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NCT ID: NCT02146508 Suspended - Esophageal Cancer Clinical Trials

Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital

EXPECT
Start date: June 2013
Phase: N/A
Study type: Interventional

Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic removal or ablation of ESD in order to prevent development of esophageal cancer.

NCT ID: NCT02146365 Completed - Clinical trials for Pneumococcal Disease

Nasopharyngeal Carriage Study in Healthy Kenyan Toddlers

Start date: September 25, 2014
Phase:
Study type: Observational

This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) and that PATH-wSP would remain safe and well-tolerated over the course of the study.

NCT ID: NCT02140255 Recruiting - HIV Infection Clinical Trials

Very Early Intensive Treatment of Infants Living With HIV to Achieve HIV Remission

Start date: January 23, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The study will explore the effects of early intensive antiretroviral therapy (ART) with or without a broadly neutralizing antibody (bNAb) on achieving HIV remission (HIV RNA below the limit of detection of the assay) among infants living with HIV.

NCT ID: NCT02124252 Completed - Clinical trials for Human Papilloma Virus Infection

Community-Driven Cervical Cancer Prevention in Western Kenya

Start date: January 2016
Phase: N/A
Study type: Interventional

There are many challenges to implementation of cervical cancer prevention in resource-limited countries, despite evidence based screening and treatment strategies. The investigators hypothesize that self-collected HPV specimens offered in a community health campaign setting will

NCT ID: NCT02118402 Completed - Anemia Clinical Trials

Iron and Prebiotics Fortification in Kenyan Infants

Iro'n'Pre
Start date: July 2014
Phase: N/A
Study type: Interventional

Iron deficiency and anemia are health issues affecting mainly infants and women in developing countries. Iron deficiency in infancy can have long-lasting impact on cognitive and motor development of the child. Iron fortification has shown to be effective against anemia. However, in areas with a high burden of infectious diseases iron may increase the risk of unfavorable gut microbiota composition possibly influencing diarrhea prevalence. Therefore we want to assess the effects of home fortification of complementary food with two iron-containing micronutrient powders (MNPs) with and without the addition of a prebiotic (7.5 g of galactooligosaccharides as GOS-75) compared to a control on the composition of the gut microbiota of Kenyan infants. In addition, iron deficiency may iimpair adaptive immunity. Following Kenyan Minstry of Health guidelines, infants receive their first measles vaccine at 9 months. In this study we will use an MNP with a moderate iron dose of 5 mg, with 2.5 mg of Fe as NaFeEDTA and 2.5 mg of Fe as ferrous fumarate (+Fe). There will be 3 study groups MNP, MNP+Fe and MNP+Fe+GOS. The infants will be enrolled in the study at the age of 6-10 months and will consume a home-fortified maize porridge for four months. At baseline and endpoint (after 4 months of intervention), we will collect blood samples of the infants in order to assess anemia, iron status, and inflammation. In addition, we will assess the effect of iron supplementation on measles vaccine response. Fecal samples (from child and mother) will be collected at baseline, 3 weeks and at endpoint in order to evaluate the changes in gut microbiota and gut inflammation. During the intervention, in a sub-group of children who receive broad-spectrum antibiotics, we will compare how the three different interventions modify the effect of antibiotics on the infant gut microbiota. We will opportunistically select children that are enrolled in the study and who become ill, and who are prescribed antibiotics by the local health care team, according to the local standard of care in the study area. Five additional stool samples from these children will be collected (day 0 (before the first antibiotic dose), 5, 10, 20 and 40) to evaluate the changes in the gut microbiota and gut inflammation. Three years after the study end, we would like to collect a blood and stool sample from the children and examine the iron status and gut microbiome respectively.

NCT ID: NCT02104635 Completed - Clinical trials for Maternal and Newborn Health

Postpartum Empowerment: an Integrated Approach Driving Demand and Delivery of High Quality, Low-cost Postnatal Services in Kenya

Start date: April 2014
Phase: N/A
Study type: Interventional

This research represents a randomized trial of a program to improve timely postnatal care, comparing post-natal check-ups performed by community health workers delivered either by phone or in person to a control group. The study hypothesis is that when community health workers check on women three days after their delivery we will see improvements in the detection of maternal and child complications, better knowledge of complications and an increase in behaviors that are expected to lead to improved maternal and child health.

NCT ID: NCT02101723 Completed - Clinical trials for Micronutrient Deficiencies

Effect of Sprinkles With and w/o Fe on Zn Absorption in Kenyan Toddlers

Start date: April 2011
Phase: N/A
Study type: Interventional

The investigators propose to study the effects of increased iron intake by home fortification of complementary foods on the gastrointestinal microbial development, inflammatory responses, and zinc (Zn) absorption. The proposed subjects are 9 month olds living in a malaria endemic area of rural Kenya who are randomized at 6 months of age to one of three fortificant groups: 1) Sprinkles™ with 12mg Iron(Fe)/day + other micronutrients, including 5mg/d Zn (test); Sprinkles™ with 0 mg/d Fe + other micronutrients, including 5mg/d Zn (control); Sprinkles™ with no micronutrients (placebo). The investigators hypothesize that the microbiome will be significantly different in the three groups and that Zn absorption and status, in addition to immune and oxidant status will be improved in the non-Fe fortified groups when compared to the Fe-fortified group.

NCT ID: NCT02099994 Completed - AIDS Clinical Trials

Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults

HIV-CORE 004
Start date: March 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.

NCT ID: NCT02097472 Completed - Clinical trials for Pneumonia, Pneumococcal

Dose-Finding Study of S.Pneumoniae Whole Cell Vaccine Adsorbed to Alum (PATH-wSP) in Healthy Kenyan Adults and Toddlers

Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.

NCT ID: NCT02079077 Completed - HIV Clinical Trials

Inducing Immune Quiescence to Prevent HIV Infection in Women

IIQ
Start date: April 2014
Phase: N/A
Study type: Interventional

In this project, the investigators want to analyse the capacity of Acetylsalicylic acid and hydoxychlroquin (HCQ) to induce an Immune Quiescence (IQ) phenotype, which has been previously associated with natural protection to HIV infection. This phenotype is characterized by lower expression of genes involved in cellular activation, lower resting levels of inflammatory cytokine production, lower level of systemic activated T cells, increased levels of systemic T regulatory, increased production of anti-viral anti-protease serpins at the female genital tract and reduced numbers of HIV target cells (mainly CD4+ CCR5+ T cells) in the FGT ( female genital tract). The objective of this study is to determine if daily oral administration of Acetylsalicylic acid or hydroxychlroroquin can reduce systemic and mucosal immune activation in HIV negative women.