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NCT ID: NCT03689504 Completed - Malnutrition Clinical Trials

Evaluating a Family-based Nutrition and Garden Intervention in Rural Guatemala

Start date: January 20, 2018
Phase: N/A
Study type: Interventional

This is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. The existing nutrition intervention is provided by community health workers affiliated with Wuqu' Kawoq | Maya Health Alliance. A single community in rural Guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. A nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control. Aims of the study include: 1. Evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity. 2. Use the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.

NCT ID: NCT03626909 Completed - Diabetes Clinical Trials

Diabetes Treatment in Rural Guatemala

Start date: January 14, 2018
Phase:
Study type: Observational

In this study, the investigators will be using a smartphone application that the investigators developed to guide community health workers through the clinical assessment of patients with diabetes including collection of demographic data and past medical history, assessment of medication history, adherence, and adverse effects, measurement of glycemic control, screening for complications, medication administration and titration, and patient counseling.

NCT ID: NCT03580369 Completed - Clinical trials for Chronic Spontaneous Urticaria

A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines

Start date: October 17, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish safety and efficacy of ligelizumab in adolescent and adult subjects with Chronic Spontaneous Urticaria (CSU) who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab and over placebo. The study population consisted of 1,072 male and female subjects aged ≥ 12 years who were diagnosed with CSU and who remained symptomatic despite the use of H1-antihistamines. This was a multi-center, randomized, double-blind, active- and placebo-controlled, parallel-group study. There was a screening period of up to 28 days, a 52 week double-blind treatment period, and a 12 week post-treatment follow-up period.

NCT ID: NCT03504124 Completed - Clinical trials for Arterial Hypertension

Multicomponent Intervention to Improve Hypertension Control in Central America

Start date: July 17, 2019
Phase: Phase 3
Study type: Interventional

The investigators propose to assess the needs, barriers, and knowledge gaps of hypertension control programs in the national health care systems of the Central America 4 region LMIC (CA-4: Guatemala, Honduras, El Salvador, and Nicaragua); to conduct a cluster randomized trial to test the effect of a multilevel and multicomponent intervention program leveraging an existing subnational primary healthcare system in Guatemala, on blood pressure (BP) control among hypertensive patients; and to evaluate the adaptability, feasibility, fidelity, and sustainability of implementing the program in the primary health care systems of the CA-4 region. The comprehensive intervention, which includes protocol-based treatment using a standard BP management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification, will last for 18 months. This implementation research study presents high public health impact because it will generate urgently needed data on effective, practical, and sustainable intervention strategies aimed at reducing BP related disease burden in Central America and other low- and middle-income countries.

NCT ID: NCT03471416 Completed - Clinical trials for Acute Lymphoblastic Leukemia

Nutritional Status in Children With ALL in Guatemala

Start date: May 1, 2019
Phase:
Study type: Observational

This study proposes to investigate the association of nutritional status of a children assessed by body mass index (BMI), triceps skinfold thickness (TSFT), and mid upper arm circumference (MUAC), with body composition, measured by dual-energy X-ray absorptiometry (DEXA), in 60 children undergoing treatment of ALL at Unidad Nacional de Oncologia Pediatrica (UNOP), in Guatemala City, Guatemala. The study also aims to establish normative values of body composition in children residing in an LMIC by examining 160 healthy siblings of children under treatment, and to measure habitual physical activity in children with acute lymphoblastic leukemia (ALL) at diagnosis and during therapy.

NCT ID: NCT03449147 Completed - Chronic Cough Clinical Trials

A Study of Gefapixant (MK-7264) in Adult Participants With Chronic Cough (MK-7264-030)

Start date: March 15, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.

NCT ID: NCT03399617 Completed - Obesity, Childhood Clinical Trials

SPOON: Sustained Program for Improving Nutrition - Guatemala

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

The primary goal of this study is to assess the impact of an innovative strategy to prevent undernutrition and obesity in early childhood in children 0-24 months in Guatemala. This study is designed to evaluate the impact of promoting adequate infant an young child feeding practices and the use of SQ-LNS (Small Quantity Lipid-Based Nutrient Supplements) on the nutritional status of infants and young children. The study will be conducted in Baja Verapaz, Guatemala in conjunction with Fundazucar, Guatemala.

NCT ID: NCT03360240 Completed - Clinical trials for Preeclampsia and Eclampsia

Blood Pressure in Adolescents With PReclampsia and Eclampsia.

ADPRE
Start date: August 1, 2017
Phase:
Study type: Observational [Patient Registry]

Levels of blood pressure in adolescents with preeclampsia and eclampsia: Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia. The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg. The sample is 1050: (350 Cases and 700 Controls).

NCT ID: NCT03345147 Completed - Vitamin A Status Clinical Trials

Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers

GloVitAS-GU
Start date: January 13, 2017
Phase: N/A
Study type: Observational

The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin A intakes (250-600 ug per day).

NCT ID: NCT03285763 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Atezolizumab (Tecentriq) to Investigate Long-term Safety and Efficacy in Previously-treated Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

TAIL
Start date: October 25, 2017
Phase: Phase 4
Study type: Interventional

This is a Phase III/IV, single-arm, multicenter study of the long-term safety and efficacy of atezolizumab treatment in participants with Stage IIIb or Stage IV NSCLC who have progressed after standard systemic chemotherapy (including if given in combination with anti-programmed cell death protein 1 [anti-PD-1] therapy, after anti-PD-1 as monotherapy, or after tyrosine kinase inhibitor [TKI] therapy). The study will consist of a Screening Period, a Treatment Period, a Treatment Discontinuation Visit, and a Follow-Up Period.