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NCT ID: NCT02407223 Terminated - Clinical trials for Nonradiographic Axial Spondylitis, Ankylosing

An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

Start date: July 13, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ustekinumab in adult participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).

NCT ID: NCT02404350 Completed - Psoriatic Arthritis Clinical Trials

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

FUTURE5
Start date: August 31, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

NCT ID: NCT02403323 Terminated - Crohn Disease Clinical Trials

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

JUNIPER
Start date: June 8, 2015
Phase: Phase 3
Study type: Interventional

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

NCT ID: NCT02401035 Terminated - Clinical trials for Gastroesophageal Reflux Disease

PREA, PK And Safety PASS Study Of IV Pantoprazole In Pediatric Subjects

Start date: May 9, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.

NCT ID: NCT02399358 Not yet recruiting - Hyponatremia Clinical Trials

Factors Associated With Hyponatremia Induced by High-dose Cyclophosphamide

Start date: December 2015
Phase: N/A
Study type: Observational

Prospoctive cohort of high-dose cyclophosphamide exposed patients. With active estandardize screening of hyponatremia development in the follow up period.

NCT ID: NCT02399072 Terminated - Geographic Atrophy Clinical Trials

A Study of Disease Progression in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Start date: March 30, 2015
Phase:
Study type: Observational

This study seeks to better characterize relationships between visual function and the progression (worsening) of geographic atrophy (GA) due to age-related macular degeneration (AMD). The study also will generate new information on the relationship between genetics and GA progression. This is a global, prospective, multicenter, epidemiologic study enrolling 200 participants with GA secondary to AMD. The study visits are scheduled to occur every 6 months. The anticipated duration of the study is up to 60 months.

NCT ID: NCT02398630 Recruiting - Women Infertility Clinical Trials

"Magnetic Resonance Imaging Hysterosalpingography for the Integral Evaluation of the Infertile Patient."

HSG-RM
Start date: September 2014
Phase: N/A
Study type: Interventional

Abstract: Recent advances in reproductive medicine have generated a demand for more accurate imaging methods for identifying the specific cause of female infertility and other gynecologic disorders. Virtual hysterosalpingography is an emerging modality in which aspects of the established technique of hysterosalpingography are combined with the cutting-edge technology of multidetector computed tomography (CT) to allow a comprehensive and highly accurate evaluation of both the female reproductive system and the pelvic anatomy generally. Unlike ultrasonography (US) and magnetic resonance (MR) imaging, multidetector CT is capable of depicting both the external and internal surfaces of the uterus, fallopian tubes, and other pelvic organs, providing high-resolution data that are suitable for two- and three-dimensional reconstructions and virtual endoscopic views. Thus, virtual hysterosalpingography may prove to be superior to other noninvasive modalities for evaluating tubal patency. Moreover, in comparison with conventional hysterosalpingography, which may involve cervical clamping, virtual hysterosalpingography is painless. Because of the health risks associated with ionizing radiation, the use of another modality (eg, MR imaging, US) may be preferred if the presence of a focal uterine lesion is strongly suspected. However, virtual hysterosalpingography with multidetector CT may provide a diagnostic advantage in complex cases.

NCT ID: NCT02397915 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays

Start date: March 26, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide information on whether subjects with allergic rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone furoate (MF) nasal spray based on how the products feel to the subjects when administered. This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose, cross-over subject preference study to evaluate and compare patient preference for FF [(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate whether this difference is reflected in the patient-assessed attributes of the two nasal sprays. The attributes or properties which are being assessed by the subjects for these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to sneeze, and irritation. The single-day study per subject comprises screening and all treatments and procedures. Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all subjects receive both products. One group of subjects will have two sprays of FF administered in each nostril whilst a second group will have two sprays of MF administered into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will switch. The first group will then have two sprays of MF administered into each nostril and the second group will then have two sprays of FF administered into each nostril. After each treatment the subject will complete two sets of attributes questionnaires ('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed immediately following each treatment and a subject-rated 'delayed' attributes questionnaire will be completed approximately 2 minutes after each treatment. Upon completion of the second set of these two attributes questionnaires (immediate and delayed), a preference questionnaire will be completed by the subject. In the preference questionnaire, the subject states their preferred treatment, if any, for each of the product attributes, and finally states their overall preferred treatment, if any. There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after administration of the last treatment. The study is planned to enroll about 300 subjects.

NCT ID: NCT02395172 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)

Start date: March 24, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study was to demonstrate superiority with regard to overall survival of avelumab versus docetaxel in participants with programmed death ligand 1 (PD-L1) positive, non-small cell lung cancer (NSCLC) after failure of a platinum-based doublet.

NCT ID: NCT02394028 Completed - Crohn Disease Clinical Trials

A Study to Assess Whether Etrolizumab is a Safe and Efficacious Treatment for Participants With Moderately to Severely Active Crohn's Disease

BERGAMOT
Start date: March 20, 2015
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and maintenance treatment of moderately to severely active Crohn's Disease (CD). The target population includes participants with CD who are refractory or intolerant to corticosteroids (CS) and/or immunosuppressant (IS) therapy and who have either not received prior anti-tumor necrosis factor (anti-TNF) therapy (TNF-naive) or who have had prior exposure to anti-TNF therapies and demonstrated inadequate responses or intolerance to anti-TNFs. The study period will consist of a Screening Phase (up to 35 days) plus (+) a 14-week Induction Phase + a 52-week Maintenance Phase + a 12-week Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving a decrease from baseline of at least 70 points in the Crohn's Disease Activity Index (CDAI) score (CDAI-70 response) without the use of rescue therapy will continue to the Maintenance Phase.