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NCT ID: NCT02535091 Completed - Partial Epilepsy Clinical Trials

Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

Start date: August 3, 2016
Phase: Phase 3
Study type: Interventional

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

NCT ID: NCT02534831 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Manual Therapy in Chronic Obstructive Pulmonary Disease

Start date: March 2012
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) is a common preventable and treatable disease characterized by progressive airflow limitation that is associated with an inflammatory response to noxious particles or gases. Manual therapy (MT) has been defined as a therapeutic intervention that uses the hands to provide treatment to the musculoskeletal and/or visceral systems. It includes techniques such as massage, myofascial release, muscle energy technique, ligament balance, joint mobilization and joint manipulation. The suggestion that MT could deliver long-term benefits to people with COPD was first put forward in 2009. Since then a number of small studies have reported medium term improvements in lung function and exercise capacity following repeated applications of MT intervention. Our aim is to measure the immediate effect on lung function of a single application of soft tissue manual therapy in patients with severe and very-severe chronic obstructive pulmonary disease.

NCT ID: NCT02528318 Terminated - Clinical trials for Respiratory Distress Syndrome

Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

Start date: August 2015
Phase: Phase 2
Study type: Interventional

This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.

NCT ID: NCT02528214 Completed - Asthma Clinical Trials

Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma

VENTURE
Start date: October 15, 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma. Secondary Objectives: - To evaluate the safety and tolerability of dupilumab. - To evaluate the effect of dupilumab in improving participants-reported outcomes. - To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

NCT ID: NCT02525939 Completed - Clinical trials for Acute Coronary Syndrome

Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS

dal-GenE
Start date: April 2016
Phase: Phase 3
Study type: Interventional

A placebo-controlled, randomized, double-blind, parallel group, phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. Subject enrollment may begin in the hospital and will continue following release from the hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (4-12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

NCT ID: NCT02518906 Completed - Clinical trials for Borderline Personality Disorder

Evaluation of AIT Study

Start date: September 2015
Phase: N/A
Study type: Interventional

Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed. In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed. Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care: - Adolescent Identity Treatment (AIT) - Dialectic Behavioral Treatment for Adolescents (DBT-A) Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning. Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.

NCT ID: NCT02508194 Terminated - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Efficacy of MEDI7510 in Older Adults

Start date: September 29, 2015
Phase: Phase 2
Study type: Interventional

This study will be the first assessment of the efficacy of MEDI7510 for the prevention of respiratory syncytial virus (RSV) disease. It will also provide estimates of vaccine efficacy and of endpoint incidence in the placebo arm. It will also assess the safety and immunogenicity of concurrent dosing of MEDI7510 and IIV to expand on the observations made in the Phase 1b study of MEDI7510. It will also expand the safety database of participants dosed with MEDI7510. The study will also assess the immune response to MEDI7510 in Season 1 and Season 2.

NCT ID: NCT02504268 Completed - Clinical trials for Rheumatoid Arthritis

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

AVERT-2
Start date: September 3, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

NCT ID: NCT02492841 Completed - Caries Clinical Trials

Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Start date: April 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Background: Dental caries is considered an oral health problem worldwide. In Chile the last national epidemiological study (2007) showed a national prevalence of dental caries in children 6 years (70.3%) and 12 (62.5%). Direct pulp capping is a preventive dental therapy, keeps the vitality of the tooth using some inductive materials mineralized tissue formation. Objective: The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials; Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars.

NCT ID: NCT02489227 Completed - Plaque Psoriasis Clinical Trials

Comparison of CHS-1420 Versus Humira in Subjects With Chronic Plaque Psoriasis

PsOsim
Start date: August 2015
Phase: Phase 3
Study type: Interventional

This is a 3-period study comparing CHS-1420 to Humira in patients with chronic plaque psoriasis.