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NCT ID: NCT03065920 Completed - Severe Asthma Clinical Trials

African Severe Asthma Program: A Research Network for Characterisation of Severe Asthma in Africans (ASAP)

ASAP
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

This study is a prospective observational multicentre cohort study of asthma patients in Eastern Africa whose objectives will be; The primary objective of this project is to identify and characterize severe asthma in Eastern Africa in order to understand its demographic, clinical, physiologic, pathologic, genomic and immunologic determinants. Secondary objective(s) are; Compare the annual healthcare utilisation (HCU) (emergency room visits, hospitalization including admission to critical care units and unscheduled outpatient clinic or office visits), exacerbation, quality of life and mortality rates of severe and not- severe asthma patients Determine the factors associated with the asthma HCU events, quality of life, exacerbations and mortality The study will enroll 1676 patients aged between 12 and 70 years and follow up each patient for up to one year.

NCT ID: NCT03065764 Active, not recruiting - Clinical trials for Non Small Cell Lung Cancer

89Zr-labeled Pembrolizumab in Patients With Non-small-cell Lung Cancer

Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

After a screening phase of up to 42 days, eligible subjects will undergo two whole body immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with and one without a preceding "cold" therapeutic dose of pembrolizumab. For the first 3 patients, PET scans will be obtained at 1, 72 and 120 hours post tracer injection to determine the optimal scan time point and to perform biodistribution measurements and dosimetry. All subsequent patients receive only 1 PET scan post-injection (i.e. two PET scans). The optimal time point is expected to be at day 5 post-injection. Pembrolizumab treatment will continue every three weeks until two years of therapy have been administered, disease progression, or unacceptable adverse event(s).

NCT ID: NCT03065088 Completed - Young Older Adults Clinical Trials

The PreventIT Trial in Young Older Adults, Comparing Two Lifestyle-integrated Exercise Interventions

PreventIT
Start date: February 28, 2017
Phase: N/A
Study type: Interventional

The feasibility randomised controlled trial is part of the EU funded project "PreventIT" (2016-2018) responding to the Horizon 2020, Personalised health and care (PHC), call PHC-21: Advancing active and healthy ageing with ICT: Early risk detection and intervention. The PreventIT project focuses on a new behaviour change activity approach for young older adults (61-70 years of age) with an overall aim of early prevention of functional decline and to empower people to take care of their own health.

NCT ID: NCT03064854 Terminated - Clinical trials for Non-small Cell Lung Cancer

PDR001 in Combination With Platinum-doublet Chemotherapy and Other Immunology Agents in PD-L1 Unselected, Metastatic NSCLC Patients

Start date: May 24, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to establish the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of PDR001 when administered in combination with platinum-doublet chemotherapy and other immunooncology agent(s) in treatment naive patients with PD-L1 unselected, advanced NSCLC, and to estimate the preliminary anti-tumor activity in this patient population.

NCT ID: NCT03063541 Recruiting - Clinical trials for Unruptured Intracranial Aneurysms

Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms

PROTECT-U
Start date: September 21, 2017
Phase: Phase 3
Study type: Interventional

Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below 120 mmHg), and a blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to standard blood pressure management, no blood pressure measuring device)

NCT ID: NCT03063086 Completed - Asthma Clinical Trials

Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma.

Start date: January 21, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess peak FEV1 of two doses of QVM149 compared to a fixed-dose combination of salmeterol/fluticasone (50/500μg b.i.d.) and to characterize the respective 24 hour bronchodilator effect profiles in patients with asthma. Data from this study will complement lung function data obtained in the pivotal QVM149 phase 3 program by assessing the bronchodilatory effect of QVM149 at multiple time-points over an entire dosing interval of 24 hours.

NCT ID: NCT03062761 Completed - Growth Clinical Trials

A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

TENUTO
Start date: April 27, 2017
Phase: Phase 2
Study type: Interventional

It is universally accepted that the best nutrition for a new-born infant is breast milk. Breast milk provides a complete set of nutrients to support growth and development of children in early life, including components that have a beneficial effect on gut health and the body's ability to defend itself against infectious organisms and other invaders (immune system).However, it may occur that a mother is unable to breastfeed her child, or chooses not to breastfeed. In such cases, an infant formula inspired by breast milk is the best alternative. Research is done to optimize milk formula for infants. One of these formulas contains 'partially hydrolyzed' proteins instead of intact proteins, meaning the proteins in this formula are broken down into smaller pieces. These smaller pieces of protein make the milk more suitable for consumption by infants at risk of developing cow's milk allergy. These types of partially hydrolyzed protein formulas have been on the market for several years, in particular for children with a family risk of allergy. So far, no safety related issues have been reported. It is also known that weight gain of infants receiving partially hydrolyzed proteins in general is appropriate according to the World Health Organisation growth standards. The main purpose of the TENUTO study is to demonstrate that infants who receive a specific partially hydrolyzed protein infant formula for the first 4 months of life have a similar weight gain compared to infants receiving standard infant formula with intact proteins. A group of infants who receive breast milk only is also included for comparison.

NCT ID: NCT03062046 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Evaluation of Ablation Index and VISITAG™ (ABI-173)

VISTAX
Start date: January 27, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the safety, acute and long term effectiveness, during standard RF ablation procedures while using Ablation Index and VISITAG™ software in combination with a Thermocool SmartTouch® (ST) or SmartTouch Surroundflow® (STSF) catheter. Furthermore, the role of Ablation Index and VISITAG™ workflow in creating contiguous ablation lines is assessed. The study is a prospective, non-randomized, post-market clinical evaluation. Up to 330 patients will be included in this study. All patients who qualify based on the study specific requirements will be invited to participate. The total duration of the study is estimated to be about 24 months (12 months enrollment period and 12 months of follow up). The clinical investigation population include subjects undergoing RF ablation for treatment of drug resistant symptomatic paroxysmal AF. Prior to enrollment in the clinical investigation, all subjects must meet the inclusion/exclusion criteria and are suitable candidates for enrollment in a clinical investigation in the opinion of the investigator. Subjects must have failed at least one antiarrhythmic drug (AAD) (Type I or III, including β-blocker) as evidenced by recurrent or are intolerant of the AAD.

NCT ID: NCT03061812 Completed - Clinical trials for Small Cell Lung Cancer

Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

TAHOE
Start date: April 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

NCT ID: NCT03061331 Completed - Cystic Fibrosis Clinical Trials

Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation

Start date: January 31, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of LUM/IVA in subjects with CF 12 years of age and older who have at least one A455E mutation.