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NCT ID: NCT01989520 Completed - Clinical trials for Uncontrolled and Persistent Asthma

Study to Investigate Relative Bioavailability of up to Five Different Formulations of AZD5069

Start date: January 2014
Phase: Phase 1
Study type: Interventional

Study to investigate relative bioavailability of up to five different formulations of AZD5069

NCT ID: NCT01989468 Completed - Psoriatic Arthritis Clinical Trials

24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Start date: April 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

NCT ID: NCT01988389 Completed - Clinical trials for Mild Hypercholesterolemia

Effect of Apples on cardioVascular Risk And Gut Health

AVAG
Start date: September 2013
Phase: N/A
Study type: Interventional

There is now considerable scientific evidence that a diet rich in fruits and vegetables could improve human health. Apples are among the most frequently consumed fruits in the world. Epidemiological studies have linked frequent apple consumption with several health benefits including a reduced risk of cardiovascular disease. Apples are an important source of polyphenols and fiber and their beneficial effects could be attributed to this content; however, their impact on our health is not clear. Although, there are some studies that have reported cholesterol lowering effects the results are inconsistent. Furthermore, few studies have explored the impact on vascular function and gut microbiota. The objective of the current study is to assess whether a regular apple consumption, reduces total cholesterol levels, improves vascular function and gut microbiota profile in mildly hypercholesterolemic subjects compared with a control, sugar matched commercial clear apple juice squash.

NCT ID: NCT01987921 Completed - Acute Kidney Injury Clinical Trials

Observational Study of Pediatric Acute Kidney Injury, Risk Factors and Outcomes

AWARE
Start date: January 2014
Phase: N/A
Study type: Observational [Patient Registry]

Pediatric acute kidney injury (AKI) is associated with increased morbidity and mortality in critically ill patients. Currently, understanding of the epidemiology and diagnosis of AKI in children is limited by single center retrospective data and inconsistent diagnostic and stratification criteria. The hypotheses of the AWARE study is that 1) renal angina, a composite of early injury signs and risk of disease, will predict severe subsequent AKI in critically ill children and 2) the incorporation of urinary biomarkers into the renal angina scoring system will improve the prediction of the severe injury. The AWARE study is conducted to describe AKI epidemiology in a heterogeneous multinational cohort of critically ill children, characterize AKI risk factors and associated morbidity, and validate the KDIGO AKI criteria as a predictor of pediatric AKI outcomes. The multi-center, multi-national registry will create the largest ever repository of information available on AKI in children.

NCT ID: NCT01987492 Completed - Asthma Clinical Trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

NCT ID: NCT01987284 Completed - Clinical trials for Isolated Systolic Hypertension

SER100 in Isolated Systolic Hypertension

Start date: October 2013
Phase: Phase 2
Study type: Interventional

Isolated Systolic Hypertension (ISH)is the dominating hypertensive disease in elderly people. Much attention has recently been drawn to the strong relationship between the systolic blood pressure and cardiovascular morbidity. In previous clinical studies carried out in individuals with normal blood pressure at baseline SER100 decreased primarily the systolic blood pressure. It is hypothesized that the effect on systolic blood pressure in hypertensive patients will be larger or equal to the fall seen in normotensive patients.

NCT ID: NCT01986608 Completed - Healthy Volunteers Clinical Trials

Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese subjects.

NCT ID: NCT01986426 Completed - Breast Cancer Clinical Trials

LTX-315 in Patients With Transdermally Accessible Tumours as Monotherapy or Combination With Ipilimumab or Pembrolizumab

Start date: November 2013
Phase: Phase 1
Study type: Interventional

The study will assess the safety, tolerability, PK and efficacy of different intra-tumoral dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses, as monotherapy or in combination with ipilimumab or pembrolizumab.

NCT ID: NCT01985334 Completed - COPD Clinical Trials

Study to Evaluate the Efficacy and Safety of Glycopyrronium or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination Regarding Symptoms and Health Status in Patients With Moderate COPD Switching From Treatment With Any Standard COPD Regimen

Start date: February 14, 2014
Phase: Phase 4
Study type: Interventional

The main goal of this study is to evaluate the efficacy and safety of glycopyrronium bromide and indacaterol maleate and glycopyrronium bromide fixed dose combination (FDC) in patients with moderate COPD who switch from their current COPD therapy. This study aims to provide data on how non-exacerbating, but still symptomatic patients with moderate COPD switching from their current COPD treatment to glycopyrronium bromide or indacaterol maleate and glycopyrronium bromide FDC maintain or improve their symptoms. Another purpose of this study is to increase awareness and usage of validated COPD symptoms tools and dyspnea questionnaires in order to facilitate clinical assessment and improve early diagnosis of symptomatic patients.

NCT ID: NCT01985230 Completed - Clinical trials for Chronic Low Back Pain

ReActiv8 for Chronic Low Back Pain (PMCF)

ReActiv8-A
Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this Clinical Study is to investigate the effect of electrical stimulation for chronic low back pain.