Clinical Trials Logo

Filter by:
NCT ID: NCT02875028 Completed - Healthy Volunteers Clinical Trials

Vorapaxar in the Human Endotoxemia Model

Start date: June 2016
Phase: Phase 4
Study type: Interventional

Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.

NCT ID: NCT02870972 Completed - Clinical trials for Hereditary Angioedema (HAE)

Efficacy and Safety of BCX7353 to Prevent Angioedema Attacks in Subjects With Hereditary Angioedema

APeX-1
Start date: August 2016
Phase: Phase 2
Study type: Interventional

This 3-part study will evaluate the safety and efficacy of an oral treatment, BCX7353, in preventing angioedema attacks in subjects with hereditary angioedema (HAE). In Part 1 of the study, eligible subjects will be randomized to receive oral BCX7353 or placebo for 4 weeks. Assuming successful completion of Part 1, additional subjects will be randomized in Part 2 to one of 2 lower doses of BCX7353 or placebo. Part 3 will enroll additional subjects into one of three doses of BCX7353 or placebo. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical and pharmacologic outcomes, and the safety and tolerability of each dose of BCX7353 compared to placebo.

NCT ID: NCT02869399 Completed - Clinical trials for Cancer of Head and Neck

Tertiary Prevention of Head and Neck Cancer With a Dietary Intervention

DietINT
Start date: November 2015
Phase: N/A
Study type: Interventional

This is an open-label randomized phase II multicenter trial. An estimated 350 patients deemed to be in complete remission at month 3 after curative treatment are considered for this trial. Two arms of intervention are foreseen: the experimental arm (arm A) based on dietary intervention in addition to standard recommendations and a control arm (arm B) including only standard recommendations. The intervention strategy is based on the AICR/WCRF recommendations for cancer and recurrences prevention and it is focused on decreasing inflammation, glycaemia and insulinaemia while promoting nutrient-rich diet. The reduction in the incidence of tumor recurrence will be analyzed comparing EFS curves between the two arms with the non-parametric Kaplan-Meier method. Secondary analyses will describe the time trend in the prevalence of side effects and quality of life, as assessed by the EORTC QLQ-H&N35 questionnaire. Translational analysis (cytokine, salivary and plasmatic miRNA) will be performed. The trial is coordinated by Istituto Nazionale Tumori, Milan and conducted in 6 European countries.

NCT ID: NCT02869087 Completed - Clinical trials for Peripheral Vascular Disease

The DESappear Study: Drug Eluting Scaffold

DESappear
Start date: October 10, 2016
Phase: N/A
Study type: Interventional

The aim of this study is to prospectively collect information to evaluate the safety and performance of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral scaffold system for the treatment of symptomatic primary atherosclerotic stenoses and occlusions of the superficial femoral artery (SFA).

NCT ID: NCT02869022 Completed - Heart Failure Clinical Trials

Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Start date: July 2016
Phase: Phase 3
Study type: Interventional

The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.

NCT ID: NCT02866175 Completed - Atrial Fibrillation Clinical Trials

Edoxaban Treatment Versus Vitamin K Antagonist in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention

ENTRUST-AF-PCI
Start date: February 24, 2017
Phase: Phase 3
Study type: Interventional

There are insufficient data on the safety and efficacy of edoxaban plus antiplatelet therapy in subjects with atrial fibrillation (AF) following percutaneous intervention (PCI) with stenting. This study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a vitamin K antagonist (VKA)-based antithrombotic regimen in subjects with AF following PCI with stent placement. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.

NCT ID: NCT02863731 Completed - Sedentary Lifestyle Clinical Trials

Effect of Alternating Postures on Cognitive Performance

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

Prolonged sitting is a risk factor for cardiovascular and musculoskeletal diseases, diabetes, several types of cancer and all-cause mortality. In combination with static and awkward postures, the prevalence of musculoskeletal diseases can increase further. Although the implementation of sit-to-stand or active workstations can help to reduce sitting time, improve physical activity at work and promote health benefits, it might also lead to changes in cognitive functions such as productivity. The purpose of this study is to evaluate the short-term effect of alternating working postures on cognitive performance for healthy people.

NCT ID: NCT02861586 Completed - Clinical trials for Chikungunya Virus Infection

Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine

MV-CHIK-202
Start date: August 17, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the immunogenicity and safety of a novel vaccine against Chikungunya virus after one or two vaccinations by comparison of two different dose levels.

NCT ID: NCT02858583 Completed - Bradycardia Clinical Trials

SI + CC Versus 3:1 C:V Ratio During Neonatal CPR

SURV1VE
Start date: October 19, 2017
Phase: N/A
Study type: Interventional

Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation? Overall objective: CC superimposed by sustained inflation will improve short- and long-term outcomes in preterm (>28 weeks or older) and term newborns. Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.

NCT ID: NCT02854631 Completed - Clinical trials for Alcoholic Hepatitis (AH)

Selonsertib in Combination With Prednisolone Versus Prednisolone Alone in Participants With Severe Alcoholic Hepatitis (AH)

Start date: September 1, 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and tolerability of selonsertib (GS-4997) in combination with prednisolone versus prednisolone alone in participants with severe alcoholic hepatitis (AH).