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NCT ID: NCT02899338 Completed - Healthy Clinical Trials

Pharmacokinetics and Safety of BI 695501

Start date: September 21, 2016
Phase: Phase 1
Study type: Interventional

To characterize and compare the pharmacokinetics and to assess the safety of BI 695501 after single injection using either auto injector or prefilled syringe.

NCT ID: NCT02899299 Completed - Mesothelioma Clinical Trials

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients

CheckMate743
Start date: November 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

NCT ID: NCT02898610 Completed - Stroke Clinical Trials

Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

CONVINCE
Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone. To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis

NCT ID: NCT02896998 Completed - Syndesmotic Injury Clinical Trials

Routine Versus on Demand Removal of the Syndesmotic Screw

RODEO
Start date: January 2017
Phase: N/A
Study type: Interventional

The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.

NCT ID: NCT02896309 Completed - Clinical trials for Chronic Kidney Disease

The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity

BIC
Start date: September 2016
Phase: N/A
Study type: Interventional

This study evaluates the effect of oral sodium bicarbonate treatment on the intrarenal renin-angiotensin-system in adult patients with a metabolic acidosis and chronic kidney disease. This treatment is compared to sodium chloride treatment, which serves as control for increased sodium-intake and no treatment, which serves as time-control.

NCT ID: NCT02896244 Completed - Clinical trials for Clostridium Difficile

AssessmeNT of the Incidence of Clostridium Difficile Infections in Hospitalized Patients on Antibiotic TrEatment

ANTICIPATE
Start date: September 27, 2016
Phase:
Study type: Observational

During or after antibiotic treatment, antibiotic residues impair the intestinal microbiota (gut flora) and lead to adverse effects such as the emergence of bacterial resistance or the occurrence antibiotic-associated diarrhoea (AAD) including antibiotic-induced C. difficile infection (CDI). The spread of resistant Gram-negative bacteria and the increasing number and severity of CDI are considered as worldwide public health threats. Da Volterra is a biotechnology company developing a novel product, DAV132 (a medical device in Europe), intended to prevent these antibiotic adverse effects. Da Volterra is planning to carry out a phase 2-3 randomized controlled trial (RCT) of DAV132 in the prevention of antibiotic-induced CDI. The RCT will involve hospitalized patients aged ≥50 years old and treated with predefined antibiotic classes known to increase the risk of CDI. The incidence of CDI in this population is unknown, yet, incidence is an important determinant for the required sample size. Therefore, the main objective of the current study is to assess CDI incidence in patients ≥50 years of age treated with predefined antibiotic classes. In addition, to optimise the target population of the DAV132 RCT, the effect of the predefined antibiotic agents on the intestinal microbiota will be assessed. Furthermore, biomarkers predictive of CDI occurrence might help identify patients at high risk for the disease, which could further optimise the RCT. No validated biomarkers have been described in the literature yet. Assessment of potential biomarkers is another aim of the present study.

NCT ID: NCT02891850 Completed - Clinical trials for Pulmonary Arterial Hypertension

Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy

REPLACE
Start date: January 11, 2017
Phase: Phase 4
Study type: Interventional

To demonstrate the effectiveness of riociguat as replacement of phosphodiesterase-5 inhibitors (PDE-5i) therapy in pulmonary arterial hypertension (PAH) patients

NCT ID: NCT02891226 Completed - Crohn's Disease Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Active Crohn's Disease

SERENITY
Start date: December 14, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.

NCT ID: NCT02890992 Completed - Clinical trials for Hypercholesterolaemia

An 8-Week Dose-Finding Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

ODYSSEY KIDS
Start date: September 15, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 8 weeks of treatment in heterozygous familial hypercholesterolemia (heFH) participants aged of 8 to 17 years, with LDL-C >=130 milligrams per deciliter (mg/dL) (3.37 millimoles per litre [mmol/L]) on optimal stable daily dose of statin therapy +/- other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins for at least 4 weeks prior to the screening period. Secondary Objective: - To evaluate the safety and tolerability of alirocumab. - To evaluate the pharmacokinetics profile of alirocumab. - To evaluate the effects of alirocumab on other lipid parameters.

NCT ID: NCT02890706 Completed - Pulmonary Embolism Clinical Trials

Iodine Mapping Using Subtraction in Pulmonary Embolism CT Versus Dual-Energy CT

InSPECT-DECT
Start date: July 7, 2016
Phase: N/A
Study type: Interventional

Comparing two techniques (Subtraction and Dual Energy CT) for functional Chest CT for patients with suspected with pulmonary embolism.