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NCT ID: NCT03471416 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Nutritional Status in Children With ALL in Guatemala

Start date: April 2018
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: NCT03360240 Completed - Clinical trials for Adolescent Pregnancy

Blood Pressure in Adolescents With PReclampsia and Eclampsia.

ADPRE
Start date: August 1, 2017
Phase: N/A
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 718: (240 Cases and 478 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 Recruiting - 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.

NCT ID: NCT03191799 Recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

STASEY
Start date: September 5, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03189719 Recruiting - Clinical trials for Esophageal Neoplasms

First-line Esophageal Carcinoma Study With Chemo vs. Chemo Plus Pembrolizumab (MK-3475-590/KEYNOTE-590)

Start date: July 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) chemotherapy versus placebo plus cisplatin and 5-FU chemotherapy as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The primary efficacy hypotheses are that both progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and determined by blinded independent central review, and overall survival (OS) are superior with pembrolizumab plus chemotherapy compared with placebo plus chemotherapy in all participants as well as participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive.

NCT ID: NCT03163446 Recruiting - Clinical trials for Staphylococcus Aureus Bacteremia

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including right-sided endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

NCT ID: NCT03114657 Recruiting - Alzheimer's Disease Clinical Trials

A Study of Crenezumab Versus Placebo to Evaluate the Efficacy and Safety in Participants With Prodromal to Mild Alzheimer's Disease (AD)

CREAD 2
Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (q4w) for 100 weeks. The primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

NCT ID: NCT03049527 Completed - Clinical trials for Chronic Kidney Disease

CKDu in Sugarcane Workers in Guatemala

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The objective of this research project is to investigate specific behaviors and exposures related to sugarcane work and their association with non-communicable diseases, specifically Chronic Kidney Disease of Unknown Origin (CKDu) among sugarcane workers in Guatemala. Over the course of the 6-month sugarcane harvest the investigators will assess risk factors for declining kidney function, and also changes in biomarkers of kidney function pre and post work shift of field and factory workers and their possible relationships with dehydration and heat stress. The investigators will also evaluate the effectiveness of an intervention aimed at increasing hydration and reducing heat stress. Finally the investigators will measure biomarkers of exposure and environmental samples for heavy metals, agrochemicals, and infectious disease (Leptospira).

NCT ID: NCT03037970 Recruiting - Clinical trials for Diabetic Foot Ulcers

Evaluation of ABSOLVE in Diabetic Foot Ulcers

ABSOLVE
Start date: January 30, 2017
Phase: Phase 2
Study type: Interventional

ABSOLVE Biologic Wound Matrix is a combination of recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) and a bovine type I collagen wound dressing matrix. ABSOLVE is under development for the treatment of chronic and acute wounds. This study investigates the safety and efficacy of ABSOLVE in chronic diabetic foot ulcers (DFUs).