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NCT ID: NCT02721966 Completed - Clinical trials for Axial Psoratic Arthritis

Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

MAXIMISE
Start date: October 3, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

NCT ID: NCT02719522 Completed - Clinical trials for Intracranial Aneurysm

Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy

SHIELD
Start date: March 2016
Phase:
Study type: Observational

This is a prospective, single-arm, multi-center post-market observational study assessing the performance of the Pipeline™ Flex Embolization Device with Shield Technology™ in subjects undergoing treatment for intracranial aneurysms in a large real-world, post-market setting.

NCT ID: NCT02719184 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Longitudinal Follow up to Assess Biomarkers Predictive of Emphysema Progression in Patients With COPD (Chronic Obstructive Pulmonary Disease)

Start date: April 13, 2016
Phase:
Study type: Observational

The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.

NCT ID: NCT02717910 Completed - Smoking Prevention Clinical Trials

Digital Health Game as an Intervention Supporting Tobacco-related Health Literacy in Early Adolescents

Start date: March 2016
Phase: N/A
Study type: Interventional

This feasibility study evaluates acceptability and preliminary effectiveness of a digital health game as an intervention supporting tobacco-related health literacy in 10- to 13-year-old early adolescents. One third of the study participants will receive the health game, on third a web page with similar content and one third will act as a control group without intervention.

NCT ID: NCT02717312 Completed - Clinical trials for Cesarean Scar Defect

Prevalence, Risk Factors and Consequences Related to Cesarean Scar Defect (Defect in Cesarean Scar)

DICE
Start date: January 2016
Phase:
Study type: Observational [Patient Registry]

The rates of cesarean section (CS) are rising all over the world. Worldwide the number of CS is millions every year. CS is one of the most frequently performed operation for women. As a consequence many women have a scar in their uterus. Cesarean scar may be associated with complications in later pregnancies. In recent years there have also been a few reports indicating that cesarean scar could potentially be associated with menstrual disorders and infertility. The impact of cesarean scar defect on long term welfare or quality of life is not clear. In some women with a history of CS it is possible to recognise a defect in the site of previous uterotomy years after the performed CS by sonographic examination. This defect in the scar, also called as a niche, is a consequence of incomplete healing of the scar in the lower part of uterus. To date there is uncertainty relating to the factors that lead to poor healing of cesarean scar. Also impact of cesarean scar defect on later well-being and later pregnancies are not properly known. The purpose of this study is to investigate the prevalence and the risk factors of cesarean scar defect. Also the impact of cesarean scar defect on women´s menstrual health, fertility, further deliveries and quality of life will be investigated. This study is a prospective observational cohort study. Women at the age of 18-45 years who will give birth by elective or emergency CS will be asked to participate. Women are recruited within two days of CS. Women with known uterus anomaly or von Willebrand disease will be excluded. The prevalence of scar defect will be evaluated by transvaginal sonography and contrast-enhanced sonohysterography using saline infusion. Both 2-dimensional and 3-dimensional sonography will be used. Sonographic evaluation will take place 6 months after the CS. The following definition for CS scar defect will be used: myometrial discontinuity with a depth of ≥2 mm at the site of cesarean scar that communicates with the uterine or cervical cavity as seen on transvaginal sonography with or without saline infusion. The prevalence of menstrual disorders will be evaluated 12 months after the CS. The subjects will be asked to report the number of menstrual bleeding days once a month during 3 consecutive months. Postmenstrual spotting is defined as ≥2 days of brownish discharge at the end of menstruation with total bleeding days of ≥7 or non-cyclic bleeding not related to menstruation.

NCT ID: NCT02717195 Completed - Schizophrenia Clinical Trials

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

DayBreak
Start date: April 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

NCT ID: NCT02709486 Completed - Clinical trials for Osteoarthritis, Knee

Study of the Analgesic Efficacy and Safety of Subcutaneous Tanezumab in Subjects With Osteoarthritis of the Hip or Knee.

Start date: March 2, 2016
Phase: Phase 3
Study type: Interventional

Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions. The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

NCT ID: NCT02706847 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

SELECT-BEYOND
Start date: March 15, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

NCT ID: NCT02701803 Completed - Parkinson's Disease Clinical Trials

Parkinson's KinetiGraph, PKG in Patients With Deep Brain Stimulation and Continuous Levodopa Infusion Therapy

Start date: October 2015
Phase:
Study type: Observational

In this study the aim is to evaluate the outcome of deep brain stimulation (DBS) and continuous intraduodenal levodopa therapy in patients with advanced Parkinson' disease by using Parkinson's KinetiGraph™ device which is a movement and acceleration measuring device. In this study we also evaluate the usability of Parkinson's KinetiGraph™ device by comparing it with written patient diaries.

NCT ID: NCT02699879 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

Evaluation of Long-Term Safety of Pirfenidone (Esbriet) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Start date: February 16, 2012
Phase: N/A
Study type: Observational

This single arm, post-authorisation study is designed to evaluate the long-term safety of pirfenidone in participants with IPF. The enrolment of participants will be completed within approximately 24 months. Participants will receive pirfenidone according to the physician discretion and will be followed for 2 years. Treating physicians will collect pre-specified data at the baseline and every 3 months thereafter, for the duration of the participants' participation in study.