injury
Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics
Narrative: Worldwide, traumatic brain injury (TBI) is a leading cause of death and disability among children and adolescents. The Investigators aim to test whether pediatric TBI treatment guided by invasive intracranial pressure…
- Trial name
- BELA TRIPP (NCT05566431)
- Testing
- ICP, CREVICE
- Where
- 11 sites in United States, Colombia and 4 more
- Volunteers
- 428 people
- Sponsor
- University of Washington
Chikungunya
Seamless Controlled Trial To Evaluate Safety And Immunogenicity of Chikungunya Vaccine in LatinAmerica and Asia
This study has a Phase II with part A and part B and a Phase III with part C. This Adaptive seamless design will prospectively include planned modifications and incorporate both dose selection (parts A and B) and confirmation of…
- Trial name
- IVICHIK001 (NCT04566484)
- Testing
- BBV87 Chikungunya vaccine, Normal Saline
- Where
- 7 sites in Colombia, Costa Rica and 3 more
- Volunteers
- 3,210 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Infant Development
Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority.
- Trial name
- NCT05106894
- Testing
- smartphone application to promote nurturing care, printed caregiving materials
- Where
- Guatemala
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Los Angeles