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NCT ID: NCT03301051 Recruiting - Clinical trials for Respiratory Tract Infections

Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults

Start date: August 31, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One dose of Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine (30 μg/strain) or of placebo will be administered to approximately 10,000 subjects.

NCT ID: NCT03296163 Not yet recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

STELLA
Start date: December 2017
Phase: Phase 3
Study type: Interventional

This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group, equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel) in subjects with Stage IIIB/IV non-squamous NSCLC

NCT ID: NCT03286712 Completed - Clinical trials for Chronic Kidney Disease

The Effect on Vascular Reactivity Using the Erythropoeitin Alpha on Incident Peritoneal Dialysis Patients

Start date: October 2015
Phase: Phase 4
Study type: Interventional

This is a prospective observational study on incident peritoneal dialysis patients on the effect of hemoglobin level and vascular reactivity using the generic erythropoietin alpha. The objective of the study is to to describe the effect of improvement in hemoglobin level and the flow-mediated dilatation using Epoeitin Alpha (Renogen). Patients who will meet the inclusion and exclusion criteria will have their baseline laboratory test and ultrasound of the brachial artery to assess the flow mediated dilatation. This is a 3-month follow up study with a monthly laboratory test to monitor the patients. The following are the outcome measures: hemoglobin level, vascular reactivity by measuring the flow mediated dilatation of the brachial artery and blood pressure.

NCT ID: NCT03286101 Recruiting - Pediculosis Capitis Clinical Trials

Efficacy and Safety of Topical 0.5% Ivermectin Lotion for the Treatment of Head Lice Infestation in Filipinos

Start date: September 14, 2017
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of a single application of 0.5% ivermectin lotion in Filipino subjects with head lice.

NCT ID: NCT03267641 Recruiting - Clinical trials for Hepatocellular Carcinoma

Prospective Cohort Study on the Clinical Trajectory of Resected Hepatocellular Carcinoma

PLANET
Start date: May 16, 2016
Phase: N/A
Study type: Observational

Hepatocellular carcinoma (HCC) is the 6th most common cancer in the world but the 2nd most important cause of cancer death. Because of its highly heterogeneous nature, the current approach to identifying druggable targets have not delivered efficacious therapies in HCC and is a main reason for the high case fatality. Even when surgical resection is potentially curative in early disease, tumor recurrence remains high and long term survival poor because of the absence of useful adjuvant therapy. To address these unmet needs, the investigators bring together internationally recognized scientists from genomics and immunology and established clinician investigators in a synergistic team. This TCR capitalizes on recent collaborative advances made by the PIs in the consortium. The investigators have shown through multi-region sampling of freshly resected HCC and phylogenetic analysis, that significant intra-tumoral heterogeneity exists and have identified the specific positions of known clonal drivers. Simultaneously the investigators have analyzed the immune landscape of the tumor microenvironment with deep immune-phenotyping and found unique inter-patient immune landscapes predictive of clinical trajectory. This TCR is a prospective study that samples resected HCC from multi-ethnic sites within the established Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, which has enrolled approximately 1000 patients through 6 multi-center trials in 35 centers in the region. Clinical trajectories are tracked and genomic and immunological studies are repeated when tumors recu r, to confirm clonally dominant driver mutations and immunological processes that are targetable. Concurrently, representative pre-clinical models will be developed from the tissues sampled. The investigators aim to combine these approaches to overcome the challenges posed by genomic heterogeneity and to guide the development of therapeutics and precision medicine in HCC.

NCT ID: NCT03225586 Recruiting - Cancer Clinical Trials

Prospective Urban Rural Epidemiology Study

PURE
Start date: January 1, 2002
Phase: N/A
Study type: Observational

To examine the impact of health determinants at the individual (e.g. health related behaviors) and societal level (e.g. environmental factors, health related policy, quality of health systems) on health outcomes (e.g. death, non-communicable disease development) across a range of socioeconomic and health resource settings. Additional components of this study will examine genetic factors for non-communicable diseases. This will be examined both through a cross sectional component, and prospectively (cohort component).

NCT ID: NCT03211234 Recruiting - Clinical trials for Age-Related Macular Degeneration

Study Assessing the Efficacy and Safety of Intravitreal Injections of DE-122 in Combination With Lucentis® Compared to Lucentis® Monotherapy in Wet Age-related Macular Degeneration Subjects

Start date: July 5, 2017
Phase: Phase 2
Study type: Interventional

To assess the safety and efficacy of repeated intravitreal injections of DE-122 (low dose and high dose) given in combination with Lucentis® in subjects with wet age-related macular degeneration (AMD) compared with Lucentis® alone.

