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NCT ID: NCT01878760 Completed - Children Clinical Trials

APRICOT: Anaesthesia PRactice In Children Observational Trial

APRICOT
Start date: March 2014
Phase: N/A
Study type: Observational

The aims of the APRICOT study are: - To establish the incidence of severe critical events in children undergoing anesthesia in Europe. - To describe the differences in paediatric anaesthesia practice throughout Europe. - To study the potential impact of this variability on the occurrence of severe critical events (Laryngospasm, Bronchospasm, Pulmonary aspiration, Drug error, Anaphylaxis, Cardiovascular instability, Neurological damage, Perianaesthetic cardiac arrest and postanaesthetic Stridor).

NCT ID: NCT01868061 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered as subcutaneous (SC) injection every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. Participants who were assigned to placebo during the placebo-controlled period of the trial will be re-randomized at Week 52 to receive blinded SC lebrikizumab 37.5 milligrams (mg) or 125 mg every 4 weeks from Weeks 53 to 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01867125 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01866111 Completed - Partial Epilepsy Clinical Trials

A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Trial of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: July 31, 2013
Phase: Phase 2
Study type: Interventional

This is a multicenter, double-blind, randomized, placebo-controlled dose response study, with an 8-week prospective baseline and an 18 week double-blind treatment period (including a 6-week titration phase and 12 week maintenance phase), followed by a 3-week blinded study drug taper period (for subjects leaving the study) or a 2-week blinded conversion period (for subjects who will participate in the open-label extension). The primary objective of this study is to determine the effective dose range of YKP3089 as adjunctive therapy for the treatment of partial seizures. The trial will also evaluate the safety and tolerability of YKP3089 in the partial epilepsy population.

NCT ID: NCT01864265 Completed - Clinical trials for Rheumatoid Arthritis

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

PreCePRA
Start date: July 2013
Phase: Phase 3
Study type: Interventional

By using functional MRI the investigators have recently shown that TNFi elicit rapid changes in brain function linked to the perception of RA [5]. Functional MRI represents a method allowing detecting tiny changes in neuronal activity by measuring alterations of blood flow in the context of neuronal activation. TNFi rapidly reversed the widespread activation of brain centers involved in pain such as the thalamus and the somatosensoric cortex, as well as those involved in the control, of mood and emotions such as the limbic system. Moreover, as small phase I study with 10 patients with RA showed that high brain activity detected in the functional MRI predicts clinical response to Certolizumab Pegol after 1 month, suggesting the central nervous system activity may be used as a tool to predict response to TNFi [8]. The rationale of this study is to test whether response to TNFi can be predicted by using functional MRI.

NCT ID: NCT01864148 Completed - Multiple Sclerosis Clinical Trials

Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

SYNERGY
Start date: August 2013
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of BIIB033 in participants with active relapsing MS when used concurrently with Avonex. Secondary objectives of this study in this study population are to assess the safety, tolerability, and population PK of BIIB033 when used concurrently with Avonex

NCT ID: NCT01862640 Completed - Alzheimer's Disease Clinical Trials

A Phase 3, 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of 2 Fixed Doses of Brexpiprazole in the Treatment of Alzheimer's Agitation

Start date: July 11, 2013
Phase: Phase 3
Study type: Interventional

To compare the efficacy of 2 fixed doses of brexpiprazole with placebo in participants with agitation associated with dementia of the Alzheimer's type.

NCT ID: NCT01857414 Active, not recruiting - Clinical trials for Myocardial Reperfusion Injury

Effect of RIC on Clinical Outcomes in STEMI Patients Undergoing pPCI

CONDI2
Start date: November 2013
Phase: N/A
Study type: Interventional

The aim of the the study is to investigate whether Remote Ischaemic Conditioning (RIC) can improve clinical outcomes (cardiac death and hospitalisation for heart failure) at one year in patients presenting with ST-elevation Myocardial Infarction and undergoing primary percutaneous coronary intervention. This will be done in a multinational investigator-driven, multi-centre, randomised, controlled, single-blind, parallel assignment, prospective clinical efficacy trial.

NCT ID: NCT01856309 Completed - Clinical trials for Arthritis, Rheumatoid

Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

SIRROUND-LTE
Start date: August 7, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

NCT ID: NCT01851824 Completed - Clinical trials for Malignant Melanoma, Neoplasms

A Study of the Effect of Vemurafenib on the Pharmacokinetics of Acenocoumarol in Patients With BRAFV600 Mutation-Positive Metastatic Malignancy

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

This open-label, multicenter, 3-period, fixed-sequence study will evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of acenocoumarol in participants with BRAFV600 mutation-positive metastatic malignancies. Participants will receive a single dose of acenocoumarol 4 mg orally on Day 1 and Day 23, vemurafenib 960 mg orally twice daily on Days 4-26. After completion of pharmacokinetic assessments on Day 26, eligible participants will have the option to continue treatment with vemurafenib as part of an extension study (GO28399 [NCT01739764]).