NCT ID: NCT03205449 Recruiting - Child Maltreatment Clinical Trials

Parenting for Lifelong Health (PLH) - Masayang Pamilya (MaPa) Evaluation Study

PLH-MaPa
Start date: June 16, 2017
Phase: N/A
Study type: Interventional

Parenting for Lifelong Health (PLH) Philippines Evaluation Study: Multisite randomised controlled trial to compare the efficacy of a culturally-adapted parenting programme, Masayang Pamilya, versus services as usual in the reduction of child maltreatment and improvement of child wellbeing in low-income Filipino families with children aged two to six years in Metro Manila (N = 120). A previous study focused on adaptation and feasibility testing was conducted from January 2016 to February 2017. Community-based participatory approaches were used to culturally adapt the Sinovuyo programme to a Filipino context. A formative evaluation using qualitative in-depth interviews and focus group discussions with parents, as well as consultative workshops with service providers and other stakeholders, examined issues regarding the needs and concerns of Filipino parents, appropriateness of intervention components and delivery, and other specific cultural issues in order to balance "fidelity" to evidence-based practices with "fit" to the local context [11]. The Sinovuyo programme was then adapted into the MaPa programme with local materials and approaches developed to fit the Philippine cultural context based on findings from the formative evaluation.

NCT ID: NCT03204175 Enrolling by invitation - Hand Hygiene Clinical Trials

Fit Plus: Assessing the Impact of a School-based Intervention on Toilet Quality

Start date: July 10, 2017
Phase: N/A
Study type: Interventional

This study will assess the impact of a school-based water, sanitation, and hygiene management intervention on toilet use and pupil handwashing in the Philippines.

NCT ID: NCT03199053 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 2

Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus Aged 10 to Below 18 Years Old

Start date: October 31, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to evaluate the efficacy and safety of the drugs dapagliflozin and saxagliptin in patients with Type 2 Diabetes who are aged 10 to below 18 years old and are currently taking metformin, insulin, or both drugs. Dapagliflozin and saxagliptin are both approved for use in patients with Type 2 Diabetes aged 18 years or older. This study will assess how well dapagliflozin and saxagliptin work by finding out how these treatments affect blood glucose (sugar) levels compared to placebo (a pill that contains no active drug), in children and adolescents. Dapagliflozin and saxagliptin are considered investigational products in this study since while they have been approved for use in adults (patients 18 years or older), they haven't been approved for children and adolescents due to lack of clinical studies in this specific population. Patients with Type 2 Diabetes have higher levels of blood glucose (sugar) than patients who do not have this disease. The high level of sugar in the blood can lead to serious short-term and long-term medical problems. The main goal of treating diabetic patients is to lower blood glucose to a normal level. Lowering and controlling blood glucose help prevent or delay complications of diabetes, such as heart disease, kidney, eye and nerve diseases, and the possibility of amputation. Dapagliflozin is a drug that helps to reduce blood glucose (sugar) levels by helping the kidneys to remove excess glucose from the blood and excrete it in the urine. It prevents the kidneys from returning glucose from the urine back into the bloodstream. Saxagliptin increases insulin production when blood glucose levels are high. Insulin is a hormone made by the pancreas that allows the body to use sugar (glucose) from the food that is eaten for energy or to store glucose for future use. Saxagliptin helps to improve blood sugar levels in response to a meal and between meals if blood glucose levels are not lowered effectively. Saxagliptin does not work when the blood glucose is low. Saxagliptin also helps to decrease the amount of sugar made by the body. Together, these processes reduce blood glucose levels and help to control Type 2 Diabetes. Dapagliflozin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 40 countries worldwide including the USA and Europe. Dapagliflozin has not yet been studied in children (pediatric patients). Saxagliptin (alone or in combination with other antidiabetic drugs) has been shown to be effective in lowering blood glucose in adults with Type 2 Diabetes and is available for use in adults (patients 18 years or older) in approximately 90 countries worldwide. Saxagliptin also has not yet been studied in children (pediatric patients). The subject will either receive one of the active study drugs or a placebo (a pill that looks identical but contains inactive drug). This study will be double blind; this means that neither the subject, nor the study doctor will know which treatment the subject will receive. Which treatment the subject receives is decided by a computer, purely by chance; this is called a "random assignment". For this study, there will first be a screening phase of up to 6 weeks, followed by a 2 week lead in phase. Thereafter there will be a 26 week short-term treatment phase (week 1-week 26), and a 26 week long-term treatment phase (week 27-week 52). Following this there will be a follow-up telephone call on week 56 and a post study visit at week 104. At day 1 visit after the lead in phase the subject will be randomly assigned to receive one of 3 treatments: dapagliflozin 5 mg, saxagliptin 2.5 mg or placebo in a blinded manner. This treatment will continue up to week 14. Then after week 14, and until the end of the study, the subject will be assigned to receive one of the following 5 treatments: dapagliflozin 5 mg, dapagliflozin 10 mg, saxagliptin 2.5 mg, saxagliptin 5 mg or placebo in a blinded manner. The drugs assigned after week 14 will be the same drugs as at Day 1, but some of the groups will receive them at a higher dose. After completion of the 26-week short-term phase, the subject will enter a 26 week long-term phase. The same treatment that the subject had been assigned to at week 14 visit will be continued. This long-term phase is primarily designed to provide additional information on how well dapagliflozin and saxagliptin are tolerated. Following the treatment phases, there will be a follow-up telephone call at week 56. The subject will be asked to visit the clinic at week 104 again for a final evaluation of the physical development (based on the stage of puberty).